HFE Practice Models: How Manufacturers Establish and Maintain HFE Competency

By Allison Strochlic, Michael Wiklund
September 6, 2016


• Categories: 04-Product Design & Development, RC - Medtech Regulatory Resource Center

UL’s human factors engineering (HFE) team has provided HFE support to more than 100 medical device and combination product manufacturers. In some cases, we have augmented a manufacturer’s internal capacity, teaming up with one or more in-house HFE specialists to conduct a usability test or develop a key HFE end-product (e.g., HFE/UE report developed for FDA submission). In other cases, our team has performed HFE Learn more about human factors engineering at the MedTech Product Development Conference | September 29-30, 2016 | Attend in-person or virtually | REGISTER HEREtasks in a more turnkey manner, executing an entire program of HFE activities from start-to-finish with only intermittent input from the manufacturer.

We most often see manufacturers execute HFE in one of the following four ways, ordered by level of a client’s in-house HFE capabilities and capacity:

1. An internal “broker” engages with external HFE consultants to perform virtually all of the hands-on work.
2. Internal HFE specialists (perhaps two or three) perform some of the HFE work and engage HFE consultants to perform selected activities, including some that might benefit from an outsider’s perspective.
3. Internal HFE specialists form a centralized team and consult with project teams as needed.
4. Internal HFE specialists are embedded within project teams and perform mostly product-specific HFE activities.

Importantly, each of the above approaches requires someone within the organization to take the helm and, at a minimum, direct and oversee the HFE work performed by others, regardless of whether those individuals are internal or external HFE specialists.

The balance of this article briefly describes each model and presents some of the key pros and cons associated with its implementation.

Model 1: Internal HFE broker

In accordance with this “minimalist” model, a single manufacturer representative engages and directs the work of external HFE consultants. This “broker” might not necessarily be an HFE specialist, but rather is oftentimes someone with a product development, engineering or regulatory affairs background who has been tapped to serve as the organization’s HFE liaison. It is most effective when the individual sincerely and fully embraces the HFE management responsibility, believes deeply in the value of HFE, and has abundant energy to ensure that HFE is applied correctly and consistently. Through close collaboration with experienced consultants, perhaps supplemented by self-study and/or participation in industry events, a broker can gain a strong understanding of core HFE principles and be well-prepared to manage and assess the work of others.

Pros

• Reduced overhead cost due to lack of internal team
• HFE bandwidth can be scaled up or down as needed through the engagement of external HFE consultants

Cons

• Limited “corporate memory” for HFE work
• Limited capacity to oversee parallel HFE work streams (and, perhaps tend to other duties)
• Potential lack of higher-level HFE knowledge and strategy
• Potential for inconsistency among HFE methods and end-products (if engaging multiple consultants)
• Increased costs of engaging consultants as compared to leveraging internal resources

Model 2: Internal HFE Specialists + Consultant support

The most common model we encounter within client organizations is one that blends internal and external HFE expertise. According to this model, a handful of internal HFE specialists perform HFE activities throughout a product’s development and engage external resources as needed to supplement their internal capacity. We find that manufacturers who have implemented this model most often call upon external HFE consultants when they (1) need to conduct usability testing (a multi-week effort including test planning, execution, and reporting), and (2) seek an independent opinion (i.e., sanity-check) on a product’s design, HFE method, and/or HFE end product.

For example, in the latter above scenario, HFE consultants might be asked to review and comment on a summative usability test plan or HFE/UE report before the critical documents are submitted to FDA for review.

Pros

• Sufficient internal capacity to help ensure that HFE expertise is applied consistently throughout product development
• Internal specialists can delegate some tasks and focus their efforts on tasks for which they add the most value
• Helps a company develop a foundation of HFE knowledge and experience
• Consultants can serve as allies, supplementing and supporting internal specialists’ opinions
• Consultants often offer a broader perspective on HFE, leveraging experience serving many clients that develop different types of medical devices

Cons

• Potential for inconsistency in how HFE is practiced and the resulting end-products (if engaging multiple consultants)
• Increased cost of maintaining internal team in addition to engaging external consultants

Model 3: Centralized Internal HFE Specialists

Some manufacturers maintain a core team of HFE specialists who collaborate with and advise on different project teams, as needed, in the course of multiple development efforts. Such a team usually comprises three or four folks at a minimum, and might include a dozen or more HFE specialists, depending on the size of the company and the number and breadth of ongoing product development efforts. The centralized HFE team might stand alone or be integrated with other disciplines within a single department (e.g., Research and Development). Most often, we see HFE specialists set up to work closely with industrial designers, resulting in a larger integrated group of professionals who focus on user-centered design and developing safe, satisfying products that meets users’ needs and facilitate the intended use.

Pros

• Sufficient internal capacity to ensure HFE expertise is available throughout product development
• Internal specialists can collaborate on and execute many HFE tasks
• Helps a company develop strong HFE knowledge and experience
• Easy to maintain consistency in HFE methods and end-products
• Suggests that HFE is a highly-valued and important aspect of the product development process

Cons

• HFE team might be target of “right-sizing” when manufacturers seek to eliminate positions, sometimes being viewed (often, naively) as a non-essential function
• HFE specialists might be pressured by peers or management to “make it pass” when conducting device summative usability tests
• Limited internal capacity might result in some projects not receiving sufficient HFE or needing to engage external HFE consultants (at added cost) to complete all required HFE work

Learn more about human factors engineering at the MedTech Product Development Conference | September 29-30, 2016 | Attend in-person or virtually | REGISTER HEREModel 4: Distributed Internal HFE Specialists

When manufacturers have several internal HFE specialists, such personnel might be distributed among and dedicated to particular project teams rather than set up as a centralized team. For example, siloed divisions for endocrinology, fertility and oncology might each include one or more HFE specialists. Ideally, these distributed HFE specialists will perform their work according to a common set of procedures that are aligned with internal and external (i.e., regulators’) requirements.

Pros (Same as Model 3, plus…)

• Potential of HFE specialists becoming particularly knowledgeable about a specific set of users, use environments, indications, and products
• HFE specialists advocating for the user throughout product development, rather than only in response to intermittent requests for support

Cons (Same as Model 3, plus…)

• Potential for HFE specialists to experience a lull in workload (and, be “right-sized”) if HFE is not needed within a division at a particular time (e.g., due to a gap in the pipeline, or reallocation of manufacturer funds to focus on a different product line)
• Potential disconnect among internal HFE specialists, which might result in a lack of information-sharing, methodological consistency and mentorship

Conclusion

There are specific advantages and disadvantages associated with each of these four HFE staffing models. That said, the success of any HFE implementation strategy depends heavily on the personnel involved and the effectiveness of the overarching management structure. Pressed to recommend one of the several viable practice models, we believe that Model 2 is a particularly good one. The model calls upon internal HFE specialists to serve a key role in completing the necessary HFE work as well as advocate for the user throughout product development. Plus, the in-house specialists can leverage the extra expertise that might be brought to bear by one or more external consultants. The best of both worlds, you might say.