Lessons Learned from the Medical Device Industry: Part III Labeling Description

We ended last year talking about Tools to Learn From Others, and how to access existing data to incorporate into design and development to learn from past mistakes. User instructions need to be organized into clear categories: Description, Operation, Troubleshooting, and Additional.  This week I'll be addressing Description.

Within the Description, the sequencing of information needs to be logical for the user.  This means as a developer you need to know your target audience.  Having a clear target audience is both a necessity from a business standpoint for launch and Go-To-Market strategy, and for the instructions to be well sequenced.

The subsections within the device Description you may consider in this preferred sequence:

  1. Name, other specific identifiers
  2. Purpose
  3. Description
  4. Risk/benefit information
  5. Expectations of device and procedure(s) associated with the device
  6. General (major) warnings

Providing the Name and other specific identifiers, such as the model/version or alternative names, allows the user to better understand the device, especially if there is the unfortunate event of a Breach.  Having clear product name with which to notify users is critical for the response and reporting to regulatory authorities.

Another subsection of the Description to pay attention to is the Risk/Benefit. Being clear in this section is both critical for users' wellbeing, as well as your business liability. Conveying Risk/Benefit can include the Contraindications, in other words 'under what conditions a device should not be used'.  This could include users' health status, environments (imagine near or on ships where the salts of an ocean can corrode metal), as well as a list of known and reasonably foreseeable hazards (not a theoretical laundry list). Again, you can use our ClearRoadmap™ Comparison module to identify technologies with similar usage or biomaterials, and compare the Contraindications section side-by-side.

This is the third part in a five part series, next week I will discuss technology literacy impacting the Labels Operation and Troubleshooting sections.

  • -- Vizma Carver, Founder and CEO, Carver Global Health Group LLC and ClearRoadmap™

vizma.carver@cg-hg.com
www.clearroadmap.com