Medical Device Commercialization Resolutions Looking for a good resolution to improve your medical device commercialization in 2019?  Here are 9 great resolutions recommended by our team of engineers, designers, QA/RA, and manufacturing professionals.

Dial in your value proposition. It is one of the hardest things to do and one of the biggest things that would give you value, but not necessarily. The subtleties between one and another will not be recognised by early investors. You would be better to go for milestones.  Bench-top proof of concepts, any sort of clinical indication or evidence, IP filings, or clarification of regulatory path are the big early valuation milestones. But don’t forget the heavy lifting on dialing in and validating your value proposition.

Don’t spend time or money on things that aren’t part of your value proposition. A lot of medical device entrepreneurs get really hung up on the QMS. They think and plan for it when they don’t probably need to. Knowing when QMS is important, not spending time on it. Sometimes medical device entrepreneurs get really interested in cool things like lasers and realize later that lasers may be useful, but aren’t what their KOLs really care about. Don`t spend a lot of time thinking about these types of things until you do the one thing which is going to give value.

Remember who your customers are and what your goal is. If you forget either of those, you can start to drift pretty quickly. Focus on exactly what the customer is going to do with your device. They’re going know if it doesn’t perform as expected. You’re trying to make is a prototype for this state or you’re trying to show X, Y or Z. Do not get ahead of that goal until approval.Top of Form

Understand your clinical outcomes before you jumping into product development. Top of Form
Really understand what your clinical outcome is and what you are expecting clinically out of your product. It’s actually something of the clinical trial that can drive a clinical decision.

Clinically better is not always a winning proposition. Usually technical investors who invest in inventors underestimate how hard it is to drive something into the market. How much better it has to be than the incumbent product in order to break into the market. Sometimes they can be blinded by their love of the technology solution. They get delusional about how much better it is and how much practical difference that will make to the life of a nurse. Three decimal places isn’t going to help anyone. Bear in mind that the value proposition that wins in the market is typically the one that delivers about the same outcome, but cheaper.

Don’t set a ridiculously short timeline to get to a full traversal of the product development lifecycle. Instead pick a shorter, more immediate, higher value increment, and still expect that there will be spins and iterations beyond that. Rather than trying to look all the way to the end, think: “Hey, what do we do in the next half year to make us more valuable?” Just lose sight for a moment (or at least let your eyes blur) on when that device might actually hit production.

Choose the market where you can get the easiest approval. Focus on simple indications for use versus solving all of the problems you’re going to solve, just to get the device on the market. Then use your own device as a predicate for additional extended labelling. Have multiple generations of the device. Don’t try to solve everything at once with a million features

Talk to more people. Talk to about 20 expert users before you start developing. That doesn’t come naturally to a lot of technical founders. Often they’d rather spend a day in the lab working on their algorithm or their proof of concept than having uncomfortable conversations with people who are skeptical of a brilliant innovation. Keep talking to people until you start hearing all the same stuff back. That number is going to be around 20 or so.

Dilutive funding is OK.  Just make sure it is the right amount of dilution at the right time. That’s the key. Be super-efficient on what you need to do to get to a higher value when your value is small. That sounds obvious, but it’s very tricky to communicate. Certain things you can kick down the road a bit until your value is higher. Then you should revisit those items.

Any of these ideas will help you deliver better results in 2019.  We  would love to hear and share your ideas or talk to you about your commercialization needs and challenges.

Astero StarFish is the attributed author of StarFish Medical team blogs.  We value teamwork and collaborate on all of our medical device development projects.

 


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