MethodSense has specific expertise in helping clients navigate the Human Factors requirements of the FDA. Over the last decade we have developed a comprehensive, practical, yet agile methodology for determining the applicability, size and scope of Human Factors Studies.
Human Factors Studies/Usability Studies are designed to ensure maximum safety for medical devices, pharmaceuticals and combination products. The design, scope and configuration of the studies must take into account the target audience(s), patient/caregiver use (or potential misuse), probability and severity of potential harm, among other things.
MethodSense has the expertise and experience you can count on to determine the need, size and scope of both formative (during design) and summative (post-design) Human Factors studies.
When do you need Human Factors Studies?
We are often asked which types of FDA submissions require Human Factors considerations. We typically work with clients seeking approval for:
- Critical Devices
- Home Use
- Combination Products
- Pharmaceutical Products
- Other products based on FDA guidance
It’s important to work with a trusted partner, because not all submissions require the same types, size and scope of Studies. MethodSense’s experience enables you to feel confident in your regulatory approach and commercialization efforts.
The MethodSense Difference
Our proven methodology helps design a comprehensive, effective, efficient and cost-conscious Human Factors Study. By deeply understanding your product and submission we can eliminate unnecessary elements and focus on the critical tasks.
The Human Factors Foundation: Comprehensive Risk Assessment
A comprehensive risk assessment becomes the roadmap for you Human Factors Studies. By determining the potential impact, and scope, of Human Factors Studies early in a product’s development cycle, MethodSense clients can feel confident in their commercialization plans and FDA approval path.
MethodSense’s Risk Assessment uncovers:
- Necessity of Human Factors Studies
- Scope, size and timing of Studies
- Comparable or predicate products that may impact the need for/scope of Human Factors Studies
- Mitigation needs/strategies
- Product design considerations and impacts
- Knowledge Probe alternatives to Human Factors Studies
- Need for formative studies v. summative studies
- Relevant FDA MAUDE database incidents
These findings become the Critical Tasks list and serve as a regulatory roadmap for product submission. Not all items considered or uncovered in a Risk Assessment become a Critical Task. MethodSense’s systemic approach, combined with our experience, creates a plan that is tailored to your unique business and your specific product.
Not a Checklist or a Template
Don’t be fooled into thinking a generic Regulatory checklist can determine your need for, or the scope of, Human Factors Studies.
MethodSense’s Human Factors consulting practice combines the experience of our engineers and technologists with a proven, comprehensive method of assessing risk and regulatory impacts.