On Wednesday, December 5, 2012, New England, USA-based networking group Medical Development Group (MDG) held its December Forum in Waltham, Massachusetts. The forum was titled Design and Human Factors are Keys to Innovative Medical Device Products and took place at the Emerging Enterprise Center at Foley Hoag in Waltham. For those who are unfamiliar, MDG is a network of medical device industry professionals dedicated to the advancement of the medical device industry in New England. MDG pursues their mission through educational programmes and forums like the December forum that drew a packed house.
To start the night, Dick O'Brien, MDG president introduced Scott Stropkay, founding partner of Essential Design, a design consultancy that develops physical products, digital products, and service experiences. Stropkay was instrumental in assembling the expert panel of human factors professionals that included Pamela Davol, clinical and regulatory project manager at Ximedica, Laurie Reed, senior human factors engineer at Farm Design and Bill Hartman, director of research at Essential Design. Together the panel offered a macro view of how and why human factors is critical to product development for medical device and related life science fields.
Scott Stropkay served as moderator and led the panel presentation with an overview of human factors and usability. He noted that the FDA has recently made a distinction between user errors and use errors, a difference which should be duly noted by practitioners. He also stressed that early attention to these issues in development makes compliance and innovation success much more likely. Stropkay then introduced Essential Design colleague Bill Hartman to discuss Human Factors in the “product definition” phase.
Hartman explained how he developed a 360-degree design approach to gain a better understanding of a new product through exploration (understanding why), then to co-creation (finding solutions), followed by evaluation and immersion to produce an almost human conceptual model that allows one to understand what we are doing and why. Hartman described five different client product cases which were examples of human factors solutions beneficial to the products’ successes. These included a cell salvage system, disease registry, diabetes management system, operating room equipment development, and a telepresence system.
Laurie Reed from Farm, a USA-based full service ISO 13485-certified and FDA-compliant product development company for medical and life science clients, took centre stage to give the audience an understanding of usability verification. Reed stressed that verification testing is necessary to implement and prove efficacy for each user need. She also discussed when to verify FDA 662346 requests (iterative testing prior to validation) as well as discussing a variety of usability verification methods. Reed cited several case studies that included a cord blood processor, diabetes management software, cardiac ablation catheter and combat drug delivery device.
Pamela Davol from Ximedica wrapped up the evening by explaining usability validation with her direct definitions: Reduce risk, address safety and efficacy by providing objective evidence. Davol recommended having a plan for success and discussed when to conduct testing in actual environments versus simulated environments. She stressed the importance of knowing your product’s environment and to expect the unexpected.
Here are a few of the highlights from the lively Q+A session that followed the panel presentations:
Q.) Recalls are OEM’s worst nightmare. How do you make human factors engineering easy, valuable and inexpensive?
A.) There needs to be collaboration between the client and developer, an integrated approach and you need to be immersed in product knowledge. –Bill Hartman, Essential Design.
Q.) Is it necessary to have medical device’s reviewed by an internal review board (IRB)?
A.) It is a good idea since it is important to protect the patient. IRB’s are highly skilled and the FDA likes to see the involvement of IRB’s. In low-use products that have normal risk - IRB’s are not necessary. – Pam Davol, Ximedica.
Q.) What is the difference between verification and validation testing?
A.) Well they are both forms of usability testing. In this field, we categorise usability testing into two overarching buckets: formative tests, which include verification testing, and summative tests, which is basically the usability validation test. Usability verification and other formative tests occur iteratively while the product is still under development to constantly re-assess the design and determine whether it meets user needs, and to inform refinements to the user interface. Usability validation testing occurs once at the end of the product life cycle with the production-ready device and any associated components.
by Laurie Reed, Farm.