Medical Device Entrepreneurship
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Medical Device Entrepreneurship, by Charalambos Anastassiou, UCY. Understanding funding, licensing from university working in one of the most entrepreneurial areas in the world, Boston Massachusetts,USA.
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Medical Device Entrepreneurship
- 1. Medical Device Entrepreneurship Working in Boston, MA Charalambos Anastassiou, PhD University of Cyprus (UCY) March 23, 2017 03/30/17 1
- 2. Overview of presentation My story Sources of funding Collaboration with University Lab usage Licensing Medical Device Registration Quality System. FDA clearance other registrations 03/30/17 2
- 3. My story starts1992 Univ. of Iowa
- 4. Graduate School Princeton University 1996
- 7. 03/30/17 7
- 8. What to do with this discovery? Can you commercialize it? Is it worth it? 03/30/17 8
- 9. 03/30/17 9 1. Seed Funding 1999
- 10. 03/30/17 10 2. Seed Funding 1999 $40,000 to purchase computers and run simulations for the idea. Rich MIT Alumni
- 11. 03/30/17 11 3. First Round Funding 2000 • Network of Angel Investors • Total $4 Million • Founding of OmniGuide Communications by 3 MIT Engineering professors and one MBA graduate
- 12. Create a new type of fiber that would transform telecommunications I join 2001 **
- 14. Technology License Office (MIT) 03/30/17 14 • Once it is patented, the founders of the company work with the TLO to get exclusive rights. Inventors have preference • Patents are never assigned to the company. Just the “exclusive rights” for certain applications • “Typical” agreement was $10,000 for 2 years plus percentage revenue if used.
- 15. Other Benefits to being close to University 03/30/17 15 • Had agreement for setting up company’s equipment at MIT. OG provided equipment, MIT the space and co used them. • Had agreements to use other lab equipment and services (paid) • Interns and employees from MIT and surrounding University. *Must be very careful not to mix the two. Need clear policies for doing this.
- 16. 03/30/17 16 The Early Years • 2000-2003. telecommunications not much traction • 2003-2005. Both telecommunication and Medical and Telecom
- 17. 03/30/17 17 Switching to Medical 2005 • Easier to focus on one. • Medical was getting a lot more attention Typical of startups. This is what is called in Lean Startup “Pivot” Discussion: Why is the Pivot necessary it seems? Why can’t you get the right idea from the beginning?
- 18. 03/30/17 18 Lessons 1 and 2 1. When the market speaks you listen. Initial assumptions don’t mean anything. Do you know what youtube was originally? How about uber, facebook? 2. Team is more important than the original idea. The talented team will adjust and “pivot” to succeed.
- 19. 2005 Medical Product Launched
- 20. 03/30/17 20 Lesson 3 3. Early Success is Important “Early success (no matter how small) in the market boosts morale, validates your assumptions and gives you momentum. It validates your timing is right and shows you how to break down long term plan into short term achievable goals”
- 21. 03/30/17 21
- 22. 03/30/17 22 What is needed for Medical Device company? REQUIREMENT USA EUROPE & PARTS OF THE WORL QUALITY SYSTEM “21 CFR PART 820” QUALITY SYSTEM REGULATION ISO 13485 CERTIFICATE SPECIFIC APPROVAL FOR YOUR DEVICE BASED ON INDICATION FDA CLEARANCE (SUCH AS 510K PREAPPROVAL) CE MARK
- 23. 03/30/17 23 SMALL DIVERSION Lets talk about QUALITY BEFORE WE GET BACK TO THE REST OF THE PRESENTATION
- 24. What is Quality? Quality is….. •Meeting goals and requirements based on acceptable performance •Assuring the fitness for purpose •Consistent from product to product. •Continuous improvement
- 25. Quality is to say what you do and to do what you say
- 26. Example: Boxes with pens 1. CAPS 2. PENS 3. BOXES
- 27. What are the requirements? All parts are good (no scratches or blemishes on the box, pen and caps and all pens function) Each box always contains 20 pens Each cap is installed exactly the same way onto the pen. The orientation of the pen/caps with respect to the box is always the same.
- 28. Quality ensures requirements are met Quality Assurance 1.Procedures are written for each step. 2.Forms are created to be filled as the product is made 3.Indicators are kept to trigger improvement actions. Statistical Analysis Quality Control 1.Final product and forms are inspected. 2.Ensure that each product that leaves the door is according to specifications. 3.Defective product analyzed
- 29. Key Performance Indicators (KPI) Number of boxes shipped per week Percentage of parts rejected incoming inspection. Percentage of boxes rejected at the final inspection. Number of customer complaints per week
- 30. Key components of Quality System Training Management Review Document Control Incident (complaint) management Internal Audit Measuring Effectiveness (key indicators)
- 31. • 2006: VP of sales hired. • 2006-2013: Another 4 rounds of VC funding (equity based) • 2013: Non-equity loan from OrbiMed “Healthcare Fund management”. Loan will be repaid from royalties. • 2014: 100,000 surgical procedures completed Back to History of OG
- 32. Review key terms Equity Taking a percentage of the company for the investment. Valuation This determines the equity taken for a given investment size. Royalties
- 33. Another 4 reasons of our success 4. Engineering and Marketing worked together from day one. 5. Key first investor, Ray Stata, mentor to the founders. 6. Prototyped early and often. 7. A “do what you can with what you have” culture coming from founder and CEO.
- 34. 03/30/17 34 Sources of Funding: Summary 1. Competitions, Awards. 2. Rich Alumni 3. Angel Investor Network. 4. Venture Capitalists 5. Traditional Banks (once you have assets) 6. Specialized Funds (typically pre IPO. Something between traditional Bank and VC)
- 35. Thank You Charalambos Anastassiou, PhD canast11@ucy.ac.cy 03/30/17 35
Editor's Notes
- Degree in Physics and Engineering 2. Very much focused on academics. Not knowing anything about companies etc.
- Interest in Entrepreneurship started with a class. Does your institution offer a class. Taught through business cases and discussions in class. Still remember a few of them. One is on valuation. How much do the investors take? What we all said and what was the correct answer.
- The invention is patented it becomes the basis for the company.
- They came 3rd and got $10,000
- Is there any fear that people will not want to patent with the So in 2000 till 2006 we have exclusive rights to commercialize telecom applications. In 2003 we also got rights for medical applications and we keep those till today.
- This is typical and nothing that should make someone upset. This is where you need to have maturity from investors. Why not get the right idea from the beginning? Part of it is because people tend to be inspired once they see, touch and feel the final product. The closer you are to final working product the easier for them to imagine and recommend new uses.
- This is typical and nothing that should make someone upset. This is where you need to have maturity from investors
- Importance of early success. It
- Early success makes everyone happy. Entrepreneurs, and investors. Everyone feels they are on the right track. You do not want to have 10 year development without a test in the market.
- Early success makes everyone happy. Entrepreneurs, and investors. Everyone feels they are on the right track. You do not want to have 10 year development without a test in the market.
- Do people know what Quality is? What is Quality assurance? What is Quality Control?
- This has the essence of what quality is. You say what you do means you have procedures, training forms so you can track and control your actions. And then you do what you say means you follow what you have written.,
- This is a very simple factory. We receive three parts (Caps, Pens and Boxes). And our product (what we sell and offer to the customer) is boxes filled with pens. What will make our product a high quality product? How do we start?
- Indicators in this case would be percentage of parts that fail initial inspection. We will look at more indicators on next page. So here you can see why the Quality person must be separate from the person who puts the product together. So there should be no conflict of interest.
- This is an example of what we would keep. You decide what is most important for your business. Now if you imagine that you have thousands of products and hundreds of thousands of customers (past and present) then you need statistical analysis and graphical presentations to monitor Quality.
- This is an example of what we would keep. You decide what is most important for your business. Now if you imagine that you have thousands of products and hundreds of thousands of customers (past and present) then you need statistical analysis and graphical presentations to monitor Quality.
- This is an example of what we would keep. You decide what is most important for your business. Now if you imagine that you have thousands of products and hundreds of thousands of customers (past and present) then you need statistifcal analysis and graphical presentations to monitor Quality.