Medical Case Studies
Examples of key problems we’ve solved for our partners
Challenge: We were approached by a Fortune 500 Medical Device Company to help them troubleshoot design-related performance issues pertaining to their gear pump design.
Goals: They were searching for a cost-effective solution that would resolve performance-related issues and, ideally, improve performance.
Solution: We redesigned the gear pump, developed a new Coreless DC motor to replace the original German motor, molded the internal gears with PEEK material to replace the original CNC Stainless Gears, and suggested cost-effective materials to help them achieve their cost target goals.
Results: We were able to achieve the partner’s performance requirements and resolve their performance-related issues.
Challenge: We were approached by a Fortune 500 Medical Device Company to help them troubleshoot design-related performance issues pertaining to their peristaltic pump design.
Goals: They were searching for a cost-effective, safer solution that would resolve safety-related issues and overcome a US ban.
Solution: We redesigned the pump, suggested improved materials, re-worked the PCBA mounting method, adjusted the pump housing design, and added additional system protection.
Results: We were able to achieve the partner’s performance requirements and resolve their safety-related issues. This allowed the partner to demonstrate to the FDA that their product was safe and effective and enabled them to restart marketing and selling their product within the US.
Challenge: We were approached by a Fortune 500 Medical Device Company to help them develop a compressor used in respiratory device applications.
Goals: They were searching for a more cost-effective solution that would perform equal to or better than the gold standard in the market.
Solution: We developed a plug-n-play compressor that replaced the standard compressor that was previously specified with respect to the product.
Results: We were able to provide the partner a more cost-effective solution without sacrificing performance, offered them a solution that allowed them to manage control over the compressor supply chain, and prolonged the overall product life by mitigating risk related to future product obsolescence as a result of changes to the compressor by the original supplier.
Highly Engineered Resins
Challenge: We were approached by a Fortune 500 Medical Device Company to supply them injection molded parts of highly engineered resins (PPSU, PEEK, PBT, ICP, PSU, PP+Gamma resistance).
Goals: They were searching for an Asia-based, more cost-effective solution that would help them replace
suppliers in higher-cost regions.
Solution: Our experience, technical expertise, tooling and injection molding know-how were invaluable in supporting the partner and helping them to achieve their goal. We built the tooling and perform the injection molding in-house in our Class 8 clean rooms.
Results: Our results exceeded our partner’s expectations. We supply those injection molded parts and
sub-assemblies to our partners’ facilities in North America and China.
Insulin Delivery Pumps
Application: Insulin Delivery
Challenge: We were approached by a fast-growing North American-based company to manufacture their insulin pumps. They were producing the pumps themselves in the US with full automation, but were achieving lower manufacturing yields and did not have sufficient capacity. Though they also had a supplier in China that was manufacturing with a manual process, their capacity needs were still not achieved.
Goals: After identifying and qualifying us as a potential manufacturer, they expressed an interest in developing a manufacturing solution that could initially start as manual, but then would require scaling in order to achieve their demand.
Solution: We proposed the manual production line solution that would quickly evolve into a semi-automated solution allowing better efficiency of production, higher yields, improved cost efficiency, stable quality, improved traceability, and automated data collection.
Results: We achieved production efficiency that exceeded the partner’s North American production as well as their other China-based contract manufacturer. Our efforts resulted in a more cost-effective product that achieved their requirements related to quality, consistency, and reliability. In addition, the production lines are networked so the partner can view the production through a secure, online portal.
Application: Chemical Dispense
Challenge: A very well-respected German company approached us to develop and manufacture a synchronous gear motor for a chemical dispense application and the expected life of the motor was 20 years.
Goals: They were looking to find a more cost-effective solution that would replace a European made motor and still meet their performance and life expectations.
Solution: We developed a motor solution that replaced the motor they were currently using in the manufacture of their product.
Results: We successfully achieved their motor performance, life, and manufacturing cost expectation. The motor has since been integrated into large scale volumes of a finished good.
Laser Diodes and LED Light-Based Technologies
Application: Hair Growth
Challenge: An innovative, evidence-based North American company was interested in translating professional hair growth technology into a consumer-based Class II medical device. They did not have a product design.
Goals: Their goal was for us to provide them with a complete design of a finished product that is incorporating the Laser diodes and LED Light-based technologies and that could be scaled up for mass production.
Solution: They engaged with us to develop the Hair Rejuvenation device and mass-produce it.
Results: Based on the customer’s device concept, we developed the device incorporating the Laser diodes and LED Light-based technologies, designed the electronic hardware and software, worked with them for the industrial design of the product, created 3D & 2D drawings, generated the Bill of Materials, generated test specifications/requirements, and developed testing software. The end result was a finished medical device designed, developed, and manufactured for the consumer market faster and more cost-effectively than the original expectation of the partner.