Oliver Puttler
By Oliver Puttler
You have carried your novel medical device a long way. What began as an idea has survived years of work, hard scrutiny, and the kind of funding that only arrives when serious people believe you are onto something. You are moving into clinical builds, and commercialization is finally on the horizon.
Now you have to choose who will actually build it.
The instinct is to evaluate medical device contract manufacturers the way you would evaluate any vendor: issue an RFP, compare responses, select the best, however you define it. The leading proposals will look reassuring. Every credible manufacturer should show you a current quality management system, ISO 13485 certification, IQ/OQ/PQ skillsets, traceability, regulatory strength, and the capability to handle your device class. But here is the uncomfortable truth: those things prove a manufacturer can execute work that is (or should be) well understood. They do not tell you enough about what happens the day an unexpected challenge arrives that no one saw coming.
And on a genuinely novel device, one always arrives.
Think of a commercial airline pilot. Pilots carry quick-reference cards for cockpit emergencies because problems have been seen, studied, and addressed in advance (as much as possible). A device already on the market has its own versions of this: instructions for use, training and procedures built from problems the field has surfaced and understood, often from robust human factors engineering and rigorous preclinical evaluation when desired or required. But a genuinely novel program will, sooner or later in its development pathway, surface an unanticipated challenge. The quick-reference card does not exist because you’re still writing it. That is not a failure of planning. It is the nature of new work.
This distinction matters. If you were manufacturing something well understood like standard extrusions, or commodity PCB assemblies, persistent unanticipated problems would be a red flag; a sign the process was not under control. That is not your situation. Your device is novel. Novelty and the unexpected travel together. The challenge can surface almost anywhere as manufacturing nears: in materials or component sourcing, in tooling and setup, in the process, or in the build itself. The question is not whether it will happen, but who will be standing beside you when it does?
This is why the contract, for all the attention it gets, is not the only thing that protects you, nor should it be. In my experience, contracts are for the basics, the anticipated, and the separations. I’ve worked with manufacturers whose agreements ran to several dozen pages, and the contracting process alone would wear you down until you would sign almost anything just to move forward. Then, the moment reality departs from the paper, the conversation goes straight to the clause that makes the challenge mine. This is miserable (or worse) when you are the one holding a novel product. You cannot pre-write every eventuality into a contract. What protects a novel program is a partner who solves the problem the contract never imagined.
So how do you find the right contract manufacturing partner for your novel medical device before you are committed to them? You ask one question.
The One Question to Ask of Any Prospective Medical Device Contract Manufacturer
“When did you last solve an unanticipated challenge on a truly novel device program in my therapeutic area, and can you show me exactly how you solved it?”
That single question does more work than an entire evaluation checklist. “Truly novel” keeps it anchored to the kind of work you are actually doing. “My therapeutic area” forces a specific, relevant answer instead of a rehearsed generality. “How” asks them to share their process with you. And a medical device contract manufacturer who claims they have never faced an unanticipated challenge during the development of a novel device is telling you something important, because in my experience it has rarely been true. If someone tells you they have never experienced this, you have to wonder if they are being straight with you.
A real answer has a few parts. You want to hear the problem itself; specific and recognizable. You want to know how quickly they responded, how they responded, and you should ask to see reasonable evidence rather than accept a generalization. You want to understand how the solution was reached, what resources were required, how fast these resources respond, and whether it was true joint problem-solving, drawing on engineering, regulatory, or other combined expertise, or something simply handed back over the wall to you. And you want to know exactly how long it took to implement.
The right answer from the right partner comes from innovation depth your program will need.
A strong answer to “the one question” is not luck. It comes from the depth a small, focused team does not have in-house, and it is genuinely hard to find. When the unexpected surfaces, the partner who resolves it quickly is the one who already has the right disciplines under one roof, be that engineering, human factors, industrial and design engineering, regulatory, or quality, and can bring them to bear at internal speed instead of pausing to source the expertise elsewhere. Every pause is schedule, and schedule is the thing a novel device program can least afford to spend.
This is where a full-lifecycle partner changes the equation. When one organization can support you across the full spectrum of product development from concepting, detailed design, design verification and validation, preclinical, clinical, initial commercial, and full commercial builds, the expertise your program needs on short notice is already in place. A small innovative team rarely has enough engineering horsepower of its own. A partner who can supply that engineering horsepower and scale you all the way up is rare, and that capacity makes a strong answer to the one question possible.
So before you make your final decision on your choice for a medical device contract manufacturer, ask this one question. If a medical device contract manufacturer can answer it clearly, specifically, and with evidence, you have learned more than any RFP response could tell you. If they cannot, you have learned that too.
About the author: Oliver Puttler has spent more than three decades in medical device manufacturing and development solving challenges ranging from initial concept development, detailed design, pilot and scaled manufacturing, as well as post market situations., He is currently Director, Product Development & Program Management at Veranex.
