Don’t lose an important project because you were caught unaware. Here are five things to watch out for.
Brianna Sporbert, Boyd Technologies
|Don't end up in a pit of gators over your materials selection. (Image of "Picturesque Hot Springs Alligator Farm 1924," courtesy of Picturesque Hot Springs National Park, E.L. Glass, Hot Springs, AR)|
“Hindsight is 20/20”: it is a common phrase that in the product development world can lead to the termination of a multi-year, capital investment project.
Here are some of the major pitfalls that occur during the material qualification stages that should be reviewed in the pre-development phases to avoid long term consequences:
1. Distributor or Raw Material Manufacturer?
Understanding your volumes is an important factor when moving through the first stage of material identification and qualification.
Having the ability to work directly with a material manufacturer is extremely important because the transparency will be much greater. There will also be a pricing benefit compared with working through a distributor. But many times in the life science filtration and medical markets, volumes do not match the requirements of the raw material manufacturer. So a distributor is needed.
Customers will often be reluctant in purchasing through distributors because of a perceived lack of transparency. However, without distributors, some development projects would be unable to proceed because of a lack of economic feasibility. If you find that your projects is in need of a distributor, ensure that from the beginning the dialogue with this organization is very open and transparent. Some distributors have recognized the market need for this transparency, but some have not. If your current distributor has not realized this need, move on to the next one.
2. Avoid Complex Supply Chains
Ideally you want no more than two vendors between the manufacturer of the raw material, and the final OEM customer. This supply chain would consist of a manufacturer, distributor, converter, and customer, but more simple supply chains are even better. The best way to limit the supply chain is identifying a precision converter who has the capabilities to complete all of your required material modifications, whether that be slitting, die-cutting, or printing etc. When you begin expanding beyond two vendors, the commercial supply chain begins having an increased risk for damaged material, late deliveries, and nonconformance issues.
3. Know the Regulatory Requirements
Regulatory requirements can end a project in late stages of development if they are not addressed during initial project discussions. It is easy for regulatory requirements to become lost in the details of the many other specifications that you will be working through, but identifying and developing a product with a material that does not meet quality regulations will put the entire product development cycle on hold. It is possible that depending on the lack of quality, you will need to return to the initial material discovery phase. In many cases this also requires retesting of all previous development work, resulting in a large capital expense. It is true that in highly regulated spaces the quality requirements will limit the available suppliers, but identifying this need in the beginning will save time and capital in the long term.
4. Know Your Sterilization Requirements
A material can be manufactured under the correct regulatory requirements without meeting sterilization requirements. Assessing the type of sterilization you would like to use for your project should be a part of the first discussions when selecting polymer compositions. Each type of sterilization method has varying degrees of complexity and cost structure, so aligning your product pricing with this requirement is critical. Sometimes product composition needs supersede the cost savings of different types of sterilization, but identifying this requirement is still of high importance. A project can be delayed one or more years if it is registered with the notified bodies under gamma sterilization, for example, but after development the composition of the product requires ethylene oxide. So sterilization requirements can be a costly and time-consuming pitfall.
5. Never Settle for, “I Don’t Need a Trial”
Some medical device designers think that if materials meet all of the required specifications that there is no need to run a trial until the final prototype is being created. This can cause significant delays if time is needed to configure and optimize the processing of component products. It is also possible that there is another aspect of the material that was not considered in the qualification process that prohibits the component from being produced to specification. Trialing each component of a product early on will reduce the need to re-engineer or re-identify materials in late stages of development.
The five pitfalls outlined above are a strong starting place for early product development discussions. Incorporating these actions into pre-development discussions will add time to this process, but it will take less time than performing a major design change in the final stages of development—or less capital than a completely failed project.
Brush up on your medical device materials knowledge at MD&M West, February 9–11 at the Anaheim Convention Center in Anaheim, CA.
Brianna Sporbert is director of Sourcebook engineering at Boyd Technologies (Lee, MA).
- Drowning in Big Data: Extracting Medical Device Quality and Safety Insights - Webcast
- Quality with Confidence – What You Need to Know About Digital Microscopes for Medical Device Quality Processes - Webcast
- Risk Management for Medical Device Manufacturers - Webcast
- 3 Steps for Designing the Ideal Medical Device Packaging System - Webcast
- Reducing Device Cost with Innovative Medical Materials - Webcast
- Automating your Quality Management System: Pitfalls & Essentials - Webcast