Feb 6, 2018

For some medical devices used in clinical and home environments, end-users are the benefactors of formal training designed to facilitate safe and effective device use. However, not all medical device training programs are created equal.

Some training programs might involve the mind-numbing presentation of hundreds of PowerPoint slides, while others are arguably more engaging, involving hands-on device use and dialogue between the trainer and trainee(s).

Based on our team’s experience helping manufacturers develop and validate medical device training programs and materials, below are some key steps to developing and delivering effective, in-person training. Notably, some steps also apply to other training approaches, including computer-based training and how a manufacturer might “train the trainers” in preparation for product launch.

Key training steps for medical device users

  • Tailor to trainee background and relevant experience. The training program should recognize and accommodate variation among trainees’ backgrounds and relevant experience. For example, content and format should differ for healthcare professionals and lay users, as well as within those groups. Surgeons and technicians are likely to be responsible for performing different device use tasks, and some lay users might have prior experience with a particular device type (e.g., an insulin pump) while others might not.
  • Accommodate the expected number of trainees. The training program should be optimized for the expected number of trainees per session, whether it be a one-on-one session with a layperson or a group of clinicians attending a small-group in-service.
  • Cover routine, critical, troubleshooting, and maintenance tasks. Training should orient users to fundamental and routine tasks, as well as critical tasks that, if performed incorrectly, could lead to mistakes (i.e., use errors) and potential harm. The program should also train users on key troubleshooting tasks, as well as device care and maintenance.
  • Provide ample hands-on time. Training should provide trainees with hands-on time to interact with the device and its disposables, accessories, and labeling. Such interactions can be summarized as a “return demonstration” following a trainer’s demonstration of a given task or feature. Trainers can also give trainees independent exploration time to freely explore a device’s user interface. Ensure there are enough sample devices and accessories to accommodate the number of trainees and afford the opportunity to practice and repeat key tasks.
  • Introduce and encourage use of resources. In addition to covering a wide range of tasks, training should orient users to – and encourage frequent use of – various resources, including printed labeling, instructional videos, and a support hotline, for example. Orienting users to these materials will likely increase the materials’ use and, ideally, facilitate safe and effective device use.
  • Include specially-designed training materials. Depending on the device’s complexity and end-users’ characteristics, it might be beneficial to supplement standard device labeling (e.g., Instructions for Use) with specific training materials such as a training topic checklist, trainee competency (skills) assessment, training video, and/or trainee workbook. It might be appropriate for trainees to retain a full set of such materials for future reference, especially during device use.
  • Include a trainee competency assessment. Some training programs incorporate a formal “skills check” wherein the trainer assesses the trainee’s ability to perform all or a critical subset of tasks safely and effectively. Trainers might be well-served to assess each trainee’s competency; formally determine whether a trainee has absorbed and understood the information presented in preparation for proper subsequent device use.
  • Deliver training in manageable “chunks.” Training should be scaled and potentially “chunked” in a manner that accounts for questions, impromptu dialogue, and breaks. Training might need to be divided into manageable modules, sometimes over multiple sessions or days, to ensure trainees absorb the content and to avoid information overload. Providing trainees with a clear training program agenda can help set expectations and facilitate absorption.

The link between medical device training and usability

As previously mentioned, not all medical device training programs are created equal. A well-designed, engaging training program enables manufacturers realize many benefits, most notably the increased likelihood of safe and effective device use brought to bear by competent and confident end-users. Other, albeit related, benefits include fewer adverse events, customer support calls, and device recalls.

Oh yes – and yet another notable benefit of great training is that it can improve outcomes from summative (i.e., validation) usability tests, which are conducted to determine if a product is subject to potentially harmful mistakes or not. FDA and other regulators require evidence of safe and effective user interaction with a given device (especially Class II and III devices) ahead of approving them.

Of course, test participants should only be trained if such training will be provided to end-users upon product launch and prior to actual use. Otherwise, summative usability tests should include untrained users, or a mix of trained and untrained users, whatever most accurately reflects intended and expected use.

Allison Strochlic is Research Director of Human Factors Engineering at UL. Read more about medical device design and usability issues at the UL Wiklund website.

Related medical device HFE, training and usability resources:

  • Human Factors Engineering (HFE) and usability testing for medical devices
  • US FDA submission support for medical device and IVD manufacturers
  • Webinar: HFE for medical devices



  • Allison Strochlic