3 min reading time

Did you know the market for precision medicine is projected to more than triple by 2026? I’m not surprised by the growth rate given everything we’re reading about personalized medicine. So I got to thinking: How would you regulate something like that?

Taken to extremes, if every device were customized to every single patient, how could the clearance for use be comprehensive enough?

How will you position yourself to ride this wave? This piece is a good thought starter: “Companion Diagnostics, Biomarkers, and Novel Innovations for Oncology and Beyond.”

You know this isn’t my personal area of expertise so you may want to download it. I pulled some of these lines for you:

• The rise of wearables and EHRs make precision medicine concepts possible.

• If medical device manufacturers are going to be successful with precision medicine, they’ll need to figure out how to navigate outcome-based compensation models for these therapies.

• Pharmaceutical companies work alongside medical device manufacturers for precision medicine. Pharma creates the targeted therapeutic; manufacturers design the diagnostics. There are 40,000+ different in vitro diagnostics (IVDs). The 2022 IVD market projection is $81.3 billion (a CAGR of 4.9%).

• 93% of drugs currently in phase III clinical trials are diagnostic-dependent.

• Multiple studies have shown that most traditional therapies in the US today are effective in fewer than 60 percent of treated patients, costing the healthcare system billions of unnecessary dollars.

• According to a National Academy of Medicine report, a precision-medicine innovation – one that more accurately identifies people who are at risk for a disease and is coupled to an intervention that reduces incidence even by as little as 10% – could generate hundreds of billions of dollars in value in the form of longer, healthier lives enjoyed by the US population.

For more information, download the paper, a courtesy of our friends at ICON, plc.

FDA webinar in two days.

Click here for the FDA content, courtesy of Jon Speer and Greenlight Guru.
They will cover:
• ‘Critical To Quality’ pilot program;
• ‘Manufacturing and Product Quality’ pilot program; and,
• Issues and concerns FDA is hearing from constituents.

And you’ll get access to the first FDA in the series where they covered what CfQ is and how FDA is engaging; summary detail on CDRH pilot programs; and, how FDA is rethinking regulations.

Members with questions

If you’ve got the answers, please share with our community.

Tautvydas Kazlauskas has a question on how to classify a fibrin-glue like medical device.

Antonia Trevisan asks, “Are custom-made devices exempt from CE marking?”

And I could really use help on Irina’s question. So far no one has answered, “How to estimate safety BSE requirements?”

A whole new world

As you can see, with our new home here in WordPress, I can add images and video each week. But even better, I have enough room to express myself and to highlight questions and contributions from group members like you!

So here’s your chance to ask a question and get a crowd-sourced answer from our members.

Just go to https://medicaldevicesgroup.net/question/add/ to ask it. The page will look like this and there’s even a way for you to get notified with each comment (just like the very old days)::

I look forward to your participation!

Thank you for being part of our Medical Devices Group community.

Make it a great week.

Joe Hage
Medical Devices Group Leader

P.S. Meet me at ConX (Sep 17, South Carolina), the MedTech Regulatory Awards at RAPS (Oct 2, Vancouver, BC), and our group’s 10x for Engineers (Oct 10-12, San Diego) – especially that last one! 😊