Case Studies

 

Bioabsorbable Success

Bioabsorbable Products: Every Bioabsorbable Material is Different

A major medical device firm was attempting to produce a micro medical device with a bioabsorbable material. They chose a micro molding company for the first stage of manufacturing. However, every lot they received from the supplier had different mechanical properties. As a result, every lot of bioabsorbable devices performed differently which created havoc when they tried to evaluate the function of their parts.
Any device maker that needs a supplier for a bioabsorbable project should find a micro molder with proven success in similar projects. Also vital is working with a micro molder with enough experience to understand the unique challenges that come with various bioabsorbable materials.

 

While the initial supplier was a micro molder (and even had the equipment to do the task properly), they didn’t have experience with this particular grade of bioabsorbable material. Because they didn’t fully understand the complexities of bioabsorbable materials, they couldn’t deliver consistent product with controlled IV loss for each sample run.

Before taking on an unfamiliar bioabsorbable material grade, the micro molder should perform testing to develop an understanding of the material. This testing provides the micro molder and the customer with the confidence needed to move forward.

 

At MTD Micro Molding, we had a great deal of experience with the material our customer wanted to use. For us, it was a matter of executing the proven protocols properly to get them the product they needed, with consistent IV loss and predictable performance.

MTD is able to develop processes for bioabsorbable projects that offer consistency in every lot. By having an IV testing machine onsite, we can determine the impact of processing variables on IV and adjust immediately. This allows us to optimize molding processes, obtain consistent IV loss and improve capability.

Even with an unknown bioabsorbable material, MTD has the skills, tools and protocols in place to ensure project success with proper evaluation and testing.

The assumption was that a part design issue caused the initial failures our customer saw in the parts received from their first supplier. After a modification was made to geometry to improve the strength, the next lot should have shown an improvement. When the strength of the next lot decreased, our customer was confused. In fact, these failures occurred because the supplier couldn’t provide molded parts with consistent IV loss.

 

MTD was able to achieve consistent IV loss with the bioabsorbable component. We averaged 6% IV loss, whereas the competition saw a range of IV loss between 20% and 100%.

For our medical device customer, this translated to success for a project that might have been scrapped had they continued with the first micro molder. In contrast with the nine months of delays they encountered before coming to MTD, they got consistency and performance on a timely basis.

Every bioabsorbable material and project is unique. When picking a supplier, there’s more involved than just choosing a micro molder, even if that company has some familiarity with bioabsorbable materials. Our customer needed comprehensive experience, which is what MTD delivered.

 

Make sure a supplier has the right equipment. Make sure they’ve worked with parts of similar geometry and can show you samples of those projects. Most important, make sure they demonstrate an ability to effectively work with your desired material. Knowledge counts, especially when it comes to unique materials and producing consistent IV data.

At MTD, we bring a formidable mix of knowledge, experience and proven protocols to every project, no matter what the material. And that breeds success for our customers, time after time.

This firm is a top-10 medical device manufacturer located on the West Coast.

 

“In my several years of dealing with bioabsorbable materials, there are truly
one to two companies in the United States who should be quoting and molding these type of materials…MTD is certainly one of them”.

– CEO, Medical Device Company

“We think very highly of MTD and recognize the high quality of their micro molding operation. The care MTD takes to characterize the materials in order to develop the most robust process possible while operating within very tight tolerances is second to none. Additionaly, it is clear that the in house tooling capabilities of MTD allow for not only incredibly precise implants, but also allow flexibility and turnaround time that our customers truly value.”

– Account Manager, Worldwide Bioabsorbable Material Vendor

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