It's more important than ever for medical device developers to embrace a collaborative design process, but a number of hurdles stand in the way of achieving that goal.
Mary Beth Privitera, M.Des., PhD, FIDSA, and Tor Alden, MS, IDSA
It is an interesting and exciting time to be in the field of medical product design. User-centered design has become widely adopted and advancements in technology have provided many opportunities to improve the medical device use experience. But these steps forward have also come with challenges. One challenge for the design and development community is demonstrating the use and usability of medical devices as required for regulatory approval.
In February 2016, FDA provided guidance regarding applying human factors engineering and usability engineering to medical devices. This guidance has been referenced throughout the main IEC documentation for medical design, including IEC 60601 3rd edition. This article highlights trending challenges and outlines a few possible mitigations to help develop an effective and collaborative human factors program throughout the design process.
As a result of recently published FDA guidance, there is an increased demand in contextual inquiry studies to determine unmet needs along with more formal formative and summative usability testing, which are a few basic requirements in a human factor dossier. This demand, plus the increased scrutiny in access to clinical sites as well as patient interaction, have combined to make a challenging situation for the design and development community. Some of the required information from clinical sites is likely a direct result of many elements including: Joint Commission expectations, Health Insurance Portability and Accountability Act (HIPAA) constraints, the Sunshine Act, and other recent legislation that has contributed greatly to the inability of hospitals and private healthcare corporations to readily enable human factors studies.
Moreover, unlike the well-established pathway for clinical trials and sales representatives to legitimately collaborate and be present in the clinical environment, there is no routine process for collaborative exchanges when it comes to human factors engineering studies. Typical human factors engineering staff may not have the credentials associated with sales representatives and/or the training required for clinical trial-like management. This less navigated pathway for clinical access of human factors engineering teams and product development professionals places a profound burden on innovation and development teams seeking user feedback. It has been our experience working collaboratively with clinical counterparts that there are three primary questions from the clinical community that the development team will need to address:
- An explanation of the purpose, intent, and focus of each type of human factors study.
- An explanation as to why it's important for users to participate, how their information will impact the design process, and how you are protecting the information they provide (e.g., specifically protected patient information).
- Assurance that the team conducting the study has the appropriate approvals and/or oversight, credentials and training to conduct the study.
Answering the first question should be easy: The goal is to identify opportunities for improving medical device use and usability. The second question, as to why the study is important, requires a bit more diligence and planning. The quick answer is that it is required by FDA that users be involved, at minimum as assessors of usability. The longer, more detailed, and likely more correct answer is that medical device developers cannot produce appropriate and valued devices without user input, nearly all devices originate from users, and without user input it is likely developers have misconceptions regarding the realities involved in delivering healthcare. Furthermore, the demands of HIPAA increasingly impact all areas related to care, and human factors engineering is among them. Planning a document trail and securing information--especially during transfer from one site to another--impacts human factors engineering processes, especially when collecting information on protected communities such as children.
The three challenges associated with human factors engineering studies have the potential to be resolved, but only with greater commitment by both users and device developers. For example, working collaboratively and directly with large hospital systems, medical device developers can organize a clear process for engaging users and healthcare professionals in order to meet the needs of device development, not necessarily limited to the discussions and testing requirements of human factors engineering processes. That approach in and of itself promotes good design and collaboration, and could eventually be recommended by regulatory agencies as best practice.
Another mitigation for human factors engineering studies is, where appropriate, following the path of a clinical trial that could alleviate the hospital's safety and privacy concerns. Clinical trials utilize the Institutional Review Board (IRB), a committee established to review and approve research involving human subjects. While including IRB oversight can increase the burden in both time and expense, if the difference is between no direct user inputs and conducting a formal IRB-approved study to determine user needs, the answer seems obvious. Developing the wrong device is far costlier than IRB oversight. The main purpose of the IRB is to ensure that all human subject research is conducted in accordance with all federal, institutional, and ethical guidelines. It can be argued that while most human factors studies are not generalizable information, they do all involve human subjects, often with video recording and therefore potential identity disclosure (think HIPAA violation). With the increased scrutiny and regulations, future contextual inquiry studies and formal summative usability testing will most likely require IRB approval and perhaps the practice should be embraced.
The application of human factors standards and the practice of user-centered design remain a priority in the industry for the development of safe, effective, and usable medical devices. Despite the challenges presented, it is clear that the industry respects these regulatory requirements and values the input of device users. As the promotion of collaborative design process intended for design optimization increases, so do the challenges and subsequent mitigations for conducting human factors studies. Within the complex healthcare environment, this may likely require a policy change and involvement of the entire human factors community.
Mary Beth Privitera, M.Des., FIDSA, PhD is principal, HFE and user research, at HS Design Inc., an ISO 13485 certified product development firm and a recognized leader in medical and life science user centered design. For further information on this subject and current research on collaborative design and meeting international HFE standards, please see this article. Reach her at firstname.lastname@example.org.
[images courtesy of HS DESIGN INC.]