Medical Mobile App Development

Paulo Pinheiro

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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