Tag Archives: mobile apps integral to medical device

Healthcare Supplier Performance Less Predictable

disruptionHealthcare industry-wide cost containment behavior is sending ripples back through the supply chain.

Are the changes a transitory event or a trend is the question facing many suppliers.  Does the change call for a permanent change to business as usual?

As unsettling as it may be, most suppliers appear to be preparing for a transition which will bring more variability and unpredictability to the results of companies which had been prized for dependability in results.

The speed with which suppliers adapt to the new environment may influence the degree of variability.  Resisting what appears to be an inevitable transition likely accentuates the disruption it causes.

As I listen to Wall Street earnings calls, healthcare industry suppliers blame weak results on cost cutting but rarely admit to what is likely the new reality.

Click here for an article by Chris Provines, author and speaker, on healthcare supplier strategies.

Click here for an article in Modern Healthcare suggesting the greatest pressure is on commodity items.

 

 Post by Dennis McCarthy

  Google

Mobile Apps Require FDA Review

SmartphoneAppsThe Food and Drug Adminstration, FDA, has provided final guidance to determine which mobile apps may require FDA scrutiny and regulation.

The more the mobile app’s intended used is as an integral part of the functioning of a medical device, the more likely it falls within regulatory scrutiny.  For example, a mobile app used to read the results of diagnostic tests are likely to be defined as a “mobile medical app” and, therefore, face FDA review.

At the other end of the spectrum, mobile apps that are used for normal office functions such as scheduling office visits or reminding patients about non-medical behavior such as getting sufficient exercise, are unlikely to face review.

Click on the links below or copy and paste the links into your browser to read a helpful summary of the FDA announcement by Foley & Lardner, the law firm, or the FDA guidance.

http://www.jdsupra.com/legalnews/fda-submits-final-guidance-on-mobile-med-92633/

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf
 
 By Dennis McCarthy
 Google