Medical Mobile App Development

Paulo Pinheiro
Sagentia 2013
2
Mobile Medical App Development
Sagentia 2013
3
Regulatory Oversight
Sagentia 2013
#
A
p
p
r
o
a
c
h

B
e
n
e
f
i
t

Regulatory oversight
Medical Device Development
FDA issued final guidance on its plans to regulate mobile medical apps

Three level of regulatory oversight as per guidance:

Unregulated -The majority of apps are not medical devices and FDA does not intend
to regulate them

Discretionary - Some apps may meet the definition of a medical device but because
they pose lower risk to the public, FDA intends to enforce discretion on those apps
Examples from guidance : BMI, Total Body water, Mean arterial pressure, Delivery date
estimator, etc.

Enforced - FDA intends to apply regulatory oversight to apps that could pose risk to a
patient if the app were not to function as intended.
Examples from guidance: Control of settings of infusion pump, settings of implantable
neurostimulator, inflation & deflation of blood pressure cuff, etc...

Sagentia 2013
#
A
p
p
r
o
a
c
h

B
e
n
e
f
i
t

Medical Device Development
Sagentia is knowledgeable of medical device development and
associated regulatory paths.

Projects are carried out under the framework of a robust product
development process which is certified to both ISO9001:2008 and
ISO13485:2003 standards.

Software development is conducted according to IEC 62304 which is the
state of the art for European certifications and recognised by the FDA.
Sagentia 2013
#
A
p
p
r
o
a
c
h

B
e
n
e
f
i
t

Mobile Medical Apps Examples
Medical Device Development
Medically regulated apps are relatively new field. To date,
only a few mobile medical apps have been cleared by the
FDA, and only one CE marked in Europe.

Sagentia are at the forefront of this field and have
significant experience of developing mobile medical apps
and associated hardware.

Areas of medical App development that we can help:
Software. Development to IEC62304
Usability. Design according to ISO62366 for several medical products
SOUP. Risk analysis and mitigations for iOS Software Development Kit (SDK)
System-led approach. Compatible App/device interface protocols
Risk management under ISO13485
Recent projects include:
VeriHaler
Senseonics Blood Glucose Monitoring System
SetPoint RxPad
Sagentia 2013
#
A
p
p
r
o
a
c
h

B
e
n
e
f
i
t

IEC 62304 applicable activities
Medical Device Development
IEC 62304 requires two top
level activities:
Software Safety Classification
Class A No injury is possible
Class B Non-serious injury is
possible
Class C Death or serious injury is
possible
Implementation of a software
lifecycle containing all the
required processes according
to the safety class of the
software.
Sagentia 2013
#
A
p
p
r
o
a
c
h

B
e
n
e
f
i
t

FDA Premarket Submissions
Medical Device Development
FDA requires the identification of level of
concern:
Software Safety Classification
Major No injury is possible
Moderate Minor injury is possible
Major Death or serious injury is possible
Unlike IEC 62304 where the software
safety class drives the activities to be
performed, the level of concern drives the
documentation to be submitted.
Sagentia 2013
#
A
p
p
r
o
a
c
h

B
e
n
e
f
i
t

Software Development Process
Medical Device Development
Mobile Medical Apps need to be developed according to accepted medical-grade
standards covering the software development lifecycle and risk management
Software Safety Class
B & C
Best practice
Software Safety Class A
Sagentia 2013
10
Development at Sagentia
Sagentia 2013
#
A
p
p
r
o
a
c
h

B
e
n
e
f
i
t

Typical Development
Medical Device Development
Phase 3: App
Verification
(2-6 weeks)
Phase 2 : App Development
(1-6 months)
Phase 1: Planning,
Specification & GUI
(3-4 weeks)
Sagentia activities:
Write App Quality Plan
Write App
Requirements
Develop GUI
wireframes
Generate GUI design
Re-plan next phases
Client activities:
Contribute & review
app requirements
Review wireframes
Review GUI graphic
design
Sagentia activities:
Setup Continuous Integration Server
App coding/testing
Device integration
App Code Reviews
Documentation updates
Re-plan
Client activities:
Review App
Design review meetings
Sagentia activities:
Write Verification
Protocol
Execute Verification
Report Verification
results

Client activities:
Review Verification
Protocol
Review Verification
Results
Review App

Interim
release
Interim
release
Interim
release
Interim
release
Interim
release
Actual duration and
activities depends on the
complexity of the app
and software safety class
Sagentia 2013
#
A
p
p
r
o
a
c
h

B
e
n
e
f
i
t

Usability
Medical Device Development
iOS7 represents
a significant
style shift
relative to iOS6
Mapping of wire
frames to
graphic design
Usability and the right look and feel is
critical to a safe and successful app
Our process begins by constructing one or more user
profiles who will be using the app with a set of use cases
that describe how they use it.

These will be constructed from meetings with the client
and app requirements.

Create low fidelity wireframes to demonstrate the flow
and how it will satisfy the use cases and requirements

Produce graphic design to match branding and app
requirements

Refine graphical design by iterations with client.
Sagentia 2013
#
A
p
p
r
o
a
c
h

B
e
n
e
f
i
t

App Development Spec
Medical Device Development
App Development Spec is crucial to clearly
formulate a shared vision of the final app.

Introduction. Describe apps goal, the target audience, mobile
platforms, OS versions, and relevant technologies.

Functional Requirements. Describe use cases, usability screens,
social media integration, collaboration with servers, offline, in-app
purchasing, geo-location services, printing, compatibility with e-
commerce engines, etc

Design. Who will do the design and what are the branding guidelines

Additional Information. Provide market research, list similar/rival
apps, express concerns and limitations

Sagentia 2013
#
A
p
p
r
o
a
c
h

B
e
n
e
f
i
t

Development Process Tools
Medical Device Development
Continuous integration
development environment

Jira to track project issues, plan work and
monitor progress
SVN software revision control
TeamCity continuous integration server
Review Board code reviews
Kiwi, KIF, etc - testing frameworks
OTA updates over the air into smartphone
for development

Team city will be used to build binaries and
run automated tests for the smartphone
simulator

Sagentia 2013
15
Case Studies
Sagentia 2013
#
A
p
p
r
o
a
c
h

B
e
n
e
f
i
t

Improving connectivity between a medical mobile app and an implantable sensor
Senseonics
The final system was delivered in time for a clinical trial for
the first generation product. Key benefits included;
Connectivity and bandwidth issues resolved with
implementation changes in the App and the transmitter
firmware.
Fast and reliable communication between app and the
embedded device, yielding a 10x bandwidth improvement.
Working in partnership with our client, we:
Analysed the existing app and transmitter firmware to identify
and resolve the origin of connection drop-outs and low data
rates
Provided possible solutions for UI improvements encompassing
iOS design rules and medical device usability standards.
Contributed to the existing documentation required to be
compliant with the Senseonics Quality & regulatory standards.
Senseonics partnered with Sagentia to resolve iOS
Bluetooth Low Energy connectivity issues for Senseonics
medical iOS app with an implanted glucose sensor.
Sagentia provided tremendous value in the
implementation of the novel Bluetooth Low Energy
Technology utilized in Senseonics Medical App.
Sagentia offered to bring in the subject matter
expert to meet the companys aggressive timeline
& partnered effectively with a start-up medical
device company like ours.
Tim Goodnow, CEO at Senseonics

iOS App
Sensor (subcutaneous)
Body-Worn Transmitter
RF Power
and Data
Sagentia 2013
#
A
p
p
r
o
a
c
h

B
e
n
e
f
i
t

Development of an iPad Mini prescription app for an implantable neuro stimulator
SetPoint Medical
The iPad App is being developed using an Agile approach;
Rapid iterations to guide development.
Process tailored to the needs
Fast and reliable communication between app and the
embedded device.
Working in partnership with SetPoint Medical, we:
Are developing the iPad App,
Are advising on the RF and Bluetooth Low Energy interfaces
within the system.
Are developing the app according to the applicable medical
device standards in line with the recent guidelines released by
the FDA.
Are generating iPad App development monthly releases
SetPoint Medical partnered with Sagentia to develop an
iPad Mini prescription app.
We at SetPoint Medical are excited to have the
bright minds of the people at Sagentia join us in
the development of this revolutionary therapy
designed to improve the lives of people with
inflammatory diseases. Together we intend to
develop a convenient and novel iOS programming
interface that will help facilitate the adoption of this
exciting new therapy.
Anthony Arnold, CEO at SetPoint Medical

Sagentia 2013
#
A
p
p
r
o
a
c
h

B
e
n
e
f
i
t

Verihaler: remote monitoring and support of drug adherence in asthma patients
A Connected Health example
Development challenges range from improving signal-to-noise for the minimally
invasive sensor, to developing novel context-aware algorithms and user interfaces to
present clear and actionable data to the relevant stakeholders.
Inhaler
Low disposable CoG
Adding sensor to
existing inhaler design
Avoid acoustic
interference
Basic data processing
(Embedded s/w)
Low power electronics
Streaming data in real
time over Bluetooth LE
Invasive delivery systems
Server
Security
Complex data
processing
Stakeholder specific,
hierarchical UI design
Prioritising key
parameters over nice
to know ones.
Data processing,
transmission back to
app in a timely fashion
Smartphone
Medically regulated
app; develop to
IEC62304
Dumb UI as far as
possible (embedded
s/w and server s/w for
critical processes)
Efficient UI design
ensures timely,
actionable data are
presented to patient