Balancing the Clinical-Commercial Tightrope

Key Learnings From Trent’s Experience

• Clinical and commercial efforts are a balancing act. You need to demonstrate your technology’s efficacy by gathering solid data for regulatory approval and reimbursement. However, you also need to consistently improve upon the design and usability of your device. Embrace the fact that the initial product may not be perfect, but if it achieves the right outcomes, you can refine it over time.

• Be willing to reassess and shift your focus, especially when facing challenging scenarios or strong competition. Don’t hesitate to reposition your product to meet emerging needs or enter less-crowded markets. Embrace change as an opportunity to prove the versatility of your technology.

• Treat your product and market with care. Be selective about who you sell to – especially if your technology requires a learning curve – in order to preserve its efficacy. Know your position in the market and articulate it clearly. Remember, a quick ‘no’ is better than a slow ‘maybe.’

Trent Reutiman brings over 25 years of leadership experience in medtech. He has been instrumental in the development and commercialization of various new technologies  – with a primary focus on minimally invasive and interventional procedures – at companies like IDEV, ROX Medical, RITA Medical Systems, Guidant, Cordis, and now Mercator MedSystems, where he’s the CEO. 

Mercator’s flagship product, Bullfrog, is a catheter-based microinfusion system designed for peripheral artery disease, and potentially other cardiovascular conditions like deep vein thrombosis (DVT) and post-thrombotic syndrome (PTS). Unlike treatments that rely on surface-coated drugs on stents or balloons, microinfusion delivers medication more efficiently and precisely, allowing for controlled drug release when the catheter is positioned in the targeted area. 

Mercator, under Trent’s guidance, has generated significant data demonstrating the Bullfrog’s efficacy in peripheral interventions. But this isn’t the only potential application for the Bullfrog; it’s regarded as an adaptable platform for various therapeutic opportunities.

Balance Commercial Efforts With Clinical Initiatives

Medical device development and commercialization require various types of data. In a lot of cases, you need solid clinical data to support your device’s regulatory pathway and/or to make a strong case for why it should be covered by insurance.

The level and type of data required depend on your specific context, like market dynamics and reimbursement scenarios. For example, if you’re in a fast-moving market and your product already has some level of reimbursement, you might be able to rely on registry data, which is less costly and easier to manage.

However, in more challenging scenarios, like getting FDA approval for a novel device or establishing a new treatment method – drug delivery for venous treatments in Mercator’s case – you might need more robust, randomized, and controlled data. In other words, you need to balance the development of the device itself versus the clinical outcomes that you aim to demonstrate. When it comes to that, there’s a decision to be made: do you focus on showcasing the most compelling clinical outcomes with the device in its current form, or do you dedicate your energy to improving it instead? 

Having said that, clinical studies and product development aren’t mutually exclusive. For instance, Mercator’s published early work on dexamethasone in arterial applications, though it never reached commercial markets, laid the groundwork for Bullfrog’s application for venous treatments.

Trent shares his take-home message, “You might not have the end-all-be-all product, particularly in the initial clinical stages, but if you’re aiming for the right outcome, you’ll always be able to come back and continue to refine the device.” The goal of an MVP is to show that it does what it’s supposed to do; that it fills a gap in healthcare. After you’ve proven this key concept, you can start to focus on things like ergonomics and ease of use, but not any sooner. You have to be clear about your priorities and sometimes accept imperfections to move forward. 

Having said that, Trent also acknowledges that it’s hard to know, in the heat of the battle, when to step on the gas and when to pull back. While obtaining 510(k) clearance or CE Mark are important milestones, they come with their own sets of challenges. For example, there’s a financial burden maintaining regulatory approvals, especially when the product is still in clinical development and not yet commercially viable. Trent shares, “It almost sounds blasphemous since everybody wants a 510(k) or aCE mark. Just be aware, pre-commercially, they're expensive to maintain.”

Tough Times Require Sharp Pivots

“The initial reaction of most people when they see Bullfrog is: ‘That's a very clever device.’ But it was initially conceived as a coronary drug delivery device,” shares Trent. Although Bullfrog was designed for something that's different from what it is now, thanks to Mercator’s flexibility and agility, the company has pivoted and evolved significantly to find its place in the workflow of physicians and, consequently, a place in the market.

The story goes like this: Mercator’s focus was initially on securing an indication for arterial applications. The team conducted studies and published data sets with that goal in mind. However, there were a few other companies – medtech giants – who were already ahead in the development of drug-coated balloons (DCBs). As a small company, Mercator wasn’t able to take on such tough competition from leading companies like Bard and Medtronic. A shift was needed. 

Trent and the team decided to pivot to below-the-knee (BTK) applications with a new drug version, following an initial study using dexamethasone – a medication that yielded comparable results to DCBs. Things were looking bright and Mercator was planning for a phase-3 study with 400 people. But everything came to a halt by COVID-19 and the challenges of enrolling patients and securing financing. 

However, these challenges turned into an opportunity to highlight the versatility of the platform. At the time, Mercator had a lot of users who worked on both the arterial and the venous sides, and physicians were really interested in the potential of anti-inflammatory steroids for venous interventions. Shifting focus to that area, Mercator gained significant traction. Trent shares, “If there is an upside to COVID, and there aren't many, for us, it’s that it unlocked the real platform capability of Bullfrog.”

Leaning on early work with their anti-inflammatory steroid, Mercator developed a larger device that is more suited for venous applications. They then extended their 510(k) to cover this new application, placing Mercator as a front-runner in bringing drug delivery to the venous space. “We're far out in front of the others now,” Trent shares.

Having said all that, Mercator’s previous efforts weren't in vain (pun intended). Trent says the company is still open to exploring arterial applications, particularly below the knee, where their phase-3 study awaits more resources or potential partnerships.

You May Not Want to Sell to Everybody 

Mercator’s commercialization strategy might seem counterintuitive to some, but the delicate balance between benefit and risk has made it a necessity. Although seemingly easy to use, Bullfrog is a device that requires a degree of sophistication, and as the saying goes, the dose makes the poison. 

Despite increased demand from distributors, Mercator doesn’t just sell to everyone. Their target customers are those who are deeply involved in clinical work and who understand where the Bullfrog device can be properly utilized – such as patients who don’t fit standard study profiles. Trent shares, “It might sound funny, but we literally have distributors chasing us down.”

Ensuring your device is used in optimal conditions for the intended outcomes is often underappreciated. Otherwise, it might get sidelined or unfairly be deemed inefficient.

Trent also warns against rushing to market without a meaningful reimbursement strategy. This might lead to inefficient use of the product – or even potentially harm the product’s reputation in the long run.

In addition to being astute about your customer base, it's also crucial to be selective about where your investment comes from. You need to clearly express who you are as a company and who your potential investors are. Trent says, “Know your own model, know your own milestones, and don’t take any more money than you have to because you’ll raise in the future again.”

Different investors focus on different stages of a company's development, from early-stage Series A to later-stage growth capital. It’s important to tailor your funding efforts to the right type of investor for your stage. In medtech, involving investors who have a medical background or understanding, such as family offices with a physician who’s part of the team, can be more productive. And a fast ‘no’ is often better than a slow ‘maybe’.