# Presentation: 106496

## NIH SBIR ConferenceCleveland Medical Devices Inc.Cleveland, OH   July 13, 2006 

- Robert N. Schmidt, Chairman
- _[Rschmidt@CleveMed.com](mailto:Rschmidt@CleveMed.com)_
- 216-619-5925
- 4415 Euclid Ave., Suite 400
- Cleveland, OH 44106

## Cleveland Medical Devices Inc.      

-  Founded in December, 1990
-  Use the Thomas Edison Model, Invention Factory
-  Stock owned by employees
-  2006 Sales ~$ 5.3 Million, Profitable
-  Awards
-  **Inc. 500**, 2000, 812% five year growth
-  **Inc. Inner City 100**, 2000 (34), 2001 (15), 2002 (27)
-  **Weatherhead 100**, (NE Ohio), 1999, 2000/01/03/04/05
-  **Ohio Emerging Technology Award**
-  **SBA Tibbetts Award**, Best SBIR Technologies/Companies
-  **NIH Success Story** (NIH Website)

## Are you sure you want to start a company?Here are my SBIR Company Rules.

- Never quit a good job to start a company.
- This is the best way to loose your house.
- If you are lucky and don’t go bankrupt, be prepared to starve for 5-10 years.
- It takes 7-10 years and 10 million dollars to make a medical device product.  _Lots_ more if it is a drug.
- If you have an engineering prototype (form, fit and function), then you may be as much as 5% of the way to commercialization.

## If this is your first SBIR proposal

- Set aside at least 400 hours for the proposal.  [Once you are a pro, you can get it down to 200 hours.]
- Start at least 2 months, preferably 3 months, before the proposal is due.
- Get your team together, you do not have enough knowledge to do this by yourself.

## Proposal Preparation

- Review the potential topics you may want to address.
- Select Preliminary Idea. **IN BROAD TERMS, define the problem, your company’s solution, and the research needed to achieve this solution.**
- Discuss with the NIH Program Manager
- Finalize which topic(s) you will bid [at least two months before the proposals are due.]
- Select Primary Author and Assemble a team to organize proposal preparation process.
- Obtain References
- Discuss with Potential Consultants
- Finalize Idea

## Proposal Preparation (Continued)

- Sketch Figure 1
- Drawing of your proposed concept
- Show details that are important
- Features (What do you have, both what others have, and what is new!  Show all functional details, novel features, and critical components.)
- Benefits (Why should anyone care!)
- Full page or half page?
- Completed a month before the proposal is due.

- Remember, this is worth a thousand words
- _It is the most important thing _
- _you can do in your proposal!_

## Proposal Preparation (Continued)

**Finalize Consultants and Review Idea and Fig. 1 with Consultants**
- Obtain Resume (NIH BioSketch) and Background papers from consultants
- Discuss preliminary Statement of Work (SOW) and preliminary cost with consultants
- Prepare Tables and Figures
**Go, No Go Decision with Management**

- If you don’t have a good concept and SOW,
- cut your losses short – quit now -
- at least three weeks before the proposal is due!

## Proposal Preparation (Continued)

- Prepare written SOW for Consultants
- Prepare Table of Contents with Assignments for Sections
- 	– this should be at the 1⁄4 page level
- 	- every page should be planned out, what will it say, and who will write it
- Obtain equipment/facilities & comments on SOW from Consultants
**Prepare first draft of proposal for review – 15 days before your proposal is due. [Don’t – **_**Don’t**_** write your first words until your tables and figures are finished.]**

- If your consultants aren’t interested now,
- it will never get any better!
- Switch consultants now or quit altogether.

## Proposal Preparation (Continued)

- Obtain Letter of Support and final cost proposal with consultants
- Management to complete cost proposal
**2nd draft of proposal – 10 days before the proposal is due.**

- This draft should be pretty good.

## Proposal Preparation (Continued)

- In-house review by non-author and where appropriate by consultant(s)
- Final draft
- Proof Read and incorporate proof readers comments – Note: the author must not be the proof reader!!
**Submit Electronically**

_**Have you answered the mail?**_
- Did you go through and answer each and every
- requirement of the FOA?

## Summary

_**Never quit a good job**_ to start an SBIR company.
- Start your proposals _**2-3 months**_ in advance and budget at least _**400 hours**_.
- In the proposal, _**answer the mail!**_
_**Network!**_  Join local/regional organizations to keep updated on SBIR/STTR news

## NIH SBIR ConferenceCleveland Medical Devices Inc.Cleveland, OH   July 13, 2006 

- _[Rschmidt@CleveMed.com](mailto:Rschmidt@CleveMed.com)_
- 216-619-5925
- 4415 Euclid Ave., Suite 400
- Cleveland, OH 44106

- Questions ?

**NIH SBIR Conference****Cleveland Medical Devices Inc.****Cleveland, OH   July 13, 2006 **