Medtech is going digital: So how do we keep it real?
One of medtech veteran Mir Imran’s biggest claims to fame is that, as a young engineer in the early 1980s, he played a pivotal role in the development of the first implantable ICD. Imran told me a startling fact a few years ago: FDA officials back then were so hesitant to approve an implantable device with software that the first generation had to be almost completely analog.
Things have changed a lot since then.
Imran, presently CEO of Rani Therapeutics, is developing a swallowable robotic pill called the RaniPill, and the FDA is testing out a program in which companies such as Apple or Johnson & Johnson could receive a precertification to create digital health software. So much for analog.
Imran’s firm is only one example. Smart devices linked to consumer products with sensors seem to be everywhere these days, and the heavily regulated, risk-averse medical device industry is turning to digital tools to better manage outcomes. Public and private healthcare payers, in fact, are demanding that providers boost results. Devices are part of the equation.
But going digital presents a host of challenges, including cybersecurity, safety, patient privacy and intellectual property.
There’s also the problem that anyone who invested in Theranos or bought tickets to the Fyre Festival should now recognize: What’s real, and what’s hype? This issue of Medical Design & Outsourcing takes a look at the issue:
- Artificial intelligence’s potential comes with an incredible level of hype, Associate Editor Fink Densford reports. “AI has the most transformative potential of anything I’ve seen in my life, and I graduated medical school 40 years ago. It’s the biggest thing I’ve ever seen by far,” Dr. Eric Topol told him. “But it’s more in promise than it is in reality.”
- The Healthcare & Public Sector Coordinating Council has a plan to boost medical device cybersecurity, Senior Editor Nancy Crotti found. Health providers and other customers buying connected medical devices should be able to remotely access a cybersecurity bill of materials (CBOM) that would list all commercial, open-source and custom-code software, the group told Crotti.
- Assistant Editor Danielle Kirsh looked at medical device companies that are actively developing AI applications in their manufacturing and supplychain operations.
- And I visited Hudson, Wis., and the headquarters of Phillips- Medisize, one of the largest medtech contract manufacturers in the world. Years ago, the company was all about the housings, assembly and packaging that went into finished drugdelivery devices. These days, its connected drug-delivery device focus has widened to include the data systems behind them.
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