6 Pitfalls In Selecting KOLs for Preclinical Medical Device Studies

Choosing the wrong KOL for preclinical testing can derail your timeline, drain your budget, and compromise study integrity. Yet medical device innovators make the same mistakes repeatedly, often because assumptions from clinical development don't translate to the preclinical arena. 

Here are the critical pitfalls to avoid when selecting a KOL for medical device preclinical work.
 

Pitfall #1: Defaulting to "The Usual Suspects" 

Your KOL roster likely features physicians who excel at awareness, market access potential and clinical trials. They have invaluable experience and relationships for which you are investing time and treasure. They're experts in organizing multi-center trials, navigating IDE submissions, coordinating 510(k) pathways, encouraging adoption of your product and managing hundreds of patients across dozens of sites. 

That expertise matters downstream. 

In the preclinical lab, these skills become liabilities. Clinical trial coordination requires different capabilities than troubleshooting why a delivery system fails in a sheep model or why anatomical constraints prevent catheter navigation. 

The usual suspects are experts of the clinic and adoption potential, not the preclinical environment. Don't confuse the two. 

What to do instead: Evaluate each KOL specifically for preclinical capabilities. Ask about their animal model experience, their willingness to adapt procedures, and how they approach technical failures in the lab. 

Pro-tip: Ask about their hobbies. As we shared in a related blog article, “Look for physicians who enjoy solving problems. Mountaineers make an excellent example of attributes of high value preclinical KOLs: they're goal-driven, understand the necessity of teamwork, have technical expertise in their gear and navigation, and know when to retreat and regroup. So do woodworkers, mechanics, and architects: creative people who appreciate that brilliant ideas must work within physical and technological constraints.” 

Pitfall #2: Too Many KOLs in the Operating Room 

Multiple expert opinions sound valuable. In practice, too many KOLs in the preclinical OR creates disaster. 

Two scenarios emerge: 

Scenario A: Alpha male competition. Who's the biggest expert? Whose approach wins? Decision-making becomes political rather than scientific. 

Scenario B: Vacation mentality. "It's only animals." "Let's have fun and not focus on what's at stake." When multiple KOLs cause a casual approach to preclinical work in the lab, focus disappears. 

Even when everyone behaves perfectly, too many voices generate too many ideas. You cannot efficiently make decisions with five strong opinions in the room. 

What to do instead: One KOL per study, period. If you need multiple perspectives, consult them sequentially, not simultaneously in the OR. 

Pitfall #3: Using GLP Studies as KOL Training 

GLP preclinical studies are not a rehearsal for clinical work. It's not an opportunity for multiple KOLs to "each try a delivery." 

GLP requires standardized procedures executed consistently. You cannot have five different physicians attempting five different approaches on the day of your regulatory study. You're funding a learning curve and putting data and reporting for regulatory consideration at risk at the most expensive, high-stakes moment possible. 

What to do instead: Complete all KOL training and technique validation during pilot, non-GLP studies. By the time you reach GLP, your approach should be perfected, and your KOL should be executing with precision. 

Pitfall #4: The Podium KOL Problem 

Podium KOLs deliver enormous value for PR, fundraising, and market adoption. When they speak, people listen. They shut down contradictions with authority. They're seductive to investors and persuasive to clinical communities. 

Out of the 100 most recognizable KOLs for a given therapeutic area, 90 of them are wrong for preclinical work. That is not to say there are not those that move between the podium and the preclinical lab with aplomb. There are. But they are very, very rare. 

Why podium KOLs fail in the lab: 

• Bandwidth: They're involved in 30-40 projects. Yours is one of many. 

• Time: Their schedule makes study coordination nearly impossible. 

• Dedication: You're not their priority, you're one of their "mistresses," not their "wife." 

• Humility: They're accustomed to deference, not collaboration. 

• Technical skill: It's surprisingly common that podium stars aren't technically excellent. They think well, strategize well, and speak brilliantly. Put instruments in their hands and they struggle. 

• Sincerity: When success depends on telling your CEO their device isn't ready, will they deliver that message? 

The best podium KOLs are great talkers but not necessarily great doers. 

What to do instead: Maintain separate KOLs for different purposes. Have your podium star for conferences and investor meetings. Bring in a different expert (probably less famous, definitely hungrier) for preclinical work. 

There are approximately 10 physicians globally who excel at both. If you find one, consider yourself extraordinarily fortunate. 

Pitfall #5: Overvaluing Human Surgical Expertise 

"I've done 5,000 of these procedures in humans over the past three years. Don't teach me how this works." 

That statement should immediately disqualify a KOL from preclinical work. 

Human surgical expertise is necessary but insufficient. Animal anatomy differs significantly. Sheep aortic surgery requires thoracotomy, not sternotomy. Anesthesia protocols vary. ECG rhythms look different between species. Vessel access points and diameters require adaptation. 

The ideal preclinical KOL adapts seamlessly. They understand translational science means exactly that: translating between human and animal models. They work hand-in-hand with veterinarians and anatomists. They're not unsettled by different approaches. 

The wrong KOL insists on human-surgery methods regardless of anatomical constraints. 

What to do instead: During initial conversations, explicitly discuss anatomical differences and procedural adaptations. Gauge their flexibility. If they resist the premise that animal work requires modification, find someone else. 

Pitfall #6: The "Super Hands" Problem 

This is subtle but critical: physicians who make everything look easy create dangerous false confidence. 

When a surgeon is so technically gifted that they can make a difficult delivery system work through sheer skill, you risk developing a device that only works in expert hands. You've validated a procedure that cannot scale to average practitioners. 

You want someone who can execute with excellence but also recognizes when success depends on their exceptional abilities rather than device design. 

What to do instead: Choose KOLs who provide honest feedback about difficulty levels. "This worked, but only because I gave it my best shot. A beginner would fail." That level of candor is invaluable. 

The Common Thread Among Pitfalls in KOL Selection for Preclinical Medical Device Studies: Mismatched Expectations 

All of these pitfalls share a root cause: assuming clinical excellence translates directly to preclinical success. 

Preclinical research is a "long, strenuous journey full of headwinds and roadblocks." You need problem-solvers who thrive in that environment. Look for physicians whose hobbies include mountaineering, mechanics, or woodworking: people who understand that physical and technological constraints require creative solutions and collaborative teamwork. 

The right preclinical KOL treats animal work with the respect and strategic focus it deserves. They understand that validating your device in the lab determines whether it reaches patients at all. 

Partner With Proven Preclinical Expertise 

At Veranex, we've guided hundreds of medical device companies through successful preclinical programs over 25+ years. 

With over 3,000 procedures annually and devices now treating 1+ million patients, we bring the strategic insight and surgical expertise to help you avoid costly missteps. Our integrated approach embedded within the industry's only iCRO, means we're partners throughout your journey, not just a testing facility. 

Let's discuss how we can help you build the right team for preclinical success.