MedTech Firms - "Houston - We have a problem!"

It’s the year 1999. I am sitting alongside 378 other batchmates intently listening to the professor teaching us about factor of safety in an engineering design class.

Which has a higher factor of safety? An aero plane or a car.

For the unlucky backbenchers who had not read the concepts in advance, we thought that an aero plane should surely have a higher factor of safety. Surely, we don’t want aero plane dropping down from the sky, or have their engines fall apart mid-air.

Well, as it turned out, if you crank up the factor of safety for an aero plane, it will become so heavy that it will not be able to fly. Usually, the factor of safety values for aircraft components ranges between 1.5 – 2.

Irrespective of the factor of safety, we expect our machines and equipment to perform reliably every single time in every single situation, all the time.

This brings me to the crux of the article and the question I am trying to explore.

If your life depended on an equipment, would you be OK knowing that it may or may not operate reliably all the time under all circumstances?

In addition, if you were a manufacturer designing, building, and selling medical devices, would you be OK selling products that may not be reliable?

FDA publishes the data around medical device product recalls and the trends have been alarming.

Since 2017, the FDA has issued 66 product recalls out of which 49 recalls are still open.

Source: Medical Device Safety | FDA

Unfortunately, these numbers and statistics do not do justice to the impact these recalls have. There's psychological impact (for patients), cost impact (logistics of managing a recall) for manufacturers and disruption for care providers/ hospitals.

One of the most high-profile recalls was Boston Scientific's Lotus Edge Aortic Valve system which was completely taken off the market in Nov 2020. The cost impact - ~$300MN.

FDA recently issued a Class I recall for Baxter's Sigma Spectrum Infusion Pumps due to the risk of not alarming for repeated upstream occlusion events. There were 51 reports of serious injuries and 3 reports of patient deaths over five years, potentially associated with the issue.

Philips recalled their V60 and V60Plus ventilators for expired adhesive that may cause the ventilator to stop working with or without an alarm. Thankfully there were no adverse health consequences reported.

Vyaire Medical recalled the bellevista 1000 and 1000e series ventilators with specific software configurations, after reports of ventilators failing to ventilate and generating a technical failure alarm. There were 18 complaints, seven injuries, and no reports of death.

My intent is not to publicly shame these firms.

On the contrary, I believe each of these firms have made significant contributions in improving health of patients and overall healthcare with their cutting-edge products.

However, it is hard to reconcile with the fact that the medical devices do not operate reliably all the time, under all circumstances.

Designing, building and bringing out a product to the market is hard. In the last five years, pretty much all devices come with some form of network connectivity and an accompanying software package. Medical devices have become more complex.

Add the complexities of training external staff at hospitals such as nurses, care providers, doctors & surgeons etc., and soon the points of failure increase manifold.

However, there are parallels to what we are observing, with the state of the PC (personal computer) market in late 90's / early 2000's.

That was the era where most users had resigned themselves to the infamous BSOD (blue screen of death) and Apple ads mocking Windows/ PC were the craze.

One could never pinpoint the exact root cause whenever the PC crashed.

Pretty much every component of the PC experience was created by a different manufacturer. Microsoft made the OS, Compaq/ Dell/ HP etc. made and sold the PC, the underlying parts like CPU, GPU, Memory, Storage, Motherboard - all were made by different manufacturers. If you added peripherals to the mix, each of them came from different manufacturers with their own compatibility software's. Software programs came from different firms as well.

It would take a miracle for everything to work in perfect harmony. And when it didn't, there was the dreaded BSOD.

Computers and computing experience have come a long way since then to create a reliable computing experience. So, what happened?

1. Market Consolidation - Industry coalesced around a few players like AMD, Nvidia for GPU's, Intel & AMDs for CPU's. Peripheral makers also coalesced around a few players such as Logitech, Razer etc. The number of big PC manufacturers can be counted on fingertips. With lesser moving parts, the points of failure reduced as well.
2. Data Collection - Most software & products started requesting for anonymous collection of usage data to further improve products and services. That is a gold mine of usage data which when paired with sophisticated AI/ML algorithms enabled for rapid outlier detection and issue identification.
3. Testing Democratization - Most firms created "insider" channels where their most fervent followers signed up for the latest and greatest version of upcoming software releases. Microsoft has a whole new name for this. "Flighting". Each software iteration is a flight that users can try out and provide feedback. When paired with anonymous data collection, this type of testing is pretty much unmatched in scale when compared to early 2000s.
4. Cloud Adoption/ Purchase vs. Subscription / Product vs. Service - With most software's transitioning to a service-based model, the era of purchasing and owning a software is long over. As more and more software products transition to the cloud, the problem of supporting 1000s of hardware configurations became less relevant. Hence more stability and reliability of experience.
5. Standards & Adoption - Better adoption of industry standards by the market players ensured better compatibility of hardware/ software and services

My hypothesis is that as the medical device industry advanced towards digital and as their products started getting more and more connected, smart, and part of an overall care ecosystem, these legacy organizations did not fully transition into the ethos of cloud native digital engineering firms.

One can make a point that the parallels between the PC era troubles and what led to a more reliable experience are not fully transferrable/ applicable, but some of the lessons can be applied in principle specifically around vertical integration of the value chain, integrated hardware/ software built from ground up for interoperability as well as increased focus on quality assurance and testing.

As products continue to get more complex, a lot more has to be done to ensure that they are reliable every time.

What is your perspective?

What do you take away from the trends of MedTech product recalls and how can the issue be addressed?