Phase Zero and Phase One Services Accelerating Wearable Pediatric Stethoscope Path to Commercialization

“I can say with confidence our journey toward commercialization of our new [wearable pediatric stethoscope] medical technology would have taken years longer without GCMI’s Phase Zero and Phase One services.”

 

As the winner of the 2021 GCMI Baby Sharq Tank competition for their innovative wearable pediatric stethoscope, the interdisciplinary team of Dr. Hong Yeo, Mr. Josh Lee, and medical advisor Dr. Kevin Maher, earned $30,000 in in-kind services from GCMI. Based on the very early ‘status’ of their idea and technology, the team activated GCMI’s Phase Zero analysis and Phase One medtech innovation services to advance the cause.

 

In early 2021, candidates for the award were selected based on their ability to best utilize the award’s funding and services to make an impact on pediatric care with their device while improving the chances of successful commercialization.

 

For the winning team, those Phase Zero and Phase One services included a close assessment of market potential, IP landscape, clinical needs, regulatory pathway and reimbursement strategy as well as well-informed estimations of the financial resources and time required to properly develop this new technology.

 

Solving an unmet clinical need in pediatric care – from scratch

 

Currently available digital stethoscopes are durable but expensive, bulky and heavy for pediatrics, not capable of continuously monitoring sounds and subject to cross contamination. The technology seeks to solve these problems with a small, flexible, wearable device that detects and transmits body sounds with remote and continuous analysis capable of accurately receiving and storing those signals.

 

Roughly 18 months since the award announcement, the wearable pediatric stethoscope team, now WisMedical, has nearly completed both of those phases of work for the FDA Class II (510k) technology.

 

“We started entirely from scratch, with only an idea,” WisMedical’s Josh Lee said. “With GCMI’s help, we now have full confidence in our IP protection, a strong business plan that includes a highly targeted initial market, a $6 billion addressable market with 15% growth rate, reimbursement strategy and a path forward that should give our technology a strong, full commercialization opportunity.

 

“In addition to shifting from Bluetooth to ultra-wide band technology, we have learned a great deal through customer discovery about specific clinical and user needs. We have also learned considerations like packaging and certain risks mitigation can elude innovators highly focused on their technology. GCMI’s process has allowed us to avoid pitfalls that would likely have been costly in time and treasure if we had not addressed them early.

 

Watch for pitfalls early include cost of goods

 

“The cost of goods estimate the team created was also a particularly high value program deliverable,” Josh said. “This is a question prospective investors ask almost 100% of the time when we pitch. Confidence in the answer to that question makes our pitch presentations much more effective.”

 

Given additional features to be added as recommended by clinicians interviewed, Josh estimates “design lock” in three to five months with a battery of tests to follow including biocompatibility, electrostatic and batteries to name a few.

 

“I can say with confidence our journey toward commercialization of our new [wearable pediatric stethoscope] technology would have taken years longer without GCMI’s Phase Zero and Phase One services especially for innovators who don’t have current, in-depth knowledge about the regulatory environment and pathways,” Josh said.

 

GCMI thanks Josh and his team for helping us share this update and for providing a detailed account of the value our phase-gated medtech innovation process and services provide.

 

Thanks for reading! And please remember, wherever you might be on your medtech or bioscience technology’s pathway, it’s never too early to get in touch with us.