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Starting a Medical Device Company: A Case Study Gerard L. Cote’, Ph.D. Department of Biomedical Engineering Texas A&M University

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Page 1: Starting a Medical Device Company: A Case Study Gerard L. Cote’, Ph.D. Department of Biomedical Engineering Texas A&M University

Starting a Medical Device Company: A Case Study

Gerard L. Cote’, Ph.D.

Department of Biomedical Engineering

Texas A&M University

Page 2: Starting a Medical Device Company: A Case Study Gerard L. Cote’, Ph.D. Department of Biomedical Engineering Texas A&M University

Introduction- Where do you start?

Money Personal Type of company Location of company NO!!!

IDEA! (I started with a patent that my advisor & I wrote when I was a

grad student that we pitched to two companies and one funded it as a grant to the Univ.)

Page 3: Starting a Medical Device Company: A Case Study Gerard L. Cote’, Ph.D. Department of Biomedical Engineering Texas A&M University

What are the ways to fund a company?

Venture Capital Angel Investors Bank Loans Friends and Family Personal Savings Federal/State Grants (SBIR/STTR)

How I started my first company as a faculty member with my Ph.D. students

Regardless of the path, writing requests for support are common, if not integral to getting the money.

Page 4: Starting a Medical Device Company: A Case Study Gerard L. Cote’, Ph.D. Department of Biomedical Engineering Texas A&M University

What are the Pro’s and Con’s of the various funding mechanisms? Risk versus reward. Who owns the

company? How much are you

personally liable for? How long are you

willing to wait?

Page 5: Starting a Medical Device Company: A Case Study Gerard L. Cote’, Ph.D. Department of Biomedical Engineering Texas A&M University

Who do you need or want to start this company with you? Board of Directors? Scientific Advisory Board? Employees

Engineers Scientists Business people Marketing Secretarial

How much experience is required of each and how much education?

Page 6: Starting a Medical Device Company: A Case Study Gerard L. Cote’, Ph.D. Department of Biomedical Engineering Texas A&M University

Where do you want to be located and why?

Big City Small Town (started here for convenience) East Coast, West Coast,

Mid West, South, International?

Where is the money? What is your family status/values? Do you need to travel a lot? What resources does the company need (personnel & goods)?

(Ended here for resources/travel)

Page 7: Starting a Medical Device Company: A Case Study Gerard L. Cote’, Ph.D. Department of Biomedical Engineering Texas A&M University

What type of industry do you want to become?

Manufacturing, R&D, consulting? Large company or small company? Bioelectronics based, biomechanics,

biocomputers/software, biochemical, consulting-think tank?

Page 8: Starting a Medical Device Company: A Case Study Gerard L. Cote’, Ph.D. Department of Biomedical Engineering Texas A&M University

Getting Started- Requests for Support

How do I request support from the government, private foundation, or VC’s?

Know your audience: High Tech versus Mostly Business?

Page 9: Starting a Medical Device Company: A Case Study Gerard L. Cote’, Ph.D. Department of Biomedical Engineering Texas A&M University

The Case Study: BioTex/Visualase

http://www.biotexmedical.com

Page 10: Starting a Medical Device Company: A Case Study Gerard L. Cote’, Ph.D. Department of Biomedical Engineering Texas A&M University

The Case Study: BioTex, Inc.

Formed in 1997: The mission of BioTex is to explore, develop, and commercialize novel optical technologies for medical, biomedical, and environmental applications.

Founders (G. Cote’, A. Gowda, R. McNichols, S. Rastegar)

Currently roughly 15 employees (4 Ph.D.’s) Focus – Early Stage Product Development using

Biomedical Optics including Diagnostics, Therapeutics, Biosensing, and Imaging

Funding – Over $20M, primarily through SBIR funds

Page 11: Starting a Medical Device Company: A Case Study Gerard L. Cote’, Ph.D. Department of Biomedical Engineering Texas A&M University

Where BioTex started

Mailing address – P.O. Box at Mailboxes etc. in College Station, TX

Working address listed as my home address; garage + office space in the house.

After our first funded grant in the glucose area we rented space in an old Bank building above the Subway in Bryan

Drs. McNichols and Gowda finally got paid but not well for Ph.D.’s

We quickly got more funding and more Space in that Building with more pay too!!

We hired our first BME UG student part time while he was finishing his B.S. and also hired other part time technical help UG’s in BME and my wife to keep the books.

Page 12: Starting a Medical Device Company: A Case Study Gerard L. Cote’, Ph.D. Department of Biomedical Engineering Texas A&M University

The first Big Move for BioTex

BioTex was working very collaboratively initially with the TAMU Vet School and then with M.D. Anderson Cancer Center and UTMB in Houston, TX

In about 2000 the studies in Houston and Galveston became more time intensive and so we decided to relocate to Houston by the medical center

Page 13: Starting a Medical Device Company: A Case Study Gerard L. Cote’, Ph.D. Department of Biomedical Engineering Texas A&M University

Current Facilities of BioTex, Inc.

BioTex currently maintains a 4300 sq.ft. research and development facility located at 8058 El Rio St. within the Plaza Del Oro Business Center in Houston, TX.

The space includes a full array of engineering and fabrication tools including dedicated areas for optics, lasers, chemistry, spectroscopy, electronics, and machining capabilities.

The facility is minutes away from the Houston Hobby Airport and The MD Anderson Cancer Center with convenient access to collaborators at other surrounding institutions including Texas A&M University and The University of Texas Medical Branch at Galveston.

Page 14: Starting a Medical Device Company: A Case Study Gerard L. Cote’, Ph.D. Department of Biomedical Engineering Texas A&M University

The Technology

Laser Therapeutics –Heart/Brain/Spine/Prostate/Liver

Laser Diagnostics – OCT Fluorescence Biosensing – Glucose

Page 15: Starting a Medical Device Company: A Case Study Gerard L. Cote’, Ph.D. Department of Biomedical Engineering Texas A&M University

The first spin-off: Visualase

Visualase, Inc. was founded in 2005 as a spin-off from BioTex, Inc., the original developer and current manufacturer of the Visualase technology. Visualase, Inc. is currently a privately held VC funded company located in Houston, Texas.

MRI guided Laser Therapy

Page 16: Starting a Medical Device Company: A Case Study Gerard L. Cote’, Ph.D. Department of Biomedical Engineering Texas A&M University

The Companies Future

The Plan More Spin Off Companies – with VC or

Angels for the more mature technologies Maintain the primary company to continue

multiple early stage product developments

Potential Problems Personal issues for the spin offs All assets regarding spin offs

Page 17: Starting a Medical Device Company: A Case Study Gerard L. Cote’, Ph.D. Department of Biomedical Engineering Texas A&M University

THANK YOU