Standardization in Action: 

A Translational Curriculum

Sharon Ku, Dept. of History

Banu Onaral, School of Biomedical Engineering, Science and Health Systems 

Drexel University
• Research faculty at the Department of History

• Physicist/Sociologist/Anthropologist of Science & Technology

• ISO TC229, ASTM E56 Nanotechnology Committee member

• US-EU nanoEHS/Nanoinformatics Planning Committee

2014 Drexel Standard Summer Institute
Wallace H. Coulter Foundation

National Translational Research Partnership
School of

Biomedical Engineering

Science and Health Systems

CONQUER CollabOrative

Cognitive Neuroengineering & Quantitative Experimental Research

4

A Collaborative = A place where all collaborators studying brain function and health 

from diverse perspectives and different purposes join arOund the circle

o The circle or zero also refers to 'zero degree of separation' 

o Technology Platform: Functional Near Infrared Spectroscopy

Formerly ‘Neuroengineering Resource Center’ 

Sponsored by DCED – Commonwealth of PA
However, the road of translation is rocky, unpaved labyrinth,

despite all the innovative technologies we’ve developed! 

Regulation

Intellectual Properties 

Market Ethics

Users

Cultures

Global economy/politics

Public-private partnership
Challenges in current STEM education

• Integration between STEM, social science and humanities

• Holistic views of knowledge ecosystem

• Global views and contemporary techno-political issues

• Lack of collaboration/mutual understanding between faculty from 

humanities and engineering

• Disconnection between classroom and co-op

• The cultural of disengagement

“STEM practitioners who understand the role of their profession in society are better at 

solving real-world problems...Engineering students left their degrees less interested in 

public welfare than when they began...This culture of disengagement is a concern because 

most STEM problems have cultural and political issues built into them.”

Cech, E (2014) Nature 505: 477
Drexel solution

Standardization in Action: A translational curriculum 

Innovation

Standard

Intellectual 

Property
Historical lesson: Standard is the 

concrete meeting point of science, 

technology, society, economy, laws, 

human/animal right, ethics and 

local/global politics!

In 1963, Dr. Howard S. Barrows, MD, created 

the first standardized patient (SP) for his thirdyear neurology clerkship.
Thinking critically and 

creatively about 

standardization in action:

• Innovation-driven standardization

• Standard-driven innovation

• What does the road of translation 

look like? What does the endpoint 

(commercialization) look like? How 

to get there?

• What are the technical, social, legal 

and ethical cost to get on the road?

How to build the car, and make it run smoothly on the road 

of translation?
Standardization in Life Science: 

An translational Curriculum

Fall 2016 Winter 

2017

Spring 

2017

HIST 280: Standardization in 

Action -- A Global Perspective X

BMES 488: Medical Device 

Development X

BMES534/535: Design Thinking 

for Biomedical Engineers X

BMES 338: Biomedical Ethics 

and Laws X X

Students senior design thesis X X X
Real-world case driven themes: Translating practitioners’ know-how 

and experience into teaching

2010 Painful self-education process to make the device translatable 2017
It would be great if we have known:

What:

• Language & Metadata Standards 

• Standardizing Body

• Standardizing Risk

• Standards & Regulation 

• Standardization and Innovation

• Standardization & Globalization

• Socio-technical Infrastructures of 

Standards 

• Ethics & Justice of Standardization

• Users/Public Participation in 

Standardization

How:

• Identify shared core themes among four 

courses: A multi-disciplinary understanding 

of “body”, “data”, “risk”, “regulation”, etc.

• Faculty’s mutual class visits/teaching 

support (History, Biomed, Design school)

• Meet-the-experts from CONQUER 

CollabOrative Staff/researchers, ISO, FDA 

and IEEE

• Field trip ASTM for mock standard review 

meetings

• Combining class with students’ design 

projects and clinical co-op learning 
Student’s Design Project: 

Standardize human-machine interaction-- virtual reality 

surgical training simulator 

• Who are the users?

• Why, when and how to incorporate standards in the innovation process?

• Which standards to be cited?

• What are the technical, social, economic, legal, and ethical consequence of citing certain standards

Reality Augmented Reality Virtual Reality

User friendly VR design 

Leveraging standards to make a socio-technically robust design 

Experiment-verified prototype
ABET requirement Standardization-in-Action Curriculum

Apply knowledge of mathematics, science, and 

engineering

Life cycle of engineering design, allowing students to develop an integrative understanding and application of STEM. 

Design and conduct experiments, as well as to 

analyze and interpret data

Performance and data/metadata standardization to help students learn the foundation of engineering 

language, grammar and practice

Design a system, component, or process to 

meet desired needs within realistic 

constraints such as economic, political, 

environmental, social, ethical, health and 

safety, manufacturability and sustainability

Comprehension of “realistic constraints”, providing a systematic approach and 

concrete intellectual space to embed societal concerns and normative ethical claim 

into engineering process.

Function on multidisciplinary teams Collaboration, communication, negotiation and consensus among stakeholders.

Identify, formulate, solve problems Immerses students in a practical problem-solving environment for realistic solutions.

Understanding of professional and ethical 

responsibility

Standardization can serve as an effective entry point to materialize abstract ethical 

concerns through which reflexivity and responsibility can be better understood. 

Communicate effectively The mechanism of communication and negotiation is the core of standardization.

Broad education to impact of engineering 

solutions in a global, economic, 

environmental, and societal context

Knowledge ecosystem to understand the inherent socio-political-technical 

infrastructures in knowledge translation and commercialization at the global scale

Recognition of the need for, and an ability to 

engage in life-long learning

Aligning engineering knowledge and engineers’ ability with evolving socio-economic dynamic and timely 

societal needs.

Knowledge of contemporary issues Standards speak for contemporary issues of innovation trend, policy direction, 

national/international interests, market demands and public trust/concerns in S&T.

Techniques, skills, and modern engineering tools 

necessary for engineering practice

Standardization requires a thorough understanding of principles, assumptions, operations, and limitations of 

modern engineering tools