In our recent FounderStart Series, we had the honor of inviting, Kareen Looi — CEO & Founder of JUMPstart portfolio company PEDRA Technology. Kareen shared her experiences on bringing PEDRA’s XAURON™ Perfusion System to U.S. Food and Drug Administration (FDA) for the consideration and subsequent awarding of the coveted Breakthrough Device Designation.
The Breakthrough Devices Program is a voluntary program for eligible medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Patients and healthcare providers will have expedited access to devices granted the Breakthrough Device Designation without compromising safety. Find out more about FDA’s Breakthrough Device Program.
Here are 3 lessons we can learn from PEDRA’s journey to Breakthrough Device Designation.
1. Traditional Indicators Of Success Might Not Always Be The Best
“Even beautiful, seemingly great results can mislead”
Every innovation must hold up to the current ‘gold standard’ but what had always been the ‘gold standard’ might not be the best indicator for success. Kareen shared an example from their UK case study wherein a patient’s condition worsened months after a procedure despite having a ‘gold standard’ test that indicated a seemingly successful treatment post-surgery. PEDRA was able to leverage their real-time perfusion system to identify and fill a gap in the monitoring of blood supply and blood flow during and after surgery.
2. Reassess Opportunities Amidst Changing Policies
“For various reasons, initially we figured maybe it wasn’t worthwhile to pursue the Breakthrough Device Designation because there was no tangible benefits at that point in time […] but certain things changed last year […] and it caused us to revisit that decision.”
Breakthrough Devices Program was launched by FDA in December 2018 to streamline and speed up the clearance and approval of new medical devices that are proven to aid high-risk patients with life-threatening or irreversibly debilitating disease or conditions.
However, PEDRA was hesitant to submit their product for consideration as there were not enough incentive in terms of coverage and reimbursements. That is, until September 2020, when the provider for Medicare (a national health insurance program in U.S.) proposed a new rule that will begin a 4-year coverage for new breakthrough devices the moment they obtain their market authorization from FDA. This new change in policy prompted PEDRA to reevaluate their decision. Spurred by the potential amidst uncertainty, they reassessed their suitability before applying to the program and was granted the designation in January 2021.
3. Never Underestimate The Power Of A Win
“I have to say, some of these benefits I didn’t quite anticipate […] before we got the breakthrough. One of it is how great a boost to team morale it was.”
With PEDRA XAURON™ officially designated as a breakthrough device, the product is now poised to receive reimbursement through the Medicare Coverage of Innovative Technology (MCIT) pathway while developing clinical documentation and evidence for permanent reimbursement in the future.
The most obvious benefits from being granted the Breakthrough Device Designation comes from the increased interest and confidence in existing and new potential investors. Apart from that, Kareen also emphasized on the importance of this unexpected team morale booster and how important that can be to pull the team together.
“Having wins like this along the way injects a great deal of energy and enthusiasm to counter all the toughness of everything else that comes with the job,” she shared with a laugh. “People were floating on air for two weeks after.”
Interested to learn more, watch the full event on our YouTube channel or click the link below:
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