Human factors optimization: How to leverage HF researchers in your medtech team

April 22, 2024

Maximize risk management with comprehensive documentation 

Before diving into new device development, you and your team brainstorm the basics: who will use the device, how, and where. Human factors (HF) researchers excel at transforming these ideas into submission-ready documentation for investigational device exemption (IDE) applications. Here’s how they can help: 

Tapping into the expertise of human factors researchers can significantly boost your medtech project.

  • Craft use specifications: HF researchers can draft a comprehensive document detailing your device’s intended use. 
  • Develop instructions for use (IFU): HF researchers can refine overarching instructions into a detailed IFU, conduct necessary testing, and even designing labeling and packaging with the help of cross-disciplinary designers. 
  • Perform use-related risk analysis (URRA): HF researchers evaluate the IFU, identify potential hazards, and assess the severity of misuse risks. 
  • Create an HF plan: HF researchers outline your device’s research objectives and methods based on your provided source materials. 

Reduce workload through outsourced human factors research

Conducting in-depth human factors research can be challenging for smaller or engineer-heavy teams. Here’s how an external HF team can support: 

  • Recruit diverse participants: Ensure a broad sample from all user groups. 
  • Design custom studies: Tailor the study setup and protocol to meet your research needs. 
  • Conduct research sessions: Observe and probe participants to gain deep insights. 
  • Produce reports: Analyze findings and offer actionable design and development recommendations. 

Navigate regulatory guidelines with expertise

Navigating the FDA submission and approval process can be tricky. Human factors researchers bring regulatory savvy: 

  • With backgrounds working with major pharmaceutical manufacturers, external HF research teams offer invaluable insights into the regulatory process. 
  • While predicting FDA decisions is impossible, the experience provides a solid foundation for navigating submissions successfully. 

It’s clear that HF researchers can support manufacturers’ in-house teams in a number of ways. But this work isn’t one-size-fits-all. Maybe you want end-to-end research and regulatory guidance for a single product. Maybe you only need a partner to conduct validation testing. Or perhaps you have enough staff on hand to handle the bulk of HF research – and just need strategic support to navigate regulations. At Bold Insight, we tailor every research project and program to your specific needs. If you’d like to learn more about how we can support your medical device development, drop us a line. We’d love to chat.