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Indias Innovation Roadmap 2020 for Non-drug Devices and Technology Sector

Essential Requirements for Promoting

Innovation in Medical Device Development

Stage of development Essential Requirements

Identification of Product National registryInvolvement of clinicians and healthcare workersMarket Survey

Development of specification Institute-Clinician-Industry participationFree access to digital librariesDatabase on success and failures

Funding Attractive schemes to encourage young innovatorsFunding to University B.Tech/M.Tech studentsLong term funding for implants (medical implants take about 7-10 years fordevelopment)

Incentives for youngsters Innovation awardsOpportunity to visit other labs in India and aboardInnovation fellowshipsConcept/Product innovation funds

Organising the team Concept and product incubation centersTechnology Innovation labsConsultants

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Stage of development Essential Requirements

MentorsGuides

Assessing the current status National registryInvolvement of cliniciansPatent searchMarket SurveyDigital online library

Development Registry of facilities and vendorsShort term courses for young innovators

Computational & analysis facilities

Prototyping Machine shop, rapid prototyping and moulding facilities to meet thebiocompatibility requirementsMould flow analysis facilities

Bench top evaluation Technology parks & test facilities

Materials Availability of certified biomaterials

Material characterisation Sample preparation and test facilities

In-vitro evaluation Technology parks & test facilities

Packing and sterilisation validation Technology parks & test facilities

Safety Electrical as well as other safety issues

Scaling up Technology parks

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Stage of development Essential Requirements

Technician training schoolsVendor development National registry of vendors

CPCSEA approval Has to be more scientific while protecting the animal welfareProvision like if no reply is received within three months investigator canproceed with the experiments

Ex-vivo/In-vivo evaluation Large & Small animal breedingAccredited test facilitiesLong term maintenance of animals

Ethics committee approval Approved bodiesSupport in preparation of documents

Clinical trials Panel of CliniciansProtocolsInsurance

Regulation Indian Medical Device Act

Continuous improvement Scope and limitations in Medical device

Quality assurance Accredited test facilitiesTraining facilities in

-Biocompatibility-Good Manufacturing Practices-Cleanroom-Sterilisation

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Stage of development Essential Requirements

-Material preparation-Cleaning validation-Package validation

IPR Support for identification, drafting & filing of IPRPCT filing

Technology Transfer Support for agreement drafting

Industrial partnership Panel of IndustriesIncentives to Industries

Protection from unhealthy competitionMarketing Incentives

Regulations encouraging indigenous products