That’s a fancy health tracker on your wrist. Is it medically accurate?

Tracking devices – monitors, if you will – have been around for a long time. In the intensive care unit, the patient is monitored 24 hours.

Your fitness tracking device may not even be FDA cleared.

Medically Accurate?

You may not be terribly concerned about slight measurement errors on your fitness tracker.

Remote patient monitoring for clinical diagnoses is a completely different animal. Material health decisions rely on accuracy.

After talking with Voler Systems President Walt Maclay, I realized this is a webinar-worthy topic. Walt agreed and we’ll co-host a live event will be Wednesday, January 23 at noon Eastern Daylight Time to discuss wearables and home patient monitoring.

Pitfalls of Medically Accurate Measurements

Walt easily rattled off a dozen watch outs for our medical device design and development communities. We’ll cover them on the 23rd but here’s a taste:

• Heart rate. Heart rate is simple to implement in theory, but difficult to measure on the wrist. Measuring the electrical EKG signal requires good contact with the skin, which does not happen often. A more reliable technique is pulse plethysmography or PPG.

• Skin temperature. Skin temperature varies greatly, so it’s not a good indicator of core temperature (to detect fever, for example) except at a few locations. The forehead and under-arm are the best locations, but you’d look pretty stupid wearing those. (Okay, that’s not exactly what Walt said.) 😛

• Measuring EKG. Measurement points have to be rather far apart (at least 1½ inches on the chest). That’s a significant issue if the device is too small. It’s particularly difficult to measure EKG on the wrist.

  A device that attaches to a cell phone to measure EKG via two electrodes can do it – one thumb is placed on each electrode and held there until the measurement is captured. This works because the two thumbs are far apart on the body.

  The Apple watch uses a similar technique. You must touch the watch with the opposite hand to measure EKG.

He had much more to say. I got tired of writing. Click the register button and we’ll share more on the 23rd.

Postscript

We want all that home-monitoring data so we can send patients home. In an outcome-based environment, we’re getting paid the same no matter how much it costs us to treat them. They’re expensive and take up available beds.

Sensor data can help manufacturers gain a competitive advantage. A wearable device can complement their main product by collecting additional data. More data, more opportunities.

Walt adds, “This isn’t innovation for innovation’s sake. Sensor data improves clinical outcomes, economic value, care delivery efficiencies, and patient experience. The proactive shift to value-based care strives to maintain healthy populations and prevent illness, and reduce the need for clinical visits and hospital care.”

Thank you, Walt, and we invite you to join us for this free educational session.

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The Medical Devices Advisory Group

If you missed it last week, we introduced the Medical Devices Advisory Board (read about it here) and co-founding member Paula Rutledge took the lead on our first report, below. Click the image to download it.

We also added more than 30 active searches, many conducted by Paula’s Legacy MedSearch group.

See the jobs here. Some need urgent filling.

Here are some new ones versus last week.

You can thank Paula in person – at the 10x Medical Device Conference. I hope the May 15-16 event is on your radar.

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New Year, New Questions!

These members have questions. Do you have the answers? Visit our community discussion board and catch up on what you missed.

• Jana in the Czech Republic has a non-EU country registration question.
• North Carolina-based Amy wants to set up an online CME course and could use your help.
• Ata in Turkey has a classification exemption question.

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

If you’re looking for work, check out the newly posted jobs here!

Make it a great week.

Joe Hage
Founding Principal,
Medical Devices
Advisory Group

P.S. Join us for Walt’s webinar on January 23 at noon Eastern Standard Time. Click here to register.