What a CDMO Wishes Every Startup Knew About Hiring

CHECKLIST

What a CDMO Wishes Every Startup Knew About Hiring

What to build in-house, what to leave with a manufacturing partner, and when that changes, from a CDMO and an executive search company who watch this decision play out program after program

A co-created perspective from Aptyx and Guided Solutions

A Napkin Sketch Is Not a Team

Most MedTech companies start the same way: one person with a clinical or technical insight nobody else has connected yet. Sometimes it’s a surgeon who has spent years in the operating room and sees exactly where the standard of care falls short. Sometimes it’s a biomedical engineer, a nurse, a researcher, or an operator who spent years inside the problem from a different angle. Whoever it is, they sketch the device that would fix it and set out to build it.

What that founder usually has is a clear clinical vision. What they usually don’t have is documented engineering specifications, a quality system, or anyone else in the room. At the outset, the company is effectively one person, working alongside a full clinical practice while also trying to be the engineering team, the quality function, and the regulatory strategist.

Aptyx and Guided Solutions have both seen this pattern up close, from different sides of it. Aptyx is a leading contract manufacturer for the medical device industry, serving programs from early prototype through full-scale commercial manufacturing under ISO 13485:2016 certification. Guided Solutions has spent 26 years building the leadership teams that sit around those devices. Between the two of us, the same question comes up on almost every program: which capabilities does this company need to own itself, and which deserve the extensive support of a partner? This checklist works through that question capability by capability, built around one program that shows what getting the answer right looks like.

The Case in Point

“He arrived with a clear clinical vision and a detailed sketch of the implant he wanted to place in the artery. What he did not have was a way to build it. The concept covered only the implant side. There was no delivery mechanism, no fully documented engineering specifications, and no quality system to support development. At the outset, the company was effectively one person: the surgeon himself, working alongside his clinical practice.”

Aptyx case study, physician-inventor program

Aptyx began by translating the surgeon’s clinical experience into documented, measurable specifications: device strength, sizing range, and deployment method. Because the company had no quality system of its own, the early-stage program ran under Aptyx’s own design controls. As the program matured, the founder’s first hire was a technical and engineering resource. From there, the program went on to first regulatory approval outside the United States within three years, CE Mark approval, FDA Breakthrough Device Designation, a Humanitarian Device Exemption, full FDA premarket approval, and acquisition by a global medical device company, with Aptyx remaining the manufacturing partner more than a decade later.

This kind of program, an implant paired with a novel delivery system, developed from concept through commercial manufacturing, sits squarely within Aptyx Interventional Systems, the division built around implants, complex catheters, and delivery systems.

The device succeeded, but the sequence is instructive for every founder in that same starting position: a manufacturing partner held the quality-system and design-control capability before the company had a team of its own to hold it. The open question this checklist works through is how a startup decides, deliberately, which capabilities to build itself, which to leave with a partner, and when that decision should change.

This sequence is not unique to one program. Aptyx has completed more than 100 development and manufacturing projects for interventional device companies over the last decade, and the starting point, a strong clinical insight with no team yet to build it, shows up on a meaningful share of them. The details vary by program, but the pattern repeats often enough to plan around rather than treat as an exception.

Three Ways to Close a Capability Gap

Every early-stage MedTech company is short the same things: a quality system, a regulatory strategy, development and engineering resources, manufacturing capacity, commercial leadership. The instinct is to treat each gap as a hiring problem. In practice, there are three ways to close one, and the right answer is different for each capability.

• Build it in-house: hire someone who owns the capability permanently, with the authority and budget to run it.
• Partner for it: leave the capability with a CDMO, contractor, or specialist firm that already has it built, tested, and certified.
• Bridge it: bring in a fractional, interim, or advisory resource that holds the capability temporarily while the company decides whether to build or partner for the long term.

Aptyx exists because the second option is often the right one, for longer than founders expect. Guided Solutions exists because the first option, done at the right time with the right person, is what makes the second and third options work. Neither of us thinks every capability should default to the same answer, which is the point of the map further down.

The Gap That Shows Up Most Often: A Regulatory, or Clinical-and-Regulatory, Resource

Asked directly what the biggest support a startup can have outside of what a CDMO provides, Aptyx’s team was specific:

“The biggest support a startup can have outside of what we provide is a regulatory resource, or even better, a clinical and regulatory resource.”

Aptyx, on the founding team gap that shows up most often

Guided Solutions sees the same thing from the search side, usually when startups come to us too late for this hire rather than too early. Regulatory strategy is not a function a company adds once it is ready to submit: the decisions that determine the submission pathway (predicate selection, classification, the clinical evidence strategy, which markets to pursue first) are made years earlier, often before the design is frozen. A founder-engineer team without a regulatory voice at the table tends to make those decisions by default rather than by design, and by the time a dedicated resource is finally brought in, some of them are already locked in.

Someone who understands both the clinical rationale and the regulatory pathway is rarer, and more valuable, than either alone. Unlike manufacturing or molding, this is a capability few startups can permanently leave with a partner; it has to become an internal voice eventually. The open question is only when, and whether the first step is a full-time hire or something smaller.

The Aptyx Perspective: What Can Stay With a Manufacturing Partner

Not every capability follows the same rule. Some of what a startup needs, complex molding, precision extrusion, specialty coatings, finished device assembly, cleanroom-controlled build, is capital-intensive, slow to build, and rarely worth owning until a program is at meaningful commercial scale. For most MedTech companies, it never becomes worth owning at all.

In practice, the capabilities that stay external longest, often permanently, are built on specialized processes and infrastructure, some highly proprietary, that take significant time and expertise to validate and qualify. Borrowing that infrastructure is almost always faster and more reliable than building it, freeing a company’s resources for the clinical, regulatory, and engineering judgment calls a partner cannot make for them.

In the case above, Aptyx held the company’s entire quality system and design controls in the earliest years, not because the founder could never build one, but because borrowing an established one was faster and more reliable than building one from nothing. That capability moved in-house, in a modified form, only as the company itself scaled past acquisition. Manufacturing capability specifically never moved in-house at all: Aptyx remains the manufacturing partner more than a decade later.

The Capability Map: Build, Partner, or Bridge

Put together, the question isn’t only when to hire. It’s which of these capabilities your company should own, which should stay with a partner, and what would tell you it’s time to change your answer.

A working map, not a rigid rule. What counts as “meaningful scale” or a “stable design” varies by device class, funding, and ambition. The pattern that holds across programs: the decision is usually made by default, whichever way inertia points, rather than on purpose.

The Guided Solutions Perspective: Building the Capabilities That Have to Be Internal

Some capabilities on the map above will always need to be built, not partnered. Guided Solutions has completed 10,000+ MedTech placements, many of them in exactly these roles: the ones that involve judgment calls a partner can support but shouldn’t be making alone, such as regulatory strategy, clinical direction, commercial leadership, and quality ownership once a company is operating as its own legal manufacturer of record.

• Bring a regulatory or clinical-regulatory voice in-house, or on as a dedicated advisor, while the design is still open, not once it is frozen.
• Treat the first technical or engineering hire as a translator between clinical intent and manufacturable design, not just a builder, since that judgment doesn’t partner out well.
• Build commercial and quality leadership ahead of the milestone they need to operate, since neither is a capability a manufacturing partner is positioned to hold for you.
• Don’t confuse a strong resume in a large device company with the ability to build a function from zero: early-stage programs need builders, not maintainers.

Quick-Reference: The Startup Hiring Self-Check

Work through this against where your program stands today. Not every item applies at every stage; the point is to see the gaps, and the decisions made by default, before a milestone forces you to.

Team & Structure

• ☐We have documented user needs and design inputs, not just a founder’s sketch or concept.
• ☐We have design controls and a quality system in place, even one borrowed from a manufacturing partner.
• ☐Our first technical or engineering hire can translate clinical intent into a manufacturable design, not just build to a spec handed to them.
• ☐We can name, in writing, who currently owns quality, who owns regulatory, and who owns engineering, even if one person holds more than one of those.
• ☐We have a plan for what happens when the founder is no longer the only person who holds the full clinical and technical picture.

Regulatory & Clinical

• ☐We have a regulatory, or ideally clinical-and-regulatory, resource involved before the design is frozen.
• ☐Our regulatory strategy (predicate selection, classification, evidence strategy, target markets) was decided deliberately, not by default.
• ☐We have traceability from user need through test protocol that could withstand regulatory scrutiny today, not just by launch.
• ☐If we’re pursuing approval outside the US first, we know how that evidence is meant to support our eventual US pathway, not just get us to a market somewhere first.
• ☐We could name the specific evidence gap a regulator or acquirer would flag in our program if asked today.

Leadership & Timing

• ☐We are building commercial and quality leadership ahead of the milestone they need to support, not after it.
• ☐We evaluate technical hires for early-stage building ability, not just pedigree from a larger device company.
• ☐We know who is accountable for each function today, even in functions where we haven’t made a permanent hire yet.
• ☐We know which upcoming milestone slips first if our next hire doesn’t happen on schedule.
• ☐We’ve tested this hiring plan against a slower fundraising timeline, not just the best case.

Resourcing & Trade-Offs

• ☐We’ve weighed the cost of building this capability in-house now (cash, equity, management time) against the cost of the gap it fills, not just against the risk of not having it.
• ☐We’ve considered a fractional, interim, or advisory resource before committing to a full-time hire for a function we don’t yet know how to manage.
• ☐We can tell the difference between a gap that blocks our current milestone and one that matters later but doesn’t need solving this quarter.

Build vs. Partner Decisions

• ☐We’ve decided, capability by capability, which ones stay with our manufacturing partner and which we’re building in-house, rather than defaulting into either.
• ☐We know which of our manufacturing partner’s capabilities we could never cost-effectively replicate ourselves, and we’re not planning to try.
• ☐We’ve set a real trigger, a metric, a milestone, a scale point, for when a partnered capability should move in-house, instead of leaving that decision open-ended.

The section with the fewest checks is usually the one worth acting on first. Across the programs we’ve both seen, that’s most often Regulatory & Clinical, but your program’s answer may differ.

Conclusion

None of this replaces judgment specific to your device, your funding position, and your team. What holds across the programs we’ve each watched, on the manufacturing side and the search side, is that the build-or-partner decision is rarely made on purpose. Capabilities default to wherever momentum was already pointing, in-house because that’s what the founder knows, or external because that’s what’s easiest to keep paying for, rather than because anyone weighed it deliberately. Use the map and the checklist above to make that call on purpose, for each capability, and revisit it as your program changes.

About Aptyx

Aptyx is a leading contract manufacturer for the medical device industry, with 75+ years of experience and a global network of 10+ locations across the US, Canada, Mexico, and China. Its integrated capabilities span design and development, complex molding, precision extrusion, specialty coatings, and finished device assembly. ISO 13485:2016 certified and FDA registered, Aptyx serves MedTech companies from early prototype through full-scale commercial manufacturing. The program featured in this checklist sits within Aptyx Interventional Systems, the division delivering expertise in implants, complex catheters, and delivery systems. Learn more at aptyx.com.

About Guided Solutions

Guided Solutions is the global executive search company exclusively dedicated to MedTech. With 26 years of specialist focus, 10,000+ placements, and a network of 200,000+ professionals across 40+ countries, the firm partners with MedTech companies from pre-seed to global scale to identify leadership that drives long-term impact. Results measured by candidate tenure and business growth. Learn more at gsmedtech.com.