This piece from ICON at https://medgroup.biz/mHealth got me thinking about mobile for medical devices.

The points that resonated most with me:
• mHealth enhances clinical trial recruitment & retention for people who AREN’T mobile; reducing in person visits for the elderly, neuro/cardiac/pulmonary and most rare-disease patients.

• It supports product design and development: You’ll identify and direct resources to your most promising projects earlier in the product development cycle.

• Mobile technologies (wearables) are instrumental for collecting real-world data. And you’ll have richer data versus readings from sporadic doctor’s visits.

• Continuous monitoring can detect intermittent symptoms, including those which could reveal a patient relapse.

• mHealth can improve patient compliance and help avoid preventable complications.

• Hospitals, fearing value-based reimbursement penalties, want solutions that lowers their readmission rate; mobile may be the competitive advantage you need.

From the report, “As payers grasp how patients make decisions, how their lives are affected by disease, and the challenges they face, payers are demanding evidence of a product’s value for cost. Real-world data collected from patient devices can provide solid real-world evidence with regard to how a product adds value beyond the existing standard of care.”

The paper also covers infrastructure requirements to implement mHealth into your product development, and discusses integrating data from mobile devices and apps with EHRs.

You’ll value https://medgroup.biz/mHealth if you are:
(1) in product design or development;
(2) planning a clinical trial; or,
(3) collecting real-world data to support real-world evidence.

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Value Analysis Committee webinar today; replay and slides at https://medgroup.biz/vac

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Make it a great week.

Joe Hage
Medical Devices Group Leader

Tom KraMer
President & CEO, Speaker
Hi Joe, I just did a lecture last week about how home health care is affecting this trend. One thing to remember about mobile health is that it is only as good as the accuracy of the input and sensors, AND that accuracy is affected by the skill of the user. In home health, much of the user population is elderly, and there can be difficulty using mobile devices accurately. This is something we really have to pay attention to when designing devices and systems for mHealth.

Sam S.
Entrepreneur | Innovation Leader | Product Manager | Agile Transformation
I have to second Joe’s comments. We ran into similar issues with our Studypal mobile app, where elder users have difficulty responding to questions on a mobile app, especially within specific disease areas. Therefore, user experience and how they engage with such apps is always one of the most important aspects. Also, every study is different and the need is different, so complexity adds to this as well.

Katie Bates
CITO MEDICAL – Biotech & Medical Product Development
Interesting perspective, thanks for this!

WahTong Lee
Chairman & Co-Founder of Soniclean Pty Ltd
Inevitable progression into development of sensors especially neuroscience so that administration of drugs and patient care take the quantum leap. Data becomes crucial and indispensable in this development cycles.

Only if the focus its on patient care and well being, above monetisation.

Ramesh Srinivasan
Global Business Development Director at Porex Life Sciences Division of Filtration Group
I agree Joe. We are seeing it, especially in diagnostics and how the devices are being designed to work with smartphones that connect to doctors offices and health providers.

Beluh Mabasa Ginting
Section Head of Standardisation at Directorate of Supervision of Medical Devices and Household Health Ministry of Health
The accuracy of the input and sensors mobile health is also depend on the result of the validation of the software (software as medical device or software in medical device) especially if there is a design development that definitely requires a review risk analysis and possibly clinical evaluation/investigation if the requirement of basic safety and essential performance are not comply and can not be demonstrated by the manufacturer.