DAY ONE | TUESDAY, FEBRUARY 25

8:00 REGISTRATION & WELCOME COFFEE

8:45 CHAIRPERSON’S OPENING REMARKS

Donna Carlson, Principal Software Quality Engineer/Scrum Master/Agile Coach, MEDTRONIC

 

8:55 OPENING ICE BREAKER: EXCHANGING VALUED VIEWPOINTS ON ADVANCES IN SOFTWARE ENGINEERING
The opening ice breaker will kick-off the event with an opportunity for all participants to discuss exciting updates and changes taking place in software engineering. Delegates will move among the conference room to meet knowledgeable peers, network, and engage in brief discussions focused on sharing software innovations of particular interest and best practices in approaching updates.

James Monroe, Director, Regulatory Affairs, TEMPLE UNIVERSITY OF PHARMACY

 

9:15 KEYNOTE PANEL: OUTLINING THE STATE OF SOFTWARE AND DIGITAL PRODUCTS IN THE MEDTECH INDUSTRY

  • Impact of digitization on healthcare and ongoing shift towards digital health
  • Increasingly new product design opportunities with innovative technology
  • Regulators’ response to specific software and digital product needs
  • Software engineering challenges in the evolving regulatory landscape
  • Discussion of next steps to continue to support innovation in the industry

MODERATOR: Mike Kijewski, MEDCRYPT

PANELISTS: Sergio de del Castillo, FDA

James Monroe, Director, Regulatory Affairs, TEMPLE UNIVERSITY OF PHARMACY

Vincent Mahfoud, MEDTRONIC

 

10:00 DEEP DIVE INTO THE FDA SOFTWARE PRECERTIFICATION PILOT PROGRAM
Recognizing the need to address SaMD differently than traditional, static, medical devices, the FDA launched the Software Pre-Cert Pilot Program in 2019 with the aim to focus scrutiny on the digital health technology developer, rather than the product itself. Software teams are looking to clarify the program process and understand more fully the FDA’s rationale for transitioning to an analysis of organizational excellence demonstrated in the development, monitoring and maintenance of SaMD. With a focus on the FDA’s Test Plan, and in particular the Excellence Appraisal and Streamlined Review mechanism, medtech professionals are able to effectively amend various procedures, including testing and documentation efforts to efficiently align with program requirements.

 

EXPECTATIONS TOWARDS SaMD MANUFACTURERS AND PRE-CERT NEXT STEPS

  • Outlining pre-certification pilot program principles and goals
  • Dissecting the Excellence Appraisal and Streamlined Review
  • Defining excellence and criteria to engage in the program
  • Description of program highlights and strategies for success
  • Program outcomes thus far and next steps

Sergio de del Castillo, De Novo Program Lead, ODE, FDA

 

10:45 COFFEE & NETWORKING BREAK

 

11:15 REGULATIONS AND STANDARDS FOR MEDICAL DEVICE SOFTWARE

  • Navigating diverse product software support
  • Quality management software application
  • Clarifying software development and validation
  • Mitigating software risk and cybersecurity concerns

Barry Ashar, President, MAKROMED U.S.

 

11:35 PANEL: ENHANCING MEDICAL DEVICE SOFTWARE COMPLIANCE THROUGH INTERNATIONAL STANDARDS

  • Spotlight on IEC 62304 and common areas of challenge
  • Use of further applicable software standards
  • Strategy design encompassing relevant standards

MODERATOR: Kathryn Culver, COVINGTON & BURLING LLP

PANELISTS: Michael Haas, MEDTRONIC

Kelly Weyrauch, ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION (AAMI)

Mark Anderson, BD

 

1:20 SHEDDING LIGHT ON EU MDR CLASSIFICATION CHANGES FOR MEDICAL DEVICE SOFTWARE PRODUCTS
To ensure compliance with EU MDR governance taking effect in May of 2020, the primary concern for software engineers in the medtech industry is with changes to medical device risk classification and the impact on embedded software and SaMD. By focusing on practical examples, discussing device classification changes, and defining which software features warrant particular classifications, engineers gain clarity on the process requirements for current devices and new classifications as well as specified steps for adherence.

  • Understanding updated classification definitions and requirements
  • EU MDR impact on new software development vs. current products
  • Documenting the changes applied to software products for compliance

Sara Jafari, AIMD Design Dossier Evaluator and Medical Device
Certification Project Manager, GMED NORTH AMERICA

 

12:20 LUNCHEON FOR ALL PARTICIPANTS

 

1:20 SHEDDING LIGHT ON EU MDR CLASSIFICATION CHANGES FOR MEDICAL DEVICE SOFTWARE PRODUCTS
To ensure compliance with EU MDR governance taking effect in May of 2020, the primary concern for software engineers in the medtech industry is with changes to medical device risk classification and the impact on embedded software and SaMD. By focusing on practical examples, discussing device classification changes, and defining which software features warrant particular classifications, engineers gain clarity on the process requirements for current devices and new classifications as well as specified steps for adherence. With an understanding of methods for updating the safety features in embedded software and SaMD, engineers maintain compliance as new safety concerns consistently emerge and updates become more complex.

  • Understanding updated classification definitions and requirements
  • EU MDR impact on new software development vs. current products
  • Documenting the changes applied to software products for compliance

Sara Jafari, AIMD Design Dossier Evaluator and Medical Device
Certification Project Manager, GMED NORTH AMERICA

 

1:50 MITIGATING CYBERSECURITY CONCERNS AND IMPROVING SOFTWARE SAFETY

  • Alleviating security concerns when using connected devices
  • Addressing patient and hospital network safety considerations
  • Examining FDA guidance, standard IEC 27001, and TIR 57
  • Focus on medical device and data exchange streams integrity
  • Lessons learned and continuously updating cybersecurity strategies

Steve Abrahamson, Senior Director, Product Cyber Security, GE HEALTHCARE

 

2:35 MANAGING PRODUCT DEVELOPMENT LIFECYCLE WHILE NAVIGATING COMPETING CYBERSECURITY PRIORITIES

  • Examine effects of security requirements on the development lifecycle
  • Evaluating security criteria for various medical device platforms
  • Security feature prioritization relative to other design requirements
  • Methods for including software supply chain in the security lifecycle

Mike Kijewski, CEO/Co-founder, MEDCRYPT

 

3:05 MASTERCLASS: ONGOING OPTIMIZATION OF VERIFICATION AND VALIDATION STRATEGIES

  • Enhancing communication with quality & regulatory
  • Sound approach to documentation in performing V&V
  • Opportunities & limitations in strategy automation
  • V&V timeline mapping throughout the software lifecycle
  • Challenges with next generation algorithmic testing
  • Continuous re-design of V&V test cases for optimization

Aprajita Mathur, Bioinformatics SQA Manager, GUARDANT HEALTH

 

3:50 OVERCOMING CHALLENGES IN ACCURATELY ASSESSING SOFTWARE FUNCTIONALITY THROUGH TARGETED TESTS

  • Common areas of difficulty in:
    • Unit testing
    • Integration testing
    • Regression testing
  • Hardware considerations in software performance testing
  • Automation opportunities and necessary manual checks
  • Best documentation practices to ensure compliance
  • Continuously improving and expediting test protocols

Michael Haas, Senior Engineering Program Manager, MEDTRONIC

 

4:35 COFFEE & NETWORKING BREAK

 

4:50 SUCCESSFULLY ACHIEVING SOFTWARE FAILURE MODES AND EFFECTS ANALYSIS

  • Proactively unveiling all possible software failures
  • Human factors considerations and investigation
  • Implementing corrective actions and re-testing
  • Practical approach to effectively enhancing SFMEA
  • Analysis of best practices for securing data transfers
  • Ensuring swiftness in test execution to contain costs

Hardik Gohel, Program Director of Computer Information System
UNIVERSITY OF HOUSTON – VICTORIA

 

5:20 BREAKOUT DISCUSSION: ENHANCING TESTING THROUGH CAREFUL PROTOCOL DESIGN AND DEVELOPMENT
Participants will gather in small groups led by moderators to share on topics focused on testing design strategies. Participants will be asked to share on the following experiences using technologies that are advancing software testing design procedures. Greater clarity is gained by exploring current updates, practical steps, and future considerations.

  • Clearly defining the scope of the test to design a relevant protocol
  • Developing a balanced mix of manual processes and automation
  • Streamlining the documentation strategy for engineering teams
  • Pros and cons to implementing and relying on of self-tests
  • Timeline and cost considerations: limiting resource expenditure

Donna Carlson, MEDTRONIC

Hardik Gohel, UNIVERSITY OF HOUSTON – VICTORIA

Richard Jackson, BIOLASE

 

5:50 CLOSING REMARKS & DAY 1 CONCLUSION

 

6:45 CONTINUED NETWORKING: FACILITATED GROUP DINNERS
With the immense value in peer-to-peer interaction and experience sharing, we wish to provide attendees with an opportunity to continue networking after the first day of the conference. Q1 Productions will arrange dinner reservations at local restaurants close to the conference hotel for those interested in joining a group of fellow participants for dinner on February 25th. Please note that dinner expenses must be covered by each participant individually.