You Do Not Have a Hiring Problem

Three numbers from the latest Medtech Big 100 and what they should change about your FY27 planning

Three numbers from Medical Design & Outsourcing’s most recent Medtech Big 100 analysis are worth putting side by side.

Aggregate revenue across the world’s largest device companies hit a record $486.7 billion, up nearly 3 percent. R&D spending across the 74 companies that disclose it came to $29.2 billion, up less than 1 percent, after growing 10 percent the year before and 20 percent the year before that. And headcount across the 83 companies that report it fell 2.9 percent, to 1.21 million.

Read individually, each of those is a data point. Read together, they describe the operating environment most of you are planning inside right now. The industry is selling more, investing in the future at a flat rate, and doing both with fewer people.

Your roadmap did not shrink 2.9 percent to match.

Why hiring will not close the gap

The instinct is to ask for headcount, and in a normal year that would be the right instinct. But the constraint most teams are hitting is not really a shortage of engineers. It is a shortage of one specific profile: deep technical capability paired with regulatory fluency. The person who can architect connected device software and also knows what design control will do to that architecture. The person who can build an AI-enabled feature and defend the validation strategy to a reviewer.

Those people are not on the market. They are employed, and they are fielding calls. A search for that profile runs four to six months before you account for ramp, and program timelines do not pause while you look.

There is a second problem underneath the first. A meaningful share of what shows up on a hiring plan is not permanent work at all. You may need serious human factors depth for one quarter of one program and then not again for two years. Hiring against that need means you either carry the cost through the quiet stretches or you lose the person before the next program needs them.

The question worth asking instead

Not how many people can we add. Which capabilities must we own permanently, and which are episodic?

Permanent means the capability has to persist across product generations and survive individual turnover. Your architecture. Your regulatory strategy. Deep knowledge of your clinical application and how your device is actually used. These are the things that compound, and losing them costs years.

Episodic means the depth is needed intensely, then not. Specialized verification. A narrow materials or electronics problem. A one-time platform migration.

Most organizations have this backwards. They hire permanently against episodic needs, then find themselves renting the capabilities they should have owned all along. That is how a company ends up with a headcount number it cannot justify and an architecture nobody inside the building fully understands.

What never leaves the building

Whatever model you land on, a few things stay in-house. Architecture ownership. Design control. QMS accountability. IP. Cybersecurity governance.

If an arrangement puts any of those outside your walls, you have not added capacity. You have added risk, and usually the kind that does not surface until an audit or a transition.

The failure modes are consistent enough to name. A partner ends up owning the architecture, which means you cannot change partners without starting over. Design control gets split across two quality systems, and traceability breaks at exactly the moment you need it intact. Or the engagement gets priced as labor arbitrage rather than capability, so you buy hours when what you needed was judgment.

That set of conditions rules out a good portion of the market, including firms we compete with. It should.

Three questions for FY27 planning

Which capabilities on our roadmap need to survive the next three product generations, and do we actually own them today?

For every role on the hiring plan, is the need permanent, or does it end when the program ends?

If we lost our two most senior systems engineers next quarter, what stops? The answer to that one tends to reveal the difference between a capability you own and a capability one person is quietly holding for you.

Budgets are not growing much this cycle. Neither is headcount. The teams that do well in that environment are usually not the ones that argued hardest for more people. They are the ones that got precise about which capabilities were worth owning, and stopped treating everything else as a hiring problem.

Suntra MedTech Solutions helps medtech developers build and extend engineering capability across consulting, engineering, and innovation, inside FDA Class II and III environments. Start the conversation at SuntraMedTech.com/contact.

Source

Medical Design & Outsourcing, “R&D alert: Research and development spending stalls in the 2025 Medtech Big 100 ranking,” September 2025, updated April 2026. https://www.medicaldesignandoutsourcing.com/rd-alert-research-and-development-spending-medtech-big-100/