Starting a Medical Device Company in Silicon Valley-Michael Allen-03/05/2013 - 8:30am

Event Information
Event Topic: 
Starting a Medical Device Company in Silicon Valley
Event Date: 
03/05/2013 - 8:30am
Event Location: 
Sunnyvale City Council Chambers, 456 West Olive Ave., Sunnyvale, CA
Speaker Information
Event Speaker: 
Michael Allen
Event Speaker Title: 
Vascular Designs
Event Speaker Company: 
President & CEO
Event Speaker Bio: 

Mr. Michael Allen

Mr. Allen is a Silicon Valley entrepreneur with 30 years’ experience managing and leading diagnostic and medical device companies from inception to exit.
Prior to joining Vascular Designs as President & CEO in August of 2012, Mr. Allen held the positions President & CEO of Xlumena, Chairman and CEO of Metrika, Vice President of Research & Development at Chemtrack and R&D Scientist at Syva (Syntex). At Syva, Mr. Allen was a member of the initial group that began Syntex Medical Diagnostics in 1982. At Chemtrak, Mr. Allen led the development and manufacturing of a series of physician office and OTC diagnostic devices and was part of a team that took the company public in 1993. At Metrika, Mr. Allen founded and led the company to a successful acquisition to Bayer Healthcare in 2006. The diabetes diagnostic created at Metrika is presently sold by Bayer Diabetes Care to primary care physicians internationally and is OTC in the US with a sales volume of 500,000 units per month. At Xlumena, Mr. Allen transformed the company from a virtual organization into a fully-functional entity, leading it through FDA clearance and commercialization of endosurgical medical devices that are presently being marketed in the US and EU. At Vascular Designs, Mr. Allen is leading a mid-stage medical device company that is commercializing a catheter based delivery device for targeted cancer therapy.
Mr. Allen holds a degree in Biochemistry from University of California Berkeley and has over 15 publications, including a book chapter and 26 issued and pending patents.

Event Details
Event Details: 

Starting a Medical Device Company in Silicon Valley
Silicon Valley is the world’s leader in the development of Medical Devices and the center of Venture Capital investing. Most medical devices and diagnostic innovations are originated in small “Start-Up” companies that are financed by Venture Capital. Silicon Valley maintains a unique combination of resources that foster innovation and successful implementation that is not found anywhere else.

The process of initiating a company starts with an energetic entrepreneur with a passion to develop a great idea and ends, if successful, with an exit that gives investors and employees a good financial return.

Although the initial product idea is the beginning, it is only a small fraction of what is needed to develop and market a product. Medical device companies are particularly difficult due to the heavy burden of regulatory requirements and the need to achieve reimbursement. The typical Medical Device Start-Up will require about $25MM-$50M, or more, in working capital to achieve an exit and only about1 in 10 provide a good return to investors.
Entrepreneurs are faced with an often painful tradeoff between developing their passion and dealing with the endless challenges that are needed to finance and operate a company.

This presentation will describe the general process to start a Medical Device/Diagnostics company and will including two different theories of venture investing, preparation for an initial financing, completing a financing, organizational structure, characteristics of a leader and a team, do’s and don’ts and will provide the trials and tribulations of several real life startups.