TL; DR: The vast majority of medtech companies never achieve commercial success, not because their products are flawed, but because their launch strategy and communications planning fall short. The most successful teams start building market readiness in parallel with regulatory work, tailor their message to each audience and secure early buy-in from decision-makers.
You can build a clinically brilliant device, pass regulatory reviews with flying colors and still struggle to get it into the hands of users. Research shows that over 75 percent of medtech companies fail to commercialize effectively. The same goes for 98 percent of digital health startups.
The problem? Often, it comes down to a weak go-to-market strategy and inadequate communications.
FDA approval or CE marking does not guarantee market traction. Hospitals, clinics and payers make decisions based on workflow fit, cost savings, outcomes data and alignment with their operational priorities. If your launch plan does not address these needs, you risk joining the majority.
If you wait for clearance before developing a market entry plan, you may find yourself fighting for attention because budgets have already been allocated and competitors are rapidly expanding their market share. The startups that excel engage the market in tandem with the regulatory process, lining up advocates, forming an economic case and sharing their value story well before approval. In doing so, they ensure momentum is already in motion when it is time to launch.
Some teams build one set of talking points and use it for every audience, which dilutes impact across the board. Providers, finance teams, administrators and patients all weigh different risks and benefits. A surgeon may focus on clinical efficacy while a CFO is interested in cost efficiency and ROI — failing to adapt your messaging could alienate both of them.
The proof that moves a procurement committee is rarely the same proof used for FDA submission. Comparative cost savings, training time, workflow disruption estimates and integration compatibility with hospital systems often matter as much as clinical outcomes.
Successful teams gather these operational and financial proof points in parallel with clinical data, sometimes through small pilot studies or simple in-house tests that show how the device performs in a real-world workflow, so they are ready before the first sales meeting.
Founders often focus on clinicians and procurement, but other players can block or accelerate a deal — and their influence is easy to underestimate. For example:
Creating a needs map for each of these groups before drafting launch messaging ensures their priorities are addressed from the start.
A product can check every clinical and operational box and still lose momentum if pricing and contract terms do not match how buyers make purchasing decisions. Capital equipment, consumables and service fees need to fit within existing procurement models, whether it is a multi-year capital plan, per-use agreements or bundled service contracts. A model that works for a private network might be impractical for a public system, or vice versa. Understanding these nuances early and offering flexible structures can remove a major barrier to entry.
Initial traction will not sustain itself. Without consistent engagement, such as training, troubleshooting and sharing fresh data, enthusiasm fades. Strong follow-through keeps champions active, builds fresh proof for prospects and helps momentum grow instead of stalling.
Top performers stress-test their commercialization plan months before launch. This includes validating pricing, contracting terms and messaging with select target buyers under NDA, then refining based on real feedback — not assumptions.
Instead of focusing on one or two primary decision-makers, they map the full journey a purchase decision takes inside a hospital or health system. This includes every committee, reviewer and approver, with tailored materials for each stage.
Campaigns are sequenced to raise visibility across professional networks, conferences, trade media, and digital channels, so prospective buyers are already familiar with the solution before the official launch.
Initial users are treated as both customers and marketing partners. Operational wins, cost savings, and workflow improvements from these pilots are packaged into proof that accelerates uptake in the broader market.
The majority of medtech commercialization failures are preventable. By investing in strategic communications and launch planning early, you can avoid common pitfalls, accelerate adoption and maximize the return on your innovation.
If you are planning a launch or struggling to gain traction, now is the time to rethink your communications strategy — before the market makes that decision for you. Partner with us to bring the experience, structure, and foresight needed to turn your innovation into a sustainable market success.
One of the leading reasons is a weak launch strategy, including unclear value messaging, missing proof points and starting market entry work too late.
Ideally, during product development, so you can build relationships, gather the right data and tailor communications before clearance.
It ensures you identify all decision-makers and influencers, from clinicians to procurement teams to payers, each of whom needs a distinct value story.
Targeted communications help each audience quickly understand your product’s relevance and benefits, reducing decision time and increasing purchase likelihood.
Yes. Smaller teams often have fewer resources and less margin for error, making early, targeted planning even more critical.
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