When Wisconsin-based WiscMed co-founder and Wispr-inventor Dr James Berbee decided to take on the formidable challenge of pursuing a medical degree from Stanford at age 42, little did he know he’d be behind a medical innovation six years in the making that would advance the standard of paediatric care.

The Wispr Digital Otoscope, which WiscMed has successfully brought to market, was originally conceived during Dr Berbee’s University of Wisconsin emergency medicine residency. While working with paediatric patients, Berbee’s extensive background in engineering and tech made it apparent to him that the design limitations of traditional otoscopy precluded a reliable diagnosis of one of the most common paediatric ailments: ear infections. Development of the solution was advanced by his coinventors, Dr Greg Rebella and Dr Azita Hamedani.

There has to be a better way

As a pragmatist with a visionary bent, Berbee and his partners knew there had to be a better way to obtain a view of the tiny paediatric ear canal and eardrum upon which a reliable diagnosis of an ear infection depends. Without this view, medical practitioners often find themselves in the position of having to guess whether an infant or young child is suffering from an ear infection and not knowing if prescribing antibiotics is the proper treatment.

A seemingly simple yet highly complicated innovation challenge

The mechanics of a traditional otoscope are relatively straightforward. However, bringing the analogue device into the digital age as optimised for paediatric care presented a host of seemingly simple yet highly complicated innovation challenges. These included the need for:

1. A tool small enough for paediatric ears with an ability to bypass partially occlusive earwax
2. A viewing apparatus that allows for a diagnostic image of the eardrum
3. Digital integrations that facilitate easy image-capture and image sharing with parents, colleagues, and learners
4. Seamless interface with current workflow and existing clinical equipment
5. Design that is drop/impact-resistant and easily cleaned between each use

The turning point

Berbee spent the next four years experimenting with different designs, reaching a turning point with a critical realisation: if the digital otoscope could be designed to be compatible with the ubiquitous Welch Allyn system, the entire US market of clinical rooms could become potential customers.

But herein lay the toughest innovation challenge WiscMed had yet encountered. In order to satisfy the Welch Allyn power requirements, the Wispr would need to contain six complex circuit boards. It would also need to undergo multiple design iterations to the existing prototype to ensure compatibility, scalability, and the unfailing performance necessary for the clinical environment.

This was a challenge WiscMed knew it was not prepared to meet on its own, and thus began the search for a proven single-source partner.

Enter Pivot International

Though WiscMed vetted multiple partners and received many international bids, Pivot International — a single-source partner with facilities worldwide and outstanding experience in medical device development, certification, and manufacturing — ultimately beat out its competitors by checking all WiscMed’s boxes.

“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. “As a startup,” Berbee continued, “this was important to us because we didn’t want to conduct an audit.”

Pivot’s Omaha location was also a decisive factor. “We’re proud to say that the Wispr is “Invented in Wisconsin, MADE IN USA,” says Berbee. Furthermore, for practical purposes, the WiscMed team wanted the option to be easily onsite and was soon to discover how important having a partner close to home in the heartland of the US would be.

From working prototype to scalable production

WiscMed came to Pivot with a working prototype and full engineering and manufacturing documents from their engineering partner, MPR of Alexandria, VA. Upon review and extensive 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.”

patience, flexibility, integrity, and teamwork

“We really appreciated Pivot’s patience in working with a startup,” said Schutte. “As a new device that had never been manufactured, we ran into issues at the 11th and 12th hours and Pivot was always great about it. There were a number of times where we had to say, ‘Stop building units because we may need to course-correct,’ and Pivot remained flexible because it understands the nature of the startup environment.”

“What’s more,” offered Berbee, “the Initial price Pivot quoted us a year ago has been rock solid. We’ve paid for some engineering changes, but where we’ve had to do small reworks to boards, they haven’t charged us. Many of the quotes were dependent on existing tariff levels with disclosure of a potential increase. But this never ended up being an issue, and Pivot never needed to make an adjustment. The relationship with Pivot has been very team-oriented and it’s really helped us in our journey to bring the Wispr to market.”

Setting a new standard of care

Six years in the making, Berbee’s vision and WiscMed’s quest for an otoscope that’s optimised for paediatric patients, reinvented for the digital age, and Welch Allyn-compatible has finally been realised. Together, WiscMed and Pivot successfully partnered to deliver a next-generation medical device that’s garnering clinical praise and setting a new standard of care. “It’s a brave new world. I think the Wispr changes the face of OM (Otitis Media) diagnosis. Parents are awed by seeing the ear. They seem to love it and are amazed. Residents love it as well and it shows great possibilities as a teaching tool.” Says Dr Ari Cohen, Chief of Pediatric Emergency Medicine at Massachusetts General Hospital.

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.”