The BOSCON 2016 call for proposals will soon be announced.
Systems and Software Quality Engineering in the Medtech Revolution:
mHealth, Wearables, Mobile Apps, Big Data, the Internet of Things (IoT)
Recent technological advances have driven down the size and power requirements of sensors and wireless communications, thus laying the foundation for the medical devices industry to innovate new ways of communicating a continuous stream of meaningful quality patient data that give a fuller picture of an individual’s health. Medtech companies that embrace these platform technologies–for instance, by leveraging remote patient monitoring–can aggregate patient data into hubs, analyze and display the information to the clinical community while helping patients take a more active role in their recovery, possibly by identifying issues before they become serious problems, thus shortening hospital stays, avoiding costly visits to the emergency room and hospital readmissions.
This presentation focuses on how a risk-based approach to the Systems and Software Development Lifecyle will thus shift focus for these new technologies onto the interfaces between the “systems of systems” that make up a complex software (and hardware!) ecology. In particular, specific suggestions for risk controls will be made that can pay down “regulatory” debt (deferred risk during the development lifecycle) while improving coherence and cohesion through loosely coupled sub-systems. Although some current software quality tools and techniques can be applied, new ones have yet to be innovated for maintaining risk control at scale.
Presented by Byron Mattingly, PhD, MPH, MBA
Dr. Byron Mattingly is the Director of Systems Quality Engineering at Pathfinder Software, LLC where he innovates and combines wireless medical devices, robotics, automation, data analytics, and machine learning in a regulated environment. Byron received his Bachelor’s degree from Princeton University, his MPhil from University of St Andrews (SCOTLAND), his MBA and MPH from U Mass Amherst, and his PhD from the State University of New York at Stony Brook. Byron is the incoming Chair of the ASQ Software Division and current Chair of the 45th Annual 2016 ASQ Boscon Conference.
Byron has over 15 years of experience leading teams in regulated environments developing pharma, healthcare IT and medical devices. He is recognized as a subject matter expert on implementing risk-based approaches towards the remediation of quality and compliance issues. He has an ASQ CBA, CMQ/OE, CQA, CQE, CRE, CSQE, CSSBB. He is also a PMI PMP and Agile Certified Practitioner, a HIMSS CPHIMS, an HL7 Certified Control Specialist, and an ANSI-ASQ ISO 17025 Certified Lead Assessor.
Click here to register for the event!
A buffet dinner is included with the meeting cost and served prior to the presentation. Please contact the Arrangements Chair at least one week prior to the event if you have special dietary needs, and we will try to accommodate them.
Because there were too few registrations, the CQA, CQE, CSQE and CSSGB certification preparation courses in Quincy and Wakefield have been canceled. They may be offered again in Spring 2016 approximately nine weeks before the examinations. Check our website asqboston.org.
If you have already registered for any of these courses for this fall, you will receive a full refund of your registration fee.
Thank you for your interest in becoming an ASQ certified quality professional.
David A. Treffs, Chair
ASQ Boston Section Education Committee