Most MedTech innovators understand that cybersecurity is a regulatory requirement. What they underestimate is the cost of treating it as someone else’s problem, to be dealt with later, once the hard work of building the device is done.
At industry events, the same conversation plays out repeatedly. An innovator approaches, acknowledges the importance of cybersecurity, and explains they are not ready yet: still in development, still sorting out the fundamentals. The implication is that security is a finishing touch, something to layer on before submission. That assumption is wrong, and it is expensive.
Consider this example: a 25-person team, a product nearing the end of development, and a cybersecurity review that came too late. The FDA submission was rejected. The delay stretched nine months. The total cost exceeded $500,000, covering re-engineering work, software developers re-engaged to fix foundational issues, staff salaries across the delay period, and regulatory resubmission costs, as well as lost time-to-market. That does not include the less quantifiable cost of a competitor reaching the market first.
The same outcome could have been avoided with approximately $5,000 of proactive security consultation at the design stage. That is not a rounding error. It is a fundamental miscalculation about where in the development cycle cybersecurity actually belongs.
The regulatory reality: cybersecurity spans the total product lifecycle
The FDA has been consistent on the underlying principle: cybersecurity is a safety and effectiveness requirement. The most current premarket guidance makes clear that security is a lifecycle obligation, not a one-time document set. The FDA’s Secure Product Development Framework (SPDF) concept reflects this directly. Security should be systematic, built into the development process, not a best-effort exercise completed in the weeks before a filing.
There is also a gating mechanism now in place. The FDA’s Refuse to Accept (RTA) policy, tied to cybersecurity information required under Section 524B of the Federal Food, Drug, and Cosmetic Act, means that submissions missing required cybersecurity elements may be treated as administratively incomplete, creating delays before substantive review even begins. For a team that has spent years on development - on average, a medical device takes seven years and $35m to bring to market - this brutal outcome is entirely avoidable.
For manufacturers pursuing global market access, the challenge is compounded. FDA clearance is one threshold. China’s National Medical Products Administration (NMPA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) each carry their own expectations around security documentation, risk management frameworks, and ongoing obligations. Clearance from one body does not translate automatically to the others. And retrofitting a cybersecurity program for each market sequentially, rather than designing for it from the outset, adds cost and delay at every stage. Manufacturers who treat cybersecurity as a market access strategy from day one are better positioned to move efficiently across multiple regulatory environments.
The $5,000 versus $500,000 decision
The cost comparison is not theoretical. It is drawn from the real pattern of how MedTech submissions fail when cybersecurity is left too late.
Early-stage cybersecurity consultation, which engages during design to conduct threat modeling, establish the right documentation approach, and ensure foundational architecture decisions are defensible, is a contained, manageable investment. The work is scoped, the findings are actionable, and the cost of implementing changes at this stage is low because nothing is locked yet.
The reactive version of that same work, carried out after a rejection, looks entirely different. It involves returning to architectural decisions that have already been built upon. Software developers who have moved on to other projects must be re-engaged. The validation cycle restarts. Staff costs accumulate across a delay that may stretch six to twelve months. And throughout that period, the product is not reaching the patients who need it.
The arithmetic of this decision should be straightforward. The reason it continues to play out badly for so many teams is that early-stage cybersecurity consultation feels like an optional cost, while the downstream consequences feel remote. They are not remote. They are the predictable result of a well-documented pattern.
What security-by-design actually looks like in practice
The term “security-by-design” appears often in regulatory guidance and industry conversation. What it means in practice, particularly for lean engineering teams without dedicated in-house security expertise, is worth making concrete.
It begins with threat modeling during the requirements and design phase, not as a standalone exercise, but as a structured process for identifying what the device needs to defend against, how it connects to hospital networks, what data it handles, and where the highest-consequence vulnerabilities could emerge. This work shapes architectural decisions. It is far less useful when those decisions have already been made.
Alongside threat modeling, a Software Bill of Materials (SBOM) should be built as the product is developed, not assembled retrospectively before submission. The SBOM is now a regulatory expectation, and maintaining it as a living document throughout development reduces the effort significantly compared to reconstructing it from scratch.
Automated vulnerability scanning, integrated into the CI/CD pipeline, adds relatively little friction to the development workflow while providing continuous visibility into emerging issues. This is the kind of control that scales well for smaller teams: it does not require a dedicated security function, and it catches problems when they are still cheap to fix.
As AI integration accelerates across the MedTech sector, the stakes around this mindset are rising. AI-enabled devices expand the attack surface, and hospital integration points all require security consideration. The cost and complexity of a bolt-on security approach, already unsustainable for conventional devices, becomes genuinely unmanageable when AI is involved. Frameworks like Good Machine Learning Practice, alongside emerging FDA guidance on AI-enabled devices, are pointing in the same direction - security must be engineered in from the start, not appended at the end.
Reframing the misconception
The “not yet” response, that I hear consistently at industry events like the JPMorgan Healthcare Conference, reflects a genuine misunderstanding of how cybersecurity requirements interact with the development process. The instinct is to treat security as a late-stage compliance task: something to be addressed once the device is built. In practice, the foundational decisions that determine how difficult and costly cybersecurity compliance will be are made during design. By the time a team is preparing a submission, most of the flexibility to address those decisions cheaply has already been used up.
This is not a theoretical risk. It is the pattern that explains why submissions are rejected, why remediation’s run to six figures, and why devices that should be on the market are not.
The reframe that matters here is a commercial one. Early cybersecurity consultation is a risk mitigation that protects the entire investment in a product. Viewed through that lens, waiting transforms a manageable expense into a much larger one, with no guarantee that the outcome will be better.
The broader cost of delay
There is one dimension of this problem that rarely features in the financial analysis: the patients waiting for the device.
Many MedTech innovators entered the field because of a specific problem they wanted to solve, often one they encountered personally or clinically. The device represents a potential improvement in quality of life, or a reduction in suffering, for a defined patient population. A nine-month regulatory delay does not just affect the manufacturer’s revenue timeline. For patients who need the device, particularly those already enrolled in clinical trials who have seen its benefits first-hand, that delay is measured in months of a condition unmanaged, a treatment unavailable, or a standard of care that is materially worse than what could have been.
In the pressure of development cycles, regulatory submissions, and investor conversations, it is easy for that original motivation to become abstracted. Cybersecurity compliance can start to feel like one more obstacle between the innovator and the market. It is worth remembering that doing it right and doing it early is precisely what gets a device to the patients who need it, faster.
‘’Cybersecurity done right prevents delays’’
