Guest Column | October 8, 2021

Medical Device Commercialization: Traits For You To Be Successful, Part 1

By Thomas Hickey, founder & host, MedTech Gurus Podcast

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In a funky coastal town known as Grayton Beach in northwest Florida, tucked among the trees is a rustic little compound called Hibiscus Coffee & Guesthouse. It’s a place to hang with local Bohemians, enjoy a little tranquility, and be within walking distance of one of America’s best-rated beaches.

Out front, an ivy-framed, gray slate chalkboard hangs from a tree with the word “BE” painted at the top. Each day before dawn, a new word is chalked in below, and each word is a virtue. BE kind … BE patient … BE understanding … BE gracious … BE driven … you get the idea. They never run out of virtue reminder words. After all, Hibiscus is “The place to BE …,” according to its website.

In similar fashion, there are virtuous ways to “BE” when you’re working hard to move your promising medtech innovation further along the pathway to commercialization, success, and prosperity. In two recent podcasts, Episode #85  & Episode #93, Med Tech Gurus spoke with Kevin Buckley and Neil Thompson of Torrey Pines Law Group and Chris Garabedian of Xontogeny and PBX Fund. Torrey Pines Law Group, with offices in Southern California, focuses almost exclusively on protecting intellectual property (IP), while Garabedian founded Boston-based Xontogeny five years ago to support hopeful new technologies from early development through clinical proof of concept. PBX Fund invests in these promising entities.

Between these three gentlemen, great insights were shared with our listening audience about how to “BE” as you bring your innovation to market. We’ll cover the first five of nine virtues below and pick up in a second article with the remaining four.

Be Humble, Vulnerable, And Trusting

In the podcast, I asked Garabedian, “What’s the one thing you wish all entrepreneurs knew about getting a company funded?” and he told me simply, “They don’t have to have everything perfect and don’t have to know every little detail about the process. There are others who can guide you. Grit and vision are important, but there’s plenty more to the process and you need the support and advice of area-specific experts. This takes humility and vulnerability.”

Be Courageous

Paranoia can lead to paralysis. Don’t feel you have to keep your idea cloistered for fear of giving away your IP. People can’t help and guide you if you’re hiding some or all your cards. You’ve got to lay your cards on the table and determine if you currently hold a winning hand. Know what’s there and what’s not. Garabedian says not to fear sharing your innovation, just be sure you’re sharing it with ethical types.

Remember, reputable venture capital firms are not in the business of stealing ideas. They’re not developers and innovators; they’re searching for what they believe is a wise, calculated financial risk for the purpose of wealth-building.

Most importantly, solicit feedback from wise business minds and give thoughtful consideration to why others believe your idea won’t fly, then course correct. Remember, you’re trying to get to the point where, with 100% confidence, you can stand up and defend why, in the face of 10 other companies that would love to pirate your IP, yours is still the best.

Be Prepared For Success

You create value when you build a purposeful program strategy. Move on from merely hoping you’ll succeed. Intend to succeed and succeed big!

Statistics show nine of 10 companies will fail to gain FDA approval. And if they do, oftentimes the profile of that product is not that great so, they underperform commercially. Basically, you have a 10% likelihood of FDA approval and 80% of those approved aren’t given the favorable profile that helps them become a blockbuster success. If you don’t do the requisite work every step of the way, especially early in the game, you’re like any high school football starter who dreams of becoming the next Tom Brady but doesn’t prepare well or plan for success. You may as well try to catch lightning in a bottle.

I’m not trying to quash your dream; I’m simply stressing the importance of being realistic and seeking ways – every step of the way -- to mitigate any forces that might work against you. The vast majority of FDA non-approvals or less-desirable profiles assigned by FDA are due to mistakes made early on in the process. You prepare yourself for success by never moving on to the next step until the current step is completed successfully. Often, that takes time. Better to do it right once than do it again and again. (“Measure twice, cut once,” as your father and grandfather likely told you.)

Putting together the right strategy isn’t an overnight thing. It often takes months and months of studying things from a multitude of perspectives to be sure you’re taking everything into consideration. Monitor the competitive landscape. Lean on experts. Get the FDA involved for the purpose of feedback and advice and do it early and often. Be obsessive about everything you do. Do all the things the right way and it will pay off later.

Bottom line: It’s a numbers game. If you’re going to play, commit to preparation and playing well. This takes a mindset of being purposeful and expecting to succeed.

Be Willing To Reach Out Early And Often

Above, I mentioned getting FDA involved early and often. Many, if not most, early-stage companies, start-ups, entrepreneurs, and medtech wizards don’t realize the FDA isn’t just a gate you must pass through to get to market, it’s also a resource that can help you increase your chances of breezing through that gate.

Don’t wait until you have all your ducks in a row to go to FDA. Get them involved early in the development process and seek their guidance, counsel, and feedback. FDA has new, flexible ways to get a fast-track designation. They want you to succeed, so they’re willing to be like a partner in the developmental process.

Once development reaches more and more milestones, more and more investors will be attracted to the company. This should all be factored into the process of mapping out how you plan to position your new medtech solution for blockbuster success.

Be Open To Guidance

I know I’m sounding like a broken record here, but nothing is more important than being open to guidance and advice.

It is said, “Success has many fathers and failures are orphans.” Consult with both the fathers and the orphans and learn what worked and what didn’t work for them. The medtech industry has far more folks who’ve failed than succeeded (remember that 90% non-approval rate and the 80% less-desirable profile I mentioned earlier), so there are plenty of people who can advise you what NOT to do, just as there are companies that can share secrets of success. Just as in Las Vegas, there are no guarantees, but there’s always a chance you’ll hit the jackpot.

To succeed requires a unique skillset and keen ability to anticipate problems and know where potential landmines are buried. It’s important to preempt them to the extent possible but accept that you will likely stub your toe somewhere along the way. That’s OK; you also have a chance to pick yourself up, dust off, and march forward in a better direction.

Finally, and this is a biggie, seek the guidance of qualified attorneys and take steps to protect your IP as if it were 100% guaranteed to be a blockbuster innovation. And do it early, early, early in the process. It’s one thing to take steps to pursue a patent, but you have to first be sure you’re not stepping on someone else’s technology.

The gents from Torrey Pines Law Group told me, “Entrepreneurs often don’t anticipate major success; they fail to dream big and plan for success. By the time they realize they have a monster opportunity, it’s often too late to legally protect IP.” And protecting IP after the fact is very, very difficult. Yes, legal costs can be pricey, but the upside of your IP can be astronomical by comparison. It’s best to invest a few thousand now to shield tens of millions of dollars down the road.

Another thing: Most entrepreneurs are good at planning but fail to plan for a “divorce” with engineers and developers once the innovation has been approved and is moving into market. Develop a multifaceted legal strategy to protect your IP domestically and internationally, and set the stage for responsibly disengaging from those team members whose expertise is no longer needed. This is all part of a master legal strategy.

In my next article, I’ll continue to review ways to “be” as you move your innovation further along the pathway to commercialization.

About The Author:

Thomas Hickey is a senior consultant at Excelerant Consulting as well as host of Med Tech Gurus, a podcast focused on medical entrepreneurship and marketing (available on Apple Podcasts and other platforms). He develops innovative strategies and tactics and possesses a deep understanding of sales strategy and sales channels. With more than 35 years’ experience in the medical device industry and executive-level experience with manufacturers and group purchasing organizations, Hickey is skilled at assessing launches, start-ups, international distribution, technology, and market feasibility. He has successfully launched several products and hired, coached, and trained hundreds of independent and distributor sales team members. He can be reached at