Pivot International, a company offering medical device development, certification, and manufacturing services, has helped WiscMed co-founder and Wispr-inventor Dr. James Berbee develop and manufacture a next-generation pediatric medical device, according to a statement provided to MD+DI.
Berbee came up with the concept for the Wispr Digital Otoscope during his University of Wisconsin emergency medicine residency. While working with pediatric patients, he saw that the design limitations of traditional otoscopy precluded a reliable diagnosis of one of the most common pediatric ailments: ear infections. So Berbee along with co-inventors Dr. Greg Rebella and Dr. Azita Hamedani set out to develop an alternative to obtaining a view of the tiny pediatric ear canal and eardrum.
After years of experimenting with different designs, Berbee opted to design a digital otoscope compatible with the ubiquitous Welch Allyn system in order to expand the universe of potential users. The team, however, needed to satisfy the Welch Allyn power requirements. For instance, the Wispr would need to contain six complex circuit boards and then need to undergo multiple design iterations to the existing prototype to ensure compatibility, scalability, and the performance necessary for the clinical environment.
Pivot offered the needed support. “Pivot was a cost-effective solution with all the medical device ‘merit badges’ in terms of device certification,” explained Berbee about WiscMed’s decision to partner with Pivot. WiscMed came to Pivot with a working prototype and full engineering and manufacturing documents from its engineering partner, MPR of Alexandria, VA. Upon review and collaboration with the WiscMed and MPR team, Pivot brought more than 50 design suggestions to the table.
“Pivot had a good sense for translating engineering drawings into production to create more operational types of pieces and assemblies,” said WiscMed VP of operations, Harry Schutte. “There was a lot of work needed on the bezel of the device, and Pivot was able to solve that, along with giving feedback on manufacturability.”
Mark Dohnalek, president and CEO of Pivot International, said: “I, along with the entire Pivot team, cannot say enough of the effectiveness that resulted in both our teams working together as partners to achieve this tremendous design success. The WiscMed team had a full understanding of the technical issues that represented the challenge of this achievement and a thorough awareness and understanding of the market needs. Working with a team that had both of these key elements professionally covered made our efforts much easier and paved the way for the success of this product. I feel strongly the future looks bright as this product enters the marketplace serving this vital area of healthcare."