Micheal Interview
Mike’s Background
Mike is an EMT and MIT professor at the Sloan School of Business dealing with medical innovation. His background is in BioMed especially around SPO_2 detection. He’s seen several projects around the detection and auto-injection space for narcan and is currently working with several student teams on this exact problem. As a volunteer EMT, Mike works in a semi-rural 6000 person town outside of Boston that skews wealthy and Educated. His town sees 4-5 overdoses per year, typically involving an elderly person with an opioid prescription who forgot that they had already taken their medications.
An EMT Case Study
Mike gets a call for a non-responsive 26 year old overdose with CPR currently underway. He arrives on scene to a patient with pulse and Agonal breathing. Mike applies a BVM with 15l of O_2 bringing the patient’s SPO2 from mid-50s to mid 80s. After insuring the patients ventilation, he starts applying Narcan in 2mg increments. This incremental application of Narcan serves three purposes. The Narcan in low doses insures that the patient doesn’t get sick, doesn’t lose their high, and the EMT can still transport the patient because the patient can’t refuse transport.
Device Problems
As an EMT, an auto-injector with a full dose of Narcan would preclude Mike from enforcing transport. As a sense and alert device, the responder would have 4-6 minutes to get to the patient, and would only be useful to people within the same household, and considering most overdose cases are when the patient is alone, this wouldn’t serve any purpose. In his words “EMTs don’t want this”. He also believes that SPO_2 is a lagging indicator, and doesn’t believe that it would be useful in effectively detecting an overdose before it’s too late. He also think that’s detecting chest movement by proxy on the shoulder wouldn’t be a good indicator. Proper ventilation detection through denote:20240315T111620][end-tidal carbon dioxide (etco2) would be the most effective way of detecting overdoses.
Go-to-market Problems
SPO_2 detection on the shoulder has no predicates, so at the very least, this product would be considered a Class 2 denote:20240315T111411][de novo device. In the worst case, this would be a Class 3 denote:20240315T111411][de novo Combination Device. This would place our device in a regulatory nightmare. His teams working on this sort of device have already been asked for clinical trials requiring at least 60,000 patients. If we needed to capture 60,000 overdose cases and considering there are approximately 90,000 overdoses per year, the clinical trial wouldn’t be feasible. And if feasible, still extremely expensive. In addition to the regulatory issues, there would be huge legal costs associated with law suits around patients who do die.
If Mike were to do this
If Mike were to tackle this problem, he’d charge 5000 per device, use a denote:20240315T111742][nasal cannula to detect denote:20240315T111620][end-tidal carbon dioxide (etco2), and have a closed loop solution that would include an algorithm for a slow Narcan drip. He’d market this to wealthy parents, and have then sign a lengthy contract with an indemnification clause.