Lessons Learned from the Medical Device Industry: Part IV Labeling Operation and Troubleshooting

arlier in the month we talked about the Description section of your devices Label, and how to sequence the information and the order of the subsections, so that users better understand the device and therefore increase the adoption of the device.

As we listed the categories in Part II Tools to learn from others, the second category of the user Label is the Operation. Knowing how to operate a device is critical for adoption.  As we all know, technology features are rarely used to their fullest, and to rely on only the principle to "build with intuitive use" in mind can become short sighted, if not validated with the target client.  Regulated technologies have over the years increased the scrutiny on the user technology literacy.  ClearRoadmap mHealth Pathways goes into an extensive tutorial on assessing your target audiences' technology literacy, as it is one of the larger barriers to product adoption.  Healthcare apps are a bit of a different breed from other business technologies.  As healthcare providers have known for years, taking one vital is just one data point, it rarely gives clear direction on the patients' health.  Similarly wellness apps that under-collect their users information will face additional challenges to show value to the user and scale adoption. Thus building with a clear understanding of the target population and their technology literacy will play a critical role in adoption, and ultimately the viability of your business.

Once you have your target audience's technology literacy well understood, including the understanding and use of icons and images, then the following sequence has been found to be most useful for Operations:

  • Set up (including calibration and other preparation)
  • Instructions for operation
  • Maintenance/storage
  • Other applicable topics associated with operating the device

It may seem obvious to use certain icons, such as a yellow triangle or a red exclamation mark for attention, but the development of icons and images that have meaning across user age, culture, gender is a process and requires evaluation with target users.  This is a place where wellness technologies can learn a lot from the regulated devices.  FDA Labeling Reviewers leverage the QSR requirements process to assess the extent at which medical device companies have validated their instructions with users, including the images.  ClearRoadmap™ can help you quickly learn about the QSR Pathways and find images that have been through review processes. The Comparison module lets you search on products of similar Indication of Use and then select up to 10 medical technologies to your custom Report.  The Report includes the latest approved PMA device labeling information with their approved images.  Of all of the underlying documents, the Labeling documents are updated by industry, with field production lessons learned. Thus, you can learn from the industry on methods that have been evaluated, reviewed, and withstood the test of time in a cost effective manner. 


Keep in mind as you learn from the regulated devices, that Troubleshooting should be called out as a separate section in the instructions, to be most effective.  Ideally Troubleshooting should follow the Set up and Operations sections, and before Maintenance and Other sections, so users can easily access as they set up and learn to use the technology. One of the critical outcomes of successful troubleshooting, is for the user to quickly determine if the trouble is with their application, or if there is a health concern that requires physicians' expertise.  The order of the potential issues a user may encounter should be grouped in categories (e.g. alarm, data entry), with each group highlighted and ordered from the most critical patient health impact, to the least critical.  Logically thinking, if the trouble is potentially harmful to the patient, you don't want the patient to have to dig for the information.

This is the fourth part in a five part series, next month will be the final of the five part series, with the last section of the Label and tools to help traverse the regulatory processes.

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