Boost­ing Med­i­cal De­vice Start-ups

BioSpectrum (India) - - BIO CONTENT - VISHNU BHAT, Chair­man, Blue Neem Med­i­cal De­vices

Med­i­cal De­vices In­dus­try is a sun­rise sec­tor in In­dia to­day. The coun­try has de­pended on im­ports for way too long. It is time for In­dia to as­sert and es­tab­lish a strong base of man­u­fac­tur­ing med­i­cal de­vices in the coun­try.

Health Care in In­dia had not taken cen­tre stage for a very long time. It is only now that we are see­ing enor­mous fo­cus on clean­li­ness, san­i­ta­tion and ba­sic health care. This is great news for the med­i­cal de­vices in­dus­try, which is still in its in­fancy in In­dia.

The first great news for any or­gan­i­sa­tion look­ing to make a dif­fer­ence in the med­i­cal de­vices in­dus­try is new reg­u­la­tory frame­work - the med­i­cal de­vices rules 2017. This is a great step to­wards build­ing a cred­i­ble and ro­bust med­i­cal de­vices ecosys­tem in the coun­try.

Cur­rently in In­dia, there are am­ple op­por­tu­ni­ties for any star­tup­whether it is about start­ing and build­ing an or­gan­i­sa­tion, which makes de­vices that have al­ready ex­isted in the mar­ket or bring­ing a com­pletely new and in­no­va­tive con­cept; also for an or­gan­i­sa­tion fo­cused on in­cre­men­tal in­no­va­tion or ones bring­ing dis­rup­tive ideas into the mar­ket. In­dia is a cru­cible for ideas in health­care in­no­va­tion. As the scale of prob­lems we have with re­spect to ac­cess to health­care, cost of health care and qual­ity of health­care is prob­a­bly un­ri­valled in any other part of the world.


Start-ups in med­i­cal de­vices and health care are gen­er­ally faced with the daunt­ing moun­tain of cap­i­tal in­vest­ment.

Also, for any start-up in med­i­cal de­vices, it is im­por­tant to en­sure pa­tient safety. There­fore the fun­da­men­tal frame­work of de­vel­op­ment is risk elim­i­na­tion. Of­ten, the over­all ef­fort re­quired to bring the prod­uct to mar­ket, tak­ing into con­sid­er­a­tion all the de­sign frame­works, de­vel­op­ing the prod­uct and test­ing is hard to gauge dur­ing the ideation stage. Sig­nif­i­cant over­runs end up be­ing a com­mon phe­nom­e­non.

Given that this is early days for med­i­cal de­vices in­dus­try, find­ing ex­pe­ri­enced tal­ent is a chal­lenge. There is of course cross learn­ing that is pos­si­ble from the well-es­tab­lished pharma or bio tech in­dus­try but med­i­cal de­vices in­dus­try has their own nu­ances tech­ni­cally.

A min­i­mum vi­able prod­uct in med­i­cal de­vices is gen­er­ally ex­pected to be in ad­vanced stage, given the risk ori­ented na­ture of their ap­pli­ca­tion. Start-up founders tend to un­der­es­ti­mate the process ori­en­ta­tion, ad­her­ence to the qual­ity man­age­ment sys­tem and ex­pec­ta­tions of the reg­u­la­tors. Many don’t see the pit­falls along the way. These pit­falls sometimes end up be­ing ex­pen­sive mis­takes that are not ac­counted for in the be­gin­ning.

Test­ing mar­ket ac­cep­tance with a beta launch is most of­ten not pos­si­ble given the na­ture of the de­vices. There­fore, a thor­ough mar­ket study needs to take place be­fore the prod­uct gets too far into the life cy­cle. Else, the mis­takes are likely to be ex­pen­sive.

Fi­nally, start-up’s that cross all hur­dles and make qual­ity prod­ucts in In­dia face the hur­dle of per­cep­tion. Tra­di­tion­ally, due to lack of reg­u­la­tions, and lo­cal ecosys­tem be­ing small, start-ups do face pre­con­ceived no­tion about qual­ity from physi­cians, pur­chase teams and con­sumers about lo­cally made prod­ucts. Sig­nif­i­cant change of per­cep­tion has to be de­vel­oped through col­lab­o­ra­tion, con­stant com­mu­ni­ca­tion and con­fi­dence build­ing mea­sures.

In con­clu­sion, de­spite the var­i­ous hur­dles a start-up has to face, the In­dian Med­i­cal De­vices in­dus­try does hold a lot of prom­ise. If there is a good idea, it will be un­for­tu­nate if the con­sumers don’t ben­e­fit from its out­come. The best prac­tices and in­ter­na­tional stan­dards have laid out sim­ple frame­work that en­sures suc­cess. The lead­er­ship needs to have the grit, de­ter­mi­na­tion and per­se­ver­ance to see through a steady state of oper­a­tions. Hav­ing the bird’s view of the world at the same time de­vel­op­ing the worm’s view of de­tails on the ground will lead to suc­cess.



Chair­man, Blue Neem Med­i­cal De­vices

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