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

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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.