The Hub will be concentrating on product development and completion of laboratory investigations leading to clinical trials. This will involve extensive experimental efforts from the part of the principal investigator of sanctioned projects. As approval procedure for marketing a medical device or instrument is very stringent, the research should be empowered to undertake such elaborate procedure. The Hub will conduct periodic training programs for this purpose.

In short, a prototype will undergo laboratory trials followed by experimental animal trials wherever necessary. At this stage, the principal investigator will be in a position to apply for ethical clearance followed by clinical trials. The Hub administration will be supporting these activities. At this stage, the Hub will identify a suitable industry for technology transfer along with the PI and the concerned institutions. The industry will be encouraged to fund the clinical trials at least partly. This is done to share the risk involved and also to get the product into the market.

The proposed action plan can be summarized as under:

1.???? Collaboration with partner institutions wherever necessary.

2.???? Preparation of specific project proposals both from MAHE as well as from outside organizations.

3.???? Identifying the technology readiness level (TRL) of each proposal. Based on this, the action plan will be drawn for each of the proposed projects.

4.???? The selection of projects for immediate funding will be on the basis of the identified TRL.

5.???? Wherever possible, prototype development will be initiated.

6.???? Once satisfactory prototype models are ready, these will be tested in the laboratories.

7.???? After obtaining a satisfactory completion certificate from the laboratory, the product will be considered ready for technology transfer.

8.???? At this stage, an appropriate industry partner will be identified, and the transfer of technology agreement will be drawn in consultation with the legal team.

9.???? Depending upon the transfer technology and the level of production ethical clearance will be obtained from the respective committees of the institutions.

10.? In case if an institution does not have the facility for ethical clearance, the hub will apply for ethical clearance from MAHE.

11.? Depending upon the ethical clearance, the stage of the prototype development, and industry involvement, the particular product will be considered ready for clinical trials.

12.? The clinical trials will be carried out in the respective institutions (depending upon the facilities available) or taken up by the hub administration. The clinical trials of such cases will be carried out at Kasturba Medical College under MAHE.

13.? The industry will be involved throughout this period along with the developing agency, sharing the expenditure wherever necessary.

14.? Depending upon the success of clinical trials, the product will be ready for marketing.

15.? The hub will conduct the market launch in the presence of MAHE officials, concerned partners, and DST functionaries.

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