Medical Device Usability Testing
Usability Testing for Medial Device Manufacturers:
Understanding Users in the World of Medicine
Human Factors Engineering, Usability Testing, and Empathy Research
in Medicine and Health Care
Human Factors Validation (510(k)) - Summative - Formative -
Root-Cause - Benchmark - Empathy Tests - Heuristic and Expert Reviews - De Novo Requests - Substantial Equivalence
WHAT WE DO
We conduct research in three areas of medicine and health care:
Human factors, usability engineering, user research of medical devices for product design, root-cause analyses, 510(k) FDA clearance.
Empathy studies of patient/provider interactions to improve preventative health care measures, health care utilization, and follow-up;
Expert reviews and heuristic evaluations of medical and health care websites to improve usability and successful task completion
TIMBS works with our clients to ensure medical products are user-friendly, safe and effective, and marketable; your web services are easy to access and navigate; and the people you serve are satisfied and likely to follow through on their health care needs.
EXPERT REVIEWS & HEURISTIC EVALUATIONS
Improving Website Usability and Successful Use
We draw on a variety of heuristic models to systematically analyze and improve users' experience with your website or online service. We examine how easy it is to navigate your website, discover essential tabs and links, enter critical information, and complete necessary tasks. We'll provide you with a detailed report that highlights sources of friction, pain points, satisfactions, and opportunities for improvement that will ensure those using your site do so successfully.
HUMAN FACTORS ENGINEERING AND USABILITY TESTING OF MEDICAL DEVICES
Making Sure your Devices are Easy to Use, Safe, and Effective
We conduct formative, summative, and benchmark usability tests for human factors engineering and 510(k) FDA clearance. We help improve your medical devices so they're easy to use and reduce use errors so you can get them to the people who need them without unnecessary and costly delays.
Summative Usability/Validation Tests:
We will assess risk management measures and uncover use errors, close calls and difficulties to reduce risks and ensure your device receives FDA clearance (510(k)).
Ex. Root Cause Analyses, Validation Testing
Formative Usability Tests:
We conduct exploratory user research early in the development stages so you can design a product that resonates with users' mental models, makes sense, and is easy to use.
With formative usability tests you can better ensure 510(k) FDA clearance and avoid costly, time-consuming mistakes by identify risks and shortcomings early, when they are easy to fix.
We conduct research with users that compares your device against prescribed standards, goals, or a leading competitor or predecessor.
Make sure your new product outshines the competition.
Areas of Focus:
Class 2 Medical Devices for iterative design and 510(k) FDA clearance
Instructions for Use
EMPATHY STUDIES OF PATIENT CARE
Building Trust and Quality Relationships with Patients
We conduct research on patients' experiences and interactions with medical professionals and institutions so that health care services are effectively utilized and without delay.
Make sure those in need feel comfortable and valued so they access healthcare before its too late.
Better usability means fewer risks, successful FDA 510(k) clearance, more satisfied customers, and better sales.
Easy to use devices and intuitive web designs create safe and successful users and repeat customers.
Health Care Professionals
Usability testing reduces mistakes and risks by making sure devices are intuitive and safe to use.
Empathy studies make sure your clients are satisfied and will seek your services when needed.
Usability testing and Empathy studies help instill in your patients a sense that they are in safe, competent, and trustworthy hands. Make sure your patients' experiences are satisfying and without friction and frustrations.
Reduce mistakes and harmful use errors by making sure your devices are user friendly for all who may use them and within their use environments.
How We Help
Effective health care requires trust and satisfaction. Medical devices must be safe and easy to use if they are to receive FDA 510(k) clearance and be adopted by users. Web services must be easy to navigate. Patient experiences must foster trust in service providers and the devices they need. When these are absent the probability and severity of harm, frustration and disappointment increases. Manufacturers make devices that go unused and are unsafe, and people cannot access needed services, and may avoid seeking health care all-together, or until it's too late.
TIMBS Consulting works to ensure your users, customers, clients, and patients get the safe, trusting, and satisfactory experience they need and deserve.
With TIMBS, you can ensure:
Your medical devices are user friendly, safe to use and receive 510(k) FDA clearance
Your websites are intuitive, easy to navigate and complete necessary tasks
Your patients are satisfied with their experience and will seek future health care before it's too late
What to Expect
A systematic analysis of your users, website or user interface, or patients according to validated frameworks and methodological best practices, delivered in a timely fashion, with actionable insights and recommendations that you can put to use toward FDA 510(k) clearance, improved and effective designs, and/or trusting patient relationships.
We will create a research plan, recruit participants, host and moderate test sessions with relevant scenarios and tasks, and report findings so that you can improve and/or validate the products and services you offer.
A standard procedure might resemble the following, but we can custom design a project to your needs.
First, lets talk and see how TIMBS Consulting can help. Working with stakeholders, we'll identify the key problems and concerns, and how we can help.
Plan of Action
Second, we'll sketch out a plan of action and get moving on research instruments, recruiting, and data collection.
Third, we'll provide you with a detailed report and follow-up to make sure you have the information and resources you need to move forward and achieve your goals.
"Steve is a pleasure to work with, he is detail oriented while seeing the big picture, highly professional and easygoing. I was very grateful to have him on my team. By working together daily we managed to pull off a project that exceeded the client’s expectations."
"Very good project management and keeping me updated. Stephen, the project lead, really went the extra mile on launching the project, staying on top of developments and changes needed, as well as in following up with requests."
"Thank you so much. This research has been illuminating and will be super useful going forward"
The Research Director of TIMBS Consulting, Stephen F. Ostertag (Ph.D. University of Connecticut) is a trained sociologist and experienced user researcher. He has over 20 years of experience in sociology and has published many peer-reviewed articles and book chapters, including research on trust and health care utilization.