Medical Device Development: Trades

Medical Device Development: Trades

As a somewhat rabid hockey fan there are a few days during the year that are considered sacred holidays: every playoff game, first day of free agency, and the trade deadline. My mind is on hockey because the trade deadline happens to be today. Outside of my insatiable desire to follow all hockey writers in the next 24 hours or so, I find myself thinking about trades in medical devices.

OK, so we're not talking about "trades" in particular - could you imagine!!! - but more trade-offs. Because medical device development lives in a world of risk management, there are always trade-offs. Look at ISO 14971 for example: you conduct an initial risk assessment, implement mitigating steps, verify implementation, score the risk again, and if that STILL isn't sufficient the standard recommends a risk-benefit analysis. A trade-off between the potential good a device can do versus the potential harm that may befall the patient/user.

Take that a step further into the business side of the industry with the trade-off of regulatory risks. Does it benefit the company to take a more aggressive approach to a regulatory strategy, hoping that the regulators agree? Or, a far less dramatic example, does an American company look to launch elsewhere (Europe, Canada, Brazil, Mexico, South Africa, etc.) because of the perception of stagnancy at the FDA? How do those strategies impact product quality? How do those strategies continue to keep businesses viable? All of these are questions asked by companies every day to weigh the benefit of each scenario and determine whether the risk is acceptable understanding the potential outcome. I wonder if someone will begin doing a business FMEA - after-all with the dFMEA and the pFMEA, doesn't the world need a bFMEA? I kid...

So, in the midst of dreams that my hometown flightless birds will once again raise what may be the most legendary of sports trophies, this trade deadline I'll also be thinking of medical device development trade-offs. And those trade-off scenarios have a deadline every day at 5:00PM...

-RTK