Designing medical components: Three things you should know

Clint D. Badowski, product engineer at Caplugs, lists three topics to discuss in detail when quoting a new medical component.

While there are no guarantees on what vendors are going to ask during the initial design review for quoting, there are some general topics you should be ready to discuss in more detail about your medical plastic component(s) during this interaction to make the process as smooth and as productive as possible.

There are general topics that are covered for all plastic components when being reviewed for a quote such as annual volume, critical dimensions, material choice, gating requirements, and quality requirements. When it comes to medical plastic components, some of these topics will need to be discussed in more detail and there could be additional topics that could/should be discussed as outlined below.

Manufacturing

Does the product have a medical class it must meet? Class I, II, IIb, and III have different requirements for production, quality methodology, process documentation and traceability, process controls, audits, corrective action procedures, preventative action operations, etc. Does the vendor have the capability and a thorough understanding of the classification to handle the production of this component? Does it have to be produced in a specific class of cleanroom or is normal floor molding ok? This may affect capacity, cavitation, quality plan, parts handling, or even if the vendor can produce the part.   

Design and use

The part design and where the part is used can have a huge effect on tool design. Will the product be used while medical personnel are wearing medical gloves? If so, this could greatly change the approach to gating style and location, parting line location, part orientation in the tool, etc. Does the part have requirements with ergonomics? Is there an area of the part that will be held in a user’s hand that will require the area to be clean of burrs and parting lines or require a specific texture? These could also change the approach to the tool design affecting cost and lead time.

Material

Do the parts have to be sterilized post molding at any stage of their life cycle? Is the part going to be reusable? Does the part encounter uncommon chemicals? Does the product require the use of a material that meets specific regulations such as FDA approved or medical grade? All these things will come into consideration when choosing a material suitable for the part and application. Are there specific features in the design that could affect material choice? Are there areas that require little to no draft? This could require a material to be selected with a higher modulus so the parts can be ejected. Is there a specific surface finish required? This could require a material that can reach the surface finish. Is over-molding going to be used?  The compatibility of the two materials would have to be considered. These scenarios would also affect the tool design and layout.   

Conclusion

Overall, medical components are more complicated for vendors to quote. These three topics are just a few that will be mentioned during conversations about a medical component when discussing the quoting of your product with a potential vendor. If these types of topics and conversations are not being brought up, there should be some concern about the vendor’s knowledge and capabilities to produce medical components.  The more information that you can bring to the table, the easier and more effective the whole process will be for both sides.