Vendor Management in Today’s MedTech World: Why “Test Balloons” Are No Longer Optional

The vendor landscape in medtech has changed. If you’ve tried to move a device forward recently, you’ve probably felt it: longer lead times, higher staff turnover, shifting expectations, and a general inconsistency that can make even straightforward tasks feel like firefighting. Test labs are booked out months in advance. Regulatory expectations keep expanding. Manufacturing teams are doing their best under significant pressure. And the number of interconnected standards a device must meet feels unending.

After more than 175 medical device projects, we’ve learned that these stresses aren’t due to bad intentions. They’re the result of an industry in transition.

Experienced machinists, seasoned technicians, and long-standing regulatory staff have retired or moved into other roles. Many test labs are no longer just testing, they’re reviewing full documentation packages for alignment across multiple standards. And vendors who once operated with near-seamless processes are still working to reestablish their own stability.

So how should founders navigate this environment?

The answer is to expect these challenges — and discover them early, on purpose.

In other words: you need test balloons.

A test balloon is a deliberate early experiment: a pilot build, a pre-test, a sprint, or a limited-scope regulatory consult. These small, intentional steps surface misunderstandings and failure modes before they become more costly.

Why Pre-Testing Matters More Than Ever

Take electrical safety testing. Many founders believe that once the electrical design is “done,” the device is ready for IEC 60601. But today, a device can’t even begin formal testing unless several things are already in place:

• The design must hold up to a level of scrutiny that often requires rework after pre-test.
• A complete, reviewable risk analysis must exist.
• Labeling, instructions, and supporting documentation must be prepared because the test lab reviews them alongside the device.

Pre-testing, whether a pre-scan or a gap analysis, is no longer optional. It’s the difference between learning in a few weeks and losing half a year.

Startups often arrive at test labs far too early because they don’t realize that testing depends on documentation, labeling, risk analysis, intended use, and performance claims, all of which must align before the lab will even schedule a test.

Specification Assumptions and Surprises

A similar pattern appears in product specification. Founders often assume a device is “easily specifiable.” Just make it work… right?

In reality, every device operates within acceptable ranges, and determining acceptable ranges is rarely straightforward. A prototype that worked once doesn’t define a final specification. Clinicians often describe performance in terms of feel rather than measurable tolerances. Inventors may assume machining can hold tolerances tighter than industry norms. Teams assume user needs map directly to design requirements, but they often don’t. Some founders expect an “industry standard” path for innovations that have never existed before.

This leads to one of the most common surprises in medtech development:
The team didn’t get what they thought they were getting.

Not because the vendor didn’t care, but because no one clearly defined what the specification should have been. Both sides moved ahead on assumptions that no one articulated.

This is why sacrificial prototypes, trial builds, and pilot sprints matter. They help you discover what you actually want before you bet your schedule on it.

Regulatory Advice That Doesn’t Blindside You

Regulatory consulting has its own version of this issue. Some consultants rely on boilerplate advice that quietly limits claims or narrows the market without explaining the tradeoffs.

Effective regulatory guidance isn’t about quick answers. It’s about mapping the levers:

• The claims you want to make
• The tests and documentation those claims will require
• The ambiguity you’re choosing to embrace
• The tradeoffs you might not have seen yet

The right consultant doesn’t eliminate uncertainty. They reveal it so you can navigate.

How to Evaluate Vendors (and Culture)

Engineering partners, test labs, and component vendors each require test balloons of their own:

• Engineering teams should provide early output: a feasibility prototype or sprint result, not distant promises.
• Test labs should perform pre-tests and gap reviews.
• Component vendors should be evaluated through small, well-defined orders with clear acceptance criteria.
• Custom components should be proven functional before full-scale commitments.

We’ve seen vendors ship assemblies that physically couldn’t function. A simple early test balloon could have prevented the delay.

Culture is also key. Many teams are stretched thin, rebuilding, or overwhelmed. Engagement varies widely. When evaluating a vendor, watch for curiosity, ownership, and thoughtful questions. If they aren’t engaged at the start, they won’t become engaged later. And we can set the tone ourselves by choosing to care about the people we work with; care is contagious.

At in2being, we often reference the “dollar in YOUR pocket” rule:

If this were your own dollar, would you do it this way? If not, what would you change?

Even if the client makes a different decision, expressing how you would safeguard their investment as if it were your own creates alignment and clarity.

Why Test Balloons Matter

Ultimately, the teams who succeed aren’t the ones who avoid uncertainty. They’re the ones who expose it early.

Every design decision creates a cascade of downstream effects. Every variable must be discovered and understood. Progress comes from intentional discovery: small starts, pre-tests, feasibility sprints, trial builds, clarified acceptance criteria, and a willingness to learn before scaling.

Vendors manage parts of the work, but the startup still owns the outcome.

Certainty in medtech doesn’t come from confidence or contracts. It comes from learning early, consistently, and intentionally.

That’s the purpose of test balloons — and why they are more essential than ever in today’s environment.

You can’t control every variable, but you can learn early and move forward with clarity. Reach out to build a smarter, more resilient path to market.