DAY TWO | WEDNESDAY, FEBRUARY 26

8:30 REGISTRATION & COFFEE

9:00 CHAIRPERSON’S OPENING REMARKS

9:15 STRENGTHENING SOFTWARE ENGINEERING BY BRIDGING COMMUNICATION GAPS WITH CORPORATE TEAMS

  • Incorporating engineering perspectives within R&D
  • Aligning software engineers and regulatory teams
  • Gaining clarity on quality management standards
  • Addressing communication challenges between teams

Barry Ashar, President, Makromed U.S.

 

10:00 EXPLORATION OF METHODS FOR ADDRESSING DIGITAL HEALTH REGULATORY CHALLENGES

  • Navigating regulatory guidance for medical device and SaMD
  • Compliance strategy development for ISO 13485 and IEC 62304
  • Aligning innovative connected device use with evolving regulations
  • Effective cloud deployment of diverse AI, DA, and ML projects

Manil Asija, Lead, Design Quality and Regulatory Compliance, IBM

 

10:20 NAVIGATING THE PROPOSED REGULATORY FRAMEWORK FOR SaMD

  • Updated AI and ML methodology and policies for SaMD
  • Enhanced algorithm development and revision
  • Improving algorithm data impartiality and objectivity
  • Ensuring appropriate regulatory alignment for SaMD

Yarmela Pavlovic, Partner, MANATT, PHELPS & PHILLIPS LLP

 

10:40 BREAKOUT DISCUSSION – DEPLOYING INNOVATIVE TECHNOLOGIES TO IMPROVE SOFTWARE DEVELOPMENT
Participants will gather in small groups led by moderators to share best practices and current experiences using technologies that are advancing SaMD and embedded software across the medical device landscape. Greater clarity is gained by exploring current updates, practical uses, and future considerations for AI and ML tools as well as effective cloud based platforms.

GROUP 1: Machine Learning
Vincent Mahfoud, MEDTRONIC

GROUP 2: Artificial Intelligence
Yarmela Pavlovic, MANATT, PHELPS & PHILIPS

GROUP 3: Cloud Services
Patrick Alff, ODDITY-X

 

11:10 COFFEE & NETWORKING BREAK

 

11:40 EFFICIENTLY EXPEDITING SOFTWARE UPDATES WHILE CONTINUOUSLY ENSURING PRODUCT PERFORMANCE

  • Remaining abreast of necessary updates in a timely manner
  • Identifying the most time-consuming tasks in updating
  • Strategies to shift towards time-efficient practices
  • Expediting performance-testing after the update

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

 

12:10 LUNCHEON FOR ALL PARTICIPANTS

 

1:10 OPTIMIZING EFFICIENCY AND FLEXIBILITY IN SOFTWARE ENGINEERING THROUGH AGILE METHODOLOGIES
Engineers working on device and diagnostic products aim to continuously enhance operations in order to ultimately deliver software products exhibiting the highest level of performance, safety and technological sophistication. Forward-thinking leaders therefore continuously explore possibilities in applying agile strategies to software development, testing and maintenance over the product lifecycle to expedite processes all while ensuring enhanced workflows and outcomes. With a variety of approaches to instilling agile methods to medtech software engineering teams, it is important to first define the desired end-goal, before engaging in restructuring teams and strategies to finally reach optimal outcomes.

PART ONE: INDUSTRY CASE STUDIES – AGILE APPROACH TO SaMD DEVELOPMENT AND MAINTENANCE

  • Defining the scope of application of agile methodologies
  • Potential need to transition to automated methods
  • Agile tool selection criteria and cost considerations
  • Limitations with traditional QMS waterfall approach
  • Practical roll-out of new methods and initial outcomes

CASE STUDY ONE:
Thomas Dasch, Software Development, SIEMENS HEALTHINEERS

CASE STUDY TWO:
Kelly Weyrauch, Instructor, ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION (AAMI)

 

2:10 PART TWO: PANEL – OPTIMIZING SOFTWARE ENGINEERING WORKFLOWS THROUGH AGILE METHODOLOGIES

  • Organizational management updates to improve team workflows
  • Enacting stronger cross-functionality to support productivity
  • Updating and advancing documentation methods and exchange
  • Continuous focus on software risk evaluation and mitigation

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

Donna Carlson, MEDTRONIC

 

2:55 CONTINUOUS IMPROVEMENT OF SOFTWARE AND ALGORITHM DEVELOPMENT

  • Risk-based approach to open source and off the shelf resources
  • Continuously enhancing AI-enabled algorithm development
  • Design methodology to successfully incorporate software modeling

Patrick Alff, Founder, ODDITY-X

 

3:40 ONGOING EVALUATION AND MANAGEMENT OF SaMD RISKS

  • Appraisal of risks impacting compliance, testing protocol, and security
  • Implementing risk mitigation during initial design and development stages
  • Continued review throughout software implementation and updates
    • Streamlining documentation
    • Continued adherence to ISO: 14971
    • Ongoing mitigation during rapid evolution
  • Implementing proactive strategies to mitigate unknown and future risks

Richard Jackson, Software Engineering Manager, BIOLASE

 

4:25 CLOSING REMARKS & CONFERENCE CONCLUSION