The line between the device and non-device components of medical device software can sometimes seem blurry. For example, medical device software may be integrated into a larger health ecosystem composed of non-device software, such as electronic health records (EHR) and picture archiving and communication system (PACS); connected to telehealth via patient apps or provider portals; or in communication with consumer fitness and wellness applications.
Making the wrong choice to not develop a software module under design controls may lead to expensive, time-consuming rework.
How do you decide which parts of your device fall under your QMS umbrella, and which don’t? And how do you account for changes to your device during development as well as its potential changes in the future?
With good planning and forethought, you can lay the groundwork for a strategy that evolves with your device, keeps development on track and prepares you for any way the wind may blow.
Orthogonal convened a webinar on February 2nd, 2024, tackling the challenge of determining when to develop software under design controls. Our panel of expert speakers brought a unique background and perspective to the conversation, leading to a rich and sophisticated discussion:
Clay Anselmo, Principal Quality and Regulatory Consultant, Shriner and Associates
Clay is an internationally recognized regulatory compliance expert with an unmatched track record in resolving pre- and post-market quality and regulatory compliance issues. Clay has provided strategic input and direction and led complex quality-related projects for hundreds of medical device companies facing regulatory enforcement. Clay regularly provides strategic consulting on complex quality and regulatory matters including quality system development, remediation, regulatory submissions and clinical studies. In addition to his duties at Shriner & Associates, Clay currently provides strategic direction as a board member to a number of life sciences companies across the globe.
Brendan O’Leary, Digital Health Technology Consultant
Brendan O’Leary provides consulting services on digital health and medical device regulatory strategy to technology developers, healthcare organizations, trade and professional associations, and other stakeholders.
Brendan worked at the FDA for 14 years in a variety of roles, most recently as the founding Deputy Director of the Digital Health Center of Excellence and as its Acting Director throughout 2022. Brendan contributed to hundreds of precedent-setting decisions and co-authored dozens of policy documents that continue to provide the foundation for the FDA’s digital health efforts. He frequently represented the FDA on digital health and other topics through presentations at conferences and professional society meetings, press interviews, and interactions with Congress. Brendan also made significant contributions to the federal government’s response to SARS-CoV-2.
Elisabeth George, Regulatory Fellow, Orthogonal
Elisabeth George is an experienced leader, business executive and consultant committed to shaping and leading global organizations in continuous improvement and innovative ways of using standards and regulations, not only for compliance but also for supporting customer value. She is committed to making an impact through her skills as a leader, her experience in Medical Device Regulations and Standards and her desire to be a learning partner in delivering positive business outcomes.
Elisabeth has held senior leadership roles for more than 30 years, joining Haemonetics in 1989 as a Director of Quality and Regulatory to Sr. Director and Vice President of Quality and Regulatory positions with Hewlett Packard, Agilent and Philips. She holds a Bachelors in Science, Biomedical Engineering from Boston University and a Masters Certificate in Engineering Management from Northeastern University.
Randy Horton, Chief Solutions Officer, Orthogonal
Randy Horton is Chief Solutions Officer at Orthogonal, a software consulting firm that improves patient outcomes faster by helping MedTech firms accelerate their development pipelines for Software as a Medical Device (SaMD), digital therapeutics (DTx) and connected medical device systems. Orthogonal makes that acceleration happen by fusing modern software engineering and product management tools and techniques (e.g., Agile, Lean Startup, User-Centered Design and Systems Thinking) with the regulated focus on device safety and effectiveness that is at the heart of MedTech.
Horton serves as Co-Chair for AAMI’s Cloud Computing Working Group, as well as AAMI CR:510(2021) and the in-process Technical Information Report #115, all of which address how to safely move medical device computing functions into the cloud. He is a frequent speaker at conferences and webinars, including events hosted by AdvaMed, AAMI, HLTH, RAPS and the Human Factors and Ergonomics Society (HFES).