Klinisch Onderzoek met Medische Hulpmiddelen (Medical Devices)

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1 Klinisch Onderzoek met Medische Hulpmiddelen (Medical Devices) Haga Ziekenhuis, Den Haag 10 November 2015 Klaas van t Klooster kvkloost@its.jnj.com

2 Inhoud Verschillen Medicijnen en Medische Hulpmiddelen Klinisch onderzoek met MHs Overwegingen van een MH fabrikant (Verwachte impact nieuwe European Medical Device regulation)

3 Pharma versus Devices The products Pharmaceuticals Limited number of products Based on pharmacology, chemistry, biotechnology and genetic engineering Biologically active and effective when absorbed by the body 10 years market exclusivity Medical devices More than products (different sizes, models, etc ) Based on mechanical, electrical and/or materials engineering Generally act by physical means No market exclusivity, but Intellectual Property (Patent)

4 Medische Hulpmiddelen 1. Passief (Medical Devices_(MDD) 93/42/EEC)) 2. Actief (met gebruik externe energie bron) (AIMDD_Active Implantable Medical Device Directive) 3. Meten (van lichaamsweefsel buiten het lichaam) (IVDD_In Vitro Diagnostics 98/79/EC) 4. (Combination Medical Device en Pharma)

5 Medical Devices High Risk Low Risk

6 7 Discovery Discovery: Opportunity Assessment; Identify unmet needs; identify potential solutions / concepts Team forms to Define Opportunity & Concepts Concept (Define & Measure): Define project concepts / measure requirements / CTQ s Concept Feasibility (Analyze ): Refine concept and analyze conceptual designs Project Charter VOC; Gather Design Inputs Pre-clinical & Technical Feasibility Early development (Design): Design in detail; Design Freeze; Process and supply chain development Development Full Development (Verify & Validate): Execute clinicals & validations Lanuch / 1 st Commercialization Commercialization Post Launch Project Team Disbands/ transfers to functional responsibilities Should Project Be Included in the Portfolio? Should Project Be Excluded from the Portfolio? Confidential Medical Devices & Diagnostics Group

7 Samenvatting verschillen pharma en medical device (onderzoek): Pharma: diagnose, werkzame bestanddeel, dosering en bijwerkingen Medische hulpmiddelen: klinische indicatie, technische specificaties van het product, toepassingsprocedure (leercurve), technische vaardigheden van de gebruiker, device/ procedure AE s. De Lifecycle van devices is vaak kort: productontwikkeling is vaak continue en in kleine stappen. (18 maanden vs 10+ jaar). Wanneer is er dan sprake van een nieuw product? Studies zijn nog niet klaar voordat er een nieuwe versie van het product wordt gelanceerd.

8 Samenvatting verschillen pharma en medical device (onderzoek): Meer nadruk op post market testing dan op pre-market Voor implantaten geen fase 1 mogelijk Vaak kleinere groepen met kortere follow up tijden Blindering vaak niet mogelijk Risico analyse is de basis van de goedkeuring (Clinical Evaluation) voor een medical device AE s: onderscheid tussen device en procedure gerelateerd Causaliteits-vraag leidt soms tot conflict met investigator

9 (Cont.) Samenvatting verschillen pharma en medical device (onderzoek): AE s kunnen ook betrekking hebben op een gebruiker (user). Standaardisering van chirurgische procedure is vaak lastig. ICH Good Clinical Practice (GCP) is bekend, maar de ISO14155 vaak niet

10 Klinisch Onderzoek_ Good Clinical Practice (GCP) Pharma: GCP-ICH Medische hulpmiddelen: ISO14155_GCP for medical devices

11 (Cont.) Samenvatting verschillen pharma en medical device (onderzoek): AE s kunnen ook betrekking hebben op een gebruiker (user). Standaardisering van chirurgische procedure is vaak lastig. ICH Good Clinical Practice (GCP) is bekend, maar de ISO14155 vaak niet ECs begrijpen soms de technische details van het device of het onderzoek niet.

12 (Cont.) Samenvatting verschillen pharma en medical device (onderzoek): Investigators moeten getraind worden in de toepassingsprocedure (operatie?) van het device. Goede chirurgen zijn soms niet de beste investigators. Devices en instrumenten opgeslagen in magazijn ipv in de apotheek. Hoge kosten + > 10+ jaar tot ontwikkelen nieuw medicijn + grotere afzet markt

13 Clinical strategy considerations New Devices Product team + Regulatory = Clinical Evaluation MEDDEV Rev Literature study Risk assessment Europe: CE US: FDA

14 Equivalence or New Device?

15 Equivalence? Clinical: used for the same clinical condition or purpose, at the same site in the body, in similar population (including age, anatomy, physiology); have similar relevant critical performance according to expected clinical effect for specific intended use. Technical: used under similar conditions of use; have similar specifications and properties e.g. tensile strength, viscosity, surface characteristics; be of similar design; use similar deployment methods (if relevant); have similar principles of operation. Biological: use same materials in contact with the same human tissues or body fluids.

16 Risk assessment_ residual risks R1 Acceptable risk R2 Residual risks: As Low as reasonably Practicable R3 Unacceptable Each company must develop its own risk analysis system. The risk matrix may differ per product. For example, a risk matrix for a heel warmer may not be adequate for an automatic defibrillator. Risk management_ ISO

17 Clinical strategy considerations New Devices Product team + Regulatory = Clinical Evaluation MEDDEV Rev Literature study Risk assessment Europe: CE US: FDA NO Pre-market study ISO14155 Post Market Surveillance Need for additional data? 1. Residual risks 2. Market Access Economic data Reimbursement Comparison against golden standard/ competitor Launch

18 European reimbursement landscape

19 Clinical strategy considerations New Devices Product team + Regulatory = Clinical Evaluation MEDDEV Rev Literature study Risk assessment Europe: CE US: FDA NO Pre-market study ISO14155 Post Market Studies Company organized Residual risks Market Access Investigator Initiated Studies (IIS) Post Market Surveillance Need for additional data? 1. Residual risks 2. Market Access Economic data Reimbursement Comparison against golden standard/ competitor Launch

20 Thank You Klaas van t Klooster kvkloost@its.jnj.com #

21 Verwachte impact nieuwe European Medical Device regulation

22 Changing European Medical Device regulation

23 Overview of the main proposed changes in the EU regulation Legislation expected to be completed Q2_2016 Where are we heading for? To establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation

24 Overview of the main proposed changes in the EU regulation Scrutiny mechanism For high-risk devices, an expert group (independent from the review by the Notified Body) may decide to scrutinize the Clinical Evaluation Report and Clinical Evidence generation plan.

25 Overview of the main proposed changes in the EU regulation Narrow the definition of equivalency..for device has been designed by modifications of a device already marketed by the same manufacturer* * Or availability of full design file

26 Overview of the main proposed changes in the EU regulation Increased postmarket surveillance requirements the manufacturer shall proactively collect and evaluate clinical data from the use in or on humans of a device. within its intended purpose. With the aim of confirming the safety and performance throughout the expected lifetime of the device, the continued acceptability of identified risks and to detect emerging risks on the basis of factual evidence Identifying possible systemic misuse or off-label use of the device with a view to verify the correctness of its intended purpose

27 Assessing Dependency (*) * Coutesy Medtech Europe Device Pre-market Post-market Device 50% PMCF 50% Expert in the field Highly trained Highly supervised 50% Tested Compatible Controlled 50% Expert in the field Highly trained Highly supervised Device PMS Patient Medical Outcome Patient Medical Outcome 50%

28 Thank You Klaas van t Klooster kvkloost@its.jnj.com #