As part of our 20^th anniversary celebrations, we asked our experts to share the biggest lesson they have learned in medical device commercialization.  Several themes emerged: budgets, production readiness, usability, and what to tackle first.  Here are their top 13 lessons learned in no particular order.

1. Take the budget you have prepared and double it. It always costs more and takes longer than you first think. If the number one lesson is double your budget, what should you do?
2. Define a goal that isn’t “be in production”. Everyone wants to be in production, but what’s the first thing you need to do to get there? Do you need a clinical trial? Do you need to raise a lot of money to solve your technical challenge? Do you need to conduct usability testing because your device is completely different from the current standard of care?
3. Don’t confuse a working proof of concept with a product. They are not the same thing. You might have a working device and think you have solved all the technical problems, but scaling can present new problems – there’s nothing worse than being ready to start manufacturing and somebody says, “It’s not safe”. Now you have to go back and completely rework the whole thing. That’s the impact of postponing non-technical or small problems to later.
4. Do not take the first device that works straight to market. Going to market with the first working device will cost you more money to make than it’s going to make for you. Even though the first device works, a good rule is to have 10 of the exact same units (or more) work without problems.
5. Fail fast and cheaply. It takes a lot of time to figure out what the first milestone is. Focus more on how to increase your valuation rather than simply plodding ahead with design and development. Identify two or three things that are your biggest risks. Decide which you will handle and which you will outsource. Get to the core of these problems sooner and cheaper.
6. Don’t try to be all things to all people. Be very focused on your next major milestone and your minimal viable product. Avoid thoughts like “Well, we can add that feature in” – that type of logic will move you further away from just getting to the first really valuable milestone.
7. Include usability early. Training and user documentation often get delayed until the end. When that happens, there are usually huge problems. Don’t think of your product as just the device itself. It’s much more than the physical thing. It’s a system that requires training and documentation. If you forget training and documentation until the end, you will incur more costs and time.
8. Don’t launch without getting your ducks in a row. With technology and usability, it’s often “Oh, we’re almost done. Let’s plow ahead. We know we’ll solve the problem eventually”. It might take a bit more time initially, but in the end it’ll save you money and time.
9. Don’t work on things that are easy or unnecessary until you solve the biggest problems first. Being laser focused on one thing doesn’t mean you should forget about usability or documentation until later. One benefit of using a service provider is their ability to add eight people to a project quickly. If you need usability or software, those people are easily identified and made available. This allows the team to focus and think of things at the right time. They can focus on the big challenges and consider what’s worth putting off until later. It’s about what’s biggest. There are lots of things that people consider big, but what’s really biggest is that which gets valuation up as fast as possible. It isn’t necessarily making a thing that technically works in all sorts of ways.  It might be showing the clinical validity of a device, or a massive market being addressed. It could be all sorts of other things that don’t immediately come down to engineering.
10. Major challenges oftentimes aren’t technical or initially identified concerns. Instead, the biggest challenges might be the usability or something that you haven’t been thinking about. That’s where experience and service providers can add value. They have been through the process many times and can see a bigger picture.
11. Consider how your technology might be applied elsewhere. Is it possible to increase the value extracted from your innovation in a completely different program, product, or market? Did you realize you could do this, something completely different, or unlock this whole market or capacity or function in a different use case? Be careful about scope creep. As we learned in lesson number 6, pivoting markets or creating a product family (one after the other) is  usually safer than trying to create a single device that does it all.
12. Understand the regulatory implications of medical products compared to non-medical applications of the same product. For example, in certain markets, you must address Reach and RoHS, or other regulations that apply to any product, not just medical devices. A great medical device could have something in it that doesn’t follow the local electronics regulations. It’s difficult and frustrating to change a complicated medical device for non-medical reasons. It’s just as difficult to make that type of change as it is for medical reasons. Non-medical commercialization is part of commercialization too.
13. Plans must be dynamic. You can have a good plan, but be ready to change it if and when a better opportunity or a challenge presents itself. Spot your opportunity. Be ready to adapt your plan to take advantage of the opportunities (or avoid or solve your challenges).

Medical device commercialization may be the closest thing there is to “rocket science”. We hope our experts’ biggest lessons will help others reach the moon in their own medical device commercialization projects.  Please comment and share your favorite lesson with other readers.