BioMedInnovations, LLC, a company focused on manufacturing and developing precision air and fluid flow devices such as lung ventilators and ex vivo tissue perfusion, swiftly pivoted its product development in 2020 in response to the global pandemic. In collaboration with Lawrence Livermore National Laboratory and other partners, the company leveraged its existing technology to develop a ventilator designed to address the critical and growing need for life-saving healthcare equipment for patients experiencing Acute Respiratory Distress Syndrome (ARDS) due to Covid-19 complications.
Laying the Groundwork
The company had already filed for its initial patent when it called on the services of Ed Sisson, Sisson IPR Law’s founder and principal patent attorney. BioMedInnovations was looking for multiple types of legal assistance, including consultation and advice on areas for patent availability, contract terms for distributors, assistance with the FDA approval filing and crafting a Cooperative Research and Development Agreement (CRADA) with Lawrence Livermore National Labs.
Ed Sisson put the legal infrastructure into place to streamline a pathway for these ventilators to get to market. The discussions and agreements had to figure in international considerations; the pandemic affected countries around the globe and the ventilator could reasonably be expected to supply assistance in any country facing the need.
Ed helped review the CRADA and supported some of the contractual details, particularly those related to ownership of intellectual property. This allowed BioMedInnovations to lock down CRADA with a public/private partnership.
In addition, Ed supported research based on the PREP Act, or Public Readiness and Emergency Preparedness Act, specifically designed for the purpose of providing immunity from liability through emergency use authorization. Ed helped define the varying levels of liability that still exist even within a government action. Eliminating or reducing risk factors can help speed potentially lifesaving measures to market.
Record Approval Time
BioMedInnovations responded rapidly to a national emergency and was ready to supply ventilators to hospitals or medical centers to treat sick patients. The submission for Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) was completed within a lightning fast nine weeks, received in June, 2020. Full details about the FDA authorization and collaborative creation are located here.
According to Ed Sisson, “Team members might be privileged once in a lifetime to be part of such a swift, historic ruling by the FDA.”
Carrie DiMarzio, CEO of BioMedInnovations, LLC, cited the responsiveness of Ed Sisson at Sisson IPR Law as a major contributing factor to the project’s successful and swift timelines. “His response time is unmatched. This is important any time, but it was particularly important during that critical time period early in the pandemic when companies were ramping up to meet a defined need.”
DiMarzio said that Ed made himself available at any time of day or night to respond to queries. Said DiMarzio, “We have clients on the west coast, and I might need to answer their questions between 5-8:00 pm EST. Ed makes himself available so I can respond to those clients without delay.”
The ventilator is not currently in use at medical facilities within the U.S. Whether or not the ventilator is eventually commercialized does not negate the success of the work and what was achieved in such a short time.
Physicians are using different therapies to treat Covid-19 patients at this time. BioMedInnovations, LLC is in discussion with several international customers to determine if its ventilator can meet their needs.
The Sisson IPR Law Difference
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