The short answer. For companies with devices already on the market we take on the engineering your team has no time for: redesign around obsolete components, firmware ports to new toolchains, adding Bluetooth, cost-down and design for manufacturing, production transfer and post-production support. We change what must change, keep what was cleared, and give your regulatory team the evidence to decide whether the change needs a new submission.
What manufacturers ask us for
Redesign around obsolete components
A device sold for years whose processor, sensor or display is end of life: new parts, same function, documented so your team can assess the change.
Firmware ports
Legacy firmware moved to a new toolchain, for example an ECG device ported from IAR Embedded Workbench to STM32CubeIDE with refactoring.
Platform modernization
New electronics around an existing analysis algorithm: on an electrocardiograph we redesigned the hardware with modern components while the client’s analysis software stayed untouched.
New connectivity
Bluetooth or Wi-Fi added to an existing product, designed with the Section 524B cybersecurity requirements for connected devices in mind.
Cost-down and design for manufacturing
Second sources, part consolidation, test strategy, tooling choices and a housing designed for the real annual volume.
Production transfer
In 2025 several clients asked us to help move production from China to Europe or the United States because of tariffs.
Projects from our portfolio
Electronics and firmware with the client’s mechanics
A rehabilitation chair: the client kept the mechanical design; we delivered two boards, a remote, firmware under software safety Class B, five pre-production units and a design history file.
Make instead of buy on a ventilator
The purchased piezo valve driver was too big and too slow. Our replacement was half the size and drove the valve 2.5 to 3 times faster, with a supply range for battery operation.
Electrocardiograph modernization
Modern components, defibrillation and ESD protection and USB-C on an existing ECG platform, with the client’s analysis software kept as it was.
Operating room device after another engineering team
A handheld device whose screen was unreadable under operating room lights: brighter display, new battery and a new casing.
Post-production support at volume
A wellness device producing 2,000 to 2,500 units a day, supported by our team after design engineering ended.
The reason turned out to be simple: the lighting in an operating room is extremely bright, and under it the screen was unreadable. All the testing had been done under normal laboratory light. The device worked perfectly everywhere except the one room it was built for.
How we protect what you already have cleared
- Change only what must change. We define the change boundary first: which boards, which firmware modules, which materials. Everything else stays identical and is documented as unchanged.
- Keep proven software intact. Algorithms and analysis software that carry your clinical evidence are kept as they are and wrapped with new interfaces rather than rewritten.
- Evidence for the decision. For each change we scope the delta: updated risk analysis inputs, verification of the changed functions, regression on the unchanged ones and the design history file updates. Your regulatory team decides whether a new submission is needed.
- Build early, fail early. A make-or-buy decision that fails on the bench in month three is cheap; a bought part that fails at integration in month eleven is not. We measure the disqualifying parameter of a bought part before the mechanics freeze around it.
Read more: outsourced R&D for hardware migration and manufacturing transfer support for medtech companies.
What design transfer includes
Design for manufacturing for an average product takes 2,500 to 4,000 engineering hours. Lisa Voronkova listed what goes into it:
| Area | What we do |
|---|---|
| Assembly | Assembly sequence and cycle time, adjusted to the equipment and capacity of the production partner |
| Boards | Panelization, test points and probe strategy |
| Tooling | Tool design support |
| Supply chain | Supplier management, final bill of materials and second sourcing, with at least three suppliers for critical parts |
| Test | End-of-line test fixture with its test software and firmware |
| Documentation | Manufacturing documentation, work instructions and assembly instructions |
| Pilot build | First batch, first inspection and analysis of the results |
| Validation | Support for process validation (IQ, OQ, PQ) at the manufacturer |
We typically look for at least three different suppliers just in case. So not to be dependent heavily of just one supplier.
So what we are doing we are trying to engage our contract manufacturer early. So not after design freeze because a good manufacturer will look at your design and tell well I don’t know there are certain features that would add you don’t know 10 bucks per unit and 6 weeks to your timeline
FDA and EU rules for changes to a marketed device
- When a change needs a new 510(k). FDA’s 2017 guidances on device changes and software changes are still current. Compare each change to the device as last cleared, add up the cumulative effect, and file when a change could significantly affect safety or effectiveness; otherwise document the decision.
- Special 510(k). For changes to your own cleared device FDA generally reviews a Special 510(k) within 30 days. In 2025, 481 of 3,198 clearances (15%) were Special 510(k)s, with a median of 30 days to clearance.
- Predetermined change control plans. Since FDORA (2022) a 510(k) or PMA can include a plan for pre-specified future changes. The guidance for AI-enabled software is final; the guidance for all devices, including hardware, is a draft from August 2024 that FDA plans to finalize in FY2027.
- Inspections. Change control is one of the six QMS areas in FDA’s inspection program since February 2026, covering product, process, software and purchasing changes.
- EU. Legacy devices stay on the EU market until 2027 or 2028 only without significant changes in design or intended purpose. MDCG 2020-3 Rev.1 lists replacing an obsolete electronic component, with board re-layout and new firmware to run it, as a non-significant change when the benefit-risk ratio does not get worse. See EU MDR transition deadlines.
What FDA data says about changes and failures
| Fact | Number |
|---|---|
| Recall events initiated in 2025 with a determined root cause that were design-related | 255 of 709 (36%); the share was 36.1% in 2024 and 36.5% in 2023 |
| Recall events with a software-related root cause (of the 709 determined) | 131 (18.5%) |
| Recall events with a change-control root cause (of the 709 determined) | 107 (15.1%) |
| PMA supplements decided in FY2025 for design, component, specification or material changes | 357 of 2,341 (15.2%) |
| PMA supplements for manufacturing process changes, mostly 30-day notices | 1,633 (69.8%) |
Questions
Can you work with our existing design files and engineers?
Yes. On the rehabilitation chair program the client’s team kept the mechanical design and we took the electronics and firmware. The interfaces between the two teams and the documents each side owns are agreed in discovery.
Will a component change need a new 510(k)?
Not necessarily. Under FDA’s 2017 guidance you compare the change with the device as last cleared and ask whether it could significantly affect safety or effectiveness; many like-for-like component replacements are documented without a new 510(k). When one is needed, a Special 510(k) for your own device is generally reviewed in about 30 days. In the EU, MDCG 2020-3 treats replacing an obsolete electronic component as non-significant when the benefit-risk ratio does not get worse. Your regulatory team makes the call; we provide the evidence.
Can you port our firmware without changing the algorithm?
Yes. We have ported legacy ECG firmware from IAR Embedded Workbench to STM32CubeIDE with refactoring, and modernized an ECG platform while the client’s analysis software stayed untouched. We keep the algorithm isolated and propose a before-and-after comparison of its outputs as part of the port.
Can you help move production out of China?
Yes. We prepare the transfer package, recover missing design files where needed, qualify the new manufacturer and support the pilot build. See manufacturing transfer support.
How is post-production support priced?
By hours at $125 per hour. Typical support for a device in production is 200 to 400 engineering hours a year; redesigns for obsolete components or relocations are scoped as separate projects.
Related pages
Have a device that needs a redesign or a new home?
Tell us what is changing: a component, a factory, a feature. An engineer will outline the change boundary and the evidence your regulatory team will need.
Sources
- Lisa Voronkova on the Global Medical Device Podcast, September 2026
- Lisa Voronkova, interview on getting a device to market, August 2026
- Lisa Voronkova on MedTech Sustainability by Design, March 2026
- Ten boards inside a carry handle: engineering a Class II portable ventilator
- FDA, Deciding When to Submit a 510(k) for a Change to an Existing Device, 2017
- FDA, Deciding When to Submit a 510(k) for a Software Change, 2017
- FDA, The Special 510(k) Program, 2019
- FDA, Predetermined Change Control Plans for Medical Devices, draft 2024
- FDA Compliance Program 7382.850, February 2026
- MDCG 2020-3 Rev.1, significant changes
- openFDA recall and PMA APIs
Updated on October 9, 2026.