Medical Device Human Factors & Engineering Services

doctor looking at xray of teeth

Sterling Medical Devices has decades of experience using human factors engineering  to improve the design of medical devices. By using Human Factors Engineering to support the design process, Sterling can ensure the best compatibility between the user and the device. Sterling incorporates medical device human factors & engineering services throughout our design process which helps to mitigate risks and save time in other phases of your development. During the usability engineering process, engineers use human factors analysis to obtain design optimization.

What is Human Factors Engineering?

Human factors engineering, or as some call it medical ergonomics, is the process of evaluating and changing the design of devices to better fit the human body and its cognitive abilities. This is accomplished by using the scientific method to view human behaviors and adapt devices to be better used by its users. When it comes to medical devices, this occurs during the usability engineering process, during which engineers use human factors analysis, testing, and validation to adapt the device’s design to ensure optimization.

Keeping Usability in Mind with Usability Testing

Sterling not only wants to make sure the medical devices are safe for their customers, but that the users of these devices have the best experience possible. Sterling leverages its testing, development, and design expertise to ensure that your medical device considers all aspects of human factors engineering and usability.

Sterling is also able to help customers with existing devices improve their usability for later updates or versions of the product. Sterling has provided human factors services and usability testing for companies ranging from start-ups to industry leaders on new and current medical devices.

Ways Sterling Can Assist You in Your Medical Device Human Factors & Engineering Services

  • Identifying and tracing requirements related to usability
  • Identifying hazards and hazardous situations related to usability
  • Analyzing residual risk associated with usability
  • Assisting in implementing the user interface using usability engineering methods
  • Assisting in usability validation
  • Assisting in the preparation of a usability engineering file
  • Meeting the ISO 62366 Standard and FDA Draft Guidance for Applying Human Factors 

Our Approach

Our multi-dimensional approach to human factors and user experience includes:

Discovery: We will apply our vast experience and deep know-how in research, human factors, design, engineering, and regulatory processes to set you on a path forward.

Research: Through extensive user research, we’ll help you understand the factors that control the quality of user interactions and ensure a safe, usable, and efficient product.

Analyses: Our range of analytics capabilities address the mental and physical interactions with the product, as well as users’ mental models, workflows, and needs.

Design: We will apply the above elements to design devices that meet manufacturers’ functional and aesthetic goals.

Evaluation: We will conduct formative and summative usability testing to evaluate the design’s usability throughout the design and development process.

Validation: Finally, we will validate the device design through comprehensive simulated use testing.

To learn more about how Sterling can help with human factors services for your medical device, contact us today.

Resources

doctor pointing to screen with icons

April 30, 2020

Device Manufacturers Face Challenges to Balance Opportunity and Risk

With an increased focus on technology advancement and product development, medical device manufacturers are beginning to improve their devices and seize new opportunities. However, this comes with an...
Read More >
View More Blogs

February 18, 2021

5 Mistakes Medical Device Startups Make

Startups are the lifeblood of medical device innovation. Without universities researching ways to solve pressing healthcare problems or doctors with experience in a particular field who have an idea to develop a prototype medical device that could help patients, the future technologies needed to help save lives wouldn't happen. But the long, arduous road through the FDA submission process to get market approval can take a long time and cost a lot of money without help. Sterling Medical Devices has been helping startups through the FDA approval process since 1998 without ever having a submission rejected.
Read More >
View More Videos
Breathing-Pacemaker

September 8, 2020

Breathing Pacemaker

Sterling Medical Devices performed design services for a Class III breathing pacemaker with Major Level of Concern software, intended for use by patients who have lost neurological control of respiration. This life-sustaining device is comprised of two main components: an internal passive receiver and an external controller....
Read More >
View More Case Studies

Need help with your medical device?

Let Sterling Medical Devices show how to bring your idea from concept to prototype to
FDA/CE approval with a free custom project analysis.
Request Free Analysis