Why Training Matters in Medical Device Testing

Bringing an innovative new medical device to market is no easy task. In the U.S., approximately 75% of medical device start-ups fail. One of the best ways to guarantee success is the rapid and mass adoption of a company’s newest device—and the best way to guarantee that is for the device to be easy to operate for the end user. Rigorous medical device testing plays a critical role in ensuring that these products meet safety and usability standards, further increasing the likelihood of successful adoption.

When to Plan for End-User Training

Planning end-user training early in the product lifecycle helps manufacturers better understand user needs, anticipate practical challenges, and ensure devices are adopted smoothly. Strong training also supports improved patient outcomes and sustained customer satisfaction.

“Ideally, manufacturers should consider training possibilities from the concept phase onward, with particular attention during the design phase’” said Dailen Brown, PhD, Study Director of NovaSterilis. 

When end-user training is considered from the outset during development, a medical device is more likely to be intuitive and user-friendly, making training sessions run smoother because the medical devices are easier to understand and operate.

To achieve this, designers, engineers, clinical experts, and those who will ultimately train users must be involved from the start—whether internally or as external consultants. It’s also recommended to engage potential end users early to gain valuable insights into what will work in real-world settings.

“Training development is a critical part of any product, especially in healthcare. You could even argue that a product is only as good as its trainability,” said Brown. “A user can’t effectively use a device without understanding its intended purpose, and many medical devices require hands-on practice to master. Thinking about training early makes it more likely that manufacturers will choose concepts and designs that are easier to teach and quicker to learn, ultimately leading to more effective and efficient devices.”

External medical device testing partners, such as iFyber, offer real-world insights into how materials, device performance, and user interaction may affect training needs and long-term usability.

Measuring Training Effectiveness: Metrics That Matter in Medical Device Testing

Incorporating insights from medical device testing and safety testing ensures that your early training metrics align with critical performance and safety benchmarks. However, choosing the right metrics is the key to knowing that training is truly effective.

“The most important metric for evaluating the effectiveness of training for any procedure is a comparison of clinical outcomes with and without the training in place,” said Brown. “However, this data typically takes years to collect and only becomes available after patients have already been treated. As a result, outcome-based metrics are often used to verify the true effectiveness of a training program, while quicker, less patient-impacting metrics are used earlier in the development process. The most relevant metrics can also differ significantly depending on the procedure and device, so manufacturers must carefully consider which evaluation methods are most appropriate for their specific context.”

Commonly used metrics that provide meaningful insights into training effectiveness include:

• Performance Comparisons – Compare novice and expert performance after training to reveal how effectively the novices progress toward expert proficiency.
• Confidence and Perception Metrics – Combine self-efficacy surveys with performance data to discover whether training builds both skill and appropriate confidence.
• Cognitive Load and Attention – Measure decision points and the time intervals between them to track how someone’s decision-making improves.
• Physical and Procedural Metrics – Tracking the motion of hands or tools provides insight into how well a trainee’s movements align with the expected steps of a task.

Ultimately, no single metric is likely to capture the effectiveness of an end-user training program in full. However, a layered approach that combines performance, perception, cognitive, and procedural data can help approximate real-world readiness in a safer and more iterative way. Working with testing specialists like iFyber can help manufacturers generate quantitative performance data tailored to their product and testing goals.

Common User Challenges and How Training Can Help Overcome Them

“There are many common medical-device-user challenges, and while training programs can help to address them, many can also be mitigated through intentional design decisions and practices that reduce the need for training altogether,” said Brown. “Considering training needs early in the product lifecycle can support the development of effective training systems and naturally improve the design by revealing opportunities to simplify and clarify user interaction.”

Some common medical device user challenges include:

Unfamiliar User Interfaces

• Design: Follow known design conventions and usability heuristics.
• Training: Provide hands-on practice to reinforce unfamiliar elements.

Cognitive Overload

• Design: Use clear icons, labels, and prompts that minimize reliance on memory.
• Training: Explain why each step matters to deepen understanding.

Misinterpretation of Feedback Systems

• Design: Align device feedback with familiar conventions and provide clear indicators.
• Training: Use demonstrations and simulations to show what feedback indicators mean in practice.

Loss of Proficiency with Infrequent Use

• Design: Make critical devices as intuitive and self-explanatory as possible.
• Training: Offer regular refresher training for rarely used but high-risk devices.

Complex Setup or Maintenance

• Design: Simplify setup and maintenance with clear labeling and sequencing.
• Training: Include these tasks in training and provide opportunities for hands-on practice.

Addressing these common challenges requires a balanced approach that combines thoughtful device design with comprehensive, user-focused training. By proactively identifying potential obstacles and integrating solutions throughout the development and training process, manufacturers can help ensure that users feel confident and competent—ultimately supporting safer device operation and better patient outcomes.

How iFyber Support Success Through Medical Device Testing and Training

A successful training program is as essential to a medical device’s success as its design and engineering. By prioritizing training early, involving the right stakeholders, and leveraging insights from medical device safety testing, manufacturers can help ensure that their devices are used safely, effectively, and confidently. Thoughtful design paired with robust training leads to better user experiences and patient outcomes.

From early design decisions to post-market performance, thoughtful training starts with understanding how real users interact with your device. iFyber helps medical device manufacturers generate the data and insights needed to inform intuitive design, validate training effectiveness, and support long-term user success. Whether you need advanced medical device testing, targeted medical device safety testing, or custom protocols from an experienced medical device testing lab, contact us today to learn how we can support your next device program.