DDF Summit 2019 Benefits and Challenges with · 4 /// Medical Software - Benefits and Challenges...

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DDF Summit 2019

Benefits and

Challenges with

Medical Software

2019-03-13 / Torsten Kneuss / Version 1.0

Agenda

Introduction

What is Medical Software?

Medical Software as part of a

combination product - a case

study

Benefits of medical software

Challenges with medical

software

Summary

/// Medical Software - Benefits and Challenges from Pharmaceutical Industry Perspective /// March 20192



Introduction

Introduction



Medical Software is a term used for software which

is regulated as a medical device (either as stand-

alone medical device or as embedded medical

device software).

For stand-alone medical software the term

“Software as a Medical Device (SaMD)” is used

SaMD is defined by the International Medical

Device Regulators Forum (IMDRF) as "software

intended to be used for one or more medical

purposes that perform these purposes without

being part of a hardware medical device."

Introduction



The Medical Device Regulation (Regulation EU 2017/745) as well as the previous Medical Device Directive explicitly highlight software in the medical device definition.

(1) ‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,

diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,

investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,

providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,

and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

(Article 2 of the Regulation EU 2017/745)

Introduction

Medical Software – Regulation depends on type of software


integrated into a hardware medical

device (“firmware”)

to be used with a medical device (no

stand-alone use)

used as stand-alone device (with or

without optional connection to a

hardware, e.g. including apps, websites)

part of the medical device

accessory to the medical device

stand-alone medical device (SaMD)

Type of software Regulated as …


Medical Software as part of a

combination product - A case

study

Introduction

Introduction

Medical Software as part of a combination product - A case study:

Overview


Electronic autoinjector which stores injection history and allows transfer to Patient app

Patient app (Win, Mac, iOS, Android) which allows data transfer from autoinjector to cloud database, as

well as review of injection data, injection planning/reminder etc.

Website which allows review of injection data by Physicians/HCPs and support of patient (e.g. via

messaging)

Cloud

Introduction


Regulatory overview


Drug product

(Biologic product)

Electronic

autoinjectorApp for patients

App for

physicians/HCPs

EU

US

Drug

Combination Product (under Biologics License Application)

Medical Device Medical Device Medical Device

Medical Device Data

System (MDDS)

Device constituent

partDevice constituent

part

Biologics (plus other

constituent parts)

Introduction


Involved partners


Benefits of

medical

software



Overview


Provides medical benefits on its own

Diagnosis ResApp for diagnosis of respiratory diseases

Treatment

…

Preventicus Heartbeats for measuring of cardiac rhythm to determine

cardiac rhythm disorders

Tinnitracks for Treatment of Tinnitus

Caterna for Treatment of Amblyopia

Compensation

of disabilityJacoti ListenApp - Hearing Aid

…


Example: ResApp by ResApp Health Limited – Diagnosis of

respiratory diseases


Instantly diagnose and manage respiratory disease

using only a smartphone.

Respiratory disease diagnosis using only the sound

of a patient’s cough


Example: Tinnitracks by Sonormed GmbH – Treatment of Tinnitus


Tinnitracks is a web application which allows you to

filter your music in order to use it for a new tinnitus

therapy that is endorsed by the latest

neuroscientific findings.

Costs for the therapy with Tinnitracks can be

reimbursement by many Health insurances in

Germany if prescribed by a physician.

Tinnitracks is a medical product as defined in § 3

No. 1a of the German Medical Products Law

(MPG) and is classified as a Class 1 medical

product in accordance with Directive 93/42 (EEC),

Annex IX, Rule 1.


Example: Caterna by Caterna Vision GmbH – Treatment of

Amblyopia


Caterna is a therapy for treatment of Amblyopia,

which is a functional disorder that usually results

from strabismus (squinting).

Costs for the therapy with Caterna can be

reimbursement by several German Health

insurances if prescribed by a physician.

Caterna is a medical device.


Example: Jacoti ListenApp by Jacoti bvb – Hearing Aid


Jacoti ListenApp® is the world’s first CE approved

medical device standalone software hearing aid

and FDA registered as a Class I medical device in

the US.


Overview


Supports benefits of drugs

Disease monitoringMonitoring/Supporting medication

compliance

Other benefits

Improvement of clinical studies Data collection for observational studies

Compliance monitoring for payers

Challenges


Challenges

Organizational integration:

Where to develop and support Medical Software in the company?


Already involved/experienced in device

development

Development of software never ends

Experienced in providing regulated products

Well prepared for routine operations

Competence in Information Technologies

(including operation of regulated

infrastructures)

Sponsor of Medical Software

Responsible for non-regulated software

Typically not prepared for (routine) operations

No experience in IT operations and similar

operations

No sufficiently integrated in GxP organization

(Quality, Regulatory)

No experience with Medical Devices

No sufficiently integrated in GxP organization

(Quality, Regulatory)

No experience with Medical Devices

Typically not prepared for (routine) operations

R&D

Manufacturing/

Operations

IT

Marketing &

Sales

PRO

Challenges

Organizational integration:

Where to develop and support Medical Software in the company?


CON

Challenges

(Additional) Processes required for Medical Software:

Overview


Challenges


Identification and categorization of Software


Identification

Categorization

Which Software (for promotional purpose) is being developed or distributed in the

company?

Establish and maintain an inventory!

Use existing processes, e.g. approval workflow for „promotional materials“

“Early categorization is key”: Early assessment if a planned software is regulated

medical software or an un-regulated promotional software

CAVE: Change Management -> How to assess changes to non-regulated apps (which

might impact the regulatory assessment)?

Process (example):

Initial assessment is being performed by the project sponsor (e.g. marketing function)

supported by documents / checklists

Borderline cases can be submitted to an expert committee which provides classification

Challenges


Supplier selection and qualification


Supplier

selection and

qualification

Involves new supplier categories (e.g. medical software manufacturer, hosting provider,

call center)

Requires adaptation of processes for supplier qualification

Criteria for supplier evaluation: see experiences in the IT area

Contents of quality assurance agreements: See Service Level Agreements from the IT area

Risk assessment of the suppliers is recommended → Take risks from hosting into account in

the development of medical device if necessary

Consider data protection requirements, clarify already during the selection of the partner the

processes from a data protection perspective (e.g. who assumes responsibility for which data)

Hosting – Clarify and agree already during the selection of the development partner, who will

take over the hosting/operation and how life-cycle management is ensured.

Challenges


Development process, (Local) Regulatory assessment


Development

Development using the development process for medical devices/combination products

Implement Design Controls (21 CFR Part 820.30 / ISO 13485 Section 7.3)

Implement IEC 62304 – medical device software – software life cycle processes

Design - Early design decisions can have major impact on future activities (e.g. change

management)

Consideration of recall/forced updates/forced shutdown, notification of users, etc.

Easy identification of software versions (for support cases)

(Local)

Regulatory

assessment

Evaluation of special requirements

e.g. medical device law in Germany, data protection in France, advertising laws?

Operation of Medical Devices regulated (e.g. Hosting)?

Approval outside the EU?

e.g. US Enforcement Discretion, Combination Product etc.?

Challenges


Localization


Localization

Definition of localizable product properties (functions can be deactivated, colors/brandings etc.)

per country

Translation of content and instructions for use on the basis of the "global" specifications of the

medical device manufacturer

CAVE: No changes to the Instructions for Use (exception: legally or officially prescribed

supplements/changes)

Local release of materials (e.g. via labeling process and/or Medical-Legal Review (MLR)) and

localization

Localization is always much more time-consuming and costly than planned

Challenges


Change Management


Requires clear responsibilities between (legal) manufacturer, pharmaceutical company and other

involved parties

Change management needs to cover additional processes and the respective partners (e.g. hosting

platform, AppStore content, changes/impact to the technical support hotline etc.)

Speed of change management process is crucial (e.g. to keep track with platform updates)

How to ensure (timely) adoptions needed due to platform updates?

Monitor updates of components (Software of Unknown Provenance (SOUP)) → Updates to safety or

performance of those components

Monitor Regulatory Changes (due to the emerging area), including Health IT and Data privacy

regulations

Challenges


Post-Market Surveillance / Complaint Management


How to process complaints?

Is a technical support hotline required?

How to deal with App Store comments/reviews, social media etc.

Pharmacovigilance relevance of the data stored in the system?

Is information shared with the pharmaceutical company or an agent of the company

Challenges


Support


Support processes depend on complexity

Supported platforms, Connectivity, Cloud-based or local software, Is availability of software critical for the user/patient?, is there a user training?, any other support channel available?

Complaint Management is not Support

Complaint Management process is not suitable for user support (process duration)

Technical support hotline

Costs vs. Benefits

Which channels are required (Phone, Chat, Email)

Consider Complaints/Pharmacovigilance

Case which has been solved during 1st level support <> complaint, however every call should be documented and evaluated

Consider Data Privacy Regulations

Escalation of Case: Which data is transferred to whom? Who informs user about solution of the issue?

Evaluate specific local regulations

Example: support of HealthCare Professionals in Germany → Call Center Agent is a “medical device consultant” (requires specific additional training

Challenges


Manufacturer vs. Operator


Requirements for Medical Device manufacturers are defined; Requirements for Operators are not harmonized

Germany: Medical Devices Operator Ordinance (MPBetreibV)

France: Approval of Hosting Provider (hosting service provider (“HSP”)) is required in certain cases (Article L.1111-8 / Public Health Code)

Manufacturer can also be Operator → Evaluate Pro’s and Con’s

Pharmaceutical Company can also be the Operator → Supposed by patients/users as data privacy issue?

Segregation of Responsibilities between Manufacturer and Operator

Precise specification of requirements for Operation (e.g. specification for Server, Infrastructure etc.)

Documented evidence about compliance with those requirements should be created by Operator

Consider Operations during complaint management process

Contract/Agreement between parties related to cooperation/communication should be available

Integration/Tests should be performed on production equivalent testing environment

Challenges


IT-Security/Cybersecurity


Safety Objectives are Confidentiality, Integrity and Availability

IT-Security needs to be considered already during Design & Development (incl. risk management)

Currently no standardized procedure available

Risk Assessment for IT-Security aspects should also be a basis for Design Inputs

Both needs to be considered: Security by Design as well as Security during Operations/Use

US FDA requires consideration of IT-Security (“Medical Device Cybersecurity) during development,

regulatory clearance and in the Post-Marketing Phase activities

Challenges


Data Privacy


Data privacy rules are inconsistent in the world

EU General Data Protection Regulation (GDPR): for Medical Software, as a rule a processing of special categories of personal data ("health data") takes place

Recommendations:

Involve data protection officers (data protection impact assessment necessary)

Design Privacy statements / Informed Consents in a user-friendly manner

Plan technical and organizational measures early on

Establish processes for data subject rights (in particular right to information, right to deletion, right to data transfer)

Issue: Data access by pharmaceutical company may be viewed critically by patients

Outsourcing of operations makes sense → Contractual exclusion of data access by the pharmaceutical company

Otherwise clear communication in the privacy policy/Informed Consent

Consider Data privacy also with complaints, support etc.

What data is collected?

Who (pharmaceutical companies, legal manufacturers, operators) receives which data from the complaint?


Summary

Benefits and Challenges with Medical Software

Summary


Medical Software is Software (e.g. smartphone apps, websites) which is regulated as it falls

under the definition of a medical device.

Medical Software allows to provide additional benefits to patients, physicians and other HCP.

It furthermore opens new opportunities for payers but also for pharmaceutical companies.

The introduction of Medical Software requires pharmaceutical companies to change existing

processes and to setup new processes, as Medical Software is a new type of product

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Thank you!

Bye-Bye

DDF Summit 2019 Benefits and Challenges with · 4 /// Medical Software - Benefits and Challenges...

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