Navigating the New MedTech Playbook: Why Commercial Readiness Matters Earlier Than Ever

Navigating the New MedTech Playbook is a series from Stifel Venture Banking’s Life Sciences & Healthcare team focused on the operational and financial realities shaping today’s medtech market. Drawing on conference takeaways, client work, investor conversations, and patterns observed across the life sciences ecosystem, the series explores the strategies, decisions, and market shifts shaping how medtech companies scale in a more disciplined capital environment.

For a long time, commercialization came relatively late in the medtech company-building process. Founders focused first on the technology, clinical evidence, and regulatory pathway, with many of the harder questions around adoption and go-to-market coming closer to launch or post-FDA approval.

Today, those commercial questions are surfacing much earlier in a company’s development, driven in part by a fundraising environment that places greater scrutiny on the path from regulatory approval to revenue and capital efficiency.

By Series A, and often earlier, investors are digging into how a product will move through the healthcare system. Who makes the buying decision? What is the reimbursement pathway? How long will adoption take? How much physician education will be required? What does the sales motion look like? And how much capital will the company need to get from regulatory clearance to meaningful revenue?

Those questions matter for reasons that extend well beyond launch. Each answer eventually influences hiring, burn, runway, revenue projections, and the timing and size of the next financing.

In my experience working with medtech founders, this is where commercial readiness and capital planning increasingly intersect. A company may have a detailed financial model, but the quality of that model depends heavily on the commercial assumptions behind it, which may be based on outdated territory and sales data. The earlier founders pressure-test those assumptions, the more useful the capital plan becomes.

What investors expect earlier

Clinical and regulatory milestones remain foundational to medtech investing. Investors also want a much clearer view of what comes next.

Investors are now expecting a stronger hypothesis around reimbursement and go-to-market, relevant comparators for the capital required, and a credible path to repeatable, scalable revenue. Questions around the economic buyer, coding and coverage, sales cycles, and clinical workflow are surfacing in the first few investor conversations, raising the level of commercial sophistication expected from founders.

There is good reason for the additional scrutiny. Investors have watched compelling technologies reach important clinical and regulatory milestones without translating that progress into sustainable commercial adoption. A product may perform well clinically and still face significant barriers if reimbursement is unclear, the workflow creates friction, the value proposition does not resonate with the economic buyer, or the technology does not meaningfully influence a treatment decision.

Those experiences have changed what investors want to understand earlier in a company’s development. Founders increasingly need a commercial hypothesis that can stand alongside the clinical and regulatory strategy, supported by a clear understanding of the major questions that still need to be answered. Investors know the strategy will develop as the company learns from the market, but they want to see that management is already doing the work to understand the buyer, reimbursement pathway, workflow, and path to revenue.

Building commercial evidence before launch

Many of the most useful inputs into a commercialization strategy come from spending time with physicians, visiting hospitals, talking with value analysis committees, studying reimbursement pathways, discussing pricing, and listening to the staff who will interact with the technology day-to-day. That means gathering real-world experience across settings, from academic medical centers to small community hospitals, and hearing from physicians beyond the traditional KOL network.

These conversations give founders a clearer picture of how the product will move through the healthcare system and can reveal meaningful gaps between early commercial assumptions and what happens in practice. The value proposition that resonates with a physician, for example, may carry less weight with the economic buyer, while a seemingly straightforward workflow change may create complications for hospital staff. Companies may also find that a product developed with one clinical setting in mind has greater potential somewhere else, or that an initial pricing assumption changes once the person controlling the budget is asked to commit actual dollars.

For founders, getting into the field early creates an opportunity to refine these assumptions before they become embedded in the commercial strategy and capital plan. When possible, I also encourage companies to include experienced commercial leaders in these conversations and to seek input not just from paid KOLs and willing hospital administrators, but also from skeptics looking for evidence of real value. Hearing feedback firsthand gives someone who has built and managed a sales organization the opportunity to recognize what a physician, buyer, or hospital administrator is really signaling and translate those insights into decisions around positioning, training, sales cycles, and headcount.

That perspective becomes especially valuable when field experience points the company toward a commercial opportunity that looks different from the one it initially envisioned.

When field experience changes the commercial thesis

Epitel, a Genoa Ventures portfolio company developing wearable EEG technology, is a useful example of how this can play out.

The intuitive market for a wireless EEG included epilepsy monitoring units, ICUs, and emergency departments, where EEG was already in use and specialists were familiar with the technology. In those settings, a product with meaningful feature advantages could offer a relatively straightforward improvement over existing options.

As Epitel spent more time in the field, however, the team saw an opportunity beyond those established settings. Access to EEG remains limited for many patients, creating an opportunity to extend monitoring beyond hospitals and specialized settings where it has traditionally been concentrated, including to rural communities where patients may otherwise have to travel significant distances for care. For a wireless EEG capable of supporting a 30-day monitoring window, that pointed to significant potential in settings where access to EEG itself was a challenge.

Through that field work, Epitel identified an opportunity in outpatient general neurology and inpatient settings where the technology could address an unmet need while fitting into the existing workflow. In turn, it helped reframe Epitel’s buyer, reimbursement approach, sales motion, and view of the broader market opportunity.

The implications extend directly to capital planning. A shift in the target customer can affect the sales cycle and reimbursement strategy, while a different sales motion can change the type of commercial team a company needs, when those hires should be made, and how quickly the organization can scale. Those decisions ultimately flow through to burn, revenue expectations, and the amount of capital required to reach the next financing milestone.

Epitel’s experience also shows how quickly early commercial assumptions can change once they are tested in the field. For founders, the challenge is identifying which of those assumptions carry the greatest financial consequences.

The assumptions that can distort the capital plan

Financial models need assumptions. For an early-stage company, there is no way around that. The important question is how much evidence sits behind the assumptions that carry the greatest financial consequences. A few areas deserve particular attention:

• Reimbursement timing. FDA clearance can be a major milestone, but it does not determine how or whether a product will be reimbursed. Coding, coverage, payment levels, and supporting evidence all influence how quickly a company can build a repeatable revenue model. Bottom line: How do you align the timing of regulatory clearance with the sales hiring ramp to manage burn effectively?
• Physician and stakeholder education. New techniques and meaningful changes in clinical practice usually require education across several stakeholders. Depending on the product, that can extend beyond the physician to operating room staff, sterile processing, hospital leadership, and others involved in adoption. Supporting that change takes people, training, and time. Bottom line: Every hospital system works differently, so onboarding timelines can vary dramatically.
• Commercial hiring. The timing of the first commercial hires has an outsized effect on burn. Companies need enough experienced talent to build the commercial infrastructure and learn from the market, while being thoughtful about adding fixed cost before the market is ready to support a larger organization. Bottom line: Do you hire one seasoned salesperson to lead a group of junior reps, or focus on core reps in key markets? What does each scenario cost, and how does it scale?
• Adoption curves. I’ve also seen early success in major cities and academic medical centers create an overly optimistic picture of subsequent expansion. Territories differ significantly, and the next ten markets may develop very differently from the first two. Bottom line: How do you build an accurate model beyond the first wave of usually top-performing reps and create a more predictable view of future growth?
• Sales productivity. In my experience, a one-year training and ramp period can be normal for a new innovative product. Companies also need infrastructure around those reps, including training, management, clinical support, and processes for sharing what the team learns in the field. Lowering the one-year ramp to six months can create a meaningful gap between projected and actual revenue. Bottom line: When does investment in sales training begin to pay off, and could outside support help mitigate some of those costs earlier?

All of these assumptions eventually show up somewhere in the financial model. Small changes in several of them at once can materially alter runway and future financing needs.

Choosing a sales model is a capital decision

One of the highest-leverage commercialization decisions a medtech company makes is how it plans to sell. A direct sales organization requires significant upfront investment, but it also gives the company greater control over training, physician engagement, clinical support, and the feedback flowing from customers back to management.

For a complex technology or a product that requires a meaningful change in clinical practice, that depth can be particularly valuable. Complexity and differentiation can create value through time or cost savings, improved clinical outcomes, and other meaningful benefits. But changing the status quo is difficult, and products that require significant behavior change often benefit from the dedicated attention of a direct sales team.

Independent reps and distributors can be effective when the product fits an established workflow and the clinical story is relatively straightforward. Existing teams may already have the right hospital relationships and understand how to navigate value analysis and purchasing processes, potentially allowing companies to generate revenue faster. The model can also support broader geographic coverage with less fixed commercial infrastructure. But a new product can easily fall to the “bottom of the bag,” and once the strongest, easiest relationships have been exhausted, growth can stagnate.

A hybrid approach is common, particularly early in the commercial journey. Companies may use a direct organization in priority markets while working with independent teams elsewhere.

Whatever the structure, founders should understand the incentives involved. An independent rep has other products to sell and needs a compelling economic reason to prioritize yours. I often use the analogy that reps are “coin-operated”: The more you put in, the more you get out. Expectations around territories, support, compensation, and the long-term relationship should be established clearly from the beginning. 

The product itself usually provides the best starting point for choosing the model. Founders should consider several questions: How complicated is it to sell? How much physician education is required? How established is the workflow? How long is the purchasing process? What level of clinical support does adoption require? And how attractive is the product economically to an independent rep?

Pressure-testing the commercial plan

The medtech financing environment has pushed commercial thinking further upstream. Investors are asking harder questions earlier because they want to understand the path from a compelling technology to a durable business.

The same questions investors are bringing into diligence can also help founders pressure-test their own commercial plans:

• Who feels the problem most acutely? 
• Who controls the budget? 
• What is your reimbursement plan?
• How much behavior needs to change? 
• What does adoption require from physicians and hospital staff? 
• Which sales model fits the product? 
• How long will the team take to reach full productivity?

Answering those questions through field work gives management a stronger foundation for the commercial strategy and the decisions around hiring, burn, runway, and fundraising that follow.

Commercial readiness at an early stage will always involve uncertainty. The companies that approach it thoughtfully understand where that uncertainty sits, which assumptions matter most, and what they need to learn next. That understanding has become an increasingly important part of building a credible capital plan and financing story.

Stifel Venture Banking is a division of Stifel Bank, Member FDIC. For informational purposes only. Stifel Bank does not provide legal, tax, or other advice. Companies and organizations listed herein are not affiliated with Stifel Bank.