Software as a Medical Device (SaMD) Challenges and Opportunities for 2021 and Beyond
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The document discusses the challenges and opportunities facing software as a medical device (SaMD) in the context of the COVID-19 pandemic, emphasizing the benefits of digital health technologies. It outlines the criteria for emergency use authorizations, FDA initiatives in digital health, and the regulatory landscape for SaMD, including best practices for agile management. It also highlights the clinical validation challenges and the expected growth in the SaMD market from 2020 to 2027.
Software as a Medical Device (SaMD) Challenges and Opportunities for 2021 and Beyond
- 1. Software as Medical Device (SaMD) Challenges and Opportunities for 2021 and Beyond DECEMBER 09, 2020 Webinar
- 2. MEDICAL DEVICE QUALITY IS ALL WE DO, AND WE’RE ALWAYS AHEAD OF THE GAME. © Copyright 2020 by Greenlight Guru
- 3. Andrew Wu Branch Manager / Software Consultant Experienced R&D Engineer and Software Quality Assurance Engineer leading multiple class II Medical Devices to commercialization in the US Serving as Lead Project Management Consultant of multiple SaMDs intended to commercialize in the US and EU 3 andrew.wu@rookqs.com https://www.linkedin.com/in/jungenwu/
- 4. Rook Quality Systems is a consulting firm dedicated to helping medical device companies develop and maintain effective and efficient quality systems. We provide specialized and custom consulting services for all classes of medical devices, including medical software and combination devices. Quality System Design Audit Support Regulatory Submission Support (Int’l) DHF/ TF Creation Software Validation Design Control Risk Management Quality System Training 4
- 5. Rook Quality Systems (RookQS) Headquartered @ Atlanta, GA, USA (2012) Taiwan Branch @ Linkou, Taiwan (2020) 5
- 6. Ø Medical device Instury under COVID-19 Ø EUA for SaMD products Ø Updates from the FDA on Digital Health Initiatives Ø Validation Challenges for SaMD manufacturers Ø Best Practices for leveraing Agile framework for SaMD Lifecycle Management Ø Forecast 6 Agenda
- 7. Medtech Industry under COVID-19 ● Traditional care delivery model is being challenged ● Digital health technologies have advantages under COVID-19 ○ Safer ○ Scalable ○ Extend care continuum ○ Accessible/Engaging ○ Improve clinical workflow ● “The Dawn of Digital Medicine” 7
- 8. ● Criteria for Issuance ○ Affect clinical management of COVID-19 ○ Known and potential benefits of the technology outweight the known and potential risks ○ No adequate, approved, available alternative to the technology ● Non-IVD EUA Requirements ○ Refer to ’Pre-Emergency Use Authorization (EUA)/EUA Interactive Review Template For Non-IVD Products’ 8 SaMD Emergency Use Authorizations
- 9. SaMD Emergency Use Authorizations 9 ELEFT Algorithm (EKO Devices) CLEWICU System (CLEW Medical Ltd) COViage (Dascena Inc) Value Proposition Screening for cardiac conditions is critical for managing patients with confirmed or suspected COVID-19 Early identification of patients susceptible to respiratory failure/decompensation or hemodynamic instability Product Profile The software analyzed a collected ECG, and within seconds displays a binary prediction of likelihood of LVEF less than or equal to 40% on a smart phone, tablet, or PC device. The software imports data from various sources (EMR, nursing assessment, medications, lab data) to compute indices that have been defined as Respiratory Decompensation Status and Hemodynamic Isntability Status. The software receives patient data from EMR to compute patient status indices that have been defined as Respiratory Decompensation Status and Hemodynamic Isntability Status.
- 10. FDA Digital Health Initiatives ● Digital Health Center of Excellence (DHCoE) ○ Listening sessions ● Framework and Update as of 2020 ○ Communicating Cybersecurity Vulnerabilities to Patients ○ Summary of Learning and Ongoing Activities for Developing Pre-Cert program 10
- 11. Leverage Frameworks 11 TIR 45 Agile Practice IEC 62304 Software Lifecycle Management N23 SaMD QMS • Traceability to 13485 sections Software Pre-Certification
- 12. DHCoE Listening Sessions “Conect and build partnership, share knowledge, and innovate regulatory approaches” 12
- 13. DHCoE Listening Sessions ● Harmonized standards or frameworks ○ New regulatory framework around AI/ML ○ Wellness versus regulated apps ○ Pre-cert ● Clinical trial requirements for digital therapeutics and ditigal diagnostics ● Digital technologies adoption 13
- 14. ● Digital therapeutic solution used in conjunction with prescribed medications ● Temporary reduction of sleep disturbance related to nightmares in adults who suffer from nightmare disorder or due to PTSD ● 30-day randomized, shame control trial of n=70 14
- 15. SaMD Clinical Validation Challenges 16 Challenge Mitigation Demonstrate level of clinical acceptance of SaMD output Early product positioning and value proposition hardening with stakeholders (e.g. independent reviews) Unsure what sources and amount of dataset needed for validation Pre-submission meeting Consider acceptable failure behavior in the clinical environment Independent review with stakeholders Functoinality and intended use might subject to changes after field data is captured Ensure robust change control and release practices are established
- 16. • Project • Release – plan for a usable product (e.g. ready to be shipped to the field) • Increment – plan for a set of useful functionalities (e.g. ready to be shipped to UAT) • Story - plan for elaboration and implementation of a small piece of functionality. Agile Increment/Evolutionary Lifecycle Risk Mgt Risk Mgt Risk Mgt Risk Mgt 17
- 17. Key Elements to Achieve Quality at Speed with Agile 18 User Stories Test Driven Development Continuous Integration Design Reviews Validation Version Control Practices Management of SOUP Regression Analysis/Testing Change Management Process CAPA
- 18. Forecast ● Incredible growth – over 20% CAGR1 from 2020-2027 ● Preventative care, early disease identification, clinical workflow streamline ● More visibility on the regulatory policies to foster growth ● Threat of data breach might hinder the growth1 19 Reference: Software as a Medical Device Market Forecast to 2027 - COVID-19 Impact and Global Analysis by Device Type, Application, Deployment Type, and Geography, Rearch and Markets, April 2020
- 19. Thanks! Any questions? 20 Contact andrew.wu@rookqs.com or visit www.RookQS.com for more questions, comments, or to set up a meeting. One of our consultants will be sure to reach out to assist!