Last week we talked about Ease of Use principles, and how small changes can help your wearable achieve the success it needs.
Since the 1990's the medical device industry has been working with patients and users to adopt mobile medical devices. Though the patients' motivation's to use devices to manage their disease span the spectrum of diabetes management to digital scales for disabled patients, regulated medical device companies are required to validate the use of their devices, and to have surveillance programs with which to monitor their products performance in the 'real world'.
The output of all of these regulatory requirements have resulted in firm set of Guidance Documents and Standards to drive quality labeling and instructions, and when necessary, labeling "Recalls". We can all imagine the stories of "pulling failed products off the shelf", but in fact recalls vary largely in their severity levels. Many Recalls are corrections to the Labeling (aka user instructions), these are a rich source of 'lessons learned' to build quality into the next generation of devices.
Subscribing to ClearRoadmap™ Comparison module, users can Search the Recalls database, for the specific "Reason for Recall" using terms such as Software. Within seconds a comprehensive list of medical devices that have had Software as a 'Reason for Recall' can be reviewed in detail, to learn the reason and the actions taken. Some of these include: "At rare, extremely high glucose levels (1024 mg/dL and above), the Blood Glucose Meter may provide an inaccurate reading", "When the meter is fixed in 12 hour mode, the time frame display of all memory data will be shown incorrectly as AM or PM", "Manufactured with an incorrect factory set unit of measure." These recalls that require technical correction and/or labeling to warn users of the range limitation, can help wellness developers incorporate more complete information into their design, development and testing scenarios.
Additionally, the FDA's Guidances such as the Patient Labeling and industry standards provide rich content with which to guide instruction development, again leveraging years of experience, numerous studies and workgroups to tune the Best Practice for User Labels. While we discuss the excerpts of the Guidances and Standards below, the ClearRoadmap QSR Pathways provides step-by-step details for device labeling and the links to the various Guidances and Standards.
User instructions need to be organized into clear categories with relevant subsections. The following 4 categories and their order provide ample organization for users to learn about the device and get the most out of it:
Using this standard for wellness applications can also provide an additional benefit, in the form of a smoother transition to a mobile medical device, if there ever comes a business decision to expand the device capabilities and apply for FDA review.
This is the second part in a five part series, next week I will discuss in detail the information and sequence of information needed in the Description section of the instructions.
- -- Vizma Carver, Founder and CEO, Carver Global Health Group LLC and ClearRoadmap™