Joseph Sener, ’93, M.S. ’10, Gives Expert Opinion on COVID-19 Medical Device Shortage
Joseph Sener, ’93, M.S. ’10, has a unique perspective on the shortage of some medical devices and life-saving equipment in the age of COVID-19.
A retired professional engineer, Sener spent two decades working in senior leadership for medical manufacturing companies like ICU Medical, Hospira and Baxter International, solving some of the toughest issues in the medical device industry. The NIU Alumni Association (NIUAA) discussed with Sener the current challenges facing hospitals and how they might be better served.
NIUAA: How might the nation go about best acquiring ventilators and other needed medical devices during this difficult time?
Sener: These days, the public is looking for an easy answer to highly technical questions. There is no sound bite answer here. We are balancing the speed of production of a highly complex electromechanical medical device with appropriate levels of patient safety. As engineers, our primary concern as described in the code of ethics for professional engineers is to “…hold paramount the safety, health and welfare of the public.” Also, one thing that may be getting in the way of the ramp-up is the cost of these ventilators. Depending on the model and functionality, these devices can cost between $5,000–$50,000. There needs to be some purchase guarantees for the hospitals, perhaps part of the stimulus that was just passed, to pay for the devices.
NIUAA: Would you walk the average alumnus through all that goes into creating life-saving medical devices, like a ventilator?
Sener: What really takes time in making a complex electromechanical medical device is the design, development, and characterization of a product. That takes 24–26 months, depending on the complexity of the device. What many do not understand is that this is about more than helping the patient breathe with a positive pressure flow. The therapy requires sufficient amounts of oxygen to be transferred to a specific patient. The amount is dependent on the needs of the critically ill patient.
The submittal for FDA review alone typically takes 12–13 months for the filing, review and approval of the FDA Form 510(k). The way to speed this up is to outsource the manufacture of an existing qualified design or to reduce the complexity of an existing design to a reduced functionality. The FDA has given signs that they will not require a 510(k) for modifications to an existing product. No matter what product we choose to make, we must establish by objective evidence that the device specifications conform with user needs and intended use cases.
NIUAA: What is the FDA’s role in this equipment production?
Sener: The FDA has shown its willingness to work with manufacturers to use existing products and modify other products for use in this crisis. They have published an Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (March 2020). This lessens the concern of an overbearing bureaucracy getting in the way beyond what is necessary to assure appropriate patient safety.
It has also released a list of manufacturers who currently make such a ventilator and has listed appropriate other devices, not specifically intended for this use, that can be considered for use during the COVID-19 crisis. The manufacturers include some well-known suppliers of medical devices, such as GE Healthcare, Vyaire Medical Inc, ResMed Inc, Amsino, Philips Respironics, and Covidien LLC, just to name a few.
NIUAA: What companies in the U.S. are already making these types of things and can ramp up production?
Sener: So why not just have GM make these? That is a viable idea, if we have a major manufacturer do what they do best—replicate a current design. GM is great at things like managing logistics and effectively making the same thing every time. If they are making a qualified design, and there are quality folks who have come from the medical device industry to assure that the product is properly qualified and tested prior to shipping, it could work well.
NIUAA: What are some of the challenges within the medical device supply chain?
Sener: The supply chain has some special challenges. For instance, let’s consider the commodity of hoses used in the ventilators. Have you ever smelled a hose and noticed the chemical odor? Those odors represent chemicals, plasticizers, and contaminants in the hoses. Depending on the elastomer or plastics used in the hose, they may be fine for use with hydraulic fluid but not fuels. We certainly cannot allow those out-gassed chemicals to enter a patient’s lungs. The proper hoses have been tested for contaminants and interaction with other gases that will be used in the ventilators.
Editor’s Note: Joseph Sener began his term as NIU Alumni Association President on July 1, 2020.