Sundhedsappsfra innovation til kommercialisering · Legislation: – Article 1-2 'medical device'...
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App Certificering Brian Hedegaard, DELTA Sundhedsapps fra innovation til kommercialisering
Transcript of Sundhedsappsfra innovation til kommercialisering · Legislation: – Article 1-2 'medical device'...
App Certificering
Brian Hedegaard, DELTA
Sundhedsapps fra innovation til kommercialisering
Apps – Hot as ever
Ref: https://ec.europa.eu/digital-agenda/en/news/mhealth-what-it-infographic
82% downloaded less 50,000 times68% generate less $10,000Research2guidance – mHealth App Developer Economics 2014
2014 ~ 97.0002015 ~ 165.000 !
50.000 …
2012 - ~ 40% medical deviceor likely to be!
CE-MARKINGMedical Device approval
EU Market and CE marking
• Legislation aligned between countries – one market
• CE marking is mandatory for most products and must be affixed before the product is placed on the market in EU
• Indicates that a product has been designed and manufactured in conformity with essential requirements in all applicable directives
• Products manufactured in compliance with harmonised standards benefit from a presumption of conformity
DEFINITIONMedical Device
Legislation: – Article 1-2 'medical device' means any instrument, apparatus, appliance,
Software, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:
Diagnosis, Prevention, Monitoring, Treatment or Alleviation of disease, injury or handicap
Required to have an intended use in a “medical context” as opposed to non-medical use, e.g. in sports
Medical devices - EU
Applicable Legislation in DK:
Council Directive 93/42/EEC of 14 June 1993 + amendments
Bekendtgørelse 1263 af 8 december 2007
Intended use:– What does it do
– Where is it intended to be used
– For whom is it intenteded
– By which means is the effect obtained
Claims !– The benefit from use you are stating
Marketing material– Web, Printed, presentations, sales reps.
What is a Medical device ?
Not a medical device
Software as medical device (MEDDEV 2.1/6)
Application Description Qualification as medical deviceHospital information systems Control of logistics – admissions,
planning and administrative tasksNo
Decision support software Planning of radiological treatment, Medication planning,
Yes
Information systems Electronic Health Records, Clinicalinformation systems
No (but might be)
Communication systems Email, mobile, video conference, swtranfer of messages like prescriptionsand Health Records
No (but might be)
Software communicating alarms basedon vital parameters for the patient
Yes
Telemedicin Telesurgery YesVideo consultation software NoHome monitoring Communications part – No,
Monitoring sw might be
Segmentation,
Registration (e.g. mapping a data set to a model or atlas or to another dataset, e.g. Registering an MRI image on a CT image),
Complex calculations,
Qualification (e.g. comparison of data against references),
Visualisation, and
Interpretation
Regulated functionalityReconstruction,
Lossy compression,
Fltering,
Pattern recognition,
Modelling,
Transformation,
Classification (e.g. scoring of tumors against specific criteria),
Rendering
For example: plotting data points over time against a bandwidth of (un)healthy values would typically be regulated functionality.
As an example, if the application is intended to carry out further calculations, enhancements or interpretations of entered/captured patient data, we consider that it will be a Medical Device.
If it carries out complex calculations, which replaces the clinician’s own calculation and which will therefore be relied upon, then it will certainly be considered a Medical Device.
NON Regulated functionality ( Currently)
Body Mass Index (BMI)
Total Body Water / Urea Volume of Distribution
Mean arterial pressure
Glascow Coma Scale score
APGAR score
NIH Stroke Scale
Delivery date estimator
Electronic copies of medical textbooks
Educational tools
Facilitate patient access to information
Business operations in healthcare settings (accounting, billing)
Generic aid (e.g. magnifying glass)
Non-Regulated functionality
DEVELOPMENTMedical device App
Path to market
Idea Requirements-User- Environment
Medical device
?
Intendeduse
Identify applicabledirectives
Classification
Choosing path to CE (Conformity assesment procedure)
Annex II
QMS
Annex VII
QA
Implementation -> Technical File
Assessment with NBRegistration
CE CExxxx
Class I Class IIa-> III
NO
YES
Annex VII
Registration(NB assesment)
CE
Class Im
Post market surveillance
In 8 small steps..
Quality Management
Risk Analysis
Step 0 – Concepting phase
IPR• Freedom to
operate• Novelty
Commercial• User need• Market potential• Market
penetration• Business case• Reimbursement• Lifecycle costs
Product• Technology• Materials• Processes
Clinical• Publications• Clinical
evaluationProduct Concept• Intended use• Claims• USP
Regulatory• Strategy• Product risks• Launch plan• Approval
process
Risk –Patient / project
Step 1 – identifying applicableDirectives (EU)Directive 93/42/EEC - medical devicesDirective 90/385/EEC - Active Implantable Medical DevicesDirective 98/79/EC - In Vitro Diagnostic Medical Devices.
Applicability is based on INTENDED USE
Medical Device Regulation
2016 ?
CLASSIFICATIONDetermining
Step 2 - Classification
Time Active product Invasive
Higher classification–more documentation and more control required
MEDDEV 2.1/6 and MEDDEV 2.4.1
18
Step 2 - Classification- EU
MEDDEV 2.4 /1 rev. 9 page 21
CONFORMITY ASSESMENTPROCEDURE
Choosing
Step 3 - Conformity assessment procedure
Annex VIIEC Declarationof conformity Annex IV
EC VerificationAnnex VI
Product qualityassurance
Annex IIFull QualityAssurance
system
Annex IIIEC Type Examination
Annex VProduction
qualityassurance
CE xxxxCE
Desi
gnM
anuf
actu
re
Hardly applicable for software
Ref: NB-MED/2.2/rec4 rev 5.
RISK MANAGEMENTAvoid harms - think
Terms and definitionsHazard:– Potential source of harm. - [ISO 14971 clause 2.3]
Hazardous situation:– Circumstance in which people or the
environment are exposed to one or more hazard(s). - [ISO 14971 clause 2.4]
Harm:– Physical injury or damage to the health of
people, or damage to poperty or the environment. - [ISO 14971 clause 2.2]
Risk management
Terms and definitionsRisk:– Combination of the probability of occurrence
of harm and the severity of that harm. - [ISO 14971 clause 2.13]
Residual risk:– Risk remaining after protective measures
have been taken. - [ISO 14971 clause 2.12]
Safety:– Freedom from unacceptable risk. - [ISO 14971 clause
2.20]
Risk management
Apps may introduce new or changed risks due to the special conditions of the platform (mobile computing platform)
Example 1: Reading and interpretation of radiological images on a mobile platform may be affected by:
– Screen size
– Contrast ratio
– Uncontrolled surroundings
Example 2: Colors
UI Considerations
DEVELOPMENTMedical device
Execution of development plan to: – Fulfill essential requirements
– Create Design History File
– Perform and update Risk assessment
– Ensure traceability in development
– Prepare Test
– Prepare Clinical evaluation
– Execute usability test
– Etc…
Step 4 – Implementation
Quality Management
Risk Analysis
TECHNICAL DOCUMENTATIONCompiling the
Compilation of documents describing the product in details eg.:– Essential requirements checklist
– Design History File
– Risk assessment
– Test Reports
– Production (and development) process
– Clinical evaluation
– Labelling
– Etc…
The manufacturer or the authorized representative established in the European Community is requested to keep copies of the technical documentation for a period of at least 5 years, in the case of implantable devices at least 15 years, after the last product has been placed on the market.
Step 5 – Compile the Technical File
Step 6 + 7 Assessment and Declaration of conformity
Assessment– Class I -No Notified Body assessment needed
– Class Im - Notified Body assessment needed - for the measurement part
– Class IIa, IIb and class III• Notified Body assessment required for the QMS and Technical file
Declaration of Conformity– Declaring conformance with ALL applicable legislation
Registration through web form (DK)
Class I device – Devicename
– Generic Device name
– Alternative device names
– Type of device (KLI, SBP, STE)
– Model
– (GMDN code)
Class IIa – >– Additional information and Notified Body declaration required
Step 8 – Apply CE- Mark / Registration
Registation fee: 1149 kr.
Yearly manufacturer fee 2015
Employees Fee0-5 4.686 kr.
6-20 14.056 kr.
21-50 23.426 kr.
51-100 39.045 kr.
Over 100 62.472 kr.
GMDN: Global Medical Device Nomenclature
ISO 13485 – Quality Control
ISO 14971 – Risk management
ISO 62304 – Software Life Cycle
ISO 62366 – Usability – Design for Human factors
ISO 60601 – Medical Electrical Systems
ISO 14155 – Clinical trials
ISO 10993 – Biocompatibility (Not for software)
Important standards –App Development
The motivation for the development is misguided– Too generic – must adress a specific problem
• If collecting data, data must be collected and filtered in a way that it translates a message to the end-user, whether that be a patient or clinician
Lack of Clinical involvement– Technologies do not operate in a vacuum – consider the environment– Think connectivity – data shall be available else where
Poor attention to Usability– Keep the user in mind (ability, educational level, surroundings)
– Design for multiple display sizes and resolution (sw)
Take home part 1
Not knowing the healthcare landscape– How can adoption be planned if the landscape is unknown
Not building to regulatory specifications– Wow effect doesn’t make the cut! Requirements from eg. FDA/MDD,
HIPAA/GDPR must be met.
Think 360°
Frontload development (refine the concept)Be agile – adapt to the market and needs– But be carefull to maintain documentation !
Selling an app does not translate to adoption. Selling a good app improves its chances dramatically !
Take home part 2
Sundheds-apps fra innovation til
kommercialiseringCertificeringer af sundheds-apps
Susie Wagner BondorfPartner og med-stifter
EU guidelines on assessment of the reliability of mobile health applicationsFirst draft of the guidelines presented at an open
stakeholder meeting in Brussels 4th of May 2016
Related Initiatives (1)üData protection
• industry-led privacy code of conduct for mobile health apps (process started in Apr 2015)
üMedical devices legislation• New regulations negotiated in the Council and EP• Updated MEDDEV guidance 2.1/6 on qualification and
classification of stand-alone software • Updated Manual on Borderline and Classification (two new
entries on mobile apps for the assessment of moles)üDigital Single Market strategy (6 May 2015)
• Public consultation on safety of apps and other non-embedded software (to be launched in May 2016)
Related initiatives (2)üEuropean standard on quality criteria for the
development of health and wellness apps• based on the PAS 277:2015 on Health and wellness apps –
Quality criteria across the life cycle (UK)• does not cover requirements for apps that are classified as
medical devices
üPolicy discussions at the Member States level (eHealth Network subgroup on mHealth)
üWHO-ITU innovation hub for mHealth (under H2020)
3.Health&wellbeingapps
Three main groups of apps
1.CE marked medical
devices.
2.Other apps used in a
medical setting.
3.Health & wellbeing
apps.
2.Otherappsusedinamedicalsetting 1.CE
marked
Additionalfocus
areaslikee.g.GUI
Process for guideline productionFirst Iteration – as presented today
Followed by stakeholder engagement and written feed-back
Second Iteration – targeted for end-MayFollowed by stakeholder engagement and changes to next draft in light of feed-back
Third Iteration – targeted for mid October Followed by stakeholder engagement and changes to next draft in light of feed-back
Fourth (and Final) Iteration – targeted for end DecemberFinal draft guidelines sent out for written comments to the extended stakeholder group.ü When feedback received, final draft guidelines produced and discussed with
Commission.ü Included in final report (2017-01-25)
Focus groupsüCitizens.
üApp developers.
üHealthcare professionals.
üPrivate & public healthcare providers, public
authorities & health ins. providers.
A view to the engine compartmentScrutiny questions:
Currently nine summary questions:üIs the app usable & accessible? (repeat for each o/s)üIs the app desirable to use?üIs the app credible?üIs the app transparent? üIs the app reliable?üIs the app technically stable?üIs the app safe?üIs the app effective?üIs the app private & secure?
CoveredbyPrivacyCofC?
Further informationFind the first draft of the guidelines here:http://ec.europa.eu/newsroom/dae/document.cfm?action=display&doc_id=15353
Thank you!
