Answers to Frequently Asked Questions

How long has the company been in business?

2015 marks our 14th year. Thank you to our customers, past and present.

Do you work on non-medical products?

No. Human Factors MD has worked exclusively for medical technology and pharmaceutical companies since the company’s inception in 2001. All of our clients are medical software firms, device manufacturers or pharmaceutical companies developing drug/device “combination” products.

How many people are on your team?

We have a core team of nine design and evaluation specialists. Bios for core team members are provided here. We also have associates that we depend upon to round-out the expertise we bring to specific projects. Our goal is to create a project team with the skills and experience you need to reach a successful outcome.

Do you take on small projects?

Certainly. We’ve worked on projects lasting a few hours and projects spanning multiple months to a year.

Where are you located?

We are a distributed company. While our official corporate office is in Ontario Canada, members of our core team and associates are located in different centers in Canada and the US. While we have clients in Canada, Europe, Israel, and Asia, the majority of our clients are based in the United States.

Who do I contact about a my project needs?

You can complete the form on our Contact Us page, or call Tim Reeves the Managing Director at 800-639-7941 ext 701. Tim’s email is tim@humanfactorsmd.com.

Do you build interactive prototypes?

We develop interactive prototypes for software design projects. We use different tools depending upon where we are in the design process (e.g., concept exploration, refinement) and the purpose of the prototype (e.g., exploring design ideas, usability testing with users). We have used PowerPoint, Balsamiq, Flash, plain-old HTML, Sketchflow, and Visual Studio to bring designs to life.

How do you recruit the end-users needed for product evaluations?

We have established working relationships with several market research firms. The firms are able to recruit all manner of clinician (e.g., physicians, nurses, pharmacists) or patients (e.g., diabetics, COPD patients, general consumers) in different geographic regions. Unless there are specific reasons for conducting an evaluation or research project in specific locations, we typically choose a center that is most convenient.

Do you have a usability testing lab?

No. We conduct testing in different locations, depending upon the needs of the project. In the past, we have conducted testing at client facilities (e.g, many clients have demonstration labs that mimic the clinical environment), market research centers, hospital simulation labs, and hotel suites (if we need to mimic the home-environment). We find locations that ensure we can recruit the required number of test participants, ideally in close proximity to our client so that they have the option of observing evaluation sessions.

Do you provide guidance on other regulatory jurisdictions, aside from the FDA?

Yes. We are well versed in European requirements for Usability Engineering. Health Canada has no explicit requirements for human factors, but in our experience Health Canada’s expectations for human factors are similar to the FDAs.