4 Steps on the Path to Medical Device Startup

Medical device startup is driven by creativity and innovation.

But without a large budget for in-house research and development (R&D), licensing or acquiring a new technology, many start-up companies lose market share to those with deep pockets.

To avoid the bureaucracy of a large organization, the bootstrapping “skunkworks” style of innovation has become much more common in recent years. As a result, expect to see a large share of the next medical device innovations coming from small companies – especially wearables and biomedical, wellness, and lifestyle applications.

Are you daunted by the idea of bringing your idea to market to compete with the big players? You aren’t alone, but it also isn’t as impossible as you might think. Many of the recent innovations begin as an interdisciplinary team of students working on degrees in engineering, medicine and business. There are lots of ways that these ideas and innovations can turn into a product in a relatively short time frame.

Tap everyone you know that can help, provide useful criticism, and lessons learned from competing or older products. this includes physicians and nurses to discuss problems they encounter and their wish lists for solutions and unmet needs first hand. Tap biomedical technicians for ideas on which products out there are ready for revision, where the weaknesses are, where the repairs seem to be most frequently required, and so forth.

This is part of your R&D. Ask patients, family and friends what they use, what they lack, and for features that they would like to see added to existing applications, tools, gadgets, or medical equipment they have been prescribed.

Couple your technical advisers with mentors that can offer real world business experience that can help you to turn your idea into an actual company. This includes attorneys, venture capital firms, investors, business school professors, and others. They will help you get past the proverbial “Valley of Death.” The National Science Foundation called this the “lull between government funding for research and industry support for prototypes and products.”

There are often business plan competitions that offer cash and in-kind prizes to startups that need funding. they give you an opportunity to pitch to pre-screened investors invited to judge the competition. Also tap the small business administration for free advice on entrepreneurship, and also the Service Corps of Retired Executives (SCORE) to benefit from their counsel.

Apply for as many grants, competitions, and funding opportunities as you can find. Make it your goal to raise at least $100,000 in non-dilutive funding. You will be pre-revenue, and you will be exposed to numerous offers from investment groups, manufacturers and distribution experts who will be excited to work with you as you continue to develop a clearly articulated plan for your product.

Taking a medical device from idea to startup company to an actual in-use device is no easy task. Here are some valuable lessons to help you along the way:

1) Besides dedication, your team is the most important factor for success. Gather a powerful interdisciplinary team to take advantage of invaluable mentoring resources. There will always be someone willing to assist or partner with you. Find them and get to work. Make sure you do the paperwork and get them to sign the appropriate non-disclosures and non-circumvention documents before sharing too much. A well-meaning relationship can turn nasty down the road when greed arises. It happens. That’s life. Expect it and prepare for it.

2) Apply for every grant, competition or funding opportunity you can find. You may only win a small portion of these grants, but without the funds to continue, the “Valley of Death” will become a frightening reality. Be as frugal as possible with every penny and every minute of your time.

3) Read “The Lean Startup” by Eric Ries and Alex Osterwalder. Some of the most important principles you’ll find there are to make a hypothesis of an idea, validate your idea with actual customers, and pivot based on the feedback. Tap as many experts to gain unbiased feedback from anyone who would use your device or technology. Be able to pivot quickly based on these responses. Another great resource to read is “Biodesign: The Process of Innovating Medical Technologies.”

4) Learn how to write a press release. There are numerous outlets to post your release for very little cash. Tie the press releases back to your website through links, and be sure to list a contact for phone calls and meeting requests. Talk about benefits of your invention instead of features. Benefits sell the product idea, while features give your competition something to copy and compete with.

We’ve helped startup medical practices, medical device startups, health tourism providers, concierge physicians and dentists, ACOs and PCMH practices, and software engineers in many projects around the world. We assist them with a product design and roll out strategy, market research, as subject matter experts, and as contracting and reimbursement strategists. Often our insight saves hours of other activities and thousands of dollars in avoided mistakes from trial and error. If you’d like to discuss how we might help you, please contact us. We love to help students and watch them succeed. But we also advise seasoned entrepreneurs and investors with due diligence, market comparisons, and idea innovation. Let us know how we might be of help.

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