On 21st May 2020, the China National Medical Products Administration (NMPA) issued the draft of the 'Guidelines for Technical Review of Human Factors Design of Medical Devices' for consultation.
These guidelines will be applicable to Class II and Class III medical devices for NMPA registration. The consultation process has now been completed, the guidelines have been refined and we look forward to the upcoming official release, and to share with you our interpretation of those guidelines and advice on how to integrate them as a key part of your product development process.
PDD is a leader in the practice of Human Factors and Usability Engineering in China
As recognised practitioners of Human Factors (HF) and Usability Engineering with over 40 years of global experience, PDD has witnessed and contributed to the establishment of this guidance in China. Over the last five years, our HF teams in our London and Shanghai studios and have been driving Human Factors and usability studies across a wide range of medical devices in China, from vascular access catheters to equipment used to treat critical diseases, alongside varying forms of drug delivery devices.
As a member of Human Factors Engineering Professional Committee of China Association for Medical Products Administration, PDD have been working tirelessly to promote Human Factors and Usability in China, sharing our experience and knowledge with medical device manufacturers in this region.
Highlights: What do we mean by Human Factors and Usability?
It is about SAFE and EFFECTIVE use of medical devices.
It involves three major components of the device-user system: (1) device users, (2) device use environments and (3) device user interfaces.
It is closely linked with risk management.
Eliminating or reducing design-related problems that contribute to or cause unsafe or ineffective use is part of the overall risk management process. For example, you can’t validate without risk management documentation in place.
The process is as important as the outcome.
Usability testing collects evidence that use-related risks have been mitigated. Documentation controls are therefore important.
Integration works on many levels.
The integration of usability activities in medical device development process is not just about sharing documentation, but sharing perspectives.
There is a need to integrate across different disciplines alongside the new product development process.
The usability study can be in different forms for different purposes:
- Contextual inquiry
- Interviews
- Heuristic review
- Formative evaluations
- Cognitive walk-through
- Simulated-use testing
Best-practice recommendations
Through our extensive experience applying Human Factors and Usability Engineering in medical devices, we have learnt what works best at every stage of the process. Here are some tips for best-practice:
Test environment:
- Simulate the real context of use where possible, for example: lighting levels, thermal environment, noise, furniture, other surrounding equipment and potential hazards, multi-tasking and distractions in the working space
- Consider testing devices in-field, for example: At home or in the clinical environment.
- For high-risk products (e.g. infusion pumps) consider validation with clinical evaluation.
Task selection:
- If possible, test every user task.
- If not, prioritize by safety-critical tasks and frequent tasks.
- Address worst case scenarios where possible.
- Link tasks to risk management.
Moderating sessions:
- Protect participants’ rights.
- Be professional and build trust.
- Create rapport, but stay in charge.
- Ask open questions.
- Don’t be a robot! – remember that the script is only a guide.
- Be unbiased.
- Let the participant speak.
- Be mindful of ‘thinking-aloud’; passing comments can derail the conversation.
- Give participants time.
- Let participants struggle, but always keep them safe.
- Watch non-verbal cues.
- Probe where appropriate to understand the root causes of people’s actions.
Data collection and error logging:
- Measure your success rate.
- Measure and capture errors, close calls, operational difficulties and their root causes.
- Take note of the assistance provided.
- Capture ‘verbatim’ comments
- Take notes of other observations and behaviours
- Record the responses to questions and ratings.
At PDD Group, Human Factors and Usability engineering has always been integral to our work.
Since IEC: 62366 / 62366-1 became a regulatory requirement, PDD has maintained a full time team of Human Factors experts who have supported an extensive number of medical device developments, and conducted over 100 Formative and Summative Usability Studies worldwide involving 1,000s of participants.
This work has been conducted across Asia, Europe, North and South America with a broad range of HCPs, caregivers and patients with a variety of conditions. We have evaluated home use medical devices and hospital equipment as diverse as disposable catheters and haemodialysis machines in many different clinical areas such as COPD, Hepatitis C, Multiple Sclerosis, Chronic Bronchitis, Emphysema, Asthma, Peripheral Arterial Disease, Psoriasis, Invasive aspergillosis, Haemophilia, Home haemodialysis system, Ventilator Acquired Pneumonia, etc. Our rigorous approach ensures that success and risk factors are considered throughout each phase of work as it progresses.
If you would like to hear more about our expertise integrating Human Factors and Usability in China or explore how we can help your organisation in light of the upcoming regulations, please drop Vicky Hong a line at [email protected]
