You are on page 1of 28

Medical Device Evaluation

Ethical & regulatory issues

Muraleedharan CV

What are medical devices ?

or compensation for an injury or handicap control of conception pharmacological.What are medical devices ?  any instrument. could be aided by such means   does not achieve its principal intended action by   . treatment or alleviation of disease. material or other article. apparatus. monitoring. appliance. prevention. immunological or metabolic means But. including the software intended to be used for human beings for the purpose of:   diagnosis.

Disposables & Reusables ) . testing kits and reagents)  Therapeutic devices (Implantables. covering 50 clinical specializations  Broadly classified as  Diagnostic devices ( Medical instrumentation.5 million different devices Consist of 900 product groups.Medical devices – range   About 1.

Medical devices – global market 80 70 60 50 40 30 20 10 0 2004 Market WHO MEDICAL DEVICE REGULATIONS Global overview and guiding principles .2005 US Europe Japan Latin America China India Others World Market in 2008 ~ $300 Billion Source – US$ (Billion) .

Medical devices – Indian market       Healthcare sector – 5.400 crores  Source : CII – McKinsey Report on Healthcare in India – 2010 & Indian Market Estimates – HIMA.000 crores Medical Instrumentation – Rs.30.12% 75 – 80 % met by imports Indigenous production : ~ Rs.5 % of GDP – Rs.000 crores Medical devices ~ Rs. 2008 .000 crores Annual growth rate : 10 .170.000 crores Pharmaceutical sector – Rs.2.15. USA .12.

Medical devices – India’s strengths  Strong and well developed healthcare segment  11500 hospitals and 14000 diagnostic laboratories   Performance in pharmaceuticals segment Human resource availability    > 500 research institutions. 400 universities Second largest pool of scientists and engineers Youngest work force amongst growing economies Shift in disease pattern – from infectious to life style related Expanding rich and middle income group  Fast growing internal market   .

Quality English language advantage HIGH .India’s competitive advantage Surplus India Indonesia Projected work force in 2020 Brazil Turkey Mexico Israel Philippines Russia China Ireland Short fall LOW HR Strength. Productivity.

Medical devices – India’s weaknesses    Very little industrial R&D Lack of adequate preclinical evaluation facilities Shortage of training facilities for medical device segment    Research and development Good manufacturing practice Regulatory issues and product certification   Limited availability of information Weak   national regulatory system focus on ethical reviews for human protection .

life cycle .Medical device .

Assurance of medical device safety     Absolute safety cannot be guaranteed A risk management problem Closely aligned with device effectiveness / performance Requires shared responsibility among the stakeholders  Risk based approach .

Risk based classification  RISK defined by nature of body contact and duration of body contact.  NATURE –    direct / indirect Internal / external Blood / bone / tissue contacting Short term <24hrs Medium term < 30 days Permanent > 30 days  DURATION –    .

Risk based classification CLASS RISK LEVEL DEVICE EXAMPLES I IIa IIb III Low Risk Low-moderate Risk Moderate-high Risk High Risk Surgical instruments / tongue depressors Hypodermic Needles / suction equipment Lung ventilator / orthopaedic implants. blood bags Heart valves / implantable defibrillator / shunts .

Level of regulation to risk Regulatory requirements High Low Device Class I IIa IIb III Increasing risk .

Medical device Vs drugs      Short product cycles ~ 5 . software (logical). nuclear and radiation. etc Great variety of scientific disciplines involved  Engineering.20 years Large variety of mechanisms of action Can fail due to myriad of faults –  mechanical. materials science. electronics. biological sciences Can fail after many years – in a manner not predictable initially . electrical.

complex than DRUGS An approach different from that of drugs is required for regulating medical devices . pharmacological function. are more multi disciplinary. side effects.Medical device Vs drugs Failure Modes  Minimal : Toxicity. removal from body Failure Modes    Gets qualified through  Preclinical safety evaluation  Phase 1 Clinical safety evaluation  Phase 2 efficacy  Phase 3 wider efficacy studies  Phase 4 : PMS     Biocompatibility Electronic instrumentation / Software Hemodynamics (blood contacting devices) Radiation Biological materials / Biodegradation Nano materials ….

Pillars of human protection Rights & welfare of human subjects ETHICAL REVIEW R E G U L AT O RY MECHANISM .

get CE Mark or FDA approval .expensive & time consuming Non-tariff barriers to trade in developed economies Difficulty in introducing into clinical trials / use No agency to assure safety  R&D labs developing medical devices   .Lack of regulatory framework  Patients / Clinicians – Compromise on safety & quality assurance Industry – no product certification for market acceptance    only way -.

Lack of ethical review  Patients / Clinicians – No independent review – lack of confidence in the device Industry – Data generated does not get accepted by regulatory bodies   Waste of effort and resources  R&D labs developing medical devices   Difficulty in introducing into clinical trials / use No legal protection .

ICMR. ICMR.Ethical guidelines     Ethical guidelines for biomedical research on human subjects. 2000 (Revised 2006) Guidance document on the humane care of animals in experimental research. ICMR. 2006 National guideline for stem cell research and therapy. 2004 . 2006 Ethical guidelines for biobanking in India.

1940  Drug to include “Devices intended for internal or external use in the diagnosis. treatment. mitigation or prevention of disease” 2006 : DCGI – notified a set of products – uses drug approach  Only a small segments of the entire medical device spectrum is covered  Documentation on regulatory mechanism and compliance requirements are not adequate .Status of regulation in India   1982 Amendments to Drug and Cosmetics Act.

Ensuring device safety Before use MED DEVICE REGULATION    During use HOSPITAL ACCREDITATION  Clinician  Hospital  Clinical engineers  Accreditation requirements  Manufacturer Regulatory authority Conformity Assessment Body (Notified body) NABH After use 1. Post-market surveillance by manufacturer Vigilance by regulatory authority . 2.

validation and risk / reliability analysis  Materials qualification  Physical and chemical characterisation  Biocompatibility evaluation  in vitro device evaluation in simulated systems  In-vivo evaluation in large animals   Quality systems & Good Manufacturing Practices 12 Aug 2011 Medical device & Ethics 23 .Device safety – Technical assessment  Pre-clinical evaluation Design control.

Good clinical practice 8-Aug-12 Medical device & Ethics 24 .CLINICAL INVESTIGATION OF MEDICAL DEVICES ISO 14155 : 2011 Clinical investigation of medical devices for human subjects -.

25.ea. PLACEBO / BLINDING / RANDOMISATION ?    Prospective control needed ? Would it improve the validity of the study? Single blinding / Randomization – would it improve the validity of the study? Controls – Starr-Edwards ball valve – Rs. – comparable ? 12 Aug 2011 Medical device & Ethics 25 .Case study – Chitra Heart Valve (ISO 5840)   Monocentric – safety study – 40 valves / 1 year Multicentric – safety & performance  + 266 added in 5 additional centres  Results compared with historical data of established mechanical valves. .000/. 35.000 ea.not comparable ? Medtronic-Hall tilting disc – Rs.

Membrane oxygenator – (ISO 7199)    Monocentric – safety study – 25 devices Multicentric – safety & performance .Case study -.additional 150 patients in 6 centres No blinding / No randomisation    Patients consenting for test device – Test group Others asked for consent to be part of Control group Is this acceptable ??   Test group – device free (without prior info) – other expenses charged except for additonal tests over standard of care. Control group – charged – except for any additional tests ? Single blinding / Randomisation – would it make the study better ? ? Cost of imported control device ?? 12 Aug 2011 Medical device & Ethics 26 .

non-device related Especially long term follow-up studies for implantable devices Now available for clinical evaluations from Indian companies  Statistical analysis and methodology   Insurance coverage  12 Aug 2011 Medical device & Ethics 27 .Other issues  Adverse event reporting  Device related vs.