Sundhedsappsfra innovation til kommercialisering

Transcription

1 Sundhedsappsfra innovation til kommercialisering App Certificering Brian Hedegaard, DELTA

2 Apps Hot as ever 2014 ~ ~ ! ~ 40% medical device or likely to be! 82% downloaded less 50,000 times 68% generate less $10,000 Research2guidance mhealth App Developer Economics 2014 Ref:

3 Medical Device approval CE-MARKING

4 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

5 Medical Device DEFINITION

6 Medical devices- EU 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 Applicable Legislation in DK: Council Directive 93/42/EEC of 14 June amendments Bekendtgørelse 1263 af 8 december 2007

7 What is a Medical device? 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 Not a medical device Claims! The benefit from use you are stating Marketing material Web, Printed, presentations, sales reps.

8 Software as medical device (MEDDEV 2.1/6) Application Description Qualification as medical device Hospital information systems Decision support software Information systems Communicationsystems Control of logistics admissions, planning and administrative tasks Planning of radiological treatment, Medication planning, Electronic Health Records, Clinical information systems , mobile, video conference, sw tranfer of messages likeprescriptions and Health Records Software communicating alarms based on vital parameters for the patient Telemedicin Telesurgery Yes Video consultation software Home monitoring No Yes No (but might be) No (but might be) Yes No Communicationspart No, Monitoring sw might be

9 Regulated functionality Reconstruction, Lossy compression, Fltering, Pattern recognition, Modelling, Transformation, Classification (e.g. scoring of tumors against specific criteria), Rendering 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 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.

10 Non-Regulated functionality 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)

11 Medical device App DEVELOPMENT

12 Path to market Idea Requirements -User - Environment Intended use Medical device? YES NO Identify applicable directives Class I Class Im Classification Class IIa-> III Choosing path to CE (Conformity assesment procedure) Annex VII Annex VII Annex II QA QMS Registration CE Implementation -> Technical File Registration (NB assesment) CE Post market surveillance Assessment with NB CExxxx

13 In 8 small steps.. Quality Management Risk Analysis

14 Step 0 Concepting phase Regulatory IPR Freedom to operate Novelty Commercial User need Market potential Market penetration Business case Reimbursement Lifecycle costs Product Concept Intended use Claims USP Clinical Publications Clinical evaluation Product Technology Materials Processes Strategy Product risks Launch plan Approval process Risk Patient / project

15 Step 1 identifying applicabledirectives (EU) Directive 93/42/EEC - medical devices Directive 90/385/EEC - Active Implantable Medical Devices Directive 98/79/EC - In Vitro Diagnostic Medical Devices. Medical Device Regulation 2016? Applicability is based on INTENDED USE

16 Determining CLASSIFICATION

17 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 18

19 Choosing CONFORMITY ASSESMENT PROCEDURE

20 Step 3 - Conformity assessment procedure Design Annex III EC Type Examination Manufacture Annex VII EC Declaration of conformity Hardly applicable for software Annex IV EC Verification Annex V Production quality assurance Annex VI Product quality assurance Annex II Full Quality Assurance system CE CE xxxx Ref: NB-MED/2.2/rec4 rev 5.

21 Avoid harms - think RISK MANAGEMENT

22 Risk management Terms and definitions Hazard: Potential source of harm. - [ISO clause 2.3] Hazardous situation: Circumstance in which people or the environment are exposed to one or more hazard(s). - [ISO clause 2.4] Harm: Physical injury or damage to the health of people, or damage to poperty or the environment. - [ISO clause 2.2]

23 Risk management Terms and definitions Risk: Combination of the probability of occurrence of harm and the severity of that harm. - [ISO clause 2.13] Residual risk: Risk remaining after protective measures have been taken. - [ISO clause 2.12] Safety: Freedom from unacceptable risk. - [ISO clause 2.20]

24 UI Considerations 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

25 Medical device DEVELOPMENT

26 Step 4 Implementation 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 Quality Management Risk Analysis

27 Compiling the TECHNICAL DOCUMENTATION

28 Step 5 Compile the Technical File 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.

29 Step 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 requiredfor the QMS and Technical file Declaration of Conformity Declaring conformance with ALL applicable legislation

30 Step 8 Apply CE- Mark / Registration 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 Registation fee: 1149 kr. Yearly manufacturer fee 2015 Employees Fee kr kr kr kr. Over kr. GMDN: Global Medical Device Nomenclature

31 Important standards App Development ISO Quality Control ISO Risk management ISO Software Life Cycle ISO Usability Design for Human factors ISO Medical Electrical Systems ISO Clinical trials ISO Biocompatibility (Not for software)

32 Take home part 1 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)

33 Take home part 2 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!

34 Sundheds-apps fra innovation til kommercialisering Certificeringer af sundheds-apps Susie Wagner Bondorf Partner og med-stifter

35 EU guidelines on assessment of the reliability of mobile health applications First draft of the guidelines presented at an open stakeholder meeting in Brussels 4 th of May 2016

36 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)

37 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)

38 Three main groups of apps 1.CE marked medical Additional focus areas like e.g. GUI devices. 2.Other apps used in a medical setting. 3. Health & wellbeing apps 2. Other apps used in a medical setting 1. CE marked 3.Health & wellbeing apps.

39 Process for guideline production First Iteration as presented today Followed by stakeholder engagement and written feed-back Second Iteration targeted for end-may Followed 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 December Final 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 ( )

40 Focus groups ücitizens. üapp developers. ühealthcare professionals. üprivate & public healthcare providers, public authorities & health ins. providers.

41 A view to the engine compartment Scrutiny 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? Covered by Privacy C of C?

42 Further information Find the first draft of the guidelines here: ay&doc_id=15353 Thank you!

43 Susie Wagner Bondorf Brian Hedegaard