2. PRODUCT MALFUNCTION THEORY:
WHEN “SMART” PRODUCTS ACT
DUMB

3. Definition
What are smart products?
Internet of Things
Network of objects that can
collect and exchange data with
people and other objects.

4. Economic impact
Internet connected products
outnumbered the human population
in 2008.
By 2020, 50 billion internet
connected devices generating $8
trillion in revenue.

5. Benefits
Fewer trips to the doctor
Reduces risk of human error
Remote adjustments

6. Mobile Apps and
Medical Devices Defined
• Mobile App – software application that can
be executed or run on a mobile platform
• Medical Device
• An instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent or other similar
or related article, including a component part which
is:
• Intended in the diagnosis, cure, treatment or prevention of disease
in man or other animals, OR
• Intended to affect the structure or function of the body, AND does
not achieve primary purpose due to chemical action in the body
AND is not dependent on being metabolized.
[add citation]

7. FDA’s Regulation of Mobile Apps:
Three Broad Categories
Mobile Medical Apps (MMA)
1. Meets the definition of a medical device
• Regulated as other Class I, II and III medical
devices
2. Meets the definition of medical device but is low
risk
• Enforcement discretion only
3. Not considered to be medical devices

8. Characteristics of MMAs
• Controls another medical device
• Transforms the mobile platform into a
medical device
• Performs patient specific analysis and
provides patient specific diagnosis or
treatment

9. Example of MMA: Alivecor Mobile
Electrocardiogram
• Device and app that enables the
user to record and review ECGs
anywhere, anytime
• Attaches to the back of most
mobile phones
• Instantly know if atrial fibrillation
(AF) is detected in the ECG
• Syncs with online account so you
can grant access to your
physician, print PDFs and email it
to caregivers or health care
professionals

10. Example of MMA:
Pulse Oximeter for Children
• Small pulse oximeter
which measures the blood
oxygen saturation and
pulse rate
• Allows parents to monitor
their child’s asthma
wherever they go
• Parents can determine
whether their child is
getting enough oxygen or
if they need to take
medication and/or rest

11. Example of MMA: Withings Blood
Pressure Monitor
• Portable blood pressure
monitor
• “Easy” and precise self-
measurement of blood with a
smart phone
• Data can be saved and
shared with physicians

12. Example of MMA:
Sense 4 Baby
• Combines a smart wireless device
and secure, HIPPA-compliant cloud
technology, to enable physicians to
perform cardiotocography for high risk
pregnancies remotely
• Provides accurate fetal heart rate
detection in near real time
• Clinicians can access traces of fetal
heart rate, uterine contractions, and
other trendable biometric data, on
their smartphone or tablet

13. MMAs:
Enforcement Discretion Only
• Help users self-manage their disease or condition without
providing specific treatment or treatment suggestions
• Provide patients with simple tools to organize and track
their health information
• Provide easy access to information related to a patient’s
health conditions or treatments
• Help patients document, show, or communicate potential
medical conditions to healthcare providers
• Automate simple tasks for healthcare providers
• Enable patients or providers to interact with personal
health records or electronic health record systems

14. Tell My Geo:
Enforcement Discretion Only
• Smart phone app that monitors and tracks the
location of Alzheimer’s patients
• Contains a comprehensive medical information
component similar to a medical alert bracelet but
also much more detailed storehouse of medical
data for use by health care providers and/or
emergency services personnel
• The Cared-For’s phone can be set to send regular
updates on their physical location at periodic
intervals
• The Call for Help button assists the Cared-For
user during periods of forgetfulness or panic

15. My Chart:
Enforcement Discretion Only
• Creates a direct communication
channel between patients and
health care providers
• Patients can check test results,
track medical treatments and
immunizations, pay medical
bills, manage appointments,
access family health
information, and upload health
and fitness data from other
health-tracking apps

16. Propeller:
Enforcement Discretion Only
• Sensor pairs with smartphone via
Bluetooth and automatically collects
environmental data when medication
is taken
• Special sensor attaches to respiratory
inhaler that compiles data to send to
physician for remote monitoring
• Propeller is a half tracking app, half
adherence tool

17. Mobile Apps That Are Not MMAs:
Key Characteristics
• Provide access to medical texts or reference
material
• Education tools for health care providers
• General patient education
• Automate general office operation
• Generic aids (magnifying glass)

18. MOBILE APPS NOT REGULATED
BY THE FDA

19. Who Is A MMA Manufacturer?
Statutory Definition
• Anyone who “initiates” specifications,
designs, labels or creates a software system
or application for a regulated medical device
in whole or in part from multiple software
components
21 CFR Parts 803, 806, 807 and 820

20. Examples of MMA Manufacturers
• Author of specifications for MMAs
• Procurer of services to develop MMAs for
subsequent commercial distribution
• Assembler of off-the shelf software components if
marketed to perform as an MMA
• Creator of MMAs and hardware attachments for a
mobile platform
• Creator of MMAs that permit access to medical
device function through website subscription or
software as a service

21. Who is Not a MMA Manufacturer?
• Distributors not engaging in manufacturing
functions
• Software developers
• Third parties who solely provide market access to
MMAs (Internet and Cloud service providers)
• Providers of tools, services or infrastructure to
create MMAs
• Licensed practitioners who manufacture or alter
MMAs solely for professional purposes
• Makers of MMAs used solely for research

22. Issues Specific to MMAs
• Communication of instructions
• Security and stability against hacking
• Deployment of updates and patches
• Compatibility and use with other apps

23. What Can Go Wrong?:
Hospira Symbiq Infusion System
• Computerized pump
designed for continuous
delivery of general infusion
therapy
• Can communicate via a
wired or wireless connection

24. What Can Go Wrong?:
Hospira Symbiq Infusion System
• July 31, 2015 FDA Safety Alert due to
“cybersecurity” vulnerabilities
• System could be accessed remotely
through a hospital’s network
• Could allow an unauthorized user to control
the device and change the dose the pump
delivers which could lead to over or under
infusion of critical patient therapies

25. Smart vehicles, potential benefits
• Potential to reduce injuries and fatalities
attributable to human error (~94% of fatalities)
• Traffic congestion reduction
• Mobility for elderly and disabled
• Urban land use
• Increased productivity

26. Nissan’s Autonomous Drive Car
“….commercially viable
autonomous drive vehicles on the
road by 2020.”

27. Automated vehicles
Spectrum of technologies from current driver
aids to future fully autonomous vehicles

28. Automation levels
• Level 1 – radar-assisted emergency braking
• Level 2 – adoptive cruise control + lane keeping
• Level 3 – “limited self-driving” under certain
specific traffic conditions but driver must remain
alert and ready to take back control

29. Automation levels
• Level 4 – capable of fully automated trip A to B
• Level 5 – fully-autonomous vehicle that does not
have human controls (no steering wheel)

30. Challenges
• Accurate description of tech and limitations
• Driver engagement and “handoff”
• “Over-the-air” update capability
• EDR
• Effect of ambient conditions on tech
• Ordinary wear and degradation
• Cybersecurity

31. Nissan Infiniti lane departure
prevention

32. Risks
Authentication
Encryption
Remote access
Each connection is an access point

33. Risks
Malware
Unauthorized access
Outdated software, updates not
done

34. Data exhaust
Biometrics
Location
Preferences
Financial information
Health information

35. Liability issues
Feb. 4, 2016 – NHTSA issued an
interpretation of FMVSS to Google,
finding the Self-Driving System is
the “driver,” not the car’s
occupants.

36. Tesla Autopilot
Model S Software Version 7.0
Features:
Autosteer
Auto Lane Change
Automatic Emergency Steering and
Side Collision Warning
Autopark

37. TESLA AUTOPILOT, AS
DESIGNED

38. TESLA AUTOPILOT, REAL
WORLD

39. Who is liable in a crash?
• Vehicle owner
• Vehicle occupant
• Manufacturer
• Software designer, programmer
• Software hacker
• Governmental agency related to
technology that supports self-
driving vehicles (internet
bandwidth, or other communication
problem).

40. Who is liable in a medical
mishap?
• Physician
• Hospital
• Manufacturer
• Software designer, programmer
• Software hacker
• Governmental agency related to
technology that supports self-
driving vehicles (internet
bandwidth, or other communication
problem).

41. Insurance issues
What changes will be made to auto
policies?
Product liability coverage will cost
more?