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BEST Design Workshop 2017

Clemson Bioengineering annually sponsors the Biomedical Engineering and Surgical Technology (BEST) Design Workshop, where stakeholders evaluate how design of medical-device prototypes may affect patient safety. The 2017 event coordinator was Dr. Melinda Harman, Director of GreenMD, Clemson’s medical device recycling and reprocessing certificate program.


One problem with device reuse is that poor design can prevent the effective cleaning and sterilization that the Food and Drug Association requires between patients. Prototype evaluation is one step in preventing patient risk of a debilitating or fatal illness caused by inadequate cleaning and sterilization.


Clemson University Biomedical Engineering Innovation Center (CUBEInC), a state-of-the art facility primarily dedicated to biomedical research and accelerated innovation, was the site of the Workshop.


CUBEInC has 30,000 sq. ft. of research laboratories and education facilities, translational/incubator space, bioimaging research facilities, and state-of-the-art surgical-skills facilities.


CUBEInC is the translational research arm of the Clemson University School of Health Research (CUSHR), providing the environment essential to developing clinically driven technology and addressing research questions. Opened in 2011, CUBEInC facilitates student and faculty collaboration with healthcare practitioners.


The Workshop included an overview of GreenMD from Dr. Harman on medical device recycling and reprocessing. GreenMD is an industry immersion and training program for engineers to adapt medical device designs for sustainability, to impact healthcare safety with green technology, and to connect with medical and industry leaders.


Market research firms agree that the global market for reprocessed medical devices will be measured in billions of dollars within the next decade. Bioengineers are expected to be involved in designing, developing, marketing and regulating such devices.


Katie Jurewicz, PhD candidate in industrial engineering, presented the keynote address on the role of human factors in medical device design.


She described human factors engineering, noting that the FDA requires that knowledge about human behavior, abilities and limitations and other characteristics of medical device users be part of the design process and included when safety and efficacy of medical device use are demonstrated.


Pitching their prototypes of medical devices for review, five bioengineering teams made presentations.


Attendees completed a reprocessing assessment report for each design to identify characteristics that could help or hinder the device’s reusability.


BEST Design Workshop: Feedback from Attendees

What kind of difference did the BEST Design Workshop make to you as a researcher and student/educator?

Melinda Harman (BIOE faculty): The BEST Design Workshop is becoming a cornerstone event in the GreenMD program. As an educator in bioengineering, this type of challenge-based learning allows us to “see the coursework in action” as the students apply knowledge they bring from all of their previous courses and experiences. This event really highlighted the advantages of engaging cross-disciplinary teams for medical device design, with enthusiastic interactions between attendees throughout the afternoon.

Katie Jurewicz (IE grad student): The BEST Design Workshop challenged me as a student and researcher. As a graduate student, I research one topic for four years, defend my dissertation and get a job, and because of the way this system is set up, it makes it easy for me to stay in my own silo of how I think and do work. The BEST Design Workshop provides the opportunity for me to see how other students interested in healthcare research approach problems, and it challenges me to think outside of the box and consider different perspectives to healthcare problems.

Angela Alexander-Bryant (BIOE post-doc): The BEST Design Workshop taught me that it is important to consider the potential for reprocessing in designing medical devices to expand their utility. Through the workshop, I also learned how to evaluate medical devices for reprocessing and reuse.

Jeremy Mercuri (BIOE faculty): What I thought was most beneficial about the event was that it really opened my eyes to thinking more critically about how to design reusable / reprocessable medical devices as opposed to the more traditional implants and biomaterials that I typically work on. It was great having cleaning and reprocessing experts there in the room with us to help critique current device designs.

Kristi Carlson (BIOE grad student): It provided a unique opportunity to hear the perspective of employees in the reprocessing industry and how real design criteria can improve the safety of reprocessing.

Moriah David (BIOE grad student): It allowed me to see the application of concepts we learn in GreenMD courses.

Joseph Pate (BIOE grad student): It provided better insight into the reprocessing industry and the skills necessary for designing medical devices that do not interfere with reprocessing.

Curt Laugh (BIOE grad student): It helped me focus on human factors in medical device design and see alternate design strategies to address those factors.

Katie Hafner (BIOE grad student): Gaining input from professionals in the reprocessing field, especially on the sales and marketing side of that industry, is a critical advantage in device design. It allowed me to hear what criteria, other than science or engineering inputs, can motivate business decisions.

Cristalei Polk (BIOE grad student): The BEST Design Workshop was a great experience. It provided me the opportunity to sit down with industry leaders and learn more about what they do. It also opened up the door for a summer internship in the reprocessing industry!

Mat Stanford (BIOE grad student): Allowed me to present my research project and prototype device to a diverse group of people and receive direct feedback to improve the design for ease of use and ease of reprocessing.

Brittney Cotton (BIOE grad student): It was beneficial the way Dr. Harman organized us into small groups to evaluate the prototype designs and to use the worksheet to document key factors related to reprocessing.

Thomas Granger (BIOE grad student): Everyone involved had different experiences, including those with skills in mechanics, manufacturing, reprocessing, sterilization, electronics, which really provided clarity about design features of the different prototype devices.

Feedback from Attendees: What did you enjoy about the workshop?

Melinda Harman: The BEST Design Workshop brought together a diverse and tremendously enthusiastic group of participants. It is an advantage in medical device design, or any design process for that matter, when there are contributions from people with different skillsets and strengths. The format of the hands-on workshop activity and networking that followed fostered opportunities for everyone to give and receive input.

Katie Jurewicz: I really enjoyed the interconnectivity and teamwork that occurred during the workshop. The only way to successfully develop a medical device that is designed for a variety of users and designed for recycling or reprocessing is to receive feedback from people with different points of view. If you are a biomedical engineering student asking another biomedical engineering student to evaluate the design of your device, you are missing the additional information that would only come from a different perspective. I think that engineers and scientists get too comfortable in their own areas to seek this type of feedback, but the BEST Design Workshop was perfect in the sense that it brought biomedical engineering students, human factors engineering students, surgical technician students, medical professionals, and those that are experts in the reprocessing design process. I think anyone interested in working in healthcare would benefit greatly from attending this workshop as you’re exposed to the different perspectives one might face when working in a healthcare setting.

Angela Alexander-Bryant: I really enjoyed interacting with the representatives from the reprocessing company. It was interesting to hear their advice on aspects of device design that should be considered for reprocessing.

Jeremy Mercuri: It provided a collaborative and engaging environment between students, faculty and device experts which fostered open discussions and learning.

Kristi Carlson: Gaining more insight about human factors and how they affect medical device designs.

Moriah David: We were able to engage local industry in evaluating medical device prototypes designed by Clemson Bioengineering students.

Joseph Pate: I really enjoyed getting a wide variety of perspectives on the prototype designs, including those from human factor specialists, industry professionals, and other students.

Curt Laugh: The interaction and group collaboration during the hands-on design evaluation activity.

Katie Hafner: I liked hearing the variety of topics discussed, from human factors to the prototype pitches from different students. The worksheet Dr. Harm provided for the hands-on activity really helped give structure to the design evaluations.

Cristalei Polk: I really enjoyed being able to see so many diverse device prototypes with different functions and clinical uses and then brainstorming with other attendees about some of the potential challenges of reprocessing them.

Mat Stanford: I liked meeting with professionals working in the medical device industry and hearing the diverse skills they use in their day-to-day jobs.

Brittney Cotton: I really enjoyed listening to all the speakers, especially the industry professionals. I felt we had very useful dialogue during the prototype evaluations in the workshop activity.

Thomas Granger: I enjoyed the input from the industry representatives who helped to broaden my knowledge about the design process used in industry/