Mobile Medical App Develoment 2014
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Transcript of Mobile Medical App Develoment 2014
Medical Mobile App Development
Paulo Pinheiro
© Sagentia 2013 2
Mobile Medical App Development
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Regulatory Oversight
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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..….
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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.
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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
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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.
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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.
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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
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Development at Sagentia
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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
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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.
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App Development Spec Medical Device Development
App Development Spec is crucial to clearly
formulate a shared vision of the final app.
• Introduction. Describe app’s 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
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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
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Case Studies
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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 company’s 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
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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
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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