BioPhorum MedTech has initiated a working group to explore the experiences and issues within human factors (HF) studies, predominately related to biomanufacturers of combination products.

Running from July 2022, the Phorum’s human factors working group has issued a survey to collect data on the current understanding of a range of topics affecting HF teams in the industry. The survey will take around 30 minutes of your time.

To respond to the survey, please click here or email the group Facilitator, victoria.ludlow@biophorum.com

We would like to receive interest from a range of related occupations, including:

• Biomanufacturer regulatory​ affairs specialists
• Human factors engineers and subject matter experts
• HF/product design consulting firms ​
• Product lifecycle vendors and suppliers.

Respondents will be invited to join an interactive webinar in Autumn 2022, with contributions being put forward to develop a best practice guidance paper, which will be presented at the Human Factors and Ergonomics Society (HFES) conference, March 26–29, 2023 in Orlando, Florida.

Enrica Papi, Human Factors Engineering Lead at GSK, commented, “Human factors is an evolving field, with varying experiences across study designs. We’d like to collect and share common practice and knowledge so we can collate best practice.”

When considering HF studies leading up to Phase III clinical trials, there is no commonly adopted best practice. There is also a lack of clarity around implementing HF regulatory guidance and study design. Perversely, current guidance can also be counter-intuitive to good practice; examples include the use of instructions for use in knowledge testing and ordering of root cause analysis. This has led to different experiences and discrepancies in agency information requests.

Without a harmonized understanding of regulation and corresponding regulatory procedures, HF studies represent a major risk in the product design process and can cause significant delays in the time-to-market. Six-month delays are common, and further inconsistencies in an agency’s review process, including those of the FDA and Notified Bodies, add risk to planning​ and timelines.

When summarizing the group’s work, Tina Rees, Director Human Factors at Regeneron, reflected, “When we first met, we realized there were varying experiences and different ways of approaching HF Studies. We’ve gathered experiences within our working group and now wish to explore wider practices and analyze them towards publishing a best practice guideline, which we hope will help industry peers execute a consistent and recommended approach.”

Maho Kanazu, Device Development Engineer at Chugai, said, “Collective sharing is really important. This survey will formalize feedback rather than rely on networking post-conference or through ad-hoc conversations, etc. The report we will publish garnered from the survey results, and the best practice guidance that will subsequently be developed, will streamline information, help reduce noise, and generate more confidence.”

Yeseul Kim, Principal Scientist of Samsung Bioepis, suggested, “Responding to this survey will, in return, generate data towards developing best practice guidance, and support future work with regulators towards harmonizing practice across the industry.”

If you are interested in joining BioPhorum MedTech’s human factors working group, please email victoria.ludlow@biophorum.com for more information and to arrange an initial conversation.