NBSIR 76-997

Proceedings of Procurement

Practices Symposium - Health

Care

October 1 4 - 1 6, 1 975

Sponsored by:

Veterans Administration

Washington, D. C. 20420

Experimental Technology Incentives Program

National Bureau of Standards

Washington, D. C. 20234

Final Report

February, 1976

Prepared by

Experimental Technology Incentives Program
EXPERIMENTAL TECHNOLOGY INCENTIVES PROGRAM (ETIP)

The Experimental Technology Incentives Program was initiated in

fiscal year 1973 as part of the President's program to learn how

the Government could stimulate technological innovation. The

objective of the program is to learn how the Federal Government

can provide policies and incentives which will encourage greater

technological innovation by the private sector. Broader application of innovative technology could lead to the amelioration of

several national problems such as a low rate of increase in productivity, negative trade balances, environmental pollution, and

public health and safety.

The interrelation of the Government and private sector is complex

and not enough is known to predict the effect on technological

innovation of a change in government policy. Consequently, various

hypotheses regarding possible federal policy are being tested with

analyses and experiments.

Four policy-related program areas have been identified for investigation and experimentation. The program areas refer to procurement

practices, regulatory practices, civilian R&D funding practices

and federal financial assistance policies. In each of these, new

or modified federal policy is being tested in cooperation with

responsible federal agencies.

In addition to these initial policy questions, the program will

conduct analyses and exploratory studies to provide an improved

basis for choice of policy questions for future investigation as

well as to permit more effective direction and evaluation of the

already selected policy questions.

The accompanying report was prepared under contract as part of the

ETIP program of the National Bureau of Standards. Statements

contained in this document represent the views of the originating

organization and do not necessarily reflect those of the National

Bureau of Standards.

Director

Experimental Technology Incentives Progran^

National Bureau of Standards

U. S. Department of Commerce
NBSIR-76-997

PROCEEDINGS OF PROCUREMENT

PRACTICES SYMPOSIUM - HEALTH

CARE

OCTOBER 14-16, 1975

Sponsored by:

Veterans Administration

Washington, D. C. 20420

Experimental Technology Incentives Program

National Bureau of Standards

Washington, D. C. 20234

Final Report

Prepared by

Experimental Technology Incentives Program

U.S. DEPARTMENT OF COMMERCE, Elliot L. Richardson. Secretary

James A. Baker, III, Under Secretary

Dr. Betsy Ancker-Johnson, Assistartt Secretary for Science and Technology

NATIONAL BUREAU OF STANDARDS, Ernest Ambler, Acting Director

February, 1976

CONTENTS

Page

PLENARY SESSION

The Honorable Richard L. Roudebush

Administrator of Veterans Affairs

Veterans Administration 3

Dr. Ernest Ambler, Acting Director

National Bureau of Standards 6

The Honorable J. Glenn Beall, Jr.

Senator, Maryland 9

Mr. Joseph G. Berke, Experimental Technology

Incentives Program, National Bureau of Standards... 15

Mr. Clyde C. Cook, Director, Supply Service,

Veterans Administration 19

WORKSHOP TOPICS 2 3

WORKSHOP REPORTS 2 7

Interaction Between the Hospital User and the

Industry Supplier 29

Research and Development for Innovative Products... 39

Product Testing and Evaluation 49

Specifications 57

Post Delivery Performance, Warranties and Training

by Vendors 6 3

Cost Saving and Quality Improvement Through

Innovative Products 69

CLOSING REMARKS 75

PARTICIPANTS/ATTENDEES BY WORKSHOP 79

i
SYMPOSIUM OBJECTIVES

• To investigate ways for improving interaction between

health care personnel and the manufacturers of hospital

products and systems , so that the demands of all

hospitals for improved and innovative products and

systems can be more adequately met.

• To explore various means available for encouraging innovation and more efficient technological change: from

initial research, through product development, user

testing and evaluation, marketing and purchasing, to

post-delivery assistance for the using services.

• To develop approaches that will permit hospitals to

acquire the latest technologies more expeditiously and

economically through the procurement process.

ii


PROCUREMENT PRACTICES SYMPOSIUM

HEALTH CARE

Sponsored by

Experimental Technology Incentives Program (ETIP)

National Bureau of Standards, U.S. Department of Commerce

Veterans Administration (VA)

The Honorable Richard L. Roudebush

Administrator of Veterans Affairs

Veterans Administration

There is something about being called on to administer a

large government program or a large government agency that

soon leads you to the conclusion that you need all the

help you can get.

I reached that conclusion about a year ago. The President

had made it final and official that I was to be responsible

for an agency that has some 2 00,0 00 employees, that spends

billions of dollars and that has as its potential clientele

nearly half the population.

He administered the oath of office and said, "I expect you

to do a good job."

There is an urgent sound to a remark of that kind that

encourages you to look around for all possible friends and

all possible resources. I have been on this lookout ever

since

.

I am glad to be with you this afternoon at this symposium

and I am glad to know that the Experimental Technology

Incentives Program is developing and progressing as a link

between government and industry that will enable both to do

a better job.

I think it has great potential as a source of help for the

Veterans Administration and it is a pleasure, personally

and officially, to attend an event in which that potential

may be discussed and explored.

For the entire 200 years of our Nation's existence there

have been programs of help for the men who fought our wars

and provided our defense. This country has done more for

its veterans than any other in history.

3
But, for at least half of our history, benefits were of the

most rudimentary kind... token payments in cash or land,

meager medical care and the promise of a place to live in

old age.

It was not until this century when large numbers of citizens

were called on to fight overseas wars that a system of cars

and benefits worthy of the name was developed.

And it was not until World War II that activities on behalf

of veterans became realistic in terms of what could be done

rather than partial programs or symbolic actions that

eased the Nation's conscience.

It was then that the decision was made to provide training, housing and job assistance that allowed new veterans

to become established as productive civilians without the

hassles earlier veterans had experienced.

And it was then that the decision was made to provide medical facilities for veterans that were as complete, as

advanced and as sophisticated as any in the country. It

was decided to m.ake them training and research centers of

high quality and to involve them and affiliate them with

the best schools and institutions existing.

Today there are 171 VA hospitals and 213 VA outpatient

clinics and VA has annual medical expenditures of more than

.^4 billion.

I think it is obvious that any agency that is entrusted

with that much of the taxpayers ' money for one of its functions has large responsibilities in the handling of that

money

.

I am talking about the responsiblity to avoid the waste

that is always a great danger in a large operation, but I am

talking about other things beyond the mere avoidance of

waste

.

A large agency with a large budget can be creative to a

certain extent in the way it uses its funds , because its

size and diversity of operations present alternatives not

available to smaller units.

A large agency can be aggressive, if you will, in the way

it uses its funds, bargaining for the best transactions

and controlling in many ways the circumstances of its

spending

.

4
And, if an agency has these abilities, I think the cause of

good government demands that they be used... and used as

extensively and as effectively as possible.

Thus, VA is not only a part of the ETIP program but subscribes to its purposes and its methods wholeheartedly.

We think this program can cause several things to happen...

not right away and suddenly, but over a period of years and

gradually, as we learn how to apply and expand the principles that underlie this new aid to better procurement.

We will get better products and equipment into the VA

health care system. They will meet our needs more closely

than other items have. They will be safer. They will last

longer. They will be more efficient from an energy use

standpoint. They will be environmentally sound. They

will, in the long run, be more economical.

Most important, they will help us carry out our mission in

a more effective way.

The end product of this venture will be better care for

veterans, relief of suffering, a greater chance to cure

illness and injury... and do it faster... and a greater

opportunity to restore people to useful living.

There will be other ramifications. If we are successful in

setting new standards of care, in creating new procedures

and in procuring better products and equipment, health care

outside the VA system will benefit as other hospitals and

institutions make use of what we have done.

Other government agencies for which VA provides procurement

services and guidance will benefit.

And there will be the economic consequences that received

so much attention as this program was being formulated...

better use of government funds and a greater volume of

business for participating firms and industries.

This is, of course, a simplified and general view of the

ETIP program from the vantange point of VA management.

I have offered no suggestions as to how these things may be

made to come about. I have given no examples of areas in

which the ETIP concept may be expected to produce the most

significant or the most prompt results.

I hope your workshop discussions during this symposium will

lead to at least some preliminary decisions in these

matters

.

5
I hope you will make progress in articulating and refining

the roles of industry and of VA and other government agencies in this program.

I hope you will give impetus to the thought and effort

required in fitting specification development, research,

testing and evaluation, training and other activities

necessary to this effort into a workable arrangement.

I hope you will make some headway in determining exactly

how a transfer of benefits between the public and private

sectors may be brought about.

I will not tell you how to do these things. It is not my

place to. I don't know how to.

But I offer you my full support and that of VA, not just

for today or for the days of this symposium but on a permanent basis, because I think this program is not only innovative and progressive but necessary and sensible.

The opportunities it gives us to increase our productivity

and our efficiency would be reason enough to proceed as

rapidly as possible.

When you add the human reasons for our proceeding ... reasons

that only those who are ill or injured and those who care

for them can appreciate fully... we are left without a

choice

.

We who are responsible for the success of VA medicine feel

that we must always be ready to do what we can to improve

patient care... that we must work hard, that we must continue

to learn and that we must never be completely satisfied with

what we are doing.

The ETIP program offers new help to VA and we intend to take

full advantage of it.

I appreciate the opportunity you have given me to talk with

you and I hope you find this symposium productive.

Dr. Ernest Ambler

Acting Director

National Bureau of Standards

I should like to welcome all of you here to the National

Bureau of Standards and note that we are very pleased to

join with the Veterans Administration in the sponsorship of

this symposium.

6
Oliver Wendell Holmes once said, "Knowledge and timber

shouldn't be much used until they're seasoned." ETIP, or

our Experimental Technology Incentives Program, is in the

business of defining and evaluating how to season our knowledge and timber so they can be "much used" to increase

American productivity. ETIP was established by Presidential

mandate at NBS in March of 1972. Specifically, it was

established to develop and test governmental policies that

will provide incentives to the private sector of the economy

to invest in innovation and technological change. In

reality, what we're trying to do is to stimulate a more

rapid transfer of technology from the laboratory to the

marketplace. The ETIP mission is twofold: First, trying

to find ways to achieve these goals; and second, identifying

ways to get these answers built into the policies and practices of the Federal Government.

ETIP is providing an arena for experiments - an environment

of real world learning experiences. Our basic operating

strategy is the design and conduct of policy experiments in

close cooperation with those agencies whose responsibilities

and activities are relevant to ETIP's goals. These operations are being carried out in four different areas: procurement, regulation, civilian research and development, and

small business.

Why should we, in the Federal Government, have a program

doing this? Very simply because in a developed economy

such as ours, technology is an extremely important element

in the system. Many of our key industries - such as agriculture, health care, manufacturing, and energy production

are strongly dependent on technology. The National Commission on Productivity has reported that technology is the

largest single contributor to productivity growth in the

United States. Department of Commerce figures show that our

foreign trade balance is in surplus only with respect to

technology intensive products, which thus help pay for our

petroleum, raw materials, and other essential imports.

As you know, NBS is concerned with the development of new

knowledge and the application of that knowledge to various

sectors in this country to enhance productivity. Thus, we

have been involved with technology and technological

change since our founding in 1901. The legislation affecting the Bureau has been amended several times since 1901 and

yet three themes have remained strong and consistent.

First, we are responsible for national measurement standards.

Second, we are responsible for the determination of physical

constants and properties of materials; and finally, we

cooperate with other government agencies. In the past 75

years, the Bureau has developed a pretty fair amount of

7
.credibility within the Federal Government, throughout

industry, and with the average consumer.

In carrying out our mission, we have long been concerned

with technology transfer. One of the most vital elements

in technological progress is the availability of adequate

and appropriate measurement capability. The Bureau of

Standards assures the availability of such capabilities by

maintaining basic standards, developing measurement techniques and establishing dissemination procedures to make

this know-how available at the point of use. For example,

we calibrate approximately 1,300 instruments and standards

for measurement per month. We have developed nearly 900

Standard Reference Materials, whose chemical and physical

properties have been certified by the Bureau. More than

32,000 of these SRM's, as we call them, are sold annually

for use in calibrating instrumentation in such diverse areas

as pollution monitoring, optical glass production, health

care and computer hardware quality control.

Through our activities with Federal, state and local governments, NBS provides measurement support in high technology

areas to safeguard against radiation hazards, to minimize

corrosive attacks of materials in magnetohydrodynamic

generation of electric power, to model the stratosphere to

assess the effects of man-made chlorof luorocarbons and many

others. All of these services directly facilitate the

transfer and utilization of technology.

You are here today to talk about health care products. I

would like to assure you that NBS is not a stranger to this

field. In fact, we have a dental research program which

began in 1919. Since 1928 the American Dental Association,

through our research associate program, has cooperated with

the Bureau in this work. Many Americans today have fillings

in their teeth which last twice as long and have superior

properties as the result of materials developed at the

Bureau. These materials, which are called composites, match

the appearance of the teeth and last longer than silicate

cement and save on replacements. The Bureau was also

responsible for the development of the panoramic x-ray

machine and the high-speed turbine drill

.

I mentioned the Standard Reference Materials Program. In

the United States there are at last 15,000 clinical laboratories which analyze billions of human serum, urine and

tissue specimens each year. NBS has developed standard

reference materials and reference methods to improve

accuracy in clinical measurements. We have prepared 20

clinical SRM's and one reference method - that for calcium

in human serum. These SRM's provide clinical laboratories

8
with a means to evaluate their measurements and to improve

their quality control.

In another project, scientists from the Bureau have worked

with an orthopedic surgeon from the George Washington

University Medical Center to characterize the "cement" used

in orthopedic surgery to stabilize total hip implants. The

emphasis has been on determination of the physical, chem.ical

and mechanical properties of poly-based cement as it is prepared and used in the surgical procedure. Such materials

used in a total hip-joint replacement and in neurosurgical

applications can help to deliver improved health care to the

patient.

Quite recently the Bureau, in conjunction with the Food and

Drug Administration, sponsored a workshop to discuss reliability technology for cardiac pacemakers. The workshop

directed attention to the procurement and assurance of

reliable, long-lived semiconductor electronic parts; the

hermiticity testing of device packages and pacemaker

systems; the activities of the several standardization

organizations; and the use of reliability data banks and

other information and service sources.

Health care delivery is one of America's largest service

industries. The time has come to bring together the needs

of your industry with the technical capabilities of our laboratories and let ETIP serve as the catalyst. One of the

finest points that ETIP offers is the fact that it is an

experiment. It is not intended to be a demonstration project. It will not be a simulation or hypothesis, but a real

world opportunity for us to find that "seasoned knowledge"

I mentioned earlier.

I am pleased that I really have two tasks this afternoon.

The first was to welcome you, but the second is to introduce

your keynote speaker, a gentleman who has been serving as

Senator from the State of Maryland since 1970, J. Glenn Beall

holds the same seat that was once held by his father.

A native of Frostburg, the Senator has been active in politics since 1962 when he was elected to the Maryland House of

Delegates. He serves on the Commerce, Labor and Public

Welfare, Budget, Special Committee on Aging, and Select

Committee on Small Business. Some of his special interests

are reflected in his subcommittee assignments which include:

health, handicapped, employment, alcoholism and narcotics,

and human resources. It is particularly fitting, therefore,

that he is with us today. Thus, it is my pleasure to

introduce to you an excellent human resource.

Senator J., Glenn Beall.

9
The Honorable J. Glenn Beall, Jr.

Senator , Maryland

It is a pleasure for me to participate in this joint National

Bureau of Standards and Veterans Administration conference.

I commend both agencies for sponsoring this dialogue between

the manufacturers of health products and systems, health

personnel, and government.

Your theme "Encouraging Innovation in Health Care Products"

is most appropriate. If there ever was an area and a time

which demanded imagination and innovation, that area is

health and that time is now.

I do not want to be misunderstood. Health care in the

United States at its best is unequaled anywhere.

But the problem is that we have not been able to deliver to

all of our people, wherever they live and at a price they

can afford, quality medical care.

Major problems confronting the health industry include:

1. The need to make certain that financial barriers do not

prevent citizens from receiving needed health care;

2. The need to correct the medical manpower geographical

and specialty maldistribution problems, and to address this

Nation's growing reliance on foreign medical graduates;

3. The need to face up to the quality issues in health;

4. The need for better health planning;

5. The need to control escalating health care costs. Of

all the health problems, this is the most serious and the

number one concern of the public. National expenditures for

health care in 1974 totaled $104.2 billion, an 8-fold

increase over the 1950 figure of $12 billion. Another way

of looking at these astronomical cost rises, which may be

especially meaningful to this audience, is that in 1974,

expenditures for what might be considered medical businessdrugs-medical supplies and equipment - will be approximately

$14 billion, a sum which exceeds the S12 billion spent for

all of health in 1950.

Health is part of what has been labeled the "growth field of

modern society" - the public service sector.

10
This sector employs six out of every ten Americans, and now

accounts for over one-half of our GNP.

Industry has always emphasized performance and productivity.

Productivity in the service sector has not received similar

attention and the record of this sector is unimpressive.

True, measuring productivity and performance in the service

sector is more difficult. However, the rapidly rising health

costs and this sector's growing importance and impact on

society, make it imperative that improved productivity be

pursued with a sense of urgency.

A labor-intensive industry characterized by rising costs and

low productivity, should be ripe for technological and

product innovations.

Technological advances in such areas as space, communications, and data processing in the last decade have been

unbelievable

.

Yet, technology has not made a similar impact on the health

system, particularly as a vehicle to advance productivity

and to contain costs.

In fact, much of the health care system continues to employ

the same manual procedures used at the turn of the century.

We desparately need to wed 20th century technology with 20th

century research to improve the delivery of health care, and

I might add 20th century procurement practices, to improve

the delivery of health care.

In the 1960 's, there were expectations that technology would

produce a "revolution in health care." This obviously has

not materialized.

Why has technology failed to live up to its expectations?

There are numerous reasons, but they would include the

following

:

1. The diffused markets in the health field;

2. The limited success of technology to date

;

3. The fears by some that technology will depersonalize

health services;

4. The inability of health institutions to examine and

evaluate technology and no central clearinghouse to do this

job for them;

5. Lack of test sites where innovations could be tested and

the results disseminated;

11
6. The reimbursement system and procurement policy often

provide the wrong or little incentives to encourage the

proper level of care or the introduction of cost-ef f ectJ.ve

technology;

7. The changes taking place and contemplated in the health

field such as in the organization and delivery systems; the

user population (more elderly); manpower, particularly the

use of paraprofessionals ; and the growing role of government;

and

8. The government's failure to give priority to the utilization of technology in the solving of health problems as has

been done, for example, in space and defense.

As a member of the Senate Health Subcomjnittee , I have been

very interested in research and development and the use of

technology in health care delivery.

In introducing legislation, S. 723 in 1972, to establish a

National Institute of Health Care Delivery, I stated:

"Since World War II, the U.S. has invested over S20 billion

in biomedical research while during this same period comparatively small investments have been made to deliver the

fruits of biomedical research to the American public."

Although this measure passed the Senate on two separate

occasions, it was not enacted. Nevertheless, S. 723 was the

first bill introduced in the Congress calling for an expanded

research effort and it helped produce an upgrading of health

care delivery research with the enactment of Public Law

93-353, the "Health Services Research, Health Statistics, and

Medical Libraries Act of 1974". This Act, among other things,

provides a legislative mandate and calls for an upgraded

National Center for Health Services Research. The Act also

incorporated a number of specific features of my original

bill, including the establishment of regional and two special

emphasis centers, a Health Care Management Center and a

Health Care Technology Center.

The Health Care Technology Center will focus on all forms of

technology and their application in the improvement of health

care

.

The Health Care Technology Center is expected to provide the

leadership and mobilize the development and the utilization

of technology. The Health Care Technology Center, and such

programs as the Experimental Technology Incentives Program

(ETIP) , must address some of the difficulties to the utilization of technology for solutions to our health problems

.

12
In a 1972 Senate floor speech, I cited some examples of

appropriate actions the Health Care Technology Center could

take or promote , and I quote

:

"Various agencies of the Federal Government operate their

own health systems, such as the Defense Department and the

Veterans Administration. These federal health systems offer

the opportunity for a market sufficiently large to attract

industry investment.

Second, the Federal Government could identify potential

opportunity for technological solutions and solicit competitive bids through requests for proposals — RFPs — as is

done by the Defense Department. Thereafter, there could be

full funding of a prototype followed by a guarantee that a

sufficient number would be purchased to insure a profit.

The units produced could then be sold, loaned, leased, or

donated to individuals or organizations that would use them

effectively .

Technology must be developed to solve health problems . As

elementary as this sounds, I am not convinced this has always

been the case. There are a number of reasons for this.

Technology in the health industry usually developed independent of, rather than in cooperation with, health institutions.

Many products were purchased at the whim of a physician or by

a health institution to keep up with a sister institution.

The health care cost crisis is and will change this. The

health system does not need, nor can we afford "technological

playthings" or "status symbols".

HEW has not designed or established the technology or management centers yet, but I am hopeful that this will be done

before the end of this year.

Unfortunately, the upgrading of health services research, at

least as far as additional resources are concerned, is not

taking place. The priority which health services research

deserves and requires has not been forthcoming. Evidently,

some shortsighted 0MB official, whose long range views and

vision extends not one iota beyond this year's budget, felt

such research was not important, and worst, his views

prevailed

.

In 1972, when my bill to establish a National Institute for

Health Care Delivery passed the Senate, I deplored the

inadequate funds going to health delivery research. That

year, the budget was $62 million.

13
Do you know what the budget will be for the National Center

for Health Services Research following the enactment of

PL 93-353 "Upgrading and Improving Research""? The answer is

between $2 3 and S26 million, a figure which will be nearly

two-thirds less than the 1972 funding level.

Considerable change is occurring in the health field. The

rapidity of change is likely to accelerate in the years ahead.

Given the many unknowns, the need for new knowledge, and the

need to apply what we already know, I find the decline in

funding for health services research deporable and shortsicrhted. Such action certainly is contrary to the intent of

PL 93-353 designed to upgrade health services research, and

is in conflict with the explicit statem.ents of HEW in its

own "Forward Health Plan". Let m.e quote to you from this

1975 document:

"The Assistant Secretary for Health is placing increasing

reliance on the National Center for Health Services Research

for advice on what is known and being discovered about health

services delivery.

High priority is placed on increased resources to enable the

center to carry out its expanded,mandate under PL 93-353 and

to provide information and advice on health services policy."

"However, even the basic elements of the National Center for

Health Services Research Legislative Mandate, including the

regional health services research centers and the intramural

program, cannot be implemented within available funds or

staffing. Given that fact, and the growing importance the

Assistant Secretary for Health is attaching to the role of

the NCHSR, this forward plan places a very high priority on

increasing the resources available to the Center. The

National Center for Health Services Research's own forward

plan for FY 1977-81 greatly increases the policy relevance

of the focus of its activities, which should help to restore . much needed confidence in the National Center."

I do note, however, that this forward plan is for Fiscal'

Years 1977-81. Hopefully, Health Secretary Cooper will

be able to convince 0MB and the appropriations committees of

the Congress of the importance of Health Research and in next

year's budget we will find funds to match the rhetoric.

The wants and needs of society present the health industry

with a major challenge and great opportunities. Never before,

in fact, has the opportunity for innovation in health care

been greater because never before have we faced the costquality-service dilemma we face today.

14
Technology has the potential of being enormously beneficial

to the health community and the public. Let us put American

technology, management, and know-how to work to solve this

Nation's health problems and to help us achieve our goal

of quality service to all our citizens.

Joseph G. Berke

Experimental Technology Incentives Program

National Bureau of Standards

I want to extend my welcome and express my appreciation for

your attendance today. This symposium, although our third

in ETIP, is our first related to medical goods and services.

Those of you here today are playing an important role in

developing, suggesting and participating in the design and

implementation of procurement experiments that will have a

positive effect on the medical industry.

Today I will be sharing the podium with Mr. Clyde Cook,

Director of Supply for the Veterans Administration. I will

review the ETIP philosophy and try to direct your thinking

to the workshops ahead, how you can contribute and what

ETIP and the VA want to get out of them.

Mr. Cook will briefly touch upon the activities in the VA

as they relate to current and future joint procurement

experiments

.

The Experimental Technology Incentives Program, or ETIP as

we call it, was created as the result of the President's

Science and Technology Message of 1972 and the Budget

Message of 1972 and the Economic Report of the President.

The budget and other documentation suggested seven possible

types of experiments for the program. These were:

1. Identifying and addressing industry-wide technical

opportunities

;

2. Aggregation of research and development capability;

3. Assistance to inventors and small innovative firms;

4. Experiments dealing with the transfer of governmentheld technology;

5 . Government procurement as an R&D incentive

;

6. Stimulating technology through market aggregation; and

7. Evaluation of advanced technologies to enhance

productivity

.

15
As I mentioned, ETIP stands for the Experimental Technology

Incentives Program and we are physically located here at

the National Bureau of Standards in Gaithersburg

.

Contrary to popular belief ETIP is not concerned with what

new technologies are needed nor are we analyzing how much

R&D support the government should provide. ETIP is a

policy research program and conducts experiments and

studies that will provide a data base upon which to recommend new government policies that will increase the private

sector investment in technological change as well as

increase the broader utilization of federally funded civilian R&D.

The ETIP mission, then, is to develop and test governmental

policies that will provide incentives to the private sector

of the economy to continue to invest in innovation and

technological change

.

The way we work is shown in this flow chart of events.

First we develop an issue that we think needs attention.

Initially in new areas the staff of the ETIP policy areas

would initiate the issue -- currently, after almost two

years of working with all levels of governm.ent, we find

that many issues that fit the ETIP objectives are originating with the agencies we work with. After an issue is

developed we try to find a contact, an in-house champion,

at as high a level as possible in the agency to ensure

approval and commitment to the issues, to supply resources

to the experiment and to carry out the experiment or study

for a period of time, from months to years.

Once the agency contact is established, the experiment

negotiation and design begins. Here responsibilities are

established, policies identified, and the experimental

approach laid out. When this is complete and all parties

are satisfied with the experiment plan, it goes through the

ETIP approval process. This consists of the Director of

ETIP, and the Director of NBS . After such approval, funds

are made available to conduct the experiment. The funds

are available for use in three ways:

1. As an interagency transfer to cover extraordinary

expenses within an agency for the conduct of the

experiment

;

2. As a transfer which the agency uses to obtain the

services of a contractor; or

3. ETIP can award a contract and have the contractor

work with the agency in question.

16
?\.fter the experiments are underway the. evaluation process

begins to take place. Policy recommendations will then

come from groups of experiments and their evaluations.

Currently, the Policy Areas of ETIP using this approach are

Procurement, Regulatory, Civilian R&D and Small Business.

Let me now move on to describe the Procurement Policy Area,

what we are and what we do

.

Our objective is to determine if procurement can be used as

an incentive for industry to continue to push technology,

and continue to offer new and better goods and services.

With this objective in mind, let me now digress a bit to

talk about how government generally does business and its

significance to the ETIP objective.

Currently, for most civilian goods and services, the government buys to the lowest common technological denominator

and to the lowest initial acquisition price. This general

procurement process tends to restrict the application of

new technology because of price and other considerations.

This present policy can and should be changed to respond to

the fundamental principle of procurement — "To get the

best deal or value for the government and the taxpayer."

This principle is within the objectives of ETIP although

the concept of the "best deal" may need to change. The

degree to which the Federal, State or local procurement

systems can be effective in stimulating technological change

depends to a great measure on how purchasing officials view

their responsibilities. Although the needs for new or improved products originate with the user agency or group, the

purchasing department and all it encompasses must assume the

responsibility and leadership to translate those needs into

appropriate specifications, prescribe test methods, evaluate

new innovations and determine the "best deal."

ETIP's role in the framework of experimental procurement

policy is to provide the umbrella under which the experiments take place and to act as the catalyst for ensuring

that the experiments do take place, evaluate the results,

disseminate the information and make policy recommendations.

Let me now leave the general statements and get specific

about how ETIP is working to test new procurement policies

and practices. The government "clout" to provide incentives

for technological change rests on the fact that the government is often the largest single buyer of commerical goods.

If you add to this federal market, the state and local

markets, the incentive to industry to serve the total is

greatly increased.

17
The mechanisms whereby this government "clout" can be harnessed reside in the procurement tools. Some of the tools

being tested by cooperating federal agencies in conjunction

with ETIP include the use of performance specifications,

life cycle costing and value incentive clauses.

You will hear a great deal more about these in the various

workshops so I will not elaborate here.

In order to assess the effectiveness and timeliness of a

procurement tool for encouraging technological change, it

is important that ETIP through its evaluations identify and

understand certain characteristics associated with industry's response to a government procurement incentive.

These characteristics are;

1. The significance of the government buy;

2. Government's knowledge of availability of technology;

3. The nature and structure of the private demand; and

4. The nature and structure of the supply and manufacturing

sector

.

The specifics of our ongoing experiments are provided in the

pamphlet you received at registration. I will not dwell on

these here.

I would like to point out that for products that are common

to State and local markets as well as the Federal market, we

will incorporate the experiment into our ongoing experiments

with NASPO and NIGP.

Briefly our state project encompasses the fifty states

through specification preparation, consensus testing procedures and uniform procurement policies for generic

products.

Our local project does essentially the same thing below the

state level. To the extent possible all levels of the

procurement process will participate in our experiments.

To have these policy type procurement experiments be

successful requires a great deal of personal attention.

Through symposia such as this one we can receive the

benefit from all your collective experience. I urge you all

to be outspoken, present an adversary position, and be constructive in your workshops and help us get moving.

18
To summarize, ETIP is interested in experiments, studies

and analyses that can be the basis for recommending policy

changes at all levels of government.

Clyde C. Cook

Director, Supply Service

Veterans Administration

I was mentally revising my remarks when Joe began talking

about being last on the program with little left to say. He

used a word that struck a memory cord when he said, "I would

'briefly' describe to you what we are doing." It reminded

me of a time some years ago when I was the last speaker on

the program and my assigned role was to summarize and fill

in the gaps. It had been a very long program and we were off

schedule, just as we are today. Late in the afternoon, the

coordinator handed me a note that said, "be brief." As we

got farther off schedule and people began to fidget, he handed

me another note that said, "be very brief." Well, as I began my part of the program, two hours after we were supposed

to adjourn, I waited for his last note. The note didn't come,

but the expression on his face said, "don't speak." That's

probably what I should do today.

I'll try to give you a frame of reference within which ETIP

will operate in the VA. For a number of years, the VA has

had a product evaluation program for the medical items used

in its hospitals and clinics. In the past, this has been a

rather modest program with a somewhat different thrust than

we anticipate it will have under ETIP. Our product evaluation programs developed somewhat informally in response to

unmet user needs. Too often, very little was known about

the performance, reliability or relative quality of the

various items which were being marketed for use in health

care facilities. Our testing and evaluation was aimed at

the rather limited objective of identifying the actual performance of these products.

Our Administrator gave you some idea of the magnitude of our

operations and I feel the VA has an ideal climate for the

kind of experimentation, product evaluation and new product

development that ETIP offers.

Some of the other testing and evaluation programs the VA has

been operating are in the area of prosthetics. There is a

prosthetics center in New York City, which evaluates aids

for the blind, equipment systems for spinal cord injury

systems, and prosthetic and orthotic upper and lower limbs.

This center has performed clinical evaluations, evaluated

experimental devices, and conducted compliance testing

against previously developed standards. It is probably the

19
most sophisticated product development program we have at

the VA. Other programs include a laboratory, run by our

Dietetic Service, which carries out sensory evaluations of

food products, and also performs in - use testing of food

service and preparation equipment, as well as a dental

program to conduct comparative evaluations of dental equipment.

The VA Marketing Center, located in Chicago, Illinois,

administers a general product evaluation system on a wide

range of medical supplies and equipment. The Center selects

new items of equipment or supplies and places them in use at

selected VA hospitals. Feedback data is gathered, and this

information determines what items will be standardized for

use throughout the system.

The VA also contracts out for testing and evaluation services.

The National Bureau of Standards tests and evaluates hearing

aid performance, while our Health Service Research and

Development Service contracts for safety evaluations of

medical equipment.

Recently, a management consulting firm made a comprehensive

study of the programs in the VA as part of a broader evaluation of the Agency. They looked at what the VA might do to

share its technology and knowledge of medical supplies and

equipment with a broader spectrum of the population. As is

usually the case in these studies, they commended our efforts,

told us about our shortcomings, and suggested a few improvements. The major deficiency that they saw was that the

program lacked formal management.

Proposals came in from almost any quarter and, while that

was good, it was frequently left to the proposer to decide

where, what, and how the item(s) would be tested and/or

evaluated. Occasionally, there was a lack of adequate evaluation protocols and procedures which affected the quality

of the evaluations themselves. This firm felt that sometimes

our evaluation results were not thoroughly analyzed, or if

they were, the analysis was not adequately recorded or

disseminated. This form recommended that the VA establish

within its Supply Service, a Testing and Evaluation Division.

This division will manage a more formalized program in close

collaboration with the using services represented by the

professional and technical staffs of the Agency. This division will also support other programs that operate laboratories

within the VA.

At this moment, we are in the process of establishing this

division. ETIP is aiding us in this venture by providing

funds to pay for part of the staff. The ETIP program has

been merged with this new division in that in many ways they

20
complement each other. To repeat, I feel that the VA has an

ideal climate for the kind of experimentation and product

evaluation of new product development that ETIP offers. We

are also working with the ETIP staff, Ross Hofmann Associates,

VA Supply Service personnel, and VA professional staff, to

develop product performance descriptions on several items.

The items selected were chosen not because they represented

the most esoteric items in which we could identify needed

improvements. We have chosen two very homely items as our

beginning point. The first item is a syringe and needle

destructor, which is a problem to the nursing staff and

many others in hospitals. The second is a bedpan sterilizer,

not a sanitizer, but a sterilizer that can be used in patient

care areas. We hope to have these descriptions in the manufacturers' hands within the next 3 to 4 weeks. After that,

depending on the response, then, if industry is ready to go,

we are. I would like to tell you what I think the biggest

difference is between our past efforts and the efforts

that we think we will be undertaking with ETIP. In the past,

with probably the notable exception of the prosthetics program,

the primary thrust of our product evaluation has been to

determine what the items being evaluated would and would not

do. ETIP adds the new dimension of evaluating not only this,

but also what the product should and should not do. We will

then attempt to translate what it will do and what it should

do into a description to the industry, of the performance

requirements and the characteristics that we need.

The thrust of these performance descriptions will be to

describe, in medical terminology, what the item should and

should not do in terms of performance. We are trying to

get away from writing technical specifications. An effort

is being made to describe the performance parameters rather

than giving an engineering design specification. I think the

most important thing with us is that the critical input will

come from our users, the staff members of VA, and the professional services. We have approximately one dozen other

items which are in various stages of development into performance descriptions. It is hoped that several of these will

be ready for presentation to industry over the next few months.

As Mr. Roudebush said, "We are open to all of the help we

can get. " We are open to any suggestions this symposium

might make in terms of items we might examine for future

development. We feel by beginning modestly, and moving

slowly (not too slowly, we hope) , we can contribute something, not only to the VA, but to the health care community

at large and also to the health care industry. We hope, from

this seminar, to get the assistance and the participation we

need to get this program going.

21

WORKSHOP TOPICS

Each workshop had co-chairpersons, with representation from

health care disciplines in government and the private sector, and from the manufacturing sector for health care products. Every encouragement was given for the workshops to

serve as forums for frank and open discussion and the free

flow of ideas, representing a broad range of opinions and

diversity of interests. The six workshops were designed to

cover a broad spectrum of interaction between suppliers and

users, and their topics were:

1 . Interaction Between the Hospital User and the Industry

Supplier . There is a continuing need for close interaction

between the user and the supplier of hospital products and

systems, so that the needs and demands of the institutions,

the staff and the patients are promptly and legitimately

answered in the development of new products and systems by

the suppliers. This need covers new items, innovative items

and improved items

.

Who should initiate interaction for such developments?

Should it be industry through its research and development

followed by aggressive merchandising to create demands

among hospital users and patients? Or, should it be hospital and medical personnel through their experience in

using products, treating and diagnosing patients, and

managing medical institutions?

What procurement procedures, such as Life Cycle Costing,

Value Engineering clauses, etc., can be an effective means

of communication on user needs and industry response?

2 . Research and Development for Innovative Products . What

should be the roles of manufacturers , the health care deliverer, the public and government in R&D to encourage technological innovation? How can industry be encouraged to

perform more R&D for products hospital users feel they

need and that do not exist at present? Through use of

specifications and standards, that reflect needs, through

R&D contracts.

Is industry willing to spend the money for R&D, and by owning the production rights, respond strictly to buying

contracts for innovative products without receiving the

monetary award for an R&D contract? How can they be assured

of a long term market, in view of diverse user opinions on

most products?

How difficult is it to achieve technology transfer from

other industries and disciplines to health care products?

23
If a research organization develops the product, what

should be the patent and licensing policy?

3. Product Testing and Evaluation . To protect their reputation, as well as to satisfy regulatory agencies, manufacturers continually test their products for quality control;

they also evaluate their new developments in the field to

ensure that they are marketable and satisfy the needs and

demands of their customers. Many hospitals feel that users

should play a larger role in evaluating products offered by

industry; that formal testing and evaluation centers and

laboratories should be established to determine, from the

user's side, whether the products meet industry's claims,

as well as the quality control and specific uses required

by hospitals.

How far should hospitals proceed in such specification

development and testing and evaluation? How much should

they duplicate the efforts industry is performing? What

is the role of government in providing technical assistance?

4. Specifications . Commercial specifications for products

and systems sold in the hospital field appear to be less

definitive than in certain other industries. A large percentage of government specifications are design oriented in

nature. Many users, as well as purchasing agents, in both

the public and private sectors feel that specifications for

hospital items should be of the performance type, including

Life Cycle Costing and Value Engineering clauses to permit

manufacturers latitude in designing details, and to protect

the user in evaluating the product.

When performance specifications or Life Cycle Costing are

used, ground rules must be established for testing and

evaluating products. Formulas and standard tests must be

followed, spelled out in advance of procurement. Testing

periods both before and after delivery must be defined.

Vague value judgments must be eliminated as much as possible. Differences between standards and specifications must

be clarified. Are performance specifications more desirable

than design specifications, why and how? How can this be

accomplished in a manner that is satisfactory for both the

user and the supplier?

5 . Post Delivery Performance, Warranties and Training

by Vendors . In the merchandising of hospital products

warranties , instruction manuals and personnel training

becoming more critical as the sophisication of medical

and diagnosis increases.

are

care

24
Tfhat forms should these take? How detailed should they be?

How long should training programs extend? What form should

they take? What are "fair" charges for post delivery assistance? What are both the user's and manufacturer's responsibilities when employees do not follow practices recommended by the supplier?

With equipment, what type of instruction manuals, parts

lists and spare parts should be furnished with the initial

delivery? What should be the lengths of warranty periods?

On items claimed to be sterile or safe, what is the protection for the buyer in specific terms?

6 . Cost Saving and Quality Improvement Through Innovative

Products . How can industry be encouraged by users to develop products and systems that legitimately save labor and

operating costs for hospitals and simultaneously assure

better control of health care delivery?

As an example, do disposables really save money, or is

efficient reprocessing the cheaper route to follow? Whose

management surveys should be used - the supplier's or the

user ' s?

How far are industry and the hospitals willing to go to

definitely establish costs as a base line for the development of labor saving devices and systems?

25

WORKSHOP REPORTS

INTERACTION BETWEEN THE. HOSPITAL USER AND THE INDUSTRY

SUPPLIER

Co-Chairpersons: Frederick W. Bauer, M.D.

Greater Baltimore Medical Center

Donald P. Whitworth

Don Sowle Associates, Inc.

RESEARCH AND DEVELOPMENT FOR INNOVATIVE PRODUCTS

Co-Chairpersons: MG Robert Berstein

Walter Reed Army Medical Center

William H. Goldwater, Ph.D.

National Institute of Health

PRODUCT TESTING AND EVALUATION

Co-Chairperson: Colonel James G. Borman

Fort Detrick

SPECIFICATIONS

Co-Chairpersons: George E. Ainsworth

Hospital Bureau, Inc.

Wilbur J. Balderson

Office of Surgeon General, DA

POST DELIVERY PERFOmiANCE , WARRANTIES AND TRAINING BY

VENDOR

Co-Chairpersons: James D. Gibson

Castle Company

Dennis A. Grote

Greater Baltimore Medical Center

COST SAVINGS AND QUALITY IMPROVEMENT THROUGH INNOVATIVE

PRODUCTS

Co-Chairpersons: David Lubin

Sinai Hospital of Baltimore

Alice H. Meyer

Greater Baltimore Medical Center

workshop 1

interaction

between the

hospital user

and the

industry supplier
0
INTERACTION BETWEEN THE HOSPITAL USER

AND THE INDUSTRY SUPPLIER

The discussion initially centered around the genesis of

product innovation in the health field. One workshop member,

an educator from MIT, contended that his studies of the subject showed that seven to ten years elapsed from the time a

user — i.e., a physician, nurse, dietician, pharmacist or

whomever — developed a device until it was commercially

available. He illustrated the typical steps involved with

this chart:

* Typical Steps in the Invention and Diffusion of a

Scientific Instrument or Instrument Improvement

(1) Significant

instrument improvement invented, built

and used by:

(2) User

diffuses results and

' how to do

it ' information via

publication

,

symposia

,

visits, etc.

(3) A few (4) Instrument

users (or company introa few dozen) duces commerbuild their cial version

own

o

o

o

others ' users ask

instrument

companies

when a

commercial

version

will be

available

ICommericalizing

Instrument

Company

Invention, prototyping, first

field use

Information

diffusion

Pre-commercial replication and

use

Commercial

manufacture

and sale

— > TIME >

<r User-dominated > <^-Manufacturer role —

steps

*Source: Professor Eric Von Hippel - "Role of the user in

the Scientific Instrument Innovation Process" - Sloan School of Management - working paper 19 75

31

I
Hospital oriented workshop members contended that the medical "industry" — the manufacturers and other suppliers -- show a remarkable lack of interest in using the "work bench"

development concept to promote technological change. Instances were cited where sophisticated items now on the

market grew from user initiative and eventual interest on

the part of the medical industry. Proponents of this philosophy expressed the view that traditionally the suppliers

of medical devices depended on the user to "lead the way."

This one-sided discussion served to highlight one basic

question of the workshop, i.e., "Who should initiate interaction for technological development — the suppliers or

hospital and other medically oriented personnel?"

The opposing position was quick to surface. Industry representatives pointed to many convincing examples of new

devices and innovative ideas that stemmed solely from industry research and development — from industry interest

in supplying a better product. Items such as disposables,

specifically, operating room drapes and gowns, were mentioned.

This example sparked a discussion of what is or is not progressive innovation. Problems of space required for storage

of such disposables, physician acceptance, or possibly lack

of acceptance and other problems were discussed. This discussion seemed to lend weight to the proposition that the

hospital user is the best source of innovative ideas.

Representatives of industry injected into the discussion real

problems involved in user-industry coordination and interchange of ideas. A user -- perhaps a physician -- approaches

a company with an idea that is represented as a panacea for

all medical problems, something that must be developed!

After much research and expenditure of funds and other resources, the company comes up with what they consider to be

the answer only to find to their dismay that the originator

of the idea is no longer interested.

Other industry "gripes" involve (1) the difficulty in getting

to the right person in a given hospital, (2) the murky channels that often exist between the professional and administrative officials that thwart them in their efforts to

interest the right people in new products and ideas and,

(3) the reluctance of professionals to listen to them,

contending professional persons are only interested in

listening to their peers.

Industry representatives contended that the difficulties encountered in getting to the persons who actually use their

products -- access to the right people — is a real detriment to industry innovations. Administrators who interfere

32
with their ready access to user personnel retard progress.

On the other hand the discussion developed that industryuser contact had to follow an orderly process involving the

officials responsible for an institution's procurement

support

.

Industry has trouble in its efforts to have hospital personnel "try" items. "We can't use it/' or "we don't like

it," is allegedly often heard before the item is ever tried.

However, the suggestion that physicians and other professional personnel are inflexible and resistant to change was

rejected. Industry representatives joined in rejecting this

contention. It is a matter of proper approach and accessibility. Physicians, as well as others, will recognize a

superior product, an improved approach. The big question

is, "What is the proper approach?"

Also rejected by many was the suggestion that industry,

being profit oriented was too interested in making a buck to

try to find out what is best for patients and patient needs.

That the progress that has been made today has been accomplished largely with industry cooperation was generally

agreed to. One company represented grew to be a multimillion dollar concern from scratch by actively seeking out

the valid needs of users. That the direct approach to the

user they employed bypassed all administrative personnel

often landed them in trouble, emphasized the need for some

orderly means of communication of ideas between the right

interested parties.

A question that repeatedly had been cropping up came up

again at this juncture: "How do we bring industry, the

hospital administrator (procurement official) and the user

together in the most effective fashion to encourage item

development?

Another question that even more often emerged was : "Where

is, or perhaps what is, the medical community?" Is there

such a thing to which the specific points being discussed

in the workshop could be addressed? If there is a "hospital

community," who is/are its spokesmen? If there is not such

a community, how does the businessman communicate with

something that does not exist?

It was generally agreed that insofar as item development and

hospital-industry communication were concerned the nation's

hospitals are not a single community, and there is no

apparatus to bring them together as such.

The many medical societies were mentioned as the possible

catalyst that is needed. Yet they, while essential professionally, are segmented and not oriented to speak for the
device needs of the man/woman at the "work bench." Industry

and professional associations interacting with the hospitals

in their many environments — private. Federal, state, municipal and other — could be helpful, but not the total

answer

.

Somehow, to optimize the possibilities for item innovation,

the segmented hospital "community" and the equally segmented

hospital "industry" must find a way to fuse their common

interests. But how?

Gaps abound I There is the gap between hospitals themselves.

Hospitals in the private sector are not aware of what their

sister institutions may be doing. Government hospital

groups are not aware of the efforts being made within each

group. Government (at whatever level) hospitals do not

know what private hospitals may need that they already have

developed — or vice versa.

How to communicate in this morass of proliferation? The

age-old problem cropped up again and again with the consensus that the gaps were indeed real, but no consensus on

how to close them.

The lack of an "item technology" data bank to prevent

duplication of effort and to promote cross fertilization of

ideas was advanced. This was regarded as a good idea.

However, as far as industry is concerned, the "does Macy

tell Gimbles" philosophy was quite properly brought up, for

it was recognized that all firms are in business to survive,

and survival means to make a profit. Yet, for the medical

community a developmental "data bank" was regarded as a

very interesting idea.

Again and again the main thread of the initial discussion

was picked up. Who has the ideas and where do we go to get

them developed? Governments, vendors, hospitals don't have

ideas, only individuals have ideas. The starting point at

least is with the individual. Many innovative ideas have

merit, many do not. All that show promise, however, should

be pursued. The individual hospital can't afford in terms

of money and time to live in isolation, ignorant of the

technological advances others have available to them.

Medical costs have risen too high for hospitals to continue

to operate technologically speaking in the dark, especially

when the means exist to shed light on their problems. Government keeps its ideas and follow-through to itself and

the independent hospital has no knowledge that an innovation

it yearns for has been developed by Government.

34
For private hospitals, costs of following up suggested innovations are prohibitive and hospitals are desperate for

technological development but frustrated in their hopes.

Congress, in the view of industry, does not help with its

hearings about high prices that do not take into consideration the high cost of initial development borne by the companies. This was brought out as a detriment to industry

development

.

Again the question: Is there a hospital "community"? That

there is a hospital market was agreed to, but a hospital

community in the conventional sense, no I There is a potential "community." Now, however, there are seven thousand

hospitals with individual needs not bound together except

within the several government agencies that operate hospitals, and even these are not tied together.

Over and over the discussion came back to frustrations stemming from the lack of a means of tying the hospital "community" together as one. Each private hospital is an entity,

each government-operated (Federal, state and local) hospital

apparatus is an entity, and there is no tie between them.

It became apparent that the flow of thought was moving

toward the notion that this workshop could only do one constructive thing beyond a healthy and invigorating exchange

of ideas and views. It could recommend a way to fill the

voids, to plug the gaps, to tie the hospital "community"

together, thus enabling ETIP-VA and all other innovative

activity to be available to all to a maximum degree.

The consensus was clear, we need a "data bank," a "sounding

board," a "clearing house," — call it what you will. What

is needed is a way to capture:

Innovations in progress

Specifications

Lists of interested suppliers

User organizations

Existing, interested programs

Lists of organizations and societies

Tie-ins with all existing systems and organizations that

will be helpful.

The information must be captured by item. It must be available for ready retrieval. It must be current.

The system must work two ways. It must be able to respond

to a query for information. It must regularly publish pertinent data, output, such as ETIP-VA experiments and their

35
status. At the least it should be able to tell a questioner

where to go for advice and information.

Whatever the system is called, names such as Health Elementary Liaison Program (HELP) , health Operations PRogram Exchange (HOPE) — and many others were suggested -- whatever

it is called, it should be seen as the needed tie to bring

the shattered hospital "community" together at least for

item development purposes.

How would such a monster operate? For a monster it could

be 1 When one considers all the supplies and equipment used

by hospitals one has covered over thirty thousand items and

has considered almost any item that readily comes to mind.

Well, we must proceed in an orderly fashion. First, items

directly related to patient care should be considered, and

within that category electronic devices should be number

one. Growth should be gradual until all significant hospital items are covered.

Should the Federal Government operate this system? The

belief was that if it had the aura of a federally imposed

program it would remain just that, a Federal "big brother"

program. No, it should be a private enterprise. To get the

idea off the ground, government funding is called for, probably ETIP, but only to get it moving. Industry representatives felt that industry subscribers would be sufficient to

sustain an ongoing effort such as we envision. At any rate

we are convinced that industry and hospital subscribers

would be sufficient to sustain it, including a regular publication, listing all item improvements wherever or whenever they might be taking place or planned as well as false

starts and item evaluation information.

Therefore, we recommend that ETIP undertake the development

of a hospital industry information interchange data bank in

four phases:

(1) Planning and organization

(2) Development of test program

(3) Phase in operational program

(4) Publicize program.

Related Matters Discussed

• An interesting discussion followed a suggestion that

the hospital community could care less when a patient was

sent home. Where is there a developmental effort for home

oxygen (or the like) equipment? Response here rebutted the

36
contention that interest was lacking but seemed to agree

that except in high intensity health centers the resources

were not available for an effective program.

• Funding is a problem. Government medically oriented

agencies are scantily funded for item R&D, though liberally

funded for medical research, out of which often grows system improvement and innovation.

• Both the usefulness of and the dangers for introducing minimal performance and other standards for the

evaluation of health care products was discussed at length.

It was recognized that such standards can become so involved and complicated such as to exclude innovation.

Nevertheless, it was recognized that the small institutions

isolated by both distance and communications from the mainstream of the health care industry often could use some sort

of "standards" for its evaluation of health care products,

especially those which are expensive. Here, it was suggested that a better word to describe what would be needed

would be evaluation guidelines rather than "standards."

• Industry people felt that government too often went

overboard on specifications. They should be loose and

allow for variations in item composition. Life cycle

costing, while received as an interesting concept and with

possible future potential in the medical field, was thought

of as something only experimental at this time. It should

be tried, was the consensus, but don't rush. One objection

voiced was that the obsolescence factor was greater in

hospital equipment than any other type of gear.

• Interaction between hospitals and industry in evolution of new ideas and products in health care depends upon

the following factors:

(1) Hospital size and type, i.e., government (Federal

or state), university, teaching community hospital,

non-teaching community hospital.

(2) Various types of patients and hospital specialities

represented very markedly among such institutions.

(3) The average length of hospitalization.

(4) The age of the institution.

(5) The number of private versus multiple bed rooms.

37
• Finally, there was a discussion of why professional

societies were not better represented. The idea was advanced that the notices did not reach the right people.

Who are the right people — chairmen of subcommittees perhaps. Criticism was also heard of the announcement letter —

governmentese , no schmaltz. Next time do a little Madison

Avenue

.

38
workshop 2

research and

development

for innovative

products

RESEARCH AND DEVELOPMENT FOR INNOVATIVE PRODUCTS

From the guidelines for the Symposium the members of this

Workshop derived the following areas of emphasis for our

discussion

:

I. What are and what should be the roles of manufacturers, health care deliverers, the public, and

Government in R&D to encourage technological

innovation?

II. How can industry be stimulated to perform more R&D

for products which hospital users feel they need but

do not exist at present?

III. How can industry be better assured of long-term.

markets and thus be willing to spend their own money

for R&D?

IV. How can technology transfer be enhanced from other

industries and disciplines to health care products?

V. What should patent and licensing policies be for

research organizations which develop needed products?

While the background and general theme for this entire

program suggested an emphasis on hospital deliverers of

health care and on manufacturers of hospital eauipment - products, the members of this Workshop have tried to consider the health care field and supplier in their broadest

sense. We have thus tried to develop recommendations which

should be applicable to R&D for all types of medical products, including drugs, vaccines, biomaterials , and various

types of medical devices and equipment used by hospitals,

clinicians, laboratories, and patients. We have viewed the

discussion topics first in the light of an overall pattern

of relationships between the various sectors involved, and

further with regard to what we regard as a somewhat logical

sequence of steps in the development and use of innovative

health care products.

A. INTERRELATIONSHIPS BETWEEN SECTORS IN R&D FOR INNOVATIVE

PRODUCTS

The Workshop sees a complex series of relationships between

the various sectors involved in R&D to encourage technological innovation in health care products, with the Government

41
playing a central catalytic role in stimulating, controlling,

and expediting the various relationships, as suggested in

Figure 1.

FIGURE 1.

SECTOR INTERRELATIONSHIPS IN R&D FOR INNOVATIVE PRODUCTS

Starting with the manufacturing phase, industry develops and

produces new products for the medical community. Government

plays a regulatory role, e.g.. Food and Drug A.dministration

,

and a standardization role, e.g.. National Bureau of Standards, in seeing to the quality, reliability and safety of

products thus produced for health care delivery.

The medical community, represented by many types of individuals and institutions delivers these products to the consumer public. Government plays various roles in this

process, ranging from direct care, as under the Veterans

Administration, Department of Defense, or Public Health

Service, to provision of insurance arrangements to cover

relationships between private individuals and non-Government

health care providers, e.g., hospitals, clinics, and

practitioners

.

As the ultimate consumers of the health care products , the

public pays directly, of course, for costs that have gone

into these products, including in a sense the earlier R&D by

the manufacturers on those products and also continuing R&D

for new and improved products. Government stimulates the

latter through award of funds for research and development

42
into new areas of product development, ranging from basic

and applied research to the actual development, testing,

and demonstration of new products in the clinical setting.

While the arrows in Figure 1, indicate the flow of processes

in one direction only, as described briefly above, the Workshop noted that most of these processes have reverse components which provide feedback to the originator of each

process

.

B. IDENTIFICATION OF NEEDS

The VJorkshop suggests that identification of needs must be

the first phase towards development of new and innovative

products for health care. So that RSD and later production

may be better attuned to the viability of future markets,

the Workshop considers a number of potential improvements:

1. Identification of future requirements should be improved

by periodic and systematic reviews of the state-of-the-art

in technological fields, and of specific user needs in the

consumer area.

2. While identifying various needs, greater attention must

be paid to the priorities which these needs fill in a total

scheme of R&D/health care requirements . Such priorities

must be reviewed regularly, frequently, and systematically,

as new social values or political currents determine changes

in the directions of health care delivery needs and of R&D

requirements to fill those needs.

3. In considering both needs and priorities for health care,

attention must be aiven not only to original costs of new

products, but also to requirements for their durability and

upkeep, particularly for all types of equipment and devices.

The Life Cycle Costing concept is particularly important in

this connection.

4. So that needs and priorities may be most adequately considered, all sectors must be involved in determinations and

decisions. While technological feasibility and delivery

capability may be determined fairly adequately by manufacturers and medical communities, it is equally important to

obtain public inputs into the decision process, to determine

attitudes of the ultimate consumers of new products. A

potentially valuable role in this process may be played by individuals with talents in the new field of" "clinical

engineering" who may help narrow gaps between basic biomedical research and health care delivery. It was noted that

the National Academy of Sciences has acted in several

43
instances as a catalytic function to such interactions

,

bringing together representatives from the various sectors

to engage in productive discourse on developing technologies;

it might serve similarly in other such capacities in more

extended efforts.

C. ANNOUNCEMENT OF NEEDS AND PRIORITIESHaving arrived at decisions on directions for developm.ent of

new health care products, it becomes necessary to bring these

to the attention of the various sectors involved in the process. The Workshop members feel that certain current or new

processes may be used to enhance such communications.

1. Periodic and regular meetings, journals, and other publications by the professional and institutional societies

provide a ready and ideal means to announce various needs to

other sectors. Access to and use of such communications

media should be improved, and opportunity should be afforded

in publications and meetings for improved communications of

established needs and priorities. Annual meetings of the

Association of Operating Room Nurses were mentioned as a

particularly notable opportunity for such dialogue, with

respect to that specific field of health care.

2. Government, through its constant interfaces with the

various performer sectors, is especially able to obtain and

maintain current information on many user needs and priorities. Agency publications and meetings should thus complement those of the private sector in assisting such

communications

.

3. A single oraanization should be considered as a logical

central focus for such communications. Such an orcranization

could serve many functions, such as maintaining and operating:

a. An advisory system for public and private sector

inputs into the decision process; and

b. An information system on health care needs, including possibly a catalogue of such needs and/or a

computer function which could be accessed by outside

users, both of which could be kept current by suitable procedures

.

Such a clearinghouse organization should preferably be located outside any one organization which pursues its own R&D

functions, to avoid potential biases for R&D programs and

goals of that organization, or against programs and goals of

other organizations. The potential of the NAS was mentioned again m connection with such a clearinghouse function.

44
D. ANNOUNCEMENT OF AVAILABLE TECHNOLOGY

Given an established set of desired product needs, it is

next desirable to bring these together with whatever technological advances may exist or may be developed to meet the

needs. The Workshop considered a number of ways this phase

may be improved:

1. The clearinghouse function mentioned under C.3, as a

source for publicizing needs and priorities, might serve

also to store and disseminate information regarding available

technologies. A catalogue and/or computer system could serve

this process just as for needs-priorities information. In

a sense, the National Technical Information Service now provides such a central focus

.

2. Professional and organizational societies should provide

additional outlets for dissemination of information about

developments in new technologies. It was noted that meetings

and publications of the Health Industry Manufacturers Association now provide such a forum.

3. Mention was made also of a new technique called "computerized conferencing," now being used in New Jersey, where

new technological information is introduced into a computer

system by technology developers, and is accessed for such

information by potential users. In turn, the latter may

enter into the system their desired product needs and uses,

for stimulation of R&D efforts by potential producers. Such

techniques should enhance the entire process of technology

transfer between different sectors and perform.ers , including

those working on various Government agency R&D programs

.

E. DEVELOPMENT OF PRODUCTS

Having brought together the different inputs of consumer

needs and available technologies, it becomes necessary to

consider ways to stimulate the manufacturers to produce

desired products for health care, given in many instances

some degrees of uncertainty regarding available markets and

potential advantages versus disadvantages to the manufacturers. We noted several points to consider in these

connections

.

1. Government agencies which are constantly in touch with

various consumer sectors are in a most favorable position

to assess potential markets for various products. Such

efforts should be improved, particularlv to provide estimates about needs for such products in terms of:

a. The size of potential populations who would provide

the market;

45
b. The availability of other products which might compete with new developments;

c. The intensity or seriousness of medical problems

which would be solved by new developments, even

lacking broad markets; and

d. The potential dollar value of potential markets,

taking all three of the previous topics into

consideration

.

2. In connection with E.l, it may be essential to provide

"seed money" somehow to encourage and even enable small

manufacturers to turn their attention to innovative efforts,

especially to encourage their participation in development

of certain specific items related to their established

abilities

.

3. Where the Government agency itself might expect to use

the desired product, either through its direct operating

functions, as with the Veterans Administration, or possibly

indirectly, as through various Public Health Service granting programs, the agency might be able to suggest a possible

or probable market or procurement which would follow production of the desired item. A prosthetic device for

limited numbers of VA patients, or a new vaccine for wide

public application, would exemplify these two types of

approaches

.

4. Consideration must be given to more flexible Governm.ent

policies towards licensing, patents, copyrights, royalties,

and other rights for developers of new products when such

products are developed under Government contracts or grants.

While Governm.ent rights must be protected under such circumstances, the attitudes and practices of some agencies are so

overly protective or demanding as to discourage some potentially valuable developers from participating under Government R&D programs

.

5. Requirements for new products must be stated in terms

that are more realistic in terms of both available technologies and potential users' needs. The Workshop noted

examples of products which fitted, for instance, certain

perceptions of consumer demands, but which, when applied

to appropriate clinical settings, failed to gain acceptance

by the users, thus negating the time and efforts put into

the development by the manufacturers.

6. Just as in B.4, for identifying needs and priorities,

the various governmental and private sectors must have

ample opportunity to interact in establishing requirements

46
cited for new health care products. Industry must be consulted as to realistic requirements for production, and the

public input must be included to ensure suitability of new

products for consumer needs

.

7. Greater reliability of new products must be ensured,

possibly by institution of new licensing or certification

programs, as now accomplished under NBS . Reliability testing

must include not only immediate safety and effectiveness

measures, but also means to establish longer-range durability

and economy of operation; these latter are particularly important in many life-supporting devices or other products.

F. DELIVERY OF HEALTH CABE

The goal of all these several processes is to see the delivery of innovative products to health care delivery systems,

for application to the ultimate consumer, i.e., patients.

Since this step goes somewhat beyond those of R&D for Innovative Products, the topic for this workshop, we did not

address so completely whatever steps might be taken in this

final phase of the total process. We did note, however,

that rapid advances in the application of new technology

to the health care field should not take place without

giving adequate attention to the interface between new products and the consumer-patient. In particular it was noted

that patient needs must be identified specifically with

product needs, and that both must be considered with respect

to the in-patient versus out-patient nature of the consumer.

Adequate consideration must be given also to interactions

of the various delivery components with the patient, through

attention to appropriate organization dynamics.

Finally, we consider it of utmost importance to give careful consideration to over-all human values in the application of innovative products to health care delivery systems.

While it may be technically and even humanly feasible to

introduce various therapeutic regimens, whether by devices,

drugs, or other materials, product safety must be considered

more important than the speed of application of products

to the delivery system. Further, even given the satisfactory nature of this factor, we point finally to the need to

keep in high priority the need to maintain above all the

dignity of the human being to whom are brought the results

of all these technical and production developments. All

the potential benefits of technological innovation will come

to naught unless we consider of primary importance the need

to enhance the quality of human existence of those consumers

for whom innovative health care products are created.

47

workshops

product testing

and evaluation

PRODUCT TESTING AND EVALUATION

Discussion

The summary which follows does not fully reflect the indepth discussion which took place in several areas. It

attempts to portray the most salient elements of the discussion as a base for conclusions, recommendations, and

possibly further study.

Much discussion centered around the extent to which producers

of medical devices, in order to protect their reputation

as a base for future markets and to satisfy requirements

of regulatory agencies, continually test their products.

This may include in-plant quality control, prototype testing

and evaluating their new developments in the field to ensure

that they are marketable and satisfy the needs and demands

of their customers. However, this testing and evaluation

is not done on a universally organized, uniform and systematic basis, against recognized and accepted predetermined

evaluation criteria and performance test standards. Criteria employed is determined on an individual basis by

such producers

.

Emphasis was placed upon the wide variation in the sophistication and quality levels in medical devices and the

problems inherent in efforts by individual hospitals to

perform adequate tests and evaluations, to determine the

capabilities of products purchased. The circumstances

extant in the field of medicines and drugs as related to

medical devices was stressed by the representative from

the Food and Drug Administration (FDA) as well as current

and possible future efforts by FDA to control such devices

to assure the safety and efficacy of devices for their

intended uses.

It was generally felt that users should play a larger role

in establishing performance requirements and evaluation

criteria as well as in actual product evaluation prior to

procurement. In this regard, it was suggested that evaluation centers and laboratories should be established and/or

designated to determine, from the user's viewpoint whether

products meet producers claims as well as specific user requirements. Such a service is now being provided for the

Department of the Army by the Medical Equipment Test and

Evaluation Division of the Army's Medical Material Agency.

It developed quickly from this disclosure that a number of

government agencies, including State and local, are testing

and evaluating medical devices in varying degrees at various

51
stages in their life cycle. When added to testing and evaluation by manufacturers and associations, there is a tremendous amount of useful information being developed regarding

the relative merits of medical devices, much if not most, of

which goes no farther than the boundaries of the organization in which the effort takes place.

Inherent in this widespread and uncoordinated testing and

evaluation are duplication, high cost, and varying levels of

dependability. Some tests and evaluations are rudimentary

and largely subjective while others are more formally designed within objective testing parameters.

Conclusions

1. Medical devices are often selected without benefit of

or consideration of specifications that reflect capabilities,

design, and performance requirements. Selections are based

upon what is recognized in the market, what is currently

available, and with some reliance upon the name and reputation of the manufacturer, if known, plus price and salesmanship; price frequently being the predominant factor in

any selection.

2. In what often is a highly competitive market, manufacturers may for various reasons take short cuts , not exercise

adequate quality control over basic materials, components or

the manufacturing process or otherwise cut costs which may

lead to product defects in terms of initial or long range

performance. It was estimated that 95 percent of the items

which should be or are tested are not adequately nor properly

tested. In addition to the reasons cited above, there is

reliance by some manufacturers upon varying degrees of indepth research, prototype testing, and production quality

control. In any event, it was the consensus of the workshop

participants that products should be adequately tested when

produced and to some extent throughout their life cycle for

reliability and for possible improvements.

3. Agencies conducting formalized testing and evaluation

programs for medical devices can serve as a nucellus for

cooperative testing. However, this will require coordination,

sharing, and widespread dissemination of protocols, test

methods, and test results from which credibility can be

established progressively. Growth in the use of such test

and evaluation results should be consistent with the growth

in credibility.

4. The information dissemination process will require centralized coordination if not actual system operation. As a

52
starting point, a wealth of information based upon a sophisticated approach to testing and evaluation is already available and growing. This could be screened and prepared in

the form of digests for dissemination.

5. A listing of government facilities performing any formalized testing and evaluation would facilitate the flow of

information among the facilities and between these facilities

(agencies) and potential users of test and evaluation results.

6. A listing of tests and evaluations conducted on medical

devices and the results in terms of test proven capability

should be given high initial priority for dissemination.

7. There is an equally great need for feedback from users

of products as an extension of the "in use" test and evaluation process. This should be disseminated to decision

making officials and to manufacturers. It has an added advantage of involving users as an integral part of a dynamic

and responsive system and as a prime source from which needs

can be expressed to procurement officials and to the entire

manufacturing community.

8. A ready and reliable source of information from testing

and evaluating agencies will support alternative procurement

procedures and policies to overcome delays usually facing

the introduction of new or more innovative items. It will

also be of considerable benefit to manufacturers in initiating design changes to improve products or to overcome deficiencies. It may also provide a basis for totally new

devices to satisfy user needs.

9. There should be centralized or cooperative testing of

comparability among products which manufacturers claim

will perform the same function or functions. Such testing

should be based upon a set of characteristics to be measured.

Objective and subjective test methods should be developed

for the conduct of tests on a uniform and systematic basis.

Such information will be invaluable to users in product

selection and to manufacturers for product improvement.

10. ETIP can play an important role and one which is consistent with its objectives, by supporting the development

of an effective information interchange system as the framework within which more effective and comprehensive cooperative testing and evaluation can evolve. This will in turn

create a more favorable environment for developing and

marketing innovative products

.

53
Recommendations

1. That an information interchange system be developed

with a view initially toward the collection and dissemination

of specifications, evaluation criteria, test methods, test

and evaluation results, and product comparability test results in the area of medical devices.

2. The range of concerns expressed by participants in this

workshop for the most part do not appear to be under the

purview of a single Federal agency. There is little to be

achieved by recommending actions where there is no known

agency to which they can be referred for consideration and

implementation. Accordingly, it is recommended that an ad

hoc committee be established to design a long range plan for

harnessing the efforts of testing and evaluating medical

devices. The following areas are among those to which

initial effort should be directed.

a. Compiling a list of agencies currently involved in

testing and evaluating medical devices.

b. Development of purchase specifications.

c. Development of test protocols and methods.

d. Development of evaluation protocols and methods.

e. Development of criteria and system for postdelivery follow-up and user feedback.

f. The identification of areas for improvement in

quality control.

g. User training and operating and training manuals.

(This is important since product performance is

related in many instances to operator proficiency.)

h. The more extensive and cooperative use of Federal,

State, and local government laboratories for

testing medical devices.

i. Laboratory accreditation programs such as that of

the American National Standards Institute, College

of American Pathologists and Communicable Disease

Center which may be applicable to the medical

devices

.

j. Industry certification programs,

k. Warranties.

54
1. Product safety testing by Underwriters Laboratories

and others.

m. Hospital inspections by various bodies whose functions overlap and require a considerable time span

(as related to product selection, installation, and

use) .

n. Identification and dating by manufacturers of

medical devices as a point of reference for use in

long term evaluation.

55

workshop 4

specifications
I
SPECIFICATIONS

INTRODUCTION

The primary objective of this workshop was to examine specification practices of Federal, State and local governments

in the procurement of medical materiel and recommend methods

for obtaining innovative products and systems.

DISCUSSION

Design specifications usually state precise measurements,

tolerances, materials, in-process and finished product tests,

quality control and inspection requirements, and other information. The procuring activity accepts general responsibility for design and related omissions and deficiencies in

the specifications, drawings and bills of materials.

Performance specifications normally state performance characteristics desired for the item and design, measurements,

etc. are not stated nor considered to be essential provided

performance requirements are met. The contractor accepts

responsibility for design, engineering and achievement of

stated performance requirements subject to final inspection

and approval of product by procuring activity.

Current specifications used in the procurement of the

majority of medical materiel by Federal, State and local

government agencies are generally design oriented which

describe brand name products desired by requesting professional users. Frequently these specifications are modified

during the procurement process to afford competition among

suppliers and results in describing items which are not

available commercially from any manufacturer. Changes in

manufacturing practices necessary to meet these unique

specifications tend to increase cost of health care delivery

system.

The need for increased use of specifications which induce

more innovation in design and production of medical materiel

is vital. These specifications must provide a means for

obtaining products which include the latest technological

advancements and meet the professional user's requirements

in an economical manner.

Although the dollar value of total Federal Government and

State and local government procurement of medical m.ateriel

averages less than one-fourth of the annual market, these organizations possess the greatest collective voice in

obtaining innovative products.

59
Special Product Improvement Proarams and Research and Development Programs relative to medical materiel are established

within some Federal Government agencies. These programs

usually apply to special requirements, e.g. military item.s

for use in combat zone, and have limited application in

other health care facilities.

Standardization Boards of certain Federal Government and

State governm.ent agencies develop essential characteristics

representing the user's requirements in performance of

products. These characteristics are normally transformed

into design specifications during the procurement process

and fail to encourage innovation in products.

Performance specifications have been used successfully by

procurement agencies of the Federal Government, but this

practice has not been applied extensively to medical items.

Industry does respond favorably to performance demands of

users in producing medical items or other commodities which

are marketable.

Implementation of optimum system(s) for providing medical

materiel support to all Federal Government activities is currently moving toward actual reality. The achievement of

effective and economical support which is responsive to

users of medical items is the ultimate objective of this

project. It includes increased commonality of medical items

and centralized procurement management prescribing practices

which provide incentives to the health care industry for

delivery of the most suitable product at the lowest cost.

The application of value management techniques in detailing

specifications and evaluating manufacturer's proposals is

slowly increasing in the Federal, State and local governments. These procedures greatly enhance the capability of

procuring products at the lowest cost consistent with require

ments for performance, reliability, quality and maintainabili

A need exists for a central repository of medical materiel

specifications, standards, test protocols and test results

for use by all Federal, State and local government activities

as well as the private sector. The National Bureau of

Standards has a library of over 200,000 Federal, State, local

and technical associations' specifications and standards.

Veterans Administration/ETIP recently developed a listing of

61 major items susceptible to procurement incentives for

encouraging innovations in health care products. Through an

evaluation process, 12 items were placed in highest priority

to be obtained through procurement methods utilized to

stimulate innovations at the marketplace. Methodology for

60
development of innovative products and systems was developed

by VA-ETIP and action has been initiated on two item.s

.

Coordination of these procedures or selection of items concerned was not accomplished with other Federal, State, or

local government medical logistical agencies.

RECOMMENDATIONS

1. Performance specifications provide the most effective

means of stimulating innovative design and construction of

products by the health care materiel industry. These specifications should include:

a. Performance criteria based on input from professional

users of materiel.

b. Only those design characteristics which are absolutely necessary to insure procurement of item desired.

c. Life cycle costing and value incentive clauses to

insure quality products having meaningful service life are

procured at the lowest cost.

d. Testing and evaluation methods to be utilized in

determining conclusively that products meet all clinical,

laboratory, safety, maintenance, life expectancy and other

requirements

.

2. ETIP should serve as the catalyst in developincr performance specifications for appropriate medical items or

systems. This type specification should be prepared in

conjunction with appropriate Federal, State, and local governments and industrial organizations. Concensus mechanism

should be used to develop and communicate these

specifications

.

3. ETIP should evaluate the expansion of NBS Standards

Information Office to serve as central repository for

standards, specifications, test protocols and test results

concerning all medical materiel. This recommendation will

provide a recognized organization having a library of technical material available to Federal, State, local and industrial activities concerned with logistical support of health

care delivery systems and result in reduced costs of medical

care

.

4. ETIP should survey other appropriate Federal, State and

local government activities to provide additional performance and requirements data relative to Bedpan Sterilizers

and- Hypodermic Devices Destructors. It is recognized that

procurement of these two items is in final phase but it is

61
considered that this additional information will solidify

these actions.

5. VA-ETIP should coordinate with appropriate Federal,

State and local government agencies future actions on all

other items within their program to solicit additional information concerning evaluation of current applicable products and suggested performance and testing criteria. This

recommendation will eliminate duplication of effort and

provide greater support for ETIP

.

6. ET-IP should monitor a Task Force for development of

performance specifications concerning Surgical Gloves and

Examination Gloves. The Task Force is composed of

Mr. George Ainsworth (Hospital Bureau Inc. of N.Y.), Chairman; Mr. Wilbur Balderson (Department of Defense)

;

Mr. Alan Wonhof (Veterans Administration); Mr. James Arnold

(City of Chicago/Cook County Hospital); Mr. Donald Carte

(State of West Virginia) ; and Mr. Ross Hofmann and

Mr. Anthony Zolenas (Ross Hofmann Associates). Methodology

established by VA-ETIP for development of innovative products will be followed by the Task Force. Detailed information concerning user complaints, procurement practices,

methods of testing and average demands for each size glove

will be provided to the Chairman by each Task Force member.

The Chairman will develop a draft of performance specifications for review by all members and prepare final proposed

specifications based on comments resulting from coordinated

actions. This data will be provided to VA for use in a test

procurement of gloves. Applicable documents will be identified as ETIP Experimental Procurement and a pre-bidders

conference will be held with qualified representatives of

industry to outline ETIP concepts and potential procurements

which may result from valid performance specifications.

Each member will participate in evaluating all aspects of

the development and evaluation of this initial interagency

test of applying ETIP principles to medical materiel.

62
workshops

post delivery

performance,

warranties and

training by

vendors
I
POST DELIVERY PERFORMANCE,

WARRANTIES AND TRAINING BY VENDORS

This report will include an exposition of the charge to and

the methodology employed by the Workshop groups . Also covered will be highlights of discussions and recommendations.

Responsibility

The Workshop was responsible for the analysis of current

practices in the area of post delivery performance. Specifically included were the topics of warranties, instruction

manuals, instruction programs, cost of instruction and parts

lists. Analysis was preparatory to the development of recommendations for improvements in current practice. Recommendations were to include suggested ETIP sub programs for

the implementation of improvements

.

Composition

There were two Workshop groups. One represented a first

choice group while the other represented second choices.

The groups were balanced in composition. Representation

from the public and private hospital sector and the vendor

community was evident. This balance was essential to the

success of the Workshop. Varied viewpoints and backgrounds

provided complete insight into problems. The resultant

recommendations represented a consensus accounting for the

rights and obligations of both user and provider. It is

recommended that ETIP consider:

This balance in future symposia;

The inclusion of this balance in an ongoing fashion via

the addition of an ETIP advisory staff.

Methodology

The groups were structured sufficiently to provide for a

maximum of interplay while accomplishing objectives. Structure consisted of the following sequence employed with each

group

:

Co-chairpersons introduced the group to the purpose and

overall discussional parameters of the Workshop ; Participants introduced themselves ; A co-chairperson introduced a specific topic, specified

an optimum length of discussion time and informed the

group that at the end of discussion a preliminary summarization with recommendations would be required ; The group discussed the topic ;

65
A summary was provided;

Recoinmendations vrere proposed, discussed and adopted;

The group proceeded to another topic.

It is recommended that ETIP consider the inclusion of this

or a similar methodology as a standard recommended structure

for future symposia.

Topics

The statements and recommendations listed below represent

the consensus of the Workshop groups after discussion and

debate

.

Warranties

There is no inflexible rule for the time frame of warranties.

The length should be variable. Its extent is dependent upon

the purpose and nature of the equipment. As a minimum it

should cover a period sufficient to establish the equipment's

ability to perform.

Post delivery warranty problems can be avoided by recognizing the importance of warranties. If significant prepurchase emphasis is placed by buyer and seller on this

topic, greater understanding of extent can be achieved prior

to delivery. Contract changes can be effected prior to

purchase to preclude post delivery conflict.

An extension of warranties is the safety certification of

equipment by independent agencies and/or regulatory bodies

.

The process of certification can be lengthy and when so

radically extends the time frame with which new technology

proceeds from development to the delivery stage. Expedition

of certification, while maintaining standards, is desirable.

It is recommended that ETIP consider the creation of an

experimental program to develop means by which certification

can be expedited.

Manuals

Operation and parts manuals are essential. Consideration

must be given to the language and level of composition prior

to purchase and requirements clearly stipulated in the

purchasing instrument.

Operating instructions should be in illustrated form and be

clearly posted on the surface of equipment. A stock of

repair parts should be maintained by manufacturers for the

service life of the equipment as a minimum.

66
Training

The manufacturer or vendor should be responsible for demonstration on the proper use of equipment. The purchaser

should be responsible for specifying prior to purchase the

type, location and extent of training.

There is an absence of uniform and universal standards for

the certification of medical equipment operators. In view

of the sophisticated, complicated and life saving nature of

this equipment, some form of uniform standard should be

universally applied.

It is recommended that ETIP consider the establishment of a

research project to investigate the development of national

standards for training, testing and certifying medical

equipment operators

.

67

workshop 6

cost saving and

quality improvement through

innovative

products
•
COST SAVINGS AND QUALITY IMPROVEMENT

THROUGH INNOVATION PRODUCTS

The opening session was a general discusssion of the

following:

1. Cost savings vs. quality care - quality care must be

maintained at a high level, safety of product is the number

one priority, and cost is carefully evaluated if the other

specifications are met.

2. Disposables vs. Reusables - since the market is abundantly supplied with all types of disposable products and

equipment, careful assessment of each item must be made as

to safety, packaging, cost, usage, inventory and disposal

as opposed to cost, safety, usage, inventory of reusables,

keeping in mind increasing cost of the labor market for

reprocessing

.

3. Standardization - those present felt that there is an

urgent need to standardize materiel and equipment for all

types of health care facilities as a means of cost containment. Several areas were discussed as to how this could be

best accomplished. Some felt that a government agency

could set standards for all to follow, while others opposed

the idea. Some were of the opinion that competition was

necessary for fair pricing on the open market and to maintain quality control. Standardization should begin at home

to be effective and then move out into the health care

field.

4. Baseline for costs - most present felt there was no

baseline from which to work and there was a basic need for

this. It could be accomplished through communication,

through other groups to define common problems, some basic

methods for specifications, and that the needs of the health

care field be projected to industry for less duplication to

conserve costs and improve quality.

These discussions were on interchange of ideas and concepts

on a frank and friendly basis. It laid the base or foundation for the discussions at the next sessions so that the

problems could be defined and solutions be found.

Wednesday's sessions were spirited and informative - not

always a matter of seeing eye to eye with one's neighbor.

71
Through constructive interchange and discussion the following recommendations were proposed by the workshop;

1. Specifications.

Performance standards where possible, rather than

specific standards or design standards for better price

and quality.

The workshop group provided a consensus in favor of

performance standards wherever possible. Many people involved in health care agree that a performance standard,

particularly in areas involving expensive equipment and

systems, can provide the health care facility with cost containment means of implementing requirements. It is also

important to note that while the value of innovation is

generally recognized, the possibility and probability of

benefiting from innovations by the manufacturer, and in some

cases, the hospital itself is greatly enhanced by performance standards.

2. Dating of Medical Supplies.

All sterile supplies need to have an expiration date

affixed to the package.

Dating of any item should not increase the acquisition cost.

In order to maintain a current, safe and in date inventory,

the need for an affixed expiration date on the package

is imperative. This assists in inventory control by proper

rotation of stock, never having old items on the shelf, and

thus eliminates obsolescence. An increase in the price of

the item on the market place should not be tolerated by the

user simply because it is dated. Dating of supplies is a

safeguard for industry and health care users in providing

quality care as well as means of cost containment.

3. Health Care Equipment - such as carts, stands, shelving,

etc

.

Equipment of this nature should be constructed of materials

selected on a basis of performance.

Performance requirements should consider structural

strength, electrical safety, and microbiological integrity.

While stainless steel historically appears to be a material

of choice, performance standards should permit and encourage

the use of other equal or more suitable materials which can

72
provide equal practical durability with enhanced electrical

safety, resistance to organism growth, cleanability , and

noise attenuation. Examples can be found in some of the

coated steel products and in some cases application of

plastic laminates.

4. Industry and Health Care Users.

A clearinghouse should be established for the receipt of

any ideas and for their dissemination to health care

facilities, manufacturers of health care products, health

care providers and users, inclusive of government, industry

and health care associations. A forum of this nature should

enable dialogue of all sorts and include the magnetism for

practical discussion of suggestions, ideas, and complaints.

The workshops recommended an approach to a continuing

dialogue between industry, government and providers and it

is recommended that the machinery for such a forum be set

up and administered by the Experimental Technology Incentives Program of the National Bureau of Standards.

It is also recommended that a sample workshop would be

feasible to promote dialogue between industry, health care

providers, and users at the next symposium with selected

subject matter posted well in advance.

The workshop felt that future sessions could be enhanced by

making an effort to include representation of the State

Hospital Association in the program.

Where possible, it is recommended that future symposia be

scheduled in coordination with the National Code and

Standard Making Agencies

.

A significant indication of this symposium was the unanimous

recommendation for the establishment of such a clearinghouse

and opportunities to pursue such a venture.

Another objective in cost containment was discussed at

length - Value Incentive Clause in contracts with manufacturers, but due to its complex nature, the workshop voted

not to recommend it. There was a fear that quality of products could be lost.

73

CLOSING REMARKS

Joseph G. Berke

Experimental Technology Incentives Program

National Bureau of Standards

As I sat here trying to take a series of notes on the outputs of all the workshops, I got so engrossed in listening

that I didn't take as many notes as I probably should have.

It became pretty obvious throughout the discussion that

there were two major aspects that will require attention

that I hope ETIP, through our experiments, can take care of.

One is the whole communications problem and the other is the

development of performance specifications. I would like to

tie into some of the recommendations that were given and

how we are working towards addressing some of these and

where we are going from here. As far as the communications

goes, first of all, everybody here will receive the report

of this symposium, the reports of all the co-chairpersons,

of all the workshops fully included with a list of the workshop participants. Secondly, any information about any of

our experiments that are going on with the Federal Supply

Service and with state and local governments, is available

to anybody who wants it. The information is available by

writing to us, or to the Federal Supply Service directly.

We have identified a heading at the National Technical Information Service (NTIS) related to all ETIP experiments.

As soon as possible, we will begin putting all of these

reports and project findings into NTIS so you can get them.

On a broader scale, you who heard Dr. Ambler talk about the

other work the Bureau is doing in surgical implants, compatibility of plastics and body fluids, standard reference

materials, etc. If you wish to know anymore about NBS '

s

medically related work, please write and we will do our

best to get you that information.

As far as keeping you informed on the various projects, we

are trying to develop a product information sheet that will

be updated every time there is a change in the procurement

process, anytime there are new findings, and anytime there

is something to report. These project sheets will also be

available upon request.

It is interesting to note that the "communications media"

discussed, although not specifically, is basically a procurement document, I think that is where the procurement

part of ETIP is going to find the greatest challenge of all.

That is, to communicate through the procurement documents.
the real needs and desires of the users and get industry to

respond. We are trying to use these initial experiments,

medical, non-medical. Federal, state and local, to find out

just exactly what is needed in a product information package, if you will, that can eventually go into a major communications system that you have all been talking about.

The need, of course, is there, the specifications that you

want should be in there, based on everybody's input. The

possible size of the market. Federal, state and local, so

that industries can tap the data base and if its a generic

product, you will be fairly confident that the VA hospital

and the Kaiser Hospital in San Francisco and Doctors Hospital in San Jose for that generic item will at least use

75% of that specification; the other 25% being regional

differences or personal desires, but at least most of the

specification is there. And you will know what the market

is, test methods, and possibly a section on procurement

policy; how the item was bought. You can have a performance

specification and you can buy it many different ways, with

a Life Cycle Costing feature or a multiple award feature or

the Value Incentive Clause feature. This should provide

some rationality and continuity in the procurement process

used at all levels, where possible, for generic products.

This kind of a product list, the content of a product experiment, could form the basis for the input to this major

communications data base. We are already doing something

like that in the non-medical products going on at Federal,

state and local through our experiments and we hope to do

the same thing, a similar format, in all our medical experiments to make it as easy as possible. If any of you

ever see a product sheet, if any of you ever have any comments on it, what it should contain, maybe it should contain more for one type of industry than another, please

let us know.

Once again, about the future symposium. We would like, of

course, to have all of you who are here fill out the questionnaire, pick some dates, hopefully not conflicitng with

the myriad of other health related conferences and things

going on around the country, which apparently this one conflicted with. We're also under the gun of having to

reserve very early in the Bureau, because we run something

like 50 conferences a year and if we don't pick June, the

next opening is sometime the latter part of the year.

Spread the word if this is informative to you, put down

things you would like to see changed and we woull love to

have the suggestions and run another symposium.

ETIP also has, for those of you interested, a traveling

booth that we can put up or loan to interested groups who

would like to have the ETIP concept displayed at your

76
particular show or convention. We can make the booth

available to you to staff with your people or somebody

from ETIP could co-person it with you and spread the word

that way. Let us know. If any other information is

necessary or if we can help in any way in providing you

with documents or be of assistance in publicizing this

through your own professional association magazines,

journals, and articles, please let us know. Keep in mind

that ETIP is the catalyst in trying to get the experiment

on its way, the VA deserves a great deal of credit and will

be doing most of the real world interaction with the users

and with the industry and I'm sure they would also appreciate any input you might have in making their job easier.

When an invitation for bid with a performance specification

comes out, don't jump all over them. Think of it as an

experiment and help VA make it better.

I hope you have found this a worthwhile symposium. I know

I've enjoyed it. Based on some of the conversations I had

last night a lot of people thought it started off slow, but

then really took off. I was very encouraged by what I

heard. We will try to run the experiments that all of you

suggested

.

So, to wrap it all up, ETIP and the VA and all other participants in our state and local programs stand ready to

carry out these experiments, provide the information and

hopefully recommend policy changes that will benefit all

of you in bringing together a more rational purchasing

procedure and causing a higher rate of technological

change. Thank you.

77

PARTICIPANTS/ATTENDEES

BY

WORKSHOP

79

INTERACTION BETWEEN THE HOSPITAL USER

AND THE INDUSTRY SUPPLIER

Melvin E. Baker

Assistant Director

Veterans Administration

Hospital

St. Cloud, MN 56301

(612) 252-1670

* Frederick W. Bauer, M.D.

Department of Pathology

Chairman, Infections Committee

6701 N. Charles Street

Towson, MD 21204

(301) 828-2257

John R. Brittingham

Veterans Administration

Post Construction Evaluation

Staff

Washington, D.C.

(202) 389-5225

Robert M. Daggett

Supply Management Representative

Federal Supply Service/GSA

Crystal Mall

Washington, D.C. 20406

(703) 557-0977

R. H. Frese

Director

Contract Division

Johnson & Johnson

New Brunswick, NJ 0 89 03

(201) 524-6723

Isadore P. Ginsberg

Director, Contracts & Grants

Division

National Institute of

Governmental Purchasing, Inc.

1001 Connecticut Avenue, N.W.

Washington, D.C. 20036

(202) 331-1357

Ken Hayes

Acting Director

Care Delivery

R&D Staff Associate Director

Veterans Administration

810 Vermont Avenue, N.W.

Washington, D.C. 20420

George W. Johnston

Pathology Service (112D)

Veterans Administration

810 Vermont Avenue, N.W.

Washington, D.C. 2 042 0

Hilda Keller, R.N.

Administrative Asst.

in Nursing Service

Montefiore Hospital and

Medical Center

111 East 210th Street

Bronx , NY

(212) 920-4466

William Lenz , Jr.

Assistant to the President

Corometrics Medical

Systems, Inc.

2 Barnes Industrial Park Rd

.

Wallingford, CT 06492

(203) 265-5631

David E. O'Neill

Supervisory Procurement

Officer

Federal Supply Service/GSA

General Products Division

Crystal Mall

Washington, D.C. 2 040 6

(703) 557-8272

William Reeves

General Manager

SystaModule

Division of General

Equipment Manufacturers

P.O. Box 1059

Jackson, MS 39205

(601) 94R-3462

81
Robert G. Rose Recorder

Director

Marketing Center Anne Deatherage

Veterans Administration National Institute of

P.O. Box 7 6 Governmental Purchasing, Inc.

Hines, IL 60141 1001 Connecticut Avenue, N.W.

(312) 343-7200 Washington, D.C. 20036

Joseph A. Sawdye

Product Manager - New Products

UCC, Linde Division

2 70 Park Avenue

New York, NY 10017

* Co-Chairpersons

George C. Smith

Director of Purchasing

Montefiore Hospital and

Medical Center

111 East 210th Street

Bronx, NY

(212) 920-4466

Professor Eric von Hippel

Massachusetts Institute of

Technology

50 Memorial Drive

Cambridge, r4A 02139

(617) 253-7155

Alfred R. Weiss

Federal Supply Service/GSA

General Products Division

Washington, D.C. 20406

(703) 557-1637

Edward 0. West

Branch Manager

Victor Graphic Systems, Inc.

716 Church Street

Alexandria, VA 22314

(703) 549-7350

* Donald P. Whitworth

Senior Consultant

Don Sowle Associates, Inc.

Suite 708, Crystal Mall One

1911 Jefferson Davis Highway

Arlington, VA 22202

(703) 979-4360

82
RESEARCH AND DEVELOPMENT FOR INNOVATIVE PRODUCTS

Ralph Alterowitz

IBM

Advanced Medical Systems

18100 Fred. Ave.

Gaithersburq, MD 2 0760

(301) 840-7409

Donald R. Barnes

National Center for

Health Services Research

5600 Fishers Lane

Rockville, MD 20852

(301) 443-2850

Victor Berlin

ETIP

National Bureau of Standards

Washington, D.C. 20234

(301) 921-3171

* MG Robert Bernstein

Walter Reed Army Medical

Center

Washington, D.C. 20012

(202) 576-3475

Montyne Bisher

Staff Assistant for

Interior Design

Veterans Administration

810 Vermont Avenue, N.W.

Washington, D.C. 2 0420

(202) 389-2178

Dr. Sanford Bordman

Director, Center for

Technology Assessment

New Jersey Inst, of Tech.

323 High Street

Newark, NJ 07102

(201) 645-5273

William H. Goldwater, Ph.D.

National Institutes of Health

Bethesda, MD 20014

(301) 496-2241

Philip T. Haines

Veterans Administration

810 Vermont Avenue, N.W.

Washington, D.C. 20420

(202) 389-3854

Frank Horton

Federal Supply Service/GSA

Marketing Division FFMM

Room 2 2 8-CMB#4

Washington, D.C 20406

(202) 557-8520

Clifford E. Lanham

Tech. Transfer Coordinator

Harry Diamond Laboratories

Adelphi, MD 2 078 3

(202) 282-2274

John LaRosa

International Paper Company

P.O. Box 797

Tuxedo Park, NY 10987

(914) 357-2101

John R. Luther

Amsco Systems

16 02 Auburn Avenue

Rockville, MD 20850

(301) 424-6607

Edward Peizer, M.D.

Assistant Director

PROSTH Center

Veterans Administration

New York, NY

James R. Reid

Market Forge

35 Garvey Street

Everett, MA 02149

(617) 387-4100

Ray R. Bramhall

Assistant Director

Program Development—SRI

1611 N. Kent Street

Rosslyn Plaza, Rosslyn

Arlington, VA

(703) 524-2053

83
G. W. H. Schepers, M.D.

Heart and Lung Program

Veterans Administration

Medical Service

810 Verm.ont Avenue, N.V?.

Washington, D.C. 2 0420

(202) 389-2550

Recorder

Barbara Boerlin

National Institute of

Governmental Purchasing, Inc.

1001 Connecticut Avenue, N.W.

Washington, D.C. 20036

* Co-Chairpersons

84
PRODUCT TESTING AND EVALUATION

* Colonel James G. Borman

Staff Director, DMMB

Fort Detrick

Frederick, MD 21701

(301) 663-2001

Colonel Edward J. Carmick

4 007 Bentway

San Antonio, TX 78217

Joseph B. Davis, M.D.

Bureau of Devices

and En-vetro Diagnostic

Products

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20852

(301) 443-1879

Nicholas DeHaas

Federal Supply Service

General Services Admin.

FMEH

Washington, D.C. 2 04 06

(703) 557-3488

Ross Hofmann

Ross Hofmann Associates

2908 Salzedo Avenue

Coral Gables, FL 33134

(305) 445-5376

John D. Jordan

Director of Marketing

JCL Clinical Research

Route 6

Knoxville, TN 37914

(615) 546-0654

Mr. Frank Leach

Veterans Administration

810 Vermont Avenue, N.W.

Washington, D.C. 20420

(202) 389-2582

Robert L. Medvee

Purchasing Department

Office Manager

Washington Adventist Hospital

7600 Carroll Avenue

Takoma Park, MD 20012

(301) 891-7166

D. A. Paustian

Instrument & Life Support

Division

Bendix Corporation

Davenport, lA 52 80 8

(219) 324-9101

James J. Smith, M.D.

Director

Nuclear Medicine Service

Central Office

Veterans Administration

Washington, D.C. 2 0420

(202) 389-3195

William D. Thom.as

4415 Aspen Hill Road

Rockville, MD 20853

(703) 557-8530

Charles Travis

Consultant

4617 Randolph Drive

Annandale, VA 2 2 003

(703) 354-8898

Marvin E. Williams

Chief, Post Construction

Evaluation Staff (lOCIC)

Department of Medicine

and Surgery

Veterans Administration

810 Vermont Avenue, N.W.

Washington, D.C. 20420

(202) 389-2752

85
Alan E. Wonhof

Chief, Marketing Division

For Medical-DentalScientific Supplies

Veterans Administration Marketing Center

P.O. Box 76

Hines, IL 60141

(312) 343-7200, x2806

Anthony Zolenas

Ross Hofmann Associates

1102 Sleepy Dell Court

Towson, MD 212 04

(301) 821-7519

George W. Dew

Professional Engineer

Health Services Research

and Development Service

Veterans Administration

810 Vermont Avenue, N.W.

Washington, D.C. 20420

(202) 389-2273

Recorder

Cindy Baker

National Bureau of Standards

ETIP

Washington, D.C. 20234

Co-Chairpersons

86
SPECIFICATIONS

* George E. Ainsworth

Purchasing Director

Hospital Bureau, Inc.

80 Wheel Avenue

Pleasantville, NY 10570

(914) 769-6800 X35

James Arnold

Purchasing Agent

City of Chicago

Purchasing Department

Room 400, City Hall

Chicago, IL 60602

(312) 744-4900

* Wilbur J. Balderson

Office of Surgeon General

U.S. Army

Washington, D.C. 20310

(202) 293-8144

Allan W. Beres

FSS/GSA, Room 1110

Crystal Mall Building #4

Washington, D.C. 2 0406

. (703) 557-1583

Albert F. Brugger

American Sterilizer Co.

Chevy Chase, MD

(301) 654-4842

Don K. Carte

Fin. & Admin.

Purchasing Division

State Capitol

Charleston, Ta^v

(304) 348-2308

Clyde C. Cook.

Supply Service

Veterans Administration

810 Vermont Avenue, N.W.

Washington, D.C. 20420

(202) 389-3808

Chris Figg

Equipment Specialist

Veterans Administration

810 Vermont Avenue, N.W.

Washington, D.C. 2 042 0

(202) 343-3610

Isabel Geller

National Institute

of Governmental Purchasing

Connecticut & K Streets

Washington, D.C. 20036

(202) 331-1357

Dix N. Hinman

Fin. & Admin.

Purchasing Division

State Capitol

Charleston, YTV

(304) 348-2314

Mary M. Kolpack

Dietetic Service

Veterans Administration

810 Vermont Avenue, N.W.

Washington, D.C. 2 042 0

(202) 389-2062

John J. Madden

Specification Specialist

Veterans Administration

810 Vermont Avenue, N.W.

Washington, D.C. 20420

(202) 389-3306

John W. Marshall

Supply Service

Veterans Administration

810 Vermont Avenue, N.W.

Washington, D.C. 2 0420

(202) 389-3608

Lawrence J. Noe

HQDA (DASG-HCL)

Washington, D.C.

(202) 293-5592

87
E. N. Patigalia

Federal Supply Service

General Services Administration

Washington, D.C.

(703) 557-7827

Bert Rosen

Mister Cubicle Co., Inc.

234 46th Street

Brooklyn, NY 11220

(212) 439-9303

Louis Sorett

AMP

General Services Administration

Washington, D.C. 20504

(202) 343-7528

Recorder

Bobbi French

National Institute of

Governmental Purchasing, Inc.

1001 Connecticut Avenue, N.W.

Washington, D.C. 20036

* Co-Chairpersons

88
POST DELIVERY PERFORMANCE,

WARRANTIES AND TRAINING BY VENDORS

Richard D. Castle

V.P. St Director of Service

Castle Company

1777 E. Henrietta Rd.

Rochester, NY 14623

(716) 271-6060

James D. Gibson

Federal Liaison Representative

Castle Company

Division of Sybron Corporation

5801 Annapolis Road, Suite 306

Bladensburg, MD 20710

Dennis A. Grote

Director, Material Management

Greater Baltimore Medical Center

6701 North Charles Street

Baltimore, MD 21204

(301) 828-2067 * Co-Chairpersons

Ann Hunt

Director, Dietary Services

Mercy Hospital

. Pittsburah, PA 15219

(412) 292-7577

Alfred Jakniunas

Bio-Medical Engineer

Howard University Hospital

Department BioMedical Eng.

Washington, D.C. 2 0 060

(202) 745-1254

Charles D. Volz

Communications Specialist

Veterans Administration

Telecommunications Serv. (353)

810 Vermont Avenue, N.W.

Washington, D.C. 20420

(202) 389-5161

Einar Windingland

Procurement Analyst

General Services Adm.

FSS, General Products Div

Crystal Mall Building #4

Washington, D.C. 20406

(703) 557-8344

Recorder

Joyce Brown

ETIP

National Bureau of

Standards

Washington, D.C. 20234

89

COST SAVINGS AND QUALITY IMPROVEMENT

THROUGH INNOVATIVE PRODUCTS

Sam O. Gilmer, Jr.

Consultant

Regional Medical Programs

Service

Rockville, MD 2 0 850

John J. Grille

Assistant Purchasing Director

Mt. Sinai Hospital

100 Street & 5th Avenue

New York, NY 10029

(212) 650-6018

Laird Smith

Federal Supply Service/GSA

Office of Customer Service

and Support

Washington, D.C. 20406

Holt Thornton

Purchase Administrator

State of North Carolina

116 W. Jones Street

Raleigh, NC

(919) " 829-4504

Douglas Hesford

Purchasing Agent

Columbia Hospital for Women

2425 L Street, N.W.

Washington, D.C.

(202) 293-6562

Recorder

Barbara Lehmuth

E-T^IP

National Bureau of Standards

Washington, D.C. 2 02 34

Joseph J. Lewis

Director of Supplies

Mt. Sinai Hospital

New York, NY 10 02 9 * Co-Chairpersons

(212) 650-6018

David Lubin

Administrator, Engineer

Sinai Hospital of Baltimore

Belvedere at Greenspring

Baltimore, MD 21215

Alice H. Meyer

C.S. Supervisor

Greater Baltimore Med. Ctr.

6701 N. Charles Street

Baltimore, MD 21204

(301) 828-2067

Robert A. Ritter

President

Ritter Engineering Ltd.

4510 10th Street, N.E.

Calgary, Alberta, Canada

(403) 276-1900

91





NBS-114A (REV. 7-73)

U.S. DEPT. OF COMM.

BIBLIOGRAPHIC DATA

SHEET

1. PUBLICATION OR REPORT NO.

NBSIR 76-997

2. Gov't Accession

No.

3. Recipient's Accession No.

4. TITLE AND SUBTITLE

Proceedings of Procurement Practices Symposium

Health Care

October 14-16, 1975

5. Publication Date

February, 19 76

6. Performing Organization Code

7. AUTHOR(S} Joseph G. Berke - Edito]8. Performing Organ. Report No.

9. PERFORMING ORGANIZATION NAME AND ADDRESS

NATIONAL BUREAU OF STANDARDS

DEPARTMENT OF COMMERCE

WASHINGTON, D.C. 20234

10. Proiect/Task/Work Unit No.

11. Contract/Grant No.

12. Sponsoring Organization Name and Complete Address (Street, City, State, ZIP)

Veterans Administration, 810 Vermont Avenue, N.W.,

Washington, D.C. 2 0420

Experimental Technology Incentives Program, NBS

13. Type of Report & Period

Covered

Final

14. Sponsoring Agency Code

15. SUPPLEMENTARY NOTES

16. ABSTRACT (A 200-word or less factual summary of most si^ificant information. If document includes a significant

bibliography or literature survey, mention it here.)

The general objectives of the conference were to investigate ways for improving interaction between health care personnel and the manufacturers

of hospital products and systems, so that the demands of all hospitals

for improved and innovative products and systems can be more adequately

met; to explore various means available for encouraging innovation and

more efficient technological change: from initial research, through product development, user testing and evaluation, marketing and purchasing,

to post-delivery assistance for the using services; to develop approaches

that will permit hospitals to acquire the latest technologies more expeditiously and economically through the procurement process. Workshops

were organized to consider procurement mechanisms, information interchange, testing and evaluation of medical products, and the interrelationship between marketing, R&D and procurement. Workshops were grouped

as follows: (1) Interaction Between the Hospital User and the Industry

Supplier, (2) Research and Development for Innovative Products, (3) Product Testing and Evaluation, (4) Specifications, (5) Post Delivery Performance, Warranties and Training by Vendors, (6) Cost Saving and Quality

Improvement Through Innovative Products

.

17. KEY WORDS (six to twelve entries; alphabetical order; capitalize only the first letter of the first key word unless a proper

name; separated by semicolons

)

Certification programs; ETIP; incentives, innovation, life cycle costing;

medical products and standards; procurement policies; product testing;

specifications; unsolicited proposals; VA

18. AVAILABILITY 5<1^ Unlimited

[ ! For Official Distribution. Do Not Release to NTIS

1 1 Order From Sup. of Doc, U.S. Government Printing Office

Washington, D.C. 20402. SD Cat. No. C13

^^X] Order From National Technical Information Service (NTIS)

Springfield, Virginia 22151

19. SECURITY CLASS

(THIS REPORT)

UNCLASSIFIED

21. NO. OF PAGES

81

20. SECURITY CLASS

(THIS PAGE)

UNCLASSIFIED

22. Price

$5.00