When you are working on a design for a new medical device, having the right mechanical components is important to ensure your device meets performance standards. Once you’ve determined the right mechanical components, your next step is to find the manufacturer that can produce your components in a cost-effective and timely manner.

But while cost and production timelines are two important factors to consider when requesting proposals, there are others that could impact your decision. These may not be initial considerations when submitting requests for proposals; however, they can have a direct impact on your project cost.

Custom Capabilities

Given today’s precision and technological advancements in medical devices, it’s likely you’ll need a custom product for your device prototype. In this case, it’s beneficial to have a spring supplier that can develop a custom spring assembly. Some suppliers may only be able to provide stock springs, while others can manufacture something entirely custom.

If you expect to have additional supplied parts (like machined metal or molded plastic components), ask manufacturers about their custom capabilities. Can they source parts they don’t have? Are they able to use customer supplied parts? Ideally, you want a manufacturer that can handle the entire assembly as opposed to using multiple manufacturers for different components. This will reduce your overall project cost and help maintain product quality.

Design Engineering Department

The need for a custom assembly often occurs during the design and engineering phase. This is when it’s beneficial to have a manufacturer that has its own engineering department. Their engineers can discuss design requirements, counterbalancing challenges, and more before you even create a prototype. Additionally, having this department in house may mean that engineers are more in tune to design changes that can impact manufacturing costs. This ultimately reduces the number of prototype revisions and speeds up testing.

In-House Tooling

In-house tooling is especially beneficial for custom products and prototypes. An in-house tool and die department can make products for custom assemblies quickly, thus reducing time and cost of your project. In-house tooling also improves quality control because you can keep everything within one manufacturing facility.

In-house tooling isn’t something every spring manufacturer can offer, but partnering with one that does opens up the possibilities for experimentation and design adjustments.

ISO Certification

While all industries require safety and quality control, these necessities are especially paramount in medical device manufacturing. For instance, an ISO 13485 certification demonstrates a manufacturer’s commitment to maintaining standards for finished medical devices and critical components within medical devices. Think of this certification as a trust signal. While a manufacturer may have other ISO certifications, this particular certification accounts for regulatory requirements and changes specific to medical device manufacturing. Consider choosing a manufacturer that has an ISO certification(s), specifically the ISO 13485 certification.

Cost and lead time aren’t the only considerations when requesting proposals from spring manufacturers. In-house capabilities like customization, tooling, and design engineering can directly affect cost and lead time. Additionally, certifications demonstrate a manufacturer’s commitment to quality standards in medical manufacturing. While these items may not be initial considerations, they can have an impact on your product and long-term success.

Visit John Evans’ Sons at Booth #2188 at the upcoming MD&M West 2019 show in Anaheim, CA, February 5-7. 

SOURCE:MDDI