Mike Cordeiro
If your medical device reached the market 15 or 20 years ago and you’re coming back for a second (or even a third) generation, the FDA’s expectations and review environment have changed materially. International requirements have multiplied and tightened. The home-use market has emerged as an entirely new design and compliance dimension that simply didn’t exist for your Gen 1 product. The documentation, testing rigor, and submission strategy that got you to market the first time are likely insufficient, sometimes irrelevant, and potentially a liability when regulators look at what your new device needs to do and where it needs to go.
Gen 2 is a fundamentally different game, and the sooner you understand that, the better positioned you are to plan realistically and move efficiently.
In short: what got your legacy medical device here won’t get you there for its second (or third) generation.
Three shifts deserve specific attention, because they are where we see legacy-device clients most frequently caught off guard. The regulatory bar has risen over the last decade but so have the engineering tools and test infrastructure that make some of the work faster, cheaper, and more accessible.
Shift 1: Human Factors is a Requirement, Not a Nice-to-Have
Many clients exploring substantial updates to legacy medical devices assume human factors evaluation is optional. That assumption is the fastest way to increase your risk of submission rejection. For many devices and use scenarios, human factors validation is expected per ISO 62366, AAMI HE75, or the United States Code of Federal Regulations. For home-use or higher-risk interfaces, it is often essential to a credible submission.
Specifically, 21 CFR 820.30(g) requires that design validation include testing of production units under actual or simulated use conditions. FDA reviewers are not going to hand-walk you through what should have been there from the start. The risk is not a deficiency letter that adds a few weeks. The risk is a submission that gets rejected and a program that loses months.
Where the home-use question intersects with human factors, the stakes multiply. A device a clinician operated with training and colleagues nearby becomes, at home, a device a 75-year-old user manages alone, with arthritis, with the TV on, with a cat on their lap. That isn’t an edge case to plan around. It is the primary use case. For more on what that shift means for device design, see Jess Willing-Pichs’ analysis of the market shift to in-home care.
Shift 2: Software and Cybersecurity Are the New Frontier
Twenty years ago, connecting a device to the web was a niche feature. Data came off the device on a thumb drive, if at all. That world is gone. Today’s SaMD and software-inclusive devices are interconnected almost by default. Every connection point, whether Bluetooth, Wi-Fi, cloud sync, or a once-obscure data port, is now scrutinized as a potential vector for corruption or attack.
Regulators are going to ask: how many vectors are there, what are they, and how do you know? Software-centric devices and any device that relies on cloud-based data transfer or services are especially exposed. Adding connectivity to a legacy device is not a feature decision. It is a commitment to serious security rigor.
Think about it the way you would think about your own connected home. Would you be comfortable not knowing where your security camera footage was stored, who could access it, or how it was protected? Likely not. Your customers, users, patients, and regulators will not be either.
For a deeper look at planning for this from the start, see A Secure-by-Design Approach to FDA Cybersecurity.
Shift 3: EMI Testing Got Sharper, and Your Old Margins May Not Hold
Here is one that surprises clients working on medical device refresh or second generation projects: the radio-frequency emissions standards your Gen 1 device was tested against may not have changed dramatically, but the testing has. That matters more than people realize.
Twenty years ago, EMI emissions testing often happened in open-air sites using manual testing and recording methods. Today, nationally recognized test labs (NRTLs) use large, enclosed semi-anechoic chambers with software-automated measurement methods that efficiently cover the emissions spectrum. This technology allows for more accurate, repeatable, faster scans. It will find everything your device is emitting. In addition, 4th edition changes to IEC 60601 require the device to be operating in modes that maximize emissions, which can include modes not previously considered.
The consequence: a device that passed comfortably under the limits in 2005 may take the same test today, with no design changes, and fail because of increased scrutiny of the emissions profile or operating mode of the device. If you are planning to bring your Gen 1 design back to a test lab and assume it will pass because it passed before, that assumption is going to cost you significantly in project resources and time to market.
The takeaway is operational: pre-screen with a working prototype as early as possible. Do not wait until the end of the program to learn whether your hardware sits in or near the danger zone. You do not want to be putting band-aids on a finished design.
The Counterweight: Where Medical Device Development for Legacy Medical Devices Got Faster and Cheaper
The pitfalls above are real. The opportunities are equally real, and they sit in places that did not exist for your Gen 1 program.
Test lab automation
The same automation that makes EMI testing sharper also makes it dramatically faster and cheaper. What used to take three or four days at a test lab can now often be done in a single half-shift, roughly four hours, at a typical cost in the low thousands. That is the difference between a single end-of-program test event and multiple opportunities to iterate, learn, and de-risk earlier in the design process.
Quick-turn PCB design
Twenty years ago, getting a printed circuit board (PCB) fabricated meant weeks of lead time and significant cost, enough that teams stayed on hand-wired breadboards for as long as they could. Today, quick-turn PCB houses can deliver prototype boards in a matter of days, often for less than the labor cost of hand-wiring, or hand modifying an existing PCB. The benefit is not just speed. It is maturity. Your prototype hardware can get closer to final hardware much earlier in the program, which means fewer redesign loops, fewer surprises downstream, and higher performance confidence going into verification.
Don’t inflate. Re-allocate.
Here is where the opportunity becomes a planning insight. If you sat with your Gen 1 program records honestly, you would likely find months of effort spent on prototyping and test efforts that today’s tools compress dramatically. That savings should not disappear from your budget. It should move to the places where the regulatory bar has moved up: human factors, cybersecurity, and opportunities for pre-screening.
Think of it like replacing a TV. You can buy one with the specs of a 2015 model for almost nothing today, but most people are still happy to spend roughly what they spent then, because for the same money they get a better featured, thinner, lighter, higher-resolution, more capable product. Same money, materially better outcome. That is the right mental model for a Gen 2 budget. Reallocating the savings from more efficient design work into HF and software rigor, for example, gives you a more de-risked submission for the same overall investment.
For more on planning across generations before you build or prepare your new, first-generation medical device for regulatory submission, see Tina Berthiaume's Navigating Tough Decisions & Multi-Generational Planning in Medical Device Development.
The One Thing to Remember - Front-load the Planning
The regulatory landscape, especially the U.S. FDA, has changed significantly. The single most valuable thing you can do is front-load the planning. Have these conversations with experts who can validate their expertise, as early as possible. The farther downstream those conversations happen, the greater the risk to your timeline, your budget, and your submission.
Every one of these activities is fundamentally about de-risking your technology and your submission. The earlier you plan, the faster you get to review. The faster you get to review, the faster you get to clearance or approval. The faster you get to clearance, the faster you get to adoption, to acquisition, to patient impact. That sequence is the whole point.
How Veranex Approaches Second Generation Medical Device Programs
Veranex is not the only regulatory and development partner in the medtech space, and you should always seek more than one perspective on a program of this complexity. Expertise that can be validated is, in our view, table stakes.
Where Veranex is built to be useful on a Gen 2 program is in what sits alongside the engineering work: access to professional excellence in Human Factors, Preclinical, Clinical Research, Regulatory, Quality, and Commercialization expertise across the total product lifecycle, under one roof. The conversations a legacy-device client most needs to have early, about HF requirements, cybersecurity architecture, EMI pre-screening, and intelligent budget reallocation, benefit from having those disciplines in the same room rather than scattered across separate vendors and timelines. That is the connection we are built to make.
About the Author
Michael Cordeiro, Electrical Engineering Lead, brings 15+ years of electrical engineering leadership to medical and industrial product development. He has held lead engineering and project management roles across programs of all scales, guiding products from concept through design, validation, and market launch. At Veranex, Michael partners with client teams to navigate complex technical challenges in regulated environments, with particular depth in design controls, quality systems, and risk management.