Healthcare is advancing. Medicine is modernizing. And the devices clinicians use to administer treatment are becoming more intricate than ever. Medical device manufacturers as a result, face a comprehensive set of requirements for proving that their device is safe and effective—a process that begets the collective input of researchers, manufacturers, suppliers, scientists, and of course, the FDA.
As the manufacturing process from development to prototype to regulatory approval advances, the manufacturer-supplier relationship is shifting from transactional to collaborative. In this blog, we’ll discuss the top ways suppliers are adding more strategic value to manufacturers during the early development stages of their healthcare products and medical devices.
Suppliers are often thought of as product vendors with a warehouse full of stock materials for engineers or designers to pick and choose from. Many suppliers, however, are actually manufacturers with state-of-the-art operations and in-house engineers who can add a superior level of insight to the early-stage development discussion based on their domain knowledge, technical expertise and experience manufacturing their own parts and products for similar devices.
For suppliers whose product is critical to the function of the medical device, such as how a spring is the operative part of a surgical stapler, being looped in during early-stage development is critical. The spring options and possibilities for a surgical stapler may influence the prototype, and thereby, the subsequent steps of the development process. By engaging a supplier in the prototyping process, manufacturers can ensure that their final prototype is designed optimally, including:
- How it looks from the buyer’s perspective
- How it functions from the user’s perspective
- How easy or difficult it will be to produce
- How much it will cost to mass-produce
- How complex it will be to make repairs
Without engaging a supplier in prototype development, medical device manufacturer’s risk creating a sub-optimally designed prototype that may require expensive, custom parts and complex maintenance.
Design for Manufacturing and Assembly Support
Design for Manufacturing and Assembly, or DFM and DFA, is the next critical aspect of every medical device design. DFM is focused on individual parts and components that will make the product less complex to manufacture, while DFA focuses on reduction and standardization of parts, sub-assemblies and assemblies. When medical device manufacturers and suppliers collaborate on DFM and DFA, the manufacturer can drive down labor costs, lead-times and increase the supplier’s productivity.
Typically, the medical device manufacturer’s product developers, design engineers and contract manufacturers will work with the supplier’s design and engineering teams from the outset of the concept to determine and integrate the DFM and DFA. These practices will answer questions like:
- Can the part be manufactured using the same material as other parts?
- How does the part in question move in relation to other moving parts?
- Can the parts be combined without need for any special process or tooling?
- If combined with another part how does that impact ease of possible disassembly?
- If combined with other parts how would it impact ease of manufacture?
Subassembly Services for Medical Device Manufacturing
Subassembly services are another strategic value-add that large suppliers can offer medical device manufacturers. In complex healthcare products and medical devices specifically, there are a lot of moving parts and pieces that make the devices function accurately, consistently and for a long duration of time. If the medical device OEM is responsible for developing the finished product, plus all of the parts that go into it, the time it takes to produce may be significantly increased.
That’s where a supplier comes in.
When a supplier is already involved in the DFM and DFA practices, offering subassembly services to the manufacturer makes sense. For spring suppliers, like us, that have manufacturing capabilities and in-house expertise readily available, we’re able to offer manufacturers with subassembly services such as:
- Clean procedures
- Spot-welding interwound springs
- Supplying springs assembled onto spools or bushings
- Winding springs into housings
- Providing springs with pins or rivets already assembled
- Etching part numbers, lot numbers or other part identifiers right onto the spring
For subassembly components beyond spring production such as molded parts and fasteners, our team, and most other suppliers, have experience with component suppliers, and therefore, can manage the supply chain to offer a more seamless and efficient sourcing process. To take it one step further, some suppliers even offer assembly capabilities for sub-assemblies, giving medical device manufacturers the advantage of end-to-end consistency and vendor consolidation.
When it comes to medical device manufacturing, the requirements are only getting more complex.
It makes sense that as complexity increases, production processes will need to change with it—and bringing in more strategic brainpower during the early development stages is certainly a smart start.
Many suppliers understand the critical nature their parts play in the overall function of the device, and therefore, operate as a true partner to their clients to deliver vendor-managed and just-in-time inventory agreements. As you assess the upcoming projects in your medical device pipeline, consider that your parts’ supplier can provide your team with more than just stock products, but rather with strategic services that can improve the overall design, prototype, manufacturing process, subassembly and final product.
At Vulcan Spring, we have experience in concept to production for medical devices spanning surgical staplers, laparoscopic devices, drug infusers and delivery systems, table and bed lifts, mechanisms, MRI and x-ray machines, surgical robots and more. Contact us with questions or about a custom spring need for your medical or healthcare device. Our responsive and helpful team is standing by.Contact Us