If you’re building technology for medical devices, you’ve probably run into this frustrating reality: selling to Medtech companies is slow, complex, and full of regulatory roadblocks.
You have a tool that could dramatically accelerate R&D, reduce the cost of development, or improve patient outcomes. But getting MedTech companies to adopt and integrate your solution feels like a never-ending cycle of meetings, legal reviews, and regulatory concerns.
Why? Because selling Tech for MedTech isn’t like selling to other industries—it’s a different game entirely. And for good reason. But, it doesn’t have to be quite as hard as it seems.
Example: In a prior role, as an executive at a Tech for Medtech firm, I spoke with multiple large Medtech manufacturers who needed a specific cybersecurity solution (i.e., asymmetric encryption). They had often already spent millions of dollars developing the solution in-house, instead of buying a solution on the market. At the time, no market-based solutions adequately fulfilled all of Medtech's performance requirements, so it seemed reasonable to build the solution in-house. But the business case was terrible; they were building a cost-center that would have to be maintained over time. Over many conversations, I learned to appreciate and navigate this landscape across a number of different types of Tech for Medtech.
MedTech Moves Slowly—Because It Has To
If you’ve ever tried selling to a medical device manufacturer (MDM), you’ve probably realized that decision-making is painfully slow compared to other industries. This isn’t just bureaucratic inefficiency—it’s intentional safety management, stakeholder management, long product development cycles, and regulatory stickiness.
✔ Regulatory Scrutiny: Any new tool—whether software, AI, cloud, or cybersecurity—must meet strict FDA and international regulations.
✔ Patient Safety Risks: Unlike other industries, mistakes in MedTech don’t just lose money—they can cost lives.
✔ Long Product Life Cycles: Medical devices take a decade to develop and remain on the market for years, even decades—so adopting new technology isn’t just a short-term decision.
💡 What This Means for Tech for Medtech Vendors: Your product introduces risk and uncertainty until you prove otherwise. Your strategy must proactively address business, patient, and regulatory risks to sell well.
4. How Tech for Medtech Vendors Can Address Risk
If you want to speed up sales cycles, reduce regulatory pushback, and increase adoption, you need to make it easier for MedTech companies to say “yes” to your technology.
✅ Strategy #1: Address Patient Safety and Regulatory Concerns in Sales
Include your proactive approach to your customer’s regulatory and safety requirements well before they ask. Consider hiring a regulatory expert in your sales team. Many tech vendors wait too long to address regulatory concerns, hoping they’ll come up later in the process. But by the time they do, the deal has already stalled.
Instead:
✔ Demonstrate you’ve considered and addressed patient safety concerns.
✔ Proactively outline how your technology meets FDA expectations.
✔ Provide documentation that Medtech companies can use in their FDA submissions.
✔ Anticipate and answer regulatory objections before they’re raised.
✅ Strategy #2: Address Regulatory Requirements in the Product Roadmap
One of the biggest reasons Medtech companies hesitate to adopt third-party tech is because they need to prove regulatory compliance for every single submission.
But what if you could eliminate that burden for them? FDA’s requirements and standards are available. You can design your product and documentation with FDA’s requirements in mind, and meet those requirements proactively.
✔ Address more customer requirements within your product
✔ Stay ahead of Big Tech competition, who likely is not specialized in Medtech
✔ Reduces sales friction and increases trust—making it easier to close deals
✅ Strategy #3: Align with a MedTech Strategic as Design Partner
Large MedTech companies sometimes build instead of buy because they know they can control product development to meet regulatory requirements. What if you could partner with a Medtech to build the tool they need, but retain the IP rights and scale the product? What if you could get paid to build the features they want?
Medtech venture arms invest not only in Medtech startups, but also in the technology and supplier firms. Consider seeking investment from strategic customers, and align them as design partners.
The Time to Differentiate is Now—Before Competitors Do
The MedTech industry is becoming more tech-driven, and the regulatory landscape is developing. This means that Tech for Medtech companies who position themselves early as regulatory-friendly vendors to Medtech will dominate the market.
Right now, large vendors of technology are just beginning to develop medtech regulatory strategies. High-tech solutions (e.g., cloud platforms, devops pipelines, cybersecurity technologies) still require a lot of customization and investment before they are turn-key solutions for Medtech customers. Soon, Big Tech will catch up, and competing will be even more difficult. First-movers with regulatory strategy will be well-positioned to compete in the years ahead.
💡 Bottom Line: If you’re selling technology to Medtech, you need a regulatory strategy. Otherwise, you’ll keep losing deals to either (1) competitors who can prove their compliance advantage or (2) to your own customers, who decide to build instead of buy.
~Shannon, the Optimistic Optimizer (with my GPT assistant)