How to Evaluate a Proposal for a Human Factors Study for a Medical Device or Combination Product

By: Marissa Docimo, Nicole Stephenson, Jack Giacomini

Selecting the right partner to support human factors (HF) research for your medical device or combination product is an important decision. The results of HF work can influence design decisions, regulatory approvals, and, ultimately, user safety. Given the complexity and importance of human factors engineering in the medical device industry, it’s essential to know what to look for when evaluating a proposal for an HF study. This post will walk you through the key criteria to consider when reviewing proposals to ensure you select a partner who can meet your project’s needs, work within your logistical constraints, and support your device’s regulatory approval. It will also help you consider how to evaluate proposals from different partners, and what to look for when selecting the option that best meets your needs.

Your vendor support needs and priorities will vary from project to project. When reviewing proposals from multiple vendors, make sure you’re comparing “apples to apples” when looking at cost. Here are some things to consider:

Do you need documentation support?

Certain key documents are the foundation of any HF work. Sometimes, the first task is to develop this documentation. Other times, this documentation may be well-developed and only need minor updates, or none at all. Before conducting HF studies, it is important to have certain documents in place, especially for an HF Validation study. Your HF vendor should inquire about the state of your HF documentation and include a plan for document work in your proposal as needed. This could range from simple expert reviews to creating documents from scratch in collaboration with your team.

How many and what type of study participants do you need?

It is important that any proposed HF work defines who your study participants will be and where they will come from. The number of participants and complexity of recruiting those participants impacts cost, so it’s important that these details are clearly defined in any HF proposal. Keep in mind that certain participant factors will increase the cost of recruiting them. If the desired participants are harder to find (for example, if they have uncommon medical diagnoses or unique experience using a certain product) or have more specialized training (for example, healthcare providers in a specific field), these participants will cost more to locate and recruit as compared to those who do not have these characteristics.

How much time do you need to spend with each study participant?

It’s important to ensure that participants have enough time in the study session to interact with your product, complete a follow-up interview to identify root causes, and provide any additional feedback. Your HF vendor should consider the complexity of your product and number of potential tasks that will be evaluated during the session to determine an appropriate session length. Additionally, the time spent with study participants should also account for any necessary training (and a decay period). Training can make a significant difference in the amount of time participants are engaged in the study, which directly impacts costs. If you notice a big difference in cost when comparing proposals, check to see if it is due to differences in the amount of time spent with participants.
 


Project communication expectations

Do you prefer to be hands-off in the HF process, or do you want a weekly meeting with your vendor? HF proposals should clarify expectations around communication and project status updates. Make sure your needs are accurately reflected in the proposal.

Carefully reviewing the text of vendor proposals and paying special attention to the factors outlined above will help you decide which vendor is best equipped to meet your needs. Of course, never be afraid to ask vendors for revisions to proposals if something isn’t quite right. Communication and transparency with potential vendors will set the project up for success.

If you’re looking for human factors support, reach out to us and we’ll be in touch with you within a business day. We are dedicated to ensuring that your projects are completed on time and on budget. We will provide as much or as little support as you need, offer advice, and answer any questions you have.