A Tale of Two Micromolding Suppliers

It was the best of times; it was the worst of times (at least with regard to a micro-molding project for a leading medtech OEM). Delays in validation, achieving multi-cavity capability, and product launch issues—these are the types of challenges that can cause a potentially successful, high precision, micro-molding project to fail. For one medical technology OEM, all of these difficulties came into play on a project involving the development of an asthma device. The reason? The OEM initially worked with a medical device supplier that turned out to offer more promises than solutions.

The Project
A medical device OEM wanted to create a device to help mitigate the impact of severe asthma attacks. To begin the process, they solicited proposals from two potential supply partners to develop a mold for a component of the device.
 
Although the part geometry was fairly basic, the tolerances required on the dimensions were tight. The first supplier proposed a multi-cavity mold option to provide an attractive part price for production. Since the quoted lead time of the second company’s proposal (MTD Micro Molding) was slightly longer and the mold costs were similar, the OEM selected the first company in the hopes of achieving a lower production component cost.
 
The OEM needed to have complete validation and pre-production runs done in time to ship the devices to their facility in Ireland. However, the selected supplier experienced multiple delays with the job. Once the project fell several weeks behind, the OEM initiated a second mold with MTD as a backup plan. That mold was completed and samples delivered for evaluation, but the OEM did not want to proceed with validation of that mold as the original supplier was now making significant progress on the project.
 
The original supplier continued to try to validate the multi-cavity mold, but after a year of struggling, they still could not achieve a successful validation. With the deadline only six weeks away, the OEM revisited with the second supplier, seeking to get the project back on track.
 
Lessons Learned
Fortunately, since MTD had completed the foundational work included in its standard process development, it was able to move quickly. There were a number of key elements throughout the process that resulted in a successful project outcome. The following represents several of the critical “lessons learned” by the OEM.

• Quality work trumped budget pricing. A quality supplier isn’t very often the least expensive option around, and some medical device OEMs will still opt for a lower price over a higher guarantee of success. As this OEM realized, however, project delays can significantly whittle down those initially proposed cost savings. Also, failing to meet the specified requirements can postpone or even cancel a market launch, meaning all the manufacturing costs could be squandered.
• Lower cavitation improved predictability and quality. Many suppliers push for high cavitation as a way to increase quantity and keep production costs attractive. For the medical technology OEM, this approach only led to more challenges when the tolerances wouldn’t hold. A better recommendation involves starting with a one-cavity tool to boost the likelihood of success and prove capability.
• Established parameters eased validation process. Before beginning validation, a molding supplier should create a robust process window and develop and validate a measurement system to evaluate the dimensional capability of the parts. Strictly adhering to such a plan results in an overall faster validation with a very high success rate.
• A team-based approach made for a stronger, more efficient process. Some suppliers assign a customer to one project manager, who shepherds the product through the process. That one-person approach can be inefficient and susceptible to errors. In contrast, a team effort can offer several advantages. Having multiple levels of expertise come into play makes the process more successful. For this specific project, the team-based approach enabled validation from scratch in less than one month.

Conclusion
As every R&D engineer knows, delays and cost overruns don’t affect only one department or one project. Especially with medical technology, products have a short lifecycle due to continuous innovation. Miss a launch window and a product could get shelved permanently, representing wasted time and development. Delays can also push on schedules in marketing and sales, negatively impact company reputation, and cost a company millions of dollars. While a low bid may initially seem attractive, perform due diligence on a potential supply partner to ensure promises being made reflect actual real-world experience serving medtech companies.