Compliance-oriented development of innovative medical devices from research to market
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1 Compliance-oriented development of innovative medical devices from research to market Workshop at BRI Pontedera, Italy Ovesco Endoscopy AG Tuebingen, Germany Dr. Sebastian Schostek
2 TRL and the valley of death Why regulations? Some basics The how-to
3 TRL and the valley of death Compliance Workshop Valley of death 3
4 TRL and the valley of death Compliance Workshop Valley of death 4 Resources spent Resources required
5 TRL and the valley of death Why regulations? Some basics The how-to
6 Innovation in medical technologies 6 Disruptive innovations cause the interface between engineering and medicine to oscillate this drives the advancement of a new field. Here: Minimally invasive surgery. Engineering: TECHNOLOGY Medicine: TECHNIQUE Technology push through a novel technique New technology requires the development of novel techniques Technology push through a novel technique Kurt Semm 1980: The advent of Minimally Invasive Surgery (MIS)
7 Innovation in medical technologies 7 The driving cycle consist of four essential steps. An advancement in one discipline requires and advancement in the other (steps 1, 3). Decisive is the purposeful translation between the fields (steps 2, 4). Engineering: TECHNOLOGY Consequence: Increased level of complexity and difficulty 2 Motivation: Facilitate / ease procedures through technology Consequence: Increased level of complexity and difficulty Medicine: TECHNIQUE Motivation: Improve safety, efficacy and patient comfort Consequence: New technique related paradigms (e.g. user interface) 4 Motivation: Improve safety, efficacy and patient comfort Kurt Semm 1980: The advent of Minimally Invasive Surgery (MIS)
8 8 Innovation in medical technologies Engineering: TECHNOLOGY Medicine: TECHNIQUE Wilhelm Conrad Röntgen 1895 Learnings: In the field of medical technology, the emergence of innovations realies on both engineers and doctors to the same extent (symmetrical). An innovation can be driven by either engineering or medicine. Decisive for exploitation is to purposefully act at the interface between both fields. Engineering: TECHNOLOGY Medicine: TECHNIQUE Kurt Semm 1980
9 Innovation in medical technologies: Stakeholders 9 Politics and authorities Medical device industry Market (Naiv population) Interface Healthcare providers Payers
10 What s so special about medical devices? 10 Industrial product, e.g. smartphone It is safe It works It is easy to use Service is provided Good guidance provided Price Colour Design Medical device, e.g. EndoVESPA It is safe It works It is easy to use Service is provided Good guidance provided Price Colour Design
11 TRL and the valley of death Why regulations? Some basics The how-to
12 Definition of a medical device (see MDD 93/42/EEC) 12 Medical device means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and 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, diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, investigation, replacement or modification of the anatomy or of a physiological process, control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
13 Compliance It s all about requirements 13 Directives and standards Top-down requirements Design input Medical device development Notified body Market Design input Bottom-up requirements User requirements, risk management file output, usability file output, manufacturability, marketing, etc.
14 Compliance It s all about requirements 14 Directives and standards Top-down requirements Design input Medical device development Notified body Market Design input Bottom-up requirements User requirements, risk management file output, usability file output, manufacturability, marketing, etc.
15 Directives Why regulations? Compliance Workshop Compliance Top-down requirements 15 Directives: MDD 93/42 or AIMD 90/385 or IVD 98/79 MDD: Medical Device Directive 93/42/EEC Applies to all other Medical devices Includes classification AIMD: Active implantable medical devices 90/385/EEC Applies to AIMD only No classification included IVD: In-vitro diagnostic medical devices 98/79/EC Applys to IVD only No classification included
16 Compliance Top-down requirements 16 MDD: Medical Device Directive 93/42/EEC Article 1: Definitions, scope Article 2: Placing on the market and putting into service Article 3: Essential requirements Article 4: Free movement, devices intended for special pruposes Article 5: Reference to standards Article 6: Committee on Standards and Technical Regulations Article 7: The Committee Article 8: Safeguard claus Article 9: Classification Article 10: Information on incidents occuring following placing of devices on the market Article 11: Conformity assessment procedures Article 12: Particular procedure for systems and procedure packs and procedure for sterilisation Article 13: Decision with regard to classification and derogation clause Article 14: Registration of persons responsible for placing devices on the market Article 15: Clinical investigation Article 16: Notified bodies Article 17: CE marking Article 18: Wrongly affixed CE marking Article 19: Decision in respect of refusal or restriction Article 20: Confidentiality Article 21: Repeal and amendment of Directives Article 22: Implementation, transitional provisions Annex I: Essential requirements Annex II: EC declaration of conformity Annex III: EC type-examination Annex IV: EC verification Annex V: EC declaration of conformity (production quality assurance) Annex VI: EC declaration of conformity (product quality assurance) Annex VII: EC declaration of conformity Annex VIII: Statement concerning devices for special purposes Annex IX: Classification criteria Annex X: Clinical evaluation Annex XI: Criteria to be met for the designation of notified bodies Annex XII: CE marking of conformity
17 Compliance Top-down requirements 17 MDD: Medical Device Directive 93/42/EEC Article 1: Definitions, scope Article 2: Placing on the market and putting into service Article 3: Essential requirements Article 4: Free movement, devices intended for special pruposes Article 5: Reference to standards Article 6: Committee on Standards and Technical Regulations Article 7: The Committee Article 8: Safeguard claus Article 9: Classification Article 10: Information on incidents occuring following placing of devices on the market Article 11: Conformity assessment procedures Article 12: Particular procedure for systems and procedure packs and procedure for sterilisation Article 13: Decision with regard to classification and derogation clause Article 14: Registration of persons responsible for placing devices on the market Article 15: Clinical investigation Article 16: Notified bodies Article 17: CE marking Article 18: Wrongly affixed CE marking Article 19: Decision in respect of refusal or restriction Article 20: Confidentiality Article 21: Repeal and amendment of Directives Article 22: Implementation, transitional provisions Annex I: Essential requirements Annex II: EC declaration of conformity Annex III: EC type-examination Annex IV: EC verification Annex V: EC declaration of conformity (production quality assurance) Annex VI: EC declaration of conformity (product quality assurance) Annex VII: EC declaration of conformity Annex VIII: Statement concerning devices for special purposes Annex IX: Classification criteria Annex X: Clinical evaluation Annex XI: Criteria to be met for the designation of notified bodies Annex XII: CE marking of conformity
18 Compliance Top-down requirements 18 MDD: Medical Device Directive 93/42/EEC Article 1: Definitions, scope Article 2: Placing on the market and putting into service Article 3: Essential requirements Article 4: Free movement, devices intended for special pruposes Article 5: Reference to standards Article 6: Committee on Standards and Technical Regulations Article 7: The Committee Article 8: Safeguard claus Article 9: Classification Article 10: Information on incidents occuring following placing of devices on the market Article 11: Conformity assessment procedures Article 12: Particular procedure for systems and procedure packs and procedure for sterilisation Article 13: Decision with regard to classification and derogation clause Article 14: Registration of persons responsible for placing devices on the market Article 15: Clinical investigation Article 16: Notified bodies Article 17: CE marking Article 18: Wrongly affixed CE marking Article 19: Decision in respect of refusal or restriction Article 20: Confidentiality Article 21: Repeal and amendment of Directives Article 22: Implementation, transitional provisions Annex I: Essential requirements Annex II: EC declaration of conformity Annex III: EC type-examination Annex IV: EC verification Annex V: EC declaration of conformity (production quality assurance) Annex VI: EC declaration of conformity (product quality assurance) Annex VII: EC declaration of conformity Annex VIII: Statement concerning devices for special purposes Annex IX: Classification criteria Annex X: Clinical evaluation Annex XI: Criteria to be met for the designation of notified bodies Annex XII: CE marking of conformity
19 Compliance Top-down requirements 19 Harmonized standards For a start: focus on standards with relevance on construction and design
20 Compliance It s all about requirements 20 Directives and standards Top-down requirements Design input Medical device development Notified body Market Design input Bottom-up requirements User requirements, risk management file output, usability file output, manufacturability, marketing, etc.
21 Compliance Bottom-up requirements 21 Risk management file User requirements EN ISO Medical device, e.g. EndoVESPA It is safe It works Usability file EN It is easy to use Service is provided Good guidance provided Manufacturer certification EN ISO Manufacturability Marketing Price Colour Design
22 TRL and the valley of death Why regulations? Some basics The how-to
23 The how-to - Compliance Workshop Methodology: Sources (non-exclusive) 23 Europe: EN ISO Chapter 7.3 For programmable electrical medical systems (PEMS): EN (3 rd edition) Chapter 14.4 For medical software: EN FDA: CFR Design controls Available online (google CFR )
24 The how-to - Compliance Workshop Methodology: Implementation Start Planning Project plan User needs A A normative and regulatory requirements User requirements Application validation plan Design Input Product requirements Test plan Execution A Risk management Usability Verification and validation Outputs Manufacturability Test reports Specifications Transfer into production List of applicable Standards Application validation Manufacturing documentation Conformity evaluation End Riskmanagement file Validation reports Technical documentation Usability file Manufacturability input
25 The how-to - Compliance Workshop Methodology: Implementation 25 Start Planning A Project plan normative and regulatory requirements User needs User requirements Application validation plan A Design Input Product requirements Test plan Execution Iterative development cycle A Risk management Usability Verification and validation Outputs Manufacturability Test reports Specifications Transfer into production List of applicable Standards Application validation Manufacturing documentation Conformity evaluation End Riskmanagement file Validation reports Technical documentation Usability file Manufacturability input
26 Thank you Compliance-oriented development of innovative medical devices from research to market Workshop at BRI Pontedera, Italy Ovesco Endoscopy AG Tuebingen, Germany Dr. Sebastian Schostek
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