Bringing your medical device to market involves a lot of trade-offs. First-to-Market Vs. robust commercialization process. Do you launch quickly with a minimum viable product? There may be significant post-launch changes in order to be the first to market.
Possible negative feedback from rushing to market may destroy any device adoption. Perhaps going through an extra spin or two to resolve potential manufacturability or production issues is warranted. Below are some trade-offs, tips, and tactics from our manufacturing and supply chain team that are worth thinking about.
Engineering drawings are not production drawings.
An engineering drawing may be sufficient to receive a prototype part. If you are only making one of a part, then the time put into a production drawing may not make sense.
Understand the process and capabilities of your vendor to make sure that your design is sound. Inspect the parts when you receive them to make sure defects do not arise. The cost of defects are eventually be pushed into the cost of the device by your supplier or contract manufacturer (CM). Design out potential yield issues to keep costs low. Discuss the prints with your vendor identify potential difficulties in production and mitigate them ahead of time.
The cost of a poorly drawn or considered part can be significant. Schedule delays due to rework or repairs, or scrap costs can add significantly to the cost of an individual component. On a quick-to-market track, an extra manufacturing review may not be possible. Getting manufacturing input early will help mitigate the above concerns.
Choose the right manufacturing process
Design the product with the manufacturing processes you want to launch with. If you want to get to market quickly, chances are you will choose a manufacturing process that is cheaper with a shorter timeline. It’s likely that you’ve just made the trade-off of cost over quality. This is perfectly fine! But it may mean the end product is not as robust as it could have been with a different process.
For example, cast urethane has a relatively low tooling costs versus injection moulding. Designing for injection moulding is different than designing for cast urethane. The latter is more forgiving, and usually different enough that you cannot use the same model for injection moulding. If you want a minimum viable product, perhaps cast urethane is sufficient. If you want more durability and higher quality, then injection moulding may be the process of choice. For injection moulding, time needs to be set aside to design and develop the components. If done early enough, the design can be submitted as part of the regulatory approval and avoid costly repeats of verification or validation testing.
All things being equal, injection moulding has a high capital cost, but low part count. Cast urethane has a lower capital cost, but higher part costs. At some volume, the costs of these two processes will cross. Injection moulding will be cheaper in the long run. But if that doesn’t happen for five years based on your quantity, then it’s not worth it.
Choosing the Right Partner
The right manufacturer can make or break a project. Ideally, you will have developed great quality vendors. Getting to market sooner may require more changes after launch. Having a vendor that can quickly iterate on design changes will reduce the defects or field issues you may experience. Having a great vendor also means that designers can get feedback on designs and avoid manufacturability issues during the design phase. This speeds up development.
Changes will happen. Parts will go obsolete; bugs will be found. With a good vendor, you can adapt, manage the timeline and transition, and phase in updates with minimal disruption.
Ideally, your CM can help troubleshoot and identify the root cause of any non-conformances that they encounter. A CM with design capabilities is usually able to understand the design requirements and develop solutions that have minimal impact on the regulatory requirements and verification.
Designing for the moulding process also sets the expectation of quality. Launching with a lower fidelity process like cast urethane means that parts will be painted and have “less crisp” features. What does that mean? Perhaps some of the industrial design features are too difficult to achieve. They may need to be designed differently to accommodate the cast urethane process while maintaining the overall look. When the transition to injection moulding occurs, modified features can be rolled back into the design.
Designers should watch out for opportunities to reduce the impact of getting to market early. For example, if you are not going through an additional design refinement, perhaps pull in some later development activities. These include cosmetic finish development or design for assembly and testing. If there is room in the schedule, focus on more technical design issues early on, and leave more solvable problems for later.
Custom or Off-The-Shelf Components
Often commercial off-the-shelf (COTS) make a lot of sense in order to get to market faster. They cut development time, but the likelihood that the part will go obsolete increases. There are no controls on how often a part changes or when it becomes obsolete. The COTS manufacturer may have a substitute, or there may be a significant departure from the original part that requires significant verification to be repeated. This is a risk that needs to be considered carefully.
In a higher volume launch, a custom design can control the obsolescence, but requires time to develop. Partnering with a manufacturer is also possible, but time may be a factor and there may be a significant MOQ (Minimal Order Quantities).
The other issue with COTS parts in low volume manufacture is availability. There can be a large variance in deliveries. This can be an issue during a changeover in revisions from the manufacturer. I’ve seen cases where the lead time has gone from 2 weeks to 16 weeks. It’s very hard to plan for! If you have a good supply chain, you can work with your vendors for last-time-buys and similar techniques to mitigate the risks. All parts are critical if you can’t get them!
Risks of Running in Parallel
Some development can be run in parallel. However there is risk if the goal is to start production as soon as regulatory is passed. There is a risk that the design must be altered to meet regulatory requirements. That will set production back and incur additional costs.
It takes time to put vendor supply agreements in place. And it takes time to set up production, incoming checks, and inline checks. Running in parallel can speed up the timeline, but understanding the regulatory requirements is the key to success. The regulatory body may require flame rated material certifications from the material supplier. A solid understanding of the regulatory path will allow you to predict your required documentation. This allows parallel launch and regulatory path activities with fewer risks. Note that adding documentation requirements can be difficult, if not impossible, once parts arrive.
The later you launch, the more time can be allowed for life testing. Launching early may get your device to market first. But without comprehensive testing, some early failures that could have been predicted may be caught by end users instead.
You may not be able to test every single use combination and permutation if you go to market quickly. And that means running the risk that you will have a field issue. Hopefully, enough design and verification diligence was done that any issues do not require a product recall. Still, even technical service bulletins can leave a bad taste in early adopters of your new device.
Inline and end of line testing are requirements for 21 CFR 820. With a complex medical device, you need to ensure that the device meets the product requirements and is safe for the end user.
The manufacturing goal is to not accept, create, or pass on defective parts. In low volume manufacture, rigorous incoming testing for printed circuit boards (PCBAs) can be very costly. You run the risk of costly rework when a faulty board reaches a test point during assembly. It is important to catch faults as early as possible. Test equipment to automatically test all functions of the board can cost tens of thousands of dollars, making their use untenable.
While you may not be able to test every component, by understanding PCBA manufacture, you can mitigate the higher risk areas and ensure that the boards are functioning well. Mitigate your costs by creating test points on the board to enable quick board tests. Powering on the boards and using test points provides confidence that the board is functioning as expected.
There is no single “best” route to bring your medical device to market. Any strategy will involve a lot of trade-offs. Follow these First-to-Market Vs. robust commercialization process trade-offs, tips, and tactics from our manufacturing and supply chain team to improve your success regardless of the path you take.
Image: StarFish Medical
Dana Trousil is a StarFish Medical Mechanical Engineer and NPI Team Lead. He has successfully launched many products, with experience in a variety of processes, including NPI for medical devices.