The SARS-CoV-2 pandemic drastically changes the landscape of digital health innovation. The FDA authorized emergency use for a variety of SaMD products including but not limited to mental health, clinical decision support and remote monitoring software applications. In addition, FDA recently launched the Digital Health Center of Excellence, provided updates on the pre-certification program, and host a session to convey FDA’s current thinking on AI/ML SaMD validation. SaMD manufacturers must keep up with the fast-evolving regulatory landscape and optimize their software development practices with a goal to demonstrate conformance to the QMS requirements effectively and efficiently. This presentation originally aired during the 2021 State of Medical Device Virtual Summit.

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!