Medical device speed to market

How fast can you launch a medical device? Wrong question — you need to ask your manufacturer about quality to market.

In the medical device design and manufacturing arena, being first to market is critical. And with the added pressure to show returns on medtech investments, everyone’s eager to get their product in front of industry changemakers and thought leaders to begin saving lives.

But we encourage medical device manufacturers and startups to pump the brakes before too much emphasis is placed on speed. To get to the finish line in the smoothest manner possible, you need a team that knows the terrain of medical device manufacturing — and can navigate you to a on-time launch with a trustworthy, quality product for patients.

Before you begin throwing out launch dates, start first with these three manufacturing checkpoints: 

• Sub-tier supplier verification

• Alignment on paperwork 

• Design validation builds

Think of these as your road-ready checklist. Start by slowing down, focusing on quality and what's actually required. From there, the speed can and will ramp up — putting you on the road to a smooth, successful and painless product launch. 

Supplier selection is critical to long-term success

There are many positive indicators you want to hear when vetting contract manufacturers for your medical device launch: 

• “We’re independently certified to ISO 9001:2015, ISO 13485:2016 and AS9100 D standards.”

• “We can provide tolerances of +/-.0001” and state-of-the-art 5 axes and Swiss machining.”

• “We have the production capabilities to ramp up from the design validation build.”

What you don’t want to hear is that an early prototyping partner — say, a small machine shop that’s close by and convenient — actually locked you into a sub-optimal material for your application. 

Smaller shops will often use the materials and sub-tier suppliers that work best for them. This works fine in the early stages of the project. But locking in a design with a non-optimal material will create roadblocks. That material they picked earlier isn’t necessarily what will work for long-term repeatability and scale.

So, you then either have to stick with a part that’s baked into your quality validation paperwork (risking increased lead times to source a material from a non-optimal supplier) or go through the pain (and added cost) of switching parts late in the game. 

• How do you handle 11th hour design changes?

• Can I reach out to you with priority parts?

• What type of “life of the program” contracts do you provide?

• Can you keep available stock of finished parts at your facility?

• What are your just-in-time part delivery capabilities?

Know who you're working with at the prototype stage — and in turn, who they’re working with. Where is the material coming from? Who are the sub-tier suppliers? Who is responsible for ensuring the device is ready for scale? The sooner you begin a partnership with a contract manufacturer that’s thinking ahead, the better.

Get aligned on paperwork 

Parts traceability and quality paperwork is not to be trifled with during the medical device manufacturing process.

Custom medical equipment startups face intense regulatory standards, including 510K submission, FDA and ISO 13485, and therefore need to consider many different forms of documentation. All product designers must heed the International Electrotechnical Commission (IEC) standard 60601-1 requirements for medical electrical equipment and guidelines for health and safety.

And compliance requirements are not all-encompassing. If a device complies with all IEC and International Standard for Organization (ISO) standards, that doesn’t mean that the Food and Drug Administration (FDA) will approve it. The FDA has its own dynamic parameters engineers must observe.

These complexities play out in dollar signs and man hours. It's a recipe for bloated material expenses and a stalling process.

The only way around this bureaucratic complexity is, well, through it. Aligning early and often with your manufacturer on documentation will set your team up for a smoother build and eventual launch.

Your non-negotiables in a contract manufacturing partner: 

• ISO 13485 certification (at least).

• A strong Quality Management system with GMP and traceability standards.

• Open, honest and frequent communication with your team on paperwork validation.

The importance of the design validation build

Designs for medical devices aren’t always immediately ready to go into production. The transition from drawing to prototype to full-scale production is a hefty one. In fact, for custom medical equipment startups especially, not having a well-defined manufacturing scope is normal and even expected. 

You need to walk before you can run; hence the design validation (DV) build.

No device turns out perfect on the first try. Even if the design is well into a mature stage, performing and documenting the build a few times ensures repeatability in the future. 

This all-important exercise gives both teams a chance to work through unexpected roadblocks that inevitably arise during the transition to the factory floor. This way, you can catch design changes before sinking hundreds of man hours into a production run and receiving design alterations from the engineers at the 11th hour. 

You may be eager to begin shipping orders within the year and earn the attention of a first-of-its-kind device. But if you kick off production with a hard-to-build product, it will chew up time on the production floor and come back to everyone at cost. 

Avoid manufacturing partners that act solely as a “yes man”. Instead, ask about the DV process and what a smaller run will look like to finalize processes before moving into full-scale production runs.

Ready to hit the pavement?

A strong development team is critical to bring a new medical device to market. You need expertise in engineering, material selection and quality assurance — and the right contract manufacturer rounds out your road-ready team. 

MultiSource has manufactured medical device components for nearly 30 years. From prototype to full-scale production and inspection, we partner with our clients through every step of the process. 

Begin a conversation about achieving a smooth launch for your next breakthrough medical device.