Medical Device Start-up Advice
Thursday, July 19, 2012

Congratulations! You have a great idea for a new product! Now, do you have the tenacity to drive it home? Being in the contract manufacturing business for medical device and start-ups, I am fortunate to routinely review many new product ideas with clients. Confidentiality Agreements, of course, prohibit sharing specific products and success stories; however, I would like to offer direction for newcomers bringing products to market based on my experience.


It is an ongoing frustration for inventors and all parties involved when incredible potential products fail to launch. Almost always--90% of the time--product failure is due to poor planning. If you are an engineer, inventor, investor, entrepreneur or simply a winner with an idea, please take the following advice into consideration before you spend another minute or dollar on your product. Your quest will be easier. You will have credibility as you gather information and partners. People and businesses will take you seriously and work harder for you when they perceive that you have done your homework. The efficiency of "trust" between all parties plays a major factor when moving forward as a team.    

I'll get right to the point in no particular order. Experience has shown us the following ideals are helpful to medical device inventors:

  1. Define your goals. Do you want to ultimately sell your idea, license IP (Intellectual Property), or market and distribute product yourself? There is no right or wrong goal, but know what you are good at. Have you any experience selling into this industry?
  2. Investigate the market size. Use research data from an established, reputable firm like Frost & Sullivan. Is there a market for 10 or 10 million devices?
  3. Do existing patent(s) search, on your own or with an attorney. Do you have freedom to operate? Are any patents infringed with your potential device?
  4. Gather preliminary manufacturing cost estimates from a reputable, experienced, ISO 13485 Certified Manufacturer. Working with designers or brokers is fine; however, if you can find a "one-stop-shop" company such as Light Fabrications, you will be able to better control costs and bring your product to market more quickly than dealing with multiple companies in different locations.
  5. You will need quotes for design, prints, prototypes, tooling, materials, clinical trials, submission of 510K, FDA regulatory testing/compliance, sterilization costs, packaging, distribution, etc. Ask a lot of questions and be open and honest with your goals.
  6. Create a business plan or work with consultants/partners to outline and define budgetary start-up costs, funding needs, risk assessment, timeline, website and general business model. Consider your manufacturer or consultant's help with FDA submission, ie. 510(k) or  513(g) to help clarify. This will be your roadmap to bring the device to fruition. You will now have credibility when finding funding, investors and buyers.
  7. For large dollar capital needs, consider a strong leadership team and dynamic experienced CEO to help promote and drive it to market as fast as possible.  With complex devices, a leadership team is as crucial to funding success as the idea itself. If you investigate, you will find individuals/teams that have demonstrated the ability to develop, make, market and sell. Partnering with a good management team will speed R&D, manufacturing and distribution channels whether it is in-house and/or outsourced.
  8. Create functional, working prototypes. Prototypes have value and purpose for market testing; not only market research but actual tests with potential users. The test type will depend on your FDA device class, I, II or III. Testing will validate your product's value proposition and clarify what is so unique or special that a hospital, distributor or user is going to purchase it. Clarify specifically how users will benefit using your product and what will motivate them to adopt it. Will they be reimbursed for using your device beyond what they normally can bill or can they increase productivity (see more patients)? Can they demonstrate that treatment in their hospital or clinics is better than others?
  9. Substantiate an exit strategy, staying in, or an industry IPO.


If you are overwhelmed, you are normal. Bringing medical products to life can be a daunting task--however, surrounding yourself with experienced players and not being afraid to take risks is key. Don't give up! We see many successes and most are those who did the work. It's hard work but it's worth the reward. Contact me to learn more and best of luck. A little luck always helps!



Jamie Cucinelli

Sales and Marketing Manager

Light Fabrications, A DIVISION OF EIS Inc.

40 Hytec Circle, Rochester, NY 14606