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When bringing a medical device to market, a 510(k) can be the right call. It’s faster, it’s cheaper, and investors like the math.
It also tells the market that your device is substantially equivalent to something they already use. Which raises a question most teams don’t ask until after clearance: if you’re equivalent, why would anyone switch?
That’s the territory Holley Proctor Miller works in. We asked her a question that sits right on the seam between regulatory and commercial work: if the fastest path to FDA approval can turn out to be the slowest path to market adoption, what should regulatory, quality, and commercial leaders decide together before the pathway gets locked in?
Holley is the Founder and President of Grey Matter Marketing, which she started 20 years ago. Before that she was at Computer Motion, now part of Intuitive Surgical, during what she calls the birth of the surgical robotics category, first running corporate communications and then as product manager for the AESOP robotic endoscope positioner.
She went on to lead marketing for the LAP-BAND system and global brand management at Allergan, and later served as Chief Marketing Officer of NewHope Bariatrics. Her firm’s operating idea stemmed from that first experience: healthcare has an adoption problem much more than an innovation problem.
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Holley’s key insights and practical takeaways
If you’re short on time, here are the most important lessons from the discussion.
Every pathway decision carries adoption assumptions, whether you name them or not. Teams weigh speed, cost, evidence requirements, indications, claims, and sometimes a predicate when they pick a pathway. Holley’s point is that each of those choices also makes a quiet bet about whether the market will have a compelling enough reason to change how it practices. Leave those bets unexamined and you may not discover they’re wrong until you’re trying to sell. Her summary: FDA clearance or approval gives you the right to enter the market. It doesn’t necessarily give the market a reason to change.
Different only counts if the market cares about the difference. You can be a red pen in a world of blue pens, but if the buyer just needs to write something down, the ink color is irrelevant. She leaned on a line widely attributed to Harvard Business School’s Theodore Levitt: nobody wants a quarter-inch drill; they want a quarter-inch hole. Her version is that it’s not what you make, it’s what you make happen. Nick recalled a CEO of a dye company who talked endlessly about the dyes and never about the outcome, which is the trap in one sentence.
The evidence that gets you approved isn’t the evidence that gets you adopted. Payers, physicians, and health systems are each being asked to change something different, so they need different proof. And the ask itself has grown. It used to be enough to get onto a surgeon’s preference card. Now you’re often asking for enterprise-level change. Evidence works best when it answers a question the market is already motivated to solve. If they don’t think there’s a problem, a stack of data won’t make them care.
If you’re for everyone, you’re for nothing. When Holley reviews investor decks, she says she doesn’t care how big the TAM is. She wants to know where you have the right to win: the segment where you’re genuinely solving a problem, which you dominate before expanding. She described a client building a robotic phlebotomy system. The device works. The harder question is whether patients and lab managers believe it’s a better way forward, and those barriers are emotional as much as rational. Nick’s read was that a company like that has to segment honestly, because some buyers will never be open to it.
Saying who you’re not for builds credibility. Brains are lazy, whether you’re a teenager or a brain surgeon. Faced with an encyclopedia-length menu, most people ask the server what to get. Fewer, clearer options help a buyer decide, and telling the market who your product isn’t for qualifies the right buyers faster. Nick, for the record, prefers a two-page menu.
Change happens in steps, starting with discomfort. Holley asks whether a problem is a paper cut or whether someone is bleeding out, because only one of those makes people act. The sequence she described: get people to see that the status quo isn’t as good as they’ve accepted, press on the pain until it becomes uncomfortable, define what a real solution has to include, then win early adopters who have conviction. Evidence then helps those early adopters defend their new position. From there comes peer-to-peer influence, committee approvals, payer coverage, and patients asking for it, until people wonder why anyone practiced the old way.
Sometimes the market doesn’t know it has a problem. Nobody needed convincing that taxis were bad, so rideshare had an easy argument. Airbnb, by contrast, wasn’t solving a hotel crisis. In medicine, everyone knew open-heart bypass was invasive, which opened the door to angioplasty, stenting, and eventually drug-eluting stents. But almost nobody questioned daily finger pricks until continuous glucose monitoring showed it didn’t have to be that way. Much of innovation, in Holley’s view, is helping people see a limitation they’ve stopped noticing.
The fastest path to approval can become the slowest path to adoption. A substantial equivalence claim invites the market to see you as a version of something it already has. If your advantage is a nice-to-have, you can clear, launch, and execute well, and still find yourself fighting account by account, watching evaluation committees reset the conversation, with high switching risk and long sales cycles that never get easier.
Category leaders take most of the value. In every market Holley looks at, there’s a category king that captures about 76% of the market economics, leaving everyone else to split what’s left. A big TAM with no clear leader can look like an invitation to grab a small percentage. In practice, it often means fighting for crumbs.
A case study in changing the question. One client was entering the bone graft market for spinal fusion, where there are more than 350 products. The plan was to compete with a product surgeons had used for about 20 years by offering a safer, cheaper option for high-risk patients. When Holley’s team asked the market, surgeons said they weren’t worried about safety and could justify the cost for high-risk patients. Further conversations revealed another variable: in high-risk patients, slow fusion increases the risk of hardware failure and reoperation. The company reoriented around fusing patients faster, and in its first ten months of launch generated more revenue than it had in the previous ten years with its first product.
Price signals more than cost. Nick shared examples of lower prices backfiring and of a company that raised its price and saw volume rise. Holley agreed that a specific audience with a specific problem will pay a premium, pointing to cash-pay dermatology, and added the principle underneath it: decisions get made emotionally and are then rationalized with data. Nick’s corollary is that when a market is choosing quality and speed, a higher price can reinforce the perception of quality.
Five questions matter more than the org chart. Asked who needs a seat before a pathway is locked, Holley said she cares less about titles than whether the people in the room collectively understand who will use the product, who approves it, who pays for it, who absorbs the workflow change, and who carries the risk if it doesn’t work. When regulatory designs for FDA, clinical designs for evidence, and commercial designs for the buyer are considered separately, you get three rational strategies that don’t add up to adoption. Alignment doesn’t mean everyone agreeing. It means everyone designing toward the same future market decision.
The mandate has to come from the CEO. Approval is a major milestone, but it isn’t the same as commercial success. Holley wants the future behaviors on the table early: a clinician switching, a hospital approving, a workflow changing, a payer covering. Then the team asks what has to be true for each to happen. The assumption she’s trying to dislodge is what she calls the product adoption lie, the belief that the best product will automatically win.
Missing reimbursement doesn’t have to stop adoption, and having it doesn’t guarantee demand. An existing CPT code is a real advantage. But companies sometimes assume no incremental reimbursement means no adoption. Robotic-assisted surgery is her counterexample: the procedure is reimbursed, the robot isn’t, and hospitals have absorbed the instrument and disposable costs, which she put at roughly $1,500 to $2,500 per case, because they see enough value. Some clients have also expected reimbursement to light a fire under demand, and it didn’t, because payment wasn’t what was holding behavior back. Her framing: regulatory answers whether you can sell, reimbursement answers whether the system will pay, adoption answers whether the market will change, and none substitutes for the others.
Early operational decisions become strategic constraints. Holley was clear that quality systems aren’t her specialty, but she sees the same principle across disciplines. The cheapest time to find out an assumption is wrong is while you can still fix it. Companies that treat product, regulatory, and commercial decisions as an interconnected strategy rather than a sequence build more investor confidence and grow more predictably. Nick, speaking from The FDA Group’s side, agreed: quality and regulatory professionals need a go-to-market person in the room, and that’s not a criticism of anyone. Everyone has a focus.
Validate behavior, not interest. “I’d use that” is not “I’m changing my practice.” Holley wants to know what customers are willing to stop doing, which obstacles they’ll personally help remove, whether a champion will bring procurement and administration into the conversation, and whether they’ll insist on change when you’re not in the room. One enthusiastic stakeholder is a fan. Someone carrying the narrative through their organization is evidence that belief is transferring. She recalled a conference session where surgeons praised a new procedure until someone asked what they’d do for their own son. And in hospital infection prevention, hospitals agreed the problem was real and costly, then pointed out they could just wash their hands more.
Conversation is not conviction. Nick described realizing he’d misjudged where the life sciences industry sits on the AI adoption curve. All the conferences, books, and talk made it feel further along than it was. When he asked his own team how much they were actually doing versus discussing, the answer put them in early adoption. Holley’s phrase for it: conversation does not equal conviction.
Market research is polite, so dig. People don’t like delivering bad news, and teams tend to hear what they want. Holley starts with qualitative research, listening for the language people use and where they hedge or lean in. Her favorite follow-up is “tell me more.” She illustrated segment-specific problems with a canceled flight. A first-class upgrade delights a CEO, but a canceled flight that makes her miss a meeting will eventually send her to another airline. A college student might happily take the $500 voucher. Same event, different problem. Nick’s habit is to ask for a rating on a scale rather than accept “better” or “worse,” and to treat sevens and eights as the undecided group worth the effort.
Invite the naysayers. For genuinely new products, Holley’s team convenes a council, explicitly not an advisory board, that includes both enthusiasts and skeptics. The skeptics eventually tell you what’s preventing them, and that becomes the roadmap for the second, third, and fourth waves of adoption.
A narrow indication isn’t necessarily a compromise. Holley challenges the assumption that a broader indication means stronger positioning. Sometimes the opposite is true. She’d start where the problem is most acute and differentiation matters most: a specific patient population, a site of service, or a physician profile. Win there, prove you can change behavior, then expand. Narrowing first can be exactly what lets you own the broader market later. Don’t be afraid to niche down.
Design post-market evidence around adoption barriers. Work backward from what stakeholders will need to believe after approval and what uncertainty will keep them from changing. Ask beyond what FDA requires, and design evidence around those uncertainties rather than only the claims you want to make.
Product, regulatory, and adoption design belong in one triangle. Holley calls it the magic triangle: product design and regulatory design on two sides, adoption design at the base. Companies engineer the first two rigorously years before launch and leave the third for later, expecting the market to sort it out. She calls that missequencing. Commercial shouldn’t dictate regulatory, but decisions across functions should be pressure-tested against the same market reality. Clearance creates availability. It doesn’t create preference or urgency, and it doesn’t make you the default.
Three questions shape almost everything downstream. What problem are we actually solving? For whom is it important enough to change behavior? What can we uniquely make happen for them? Those answers drive population, evidence, endpoints, segmentation, and launch strategy. Without market evidence behind them, Holley says, you don’t have an adoption strategy. You have assumptions.
Be different, not better. Her closing mantra, which she says forces a choice instead of a comparison. Category design is common in healthcare even when nobody calls it that, and she’s spent her career bringing the discipline into the field. She also pointed to structural shifts she calls ocean currents, like care moving to outpatient settings and virtual care, as signals companies can design toward now.
For anyone who wants to go deeper, her team publishes diagnostics and a case study at BeLaunchReady.com.
One thing to bring back to your team
Before your next pathway discussion, write down the adoption assumptions it contains.
Not the regulatory rationale, which you already have. The commercial bets underneath it. If the plan is a 510(k), write the sentence explaining why a buyer would switch to something substantially equivalent to what they use today.
If the plan is a narrow indication, write down who in that segment is bleeding out rather than nursing a paper cut. If reimbursement is pending, write down what’s actually keeping physicians from changing.
Then put that page in front of regulatory, clinical, quality, and commercial at the same time. If the assumptions don’t hold up, you’ve found out at the cheapest possible moment.
Holley Proctor Miller is Founder and President of Grey Matter Marketing, which she founded in 2006 to help life sciences companies drive adoption of products that change the standard of care. Earlier in her career, she spent five years at Computer Motion, now part of Intuitive Surgical, as corporate communications manager and then as product manager for the AESOP robotic endoscope positioner. She later led U.S. marketing for the LAP-BAND system and served as Director of Global Brand Management at Allergan, where she was named Medical Marketer of the Year in 2006 by the Medical Marketing Association, and served as Chief Marketing Officer of NewHope Bariatrics. She holds a BA in political science and visual arts from Washington and Lee University and is based in the San Francisco Bay Area.
Connect with Holley on LinkedIn here.
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