6 Big Questions to your MedTech Manufacturing Partner
Finding a compatible, friendly, and expertised MedTech manufacturing partner might be harder than reading color codes on tiny resistors – we get it. There are hundreds of potential subcontractors out there, and each of them probably claims to suit your requirements one way or another. How to choose the perfect match for your solution? What should the criteria be, and what should you actually look for during conversations?
At Consonance, we offer these exact manufacturing services, so we could easily just list the questions we would answer perfectly to make you choose us. Instead, we want to be fully transparent. We hire our own subcontractors too, so we know the drill. In this article, we are going to share our exact internal thinking process for verifying suppliers. This material is a guideline built from our own experience, and we hope it will be a game-changer for your startup.
Why Do You Even Need a MedTech Manufacturing Partner?
Obviously, you can try to do it all by yourself. But fortunately, you do not have to. Manufacturing a medical device requires specialized knowledge, specific machinery, clean rooms, and strict quality control. If you lack the people, time, or infrastructure, outsourcing could be the smartest move.
Outsourcing production to experts who will set up a manufacturing line in three months is fundamentally cheaper than trying to build it yourself for a whole year and potentially facing the harsh consequences of production mistakes for the next several. Compare it to renovating your house: you can paint the walls yourself pretty easily, but when it comes to installing complex plumbing or electrical switches, hiring an expert is always faster and safer.
Remember that time equals costs. Doing everything in-house might seem like the cheapest option, but only if you can do it flawlessly in the similar amount of time as professionals. Sometimes, it is better to pay for a certain, expected outcome rather than playing around and collecting bills for fixing your own manufacturing mistakes along the way. You learn along the way, but a reliable MedTech manufacturing partner will drastically speed up your medical device development process under one condition: they must be perfectly aligned with your goals.
Outsourcing production to your MedTech manufacturing partner.
Is It a Match? How to Prepare Before the First Handshake
Before you start searching for a MedTech manufacturing partner, you must prepare yourself first. Make sure you can precisely define what you want, need, and expect. If you don’t know how, at least be honest about it and tell it beforehand. It’ll explain what’s in your head really is and would help your future partner to adjust the starting point to your knowledge and your perception of what’s coming soon. However, the best thing you could do for yourself is to do some homework. Having clear targets and a drafted scope of work is a nice-to-have before any outreach. Even if you’re wrong at some point your meetings would get more fruitful and might end with concrete manufacturing plans instead of hours of guessing what you actually had in mind.
You could not only prepare your technical basics but also your conversational strategy. During the first contact, avoid generic yes-or-no questions like “Can you manufacture this?” or “Are you able to do it?”. They are prepared for these questions and will act like “yes-men” because they know exactly what answer you expect to hear.
Instead of asking if they can do it, you want to uncover how they will achieve it, with what methods, and why they estimate specific costs and timelines. Ask questions that give you a holistic view of their knowledge and experience.
Furthermore, once you find the right manufacturer, aim for a long-term and constant partnership. It is rare to find a match in the industry when it comes to manufacturing partners. Even if you start by ordering relatively replaceable components, this relationship can escalate into a huge contract in the future as your production scales. Professionalism is crucial, but a friendly, honest approach to every subcontractor pays off vastly in the MedTech industry.
6 Big Questions to Discover Your Partner’s True Value
In this section, you will not get a simple list of questions to read aloud during your first meeting – that would be ineffective. Think about it: you don’t ask a construction contractor, “Can you lay this floor straight?”, because of course they will say yes. Instead, you casually ask, “How exactly are you going to prepare the surface first?” to see if they actually understand the whole process and not just the final result.
Here are 6 crucial questions you must ask yourself, reading between the lines of your conversation, to confirm your potential MedTech manufacturing partner’s true value.
- The Scope Reality Check: “Do they actually understand what we are building together?”
- The Workflow and Logistics: “Who brings the screws, and who brings the screwdriver?”
- The Competence Proof: “Can they show us their projects?”
- Method #1: References
- Method #2: Portfolio
- Method #3: Hire an auditor
- The Communication Test: “Are they partners or just order-taskers?”
- The Bureaucracy Trap: “Are they over-formalizating?”
- The Strategic Shortcut: “Are they able to do it all?”
After the first contact, it is crucial to ensure you and your subcontractor are walking the same path. You must divide tasks clearly so your partner knows the exact scope of their work: are they only doing the final assembly, or are they also taking part in designing and the regulatory process?
How to feel it out: If your potential partner is able to paraphrase your idea and proactively points out missing parts of your manufacturing plan that you hadn’t considered, it means they clearly understand your vision and they aren’t just blindly taking an order.
Logistics are just as important as the actual engineering when it comes to your budget. To avoid hidden costs, you need to know how they operate on a daily basis. How do they handle the Bill of Materials? Will you need to supply them with specific electronic components, or do they source everything themselves?
How to feel it out: You can often test this by comparing deliveries of a simple, small batch among several companies to check their quality, timing, and how they prioritize you. Also, consider the size of the supplier. If your startup accounts for less than 2% of their income, you won’t be a priority. On the other hand if you represent over 50% of their income, it is a huge risk because they might not have the capacity to navigate your project to the end.
This is a great challenge, because how can you tell if an expert is truly qualified in a field you know little about? How do you examine them?
If a family member or close friend tells you they used a specific contractor to finish their kitchen flawlessly, you hire them without a second thought. In MedTech, it is the same. Ask for contacts to their previous clients or partners and try to directly contact them.
True professionals will show you their past manufacturing projects without hesitation. Dig deeper and ask: What was your exact input to this device?
Just like a CEO hires an HR team for recruitment, you can hire an independent consultant to conduct the technical assessment for you.
How to prove a MedTech manufacturing partner’s competence.
It is worth observing your potential partner’s decision-making process and responsiveness. Constant, clear contact during the manufacturing phase is critical. Even their basic communication habits can tell you a lot. If they send you an email with several attachments just to ask a simple question that could be resolved with a 3-minute phone call, it says a lot about their communication approach.
How to feel it out: The NDA signing process is a perfect test – if they handle standard non-disclosure agreements efficiently and understand the industry norms, it proves their professionalism. Ghosting you for two weeks because “the legal department is checking it,” means you should expect similar delays in production.
This is a trap that should serve as a major warning before signing a contract. If a company focuses excessively on forms and rigid procedures for a very simple manufacturing task, your cooperation will take much longer than assumed. Documentation is obviously mandatory in MedTech, but it must be kept at a rational ratio.
How to feel it out: The golden ratio is when they prove their knowledge through actions on the factory ground, not just by hiding behind paperwork. Keep in mind that having an ISO 13485 certificate for design is an addition, but having ISO 13485 specifically for production is a massive proof of credibility for a manufacturing partner. However, if they use certificates solely as an excuse to drastically overcharge you, stay alert.
Finding a subcontractor who understands your project and meets your quality standards is already an achievement. But finding one who can “do it all” is the next level.
You can absolutely divide your project into separate phases and hire a different partner for prototyping, testing, and mass production. However, this comes with a high hazard: poor communication between different companies can derail the entire timeline, and each subcontractor might understand your core aim slightly differently.
How to feel it out: Even if you currently only need a manufacturing partner, a company that also has deep knowledge of R&D, DFM, and regulatory phases will navigate the pre-production stage much safer, ensuring the final manufactured product complies with all strict MedTech laws.
Ready To Manufacture a Product With Your MedTech Partner?
With a properly prepared Feasibility Study, you should already know exactly what stage of medical device development you are currently at. However, a great MedTech manufacturing partner – one who understands the entire lifecycle from concept to assembly line – will help you realize what might still be missing from your project before you hit the production floor.
Building a relationship based on the six points above will protect you from incredibly costly production mistakes and months of delays. These are our exact, internal methods for verifying subcontractors and partners, feel free to use them to your advantage.
Are you looking for a reliable partner, or do you have any doubts about scaling your current project? Reach out to us – we would be happy to clear things up and see if we are the perfect match for your medical device!
