Fra udvikling til kommercialisering af kliniske apps Apps som medicinsk udstyr? 29/ Brian Hedegaard, DELTA

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1 Fra udvikling til kommercialisering af kliniske apps Apps som medicinsk udstyr? 29/ Brian Hedegaard, DELTA

2 Awareness please..

3 Brian Hedegaard Senior Consultant - Medical devices Approval Management Compliance engineering Telemedicine solutions Software Project Management Chair of Medical device software expert group Danish Medical device Industry association Continua ( Personal Connected Health Alliance) Co-Chair EU Regulatory task force EU WG, Regulatory WG Electronics engineer Software development and test Process improvement Management

4 Who is DELTA

5 DELTA at a glance Advanced Technology Group (GTS) Universities GTS Industry Technology Research Commercialisation of technologies Production Consultancy Test

6 DELTA at a glance From Idea to Market Mockups / sketching Rapid functional prototypes Development processes - Improvability Compliance processes -QMS Components: Asic s and optical filters Design test -HALT / HACT -Acoustics OEM developments MDD/IVD Compliance testing EMC, Wireless - Reliability, Transportation - Software certification Idea & Requirements Design Implementation Test Manufactoring & Operations Regulatory, compliance and technical Consultancy

7 DELTA App services Afklaring af hvorvidt en app er medicinsk eller ej Udarbejdelse af regulatorisk strategi Etablering af kvalitetssystem I henhold til ISO Facilitering af risiko analyse Rådgivning omkring telemedicin og Continua og Continua certificering Workshop for modning af organisationen til håndtering af medicinsk udstyr Agile Engine Projektledelse på approval management produkt godkendelse Test med brugere I CoLab Denmark

8 What is an APP

9 Apps App is an abbreviation for (software) APPlication. An app can run on the Internet, on a computer, or on your phone or other electronic devices. An app is considered stand alone software

10 The world of m-health APPs

11 Health and fitness apps Ref: https://ec.europa.eu/digital-agenda/en/news/mhealth-what-it-infographic

12 Health and fitness apps Over 50% Of Mobile Health Apps Are Downloaded Less Than 500 Times 82% downloaded less than 50,000 times 68% generate less $10,000 Research2Guidance mheath App Developer Economics 2014 Ref: https://ec.europa.eu/digital-agenda/en/news/mhealth-what-it-infographic

13 Health & Fitness Apps - usage General health and fitness apps are Currently the largest sector of mhealth apps and most profitable. 70 %of Americans use some form of mobile health (mhealth) app every day.. Analysis of health apps in app stores from 2012 showed ~8% clearly regulated ~16% possibly regulated ~17% might be regulated ~2% FDA approved Potentially apps in the market posing potential risk to users

14 App developers paradigme App development Idea > hack-> launch -> succes or failure If Fail..Go to start If Success - Go to the bank Business case confirmed or busted Medical App development Idea > Concept > Business case > Planning > Documenting >Developing > Testing/Verification > Validation > Clinical evaluation ->Registration > Post market survailance-> Planning If Fail Go to the bank If Succes Go to start..

15 What makes a MEDICAL DEVICE

16 Definition of Medical Device - EU Council Directive93/42/EEC (General) any instrument, apparatus, appliance, Software, material. 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...(1) Required to have an intended in a medical context as opposed to nonmedical use, e.g. in sports Accessory means an article which whilst not being a medical device is intended to be used together with a medical device to enable it to be used as intended by the manufacturer of the device Accessories shall be treated as medical devices in their own right (1) Ref: Council Directive 93/42/EEC of 14 June amendments

17 Regulated functionality - EU Regulated functionality (according to MEDDEV) reconstruction, lossy compression, filtering, pattern recognition, modelling, transformation, classification (e.g. scoring of tumors against specific criteria), 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), rendering, 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.

18 Non regulated functionality NON Regulated functionality (FDA) 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)

19 Upcoming regulation at a glance Harmonized legislation across EU (Regulation) Accessory: whilst not being a medical device, is intended.. to be used with medical device(s) to specifically enable or assist the device(s) to be used in accordance with its/their intended purpose(s) Some new requirements to software validation and verification under proposed new medical devices rules: Introduction of mobile computing platform Enhanced focus on development processes NOTE! The regulation is still in draft and subject to change

20 Awareness please.. And the answer is??

21 Case 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

22 App extensions WEARABLES AND e-health

23 Wearables and accessories

24 Wearables - data collection Source:

25 Wearables - data collection

26 Security.. and data protection

27 Path to certification in 8 Steps DEVELOPING MEDICAL DEVICES

28 IPR Freedom to operate Adequate inventiveness / novelty Commercial User need Market potential Market penetration Business case Product Concept Intended Use Claims USP Reimbursement Cost in use Quality of life Regulatory Regulatory Strategy - Product risk - Launch plan - Registration priority Approval process Idea Clinical Publications Clinical evaluation - Literature study - Clinical trial Product Technology Materials Processes Risk Management End User focus

29 From idea to market in 8 small steps Quality Management Risk Analysis

30 Risk Management ISO Hazard (Potential source of harm) Hazardous situation (Circumstance in which people or the environment are exposed to one or more hazard(s)) Harm (Physical injury or damage to the health of people, or damage to property or the environment) Risk (Combination of the probability of occurrence of harm and the severity of that harm) Residual risk (Risk remaining after protective measures have been taken) Safety (Freedom from unacceptable risk)

31 Important standards and guidance documents 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) And potentially many more Depends on the product and intended use Guidance documents: MEDDEV 2.1/6 MEDDEV Classification of medical devices FDA MMA guidance

32 Where to go..

33 MedicoApp.dk

34 Brian Hedegaard

35 Legal stuff The information in this presentation is provided for information purposes only and is not exhaustive. While every endeavor is made to ensure that the information is correct at the time of publication The information provided may not be fully applicable for all devices or product and does not take into account the specifics of any person's position or variations in local implementations. The information is not intended to be legal advice, cannot be relied on as legal advice and should not be a substitute for legal advice.

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