Changes introduced once the software development process has begun can have an adverse impact on budget, schedule and the product itself. Fortunately, meticulous planning can mitigate most last-minute changes and minimize the impact of those deemed absolutely necessary. This webinar will cover 5 key aspects you should address at the outset of the SaMD development process, from regulatory concerns to technology considerations, to keep your project running smoothly.

1. Integrated Computer Solutions Inc. www.ics.com
5 Key Considerations at the Start
of SaMD Development
1
Magda Kocot, Regulatory Project Manager, ICS

2. Integrated Computer Solutions Inc. www.ics.com
About ICS and Boston UX
Creating Transformative Products That Advance Patient Care
2
www.ics.com/medical
ICS’ design studio
specializes in intuitive
touchscreen and
multimodal interfaces for
high-impact embedded and
connected devices.
Established in 1987, ICS delivers innovative
medtech solutions with a full suite of
services to accelerate development, testing
and certification of successful next-gen
products.
ICS and Boston UX are headquartered in
Waltham, Mass. with offices in California,
Canada and Europe.

3. Integrated Computer Solutions Inc. www.ics.com
Delivering a Full Suite of Medtech Services
3
● Human Factors Engineering
● IEC 62366-UX/UI Design
● Custom Frontend and Backend Software Development
● Development with IEC 62304-Compliant Platform
● Low-code Tools that Convert UX Prototype to Product
● Medical Device Cybersecurity
● AWS and Azure Cloud Services and Analytics
● ISO 14971-Compliant Hazard Analysis
● Software Verification Testing
● Complimentary Software Technology Assessment

4. Integrated Computer Solutions Inc. www.ics.com
“ Software intended to be used for one or more
medical purposes that perform these purposes
without being part of a hardware medical
device.
IMDRF/SaMD WG/N10FINAL:2013
4
Software as a Medical Device

5. Integrated Computer Solutions Inc. www.ics.com
What impacts SaMD development (risks)
5
Regulatory
requirements
Technology
Changes
Business
contexts
User needs

6. Integrated Computer Solutions Inc. www.ics.com
User Needs
6
#1

7. Integrated Computer Solutions Inc. www.ics.com
User needs
● Who is the intended user of the SaMD (knowledge/age/sex)
● Where and when will the medical software be used? (home/hospital/means
of transport)
● What is the underlying problem that the SaMD is solving?
Intended use statement
[Product Name] is a mobile medical application intended to provide cognitive behavioral therapy
(CBT) for the treatment of the Substance Use Disorder (SUD) in patients 18 years of age and older.
[Product Name] is intended to be used as an adjunct to a contingency management system, for
patients who are currently enrolled in outpatient treatment under the supervision of a clinician.
7

8. Integrated Computer Solutions Inc. www.ics.com
User needs
8
Define underlying problem
Discover the solution that solves the
problem and meets user needs
Initial requirements
Tests with real users
Get feedback and adjust requirements

9. Integrated Computer Solutions Inc. www.ics.com
User testing
9
Use available methods and tools and get your ideas in front of end users early and
often.

10. Integrated Computer Solutions Inc. www.ics.com
UX/UI design
10
● Easy to use, intuitive for the target user
● Appropriateness of designs for the target platform (desktop monitor vs
mobile screen)
● Engaging
● Appropriate means to display information (e.g regionalization parameters,
selection/display of units)
● Real-world clinical workflows
POORLY DESIGNED INTERFACES LEAD TO USE ERROR

11. Integrated Computer Solutions Inc. www.ics.com
Technology
11
#2

12. Integrated Computer Solutions Inc. www.ics.com
Technology
Technology
12
Functionality
● Get developers perspective on the initial requirements
● Come up with the general idea of how to build the system and initial
architecture

13. Integrated Computer Solutions Inc. www.ics.com
Development process
13

14. Integrated Computer Solutions Inc. www.ics.com
Defects
Defects introduced at the start of SaMD development account for nearly half of
the total number of defects
Create verification strategy and apply it from the start:
- Perform code reviews
- Use static and dynamic code analysis
- Develop unit tests
- Create coding standards
- Use coding best practices
14

15. Integrated Computer Solutions Inc. www.ics.com
Regulatory Requirements
15
#3

16. Integrated Computer Solutions Inc. www.ics.com
Regulatory strategy
● What are the regulations and standards that apply to your
SaMD?
● What class is your medical device?
● What class is your software per 62304?
● What is the route to market?
16

17. Integrated Computer Solutions Inc. www.ics.com
Standards and regulations
17
Standard Standard Name
21 CFR part 820
MDR 2017/745
Medical device regulations
ISO 13485 Medical devices — Quality management systems — Requirements for
regulatory purposes
IEC 62304 Medical device software – software life cycle processes
IEC 14971 Application of risk management to medical devices
IEC 62366 Application of usability engineering to medical devices

18. Integrated Computer Solutions Inc. www.ics.com
Medical device classification
18
Class I - general controls
Class II - general and special controls
Class III - premarket approval
H
i
g
h
r
i
s
k
L
o
w
r
i
s
k

19. Integrated Computer Solutions Inc. www.ics.com
Software classification per 62304
19
Impact: Minor
No possibility of
damage to health
CLASS A
Impact: Moderate
Possibility of non
serious injury
CLASS B
Impact: Major
Possibility of death
or serious injury
CLASS C

20. Integrated Computer Solutions Inc. www.ics.com
Software classification per 62304
20
Software Documentation Class A Class B Class C
Software development plan X X X
Software requirements specification X X X
Software architecture X X
Software detailed design X
Software unit implementation X X X
Software unit verification X X
Software integration and integration testing X X
Software system testing X X X
Software release X X X
Software maintenance process X X X
Software risk management process X X
Software configuration management X X X
Software problem resolution X X X

21. Integrated Computer Solutions Inc. www.ics.com
Business Contexts
21
#4

22. Integrated Computer Solutions Inc. www.ics.com
Business
● What are the potential markets for your product?
● Is there a predicate device on the market? What’s the
competition?
● Who is the customer?
● What other products or system will the device
communicate and interact with?
22

23. Integrated Computer Solutions Inc. www.ics.com 23
USA EU
21 CFR part 820 MDR 2017/745, IVDR 2017/746
FDA approval is not time limited Repeated certification process (notified body audits)
Class I, II, III Class I, Im, Is, IIa, IIb, III or
A, B, C, D (IVDR)
510(k), de novo, PMA
Enforcement discretion
Conformity assessment (most often technical
file+QMS)
QSR/QMSR QMS ISO 13485
HIPAA GDPR
Potential markets

24. Integrated Computer Solutions Inc. www.ics.com
Competition
Predicate device
● already legally
marketed in the US
● similar to your
device with regard to
indications for use
and technological
characteristics.
24
Innovation
● Clinical trials
● More expensive
and time
consuming
certification path

25. Integrated Computer Solutions Inc. www.ics.com
Clients
25

26. Integrated Computer Solutions Inc. www.ics.com
Interoperability
Integration with external systems (e.g. HIS, LIS)
Communication with other devices / medical devices (e.g. smart watches,
hardware medical devices)
● Safeguard data at rest and in-transit
● System and hardware requirements and testing
● Implement uniform standards for health care data (HL7, FHIR)
26

27. Integrated Computer Solutions Inc. www.ics.com
Changes
27
#5

28. Integrated Computer Solutions Inc. www.ics.com
Change management
Introduce changes early in the development process
28

29. Integrated Computer Solutions Inc. www.ics.com
Change management
Set up a change management process that best suits your
needs and meet regulatory requirements
- Define significant and non-significant changes that are
specific to your product
- Document carefully the design structure and
interrelationships of modules to limit the validation effort
needed when a change is made
- Separate high risk medical modules from the low risk one
29

30. Integrated Computer Solutions Inc. www.ics.com
Key takeaways
● Define user needs and perform user testing early and often
● Involve engineers early in the process to define the initial design of the
system and minimize defects by applying verification means
● Define regulatory strategy that includes medical device class, applicable
regulations, software safety class and product certification path
● Define intended markets, competition, legal requirements and interoperability
● Define change management procedure and adjust it to the product
Resources:
1. https://radiant.digital/wireframe-mockup-and-prototype-whats-the-difference
2. https://customerthink.com/agile-versus-waterfall-for-crm-implementation-success/
3. http://www.ambysoft.com/essays/agileLifecycle.html
4. https://www.guru99.com/software-testing.html
5. INSPIRED: How to Create Tech Products Customers Love, Marty Cagan
30

31. Integrated Computer Solutions Inc. www.ics.com
Integrated Computer Solutions Inc.
Thank you!
Any questions?
Magda Kocot
Regulatory Project Manager, ICS
mkocot@ics.com
31