What Are People Missing When They Go to Manufacturing?
Manufacturer vs. Designer?
Start with the end in mind.
It’s important advice!
In fact, in2being recently released a planning worksheet to help you do just that. You can find that linked here.
Is your endpoint volume manufacturing of a cleared medical device? That’s a common and important endpoint! After all, getting these devices into the hands of doctors and patients is kind of the whole point.
Startups sometimes make the mistake of not really thinking about their end goal—focusing only on their next step. And that mindset can lead to some missteps when the perceived next step isn’t actually in service of the true goal.
Common “next steps” that often turn out to be red herrings include: “build a complete QMS,” “run a clinical trial,” and “find a manufacturer.” Not that any of these are bad in and of themselves—there’s a right time and place for all of them.
Really, there’s an error on each side.
If you start with the end in mind but don’t work backwards all the way to identify the right next steps, you’re likely to miss something. And if you start with immediate steps without working all the way forward to the real end goal, you might be spinning your wheels.
So let’s talk about contract manufacturing.
When’s the right time to engage one? What are you looking for? How do you know if you’ve found the right partner?
The first thing to realize is: not all contract manufacturers offer the same capabilities.
At the highest level, a catheter manufacturer probably isn’t the best choice to make your new wheelchair, and a robotics manufacturer probably isn’t the best fit for a diagnostic assay. Ask yourself: Does this manufacturer have the built-in talents, workflows, and equipment to work efficiently on a product like mine?
Another question: Are they a high-volume or low-volume operation?
As flashy as a multinational, high-volume CM can seem, they may not be much help during the critical transition period where mid-volume prototyping is needed. If they’re built to pump out millions of units, they may balk when you ask for “only” a thousand.
The most common mistake we see?
Startups going to a manufacturer with little more than a napkin sketch. Certainly not a complete design history file or device master record that meets FDA expectations.
We once had a client come to us, frustrated that a manufacturer had “no-quoted” them (that’s when they decline to even bid on your work). We helped the client build a proper design package, went back to that very same manufacturer, and—surprise—they got a quote and ultimately a great product.
The moral of the story: Manufacturers aren’t designers, and designers aren’t manufacturers.
A good design firm (like in2being) collaborates with your chosen manufacturing partners, making sure they’re treated like the valuable stakeholders they are and have what they need to build your product.
Design for Manufacturing (DFM) isn’t some magical “turnkey” switch. It’s a dialogue between your design team and your manufacturer, where insights go both ways to produce the most efficient and effective version of your product.
So don’t underestimate the power of a good design house paired with a good manufacturing partner.
Remember what drives contract manufacturers.
They live and breathe three letters: Q-T-Y.
That’s short for “Quantity.” If you’re not actually on a clear path to volume manufacturing, there’s a limit to how much free help they can afford to give.
That’s why it’s important to come to CMs with three things:
- A solid design package
- A request for quote with a defined quantity
- A timeline for the purchase
One last thing worth noting:
Our small, nimble team at in2being brings over 100 years of combined experience in medical device design, regulatory strategy, and product development. That means we’ve seen these patterns play out—successfully and not-so-successfully—again and again. We’re here to help you avoid the pitfalls and move forward with clarity.
If you have questions about how to set yourself and your device up for successful contract manufacturing from the design side please don’t hesitate to reach out.