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Medical Device Product Development Design-for-Usability
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Design-for-Usability: An increasingly critical aspect of medical device product development

10/2/2019
When: October 2, 2019
5:30-8:30 PM
Where: Regis College, Fine Arts Center
235 Wellesley St
Weston, Massachusetts  02493
United States
Contact: Bill Munger
617-620-4161


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Medical Device Product Development
Design-for-Usability
Oct 2 - Wednesday
 
Design-for-Usability is a Critical Aspect of
Medical Device Product Development

More than a third of medical device incidents involve a use error and more than half of all device recalls for design problems involve the user interface.

Because of this, the FDA has made medical device usability a key topic of concern and has issued guidance.

User experience plays a vital role throughout the development process from early feasibility to validation to prevent these user errors from occurring.

Evan Gyllenhaal, Senior R&D Manager, Boston Scientific
will be the MODERATOR for this panel discussion about the importance of Usability in medical device design from software, hardware, human factors, clinical and regulatory perspectives.

Dorothy Shamonsky, Chief UX Strategy Officer, Boston UX
In February 2016, the FDA issued final guidance to help reduce the frequency of use errors and injuries associated with Medical Devices through the application of Usability Engineering. In, Applying Human Factors and Usability Engineering to Medical Devices, the FDA details its expectations to industry. Part of fulfilling those expectations is a long journey through the Human Factors design process. In this presentation Dorothy will discuss some of the essential processes inherent in good usability design.

Dr. Jason Gee, Urologist, Emerson Hospital
As a clinician, Dr. Gee will address the importance of medical device usability from the user perspective and the importance of collaboration in identifying the most relevant clinical problems to address. Dr. Gee will discuss practical aspects of device development and clinical trial design from a physician/medical perspective.


Bruce Johnston, Senior Software Engineering Specialist, MedAcuity
Software engineering plays a critical role in medical device usability. When properly implemented and tightly-coupled with a proactive human factors analysis, a software development team can effectively mitigate the risk of usability issues downstream, resulting in optimal project outcomes.

Scott Blood, Principal Quality and Regulatory Consultant, MEDIcept
From a regulatory perspective, FDA and other regulatory bodies include use-centered studies as part of the validation that your device is safe and effective. The prevalence of home-use devices is making that a priority. It's important to know the WHY's as much as the HOW's when developing your usability plan and protocols. Speaking eloquently to FDA (and others) with this knowledge will ensure success in your device clearance or approval.


Oct 2 - Wednesday 
 5:30-8:30 PM
Regis College, Fine Arts Center
 
Join us for this discussion
on the increasing importance
of usability in all stages of
medical device product development


 Earlybird Fees by Sept 25
 Member/Alliance Partner - $35         
   Non-member - $45

Regis Alumni - $25

   Student (member) - $10
   Student (non-member) - $15
Gold Member - No Charge
     
Event Sponsorship - $750
(contact sponsorship@mdgboston.org)
 

Event Sponsors


Who Should Attend: 
  • Science, design and engineering professionals involved in medical device research and product development
  • Regulatory, clinical and quality professionals with an interest in medical device usability
  • Marketing and sales professionals interested in exploring how usability plays a role in the medical device industry
Bios of Our Distinguished Panel 
 
Evan Gyllenhaal - MODERATOR
Senior R&D Manager, Boston Scientific
Evan Gyllenhaal is a Senior R&D Manager of the Capital Systems team in the Boston Scientific Urology and Pelvic Health division where he is focused on building the future of the urology operating room. Prior to Boston Scientific, Evan worked as a product development program manager and systems engineer at Philips designing diagnostic ultrasound devices. Evan holds a BS in Electrical Engineering from Lehigh University, MSEE from Syracuse University, and an MBA from Babson College.

 


Dorothy Shamonsky
Chief UX Strategy Officer, Boston UX
Dorothy Shamonsky has over thirty years of experience in the field of interface design and user experience and is currently Chief UX Strategy officer at Boston UX. She is also Adjunct Professor in the User-Centered Design Program, Brandeis University, Waltham MA. She possesses a PhD and MS from the Massachusetts Institute of Technology and a BFA from the Rhode Island School of Design.

 

Dr. Jason Gee
Urologist, Emerson Hospital
Dr. Gee is a Urologist at Emerson Hospital specializing in urologic cancer surgery and research. Following studies for a degree in biomedical engineering at Tulane and Oxford University, Dr. Gee attended Harvard Medical School for his medical doctorate degree. He then completed his urology residency at Lahey Clinic, followed by a urologic surgical oncology fellowship at MD Anderson Cancer Center. After spending six years as an Assistant Professor at the University of Wisconsin, he returned to the Lahey Clinic as Senior Staff Urologist and Associate Professor of Urology with Tufts University School of Medicine. He has chaired multiple NIH-funded clinical trials in urologic cancer and translational research.

 

Dr. Bruce Johnston
Senior Software Engineering Specialist, MedAcuity
Dr. Johnston has 25+ years’ experience designing and developing complex software systems and 15+ years’ experience working in regulated medical software development. Much of this experience has be focused on UI design and Human Factors aspects of Class II and Class III medical device programs. Most recently Bruce has been providing strategic insight to a variety of clients on the intersection of modern software development methodologies, including HF/Usability and Agile practices, and the regulated medical environment. Bruce has earned a BS in Mechanical Engineering from the University of New Hampshire, an MS in Civil Engineering from Rensselaer Polytechnic Institute, and his PhD in Mechanical Engineering from Worcester Polytechnic Institute.

Scott Blood
Principal Quality and Regulatory Consultant, MEDIcept
Scott brings more than 25 years of professional experience and leadership in quality, regulatory, operations, and product design for MedTech and life sciences companies including Solace Therapeutics, NinePoint Medical, Candela Corporation, InfraReDx, Inc., Fossa Medical, and PercuSurge, Inc. As the Past Chair of the Biomedical Division of the American Society of Quality (ASQ), a former member of the Board of Directors of the Massachusetts Medical Device Industry Council (MassMEDIC), and a member of the Regulatory Affairs Professionals Society, Scott speaks frequently on regulatory topics relevant to the medical device industry.

 

Co-Champions
Andrea Cahill
Systems Engineer, Boston Scientific;
Board of Directors, MDG Boston
Janel Heilbrunn
Marketing Program Manager,
Boston UX
Jim Roman
VP of Business Development, MedAcuity
Fees -  (Light dinner included)
Fee Category Early Registration
By Sept 25
Week Prior
Sept 25 - Oct 2 

At the Door
Oct 2
 
Member/Alliance Partner: $35 $35 $45
Non-Member: $45 $55 $65
Regis Alumni $25 $25 $25    
Student Member $10 $12 $15    
Student Non-member w/ a valid ID $15 $18 $20 
Gold Member No Charge No Charge  No Charge 
 
      
Event Sponsor - $750 -  Contact Joe Berkowitz for details - jberkowitz@mdgboston.org

 

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