MA­JOR PLAY­ERS IN THE IVD MAR­KET

BioSpectrum (Asia) - - Cover Story - Source- Eval­u­ateMedtech

data from med­i­cal grade de­vices and pro­vides an in­dex which helps clin­i­cians as­cer­tain if a pa­tient is go­ing to have a health de­te­ri­o­ra­tion all within a se­cure net­work. This en­ables med­i­cal in­ter­ven­tion in ad­vanced of the pa­tient be­ing ad­mit­ted to hos­pi­tal. Hence im­prov­ing pa­tient clin­i­cal care, qual­ity of life and also sav­ing pre­cious re­sources. Im­por­tantly, pro­vid­ing con­sumer con­fi­dence in per­sonal data se­cu­rity is crit­i­cal if we are to reach the full po­ten­tial of this con­ver­gence” says Kuldeep Singh of Bio­four­mis.

He fur­ther says “Bio­four­mis is work­ing to de­ploy re­mote clin­i­cal care ser­vices for pa­tients post dis­charge from hos­pi­tal. Pa­tients are mon­i­tored util­is­ing med­i­cal grade sen­sors and ac­cess their clin­i­cal care team through a mo­bile app. The care team them­selves have a dash­board that pro­vides them with on­go­ing phys­i­o­logic data from the pa­tient’s de­vices. Cost con­tain­ment is be­ing achieved through ac­cess­ing tele­health rev­enue streams and mea­sur­ing out­comes to prove th­ese new ser­vices gen­er­ate net sav­ings and im­prove qual­ity of life. Im­prove­ments in mo­bile in­fra­struc­ture and high adop­tion of mo­bile de­vices has en­abled the de­ploy­ment of such care path­ways.”

Growth in the fu­ture

Based on the emer­gence of new, more user-friendly tests, in­no­va­tions and tech­nolo­gies, in­creas­ing ac­cess to health­care, and the preva­lence of sev­eral chronic and in­fec­tious diseases, the IVD mar­ket in APAC and around the globe is likely to re­main vig­or­ous.

“We see the in­dus­try mov­ing to­wards a greater re­liance on data, gath­ered in near real-time, to in­form de­ci­sion-mak­ing for prod­ucts in mar­ket and pre­dic­tive fore­casts for mar­ket en­try strat­egy. Ad­di­tion­ally, the bar­ri­ers to high-value de­sign and man­u­fac­tur­ing will be low­ered due to ad­vance­ments in bench-top sim­u­la­tion mod­els and 3D print­ing us­ing new medi­ums be­yond poly­mers and al­loys”, says Wil­son Tan.

Har­mo­niza­tion across reg­u­la­tory bod­ies on risk clas­si­fi­ca­tions and sub­mis­sion re­quire­ments is needed. This will cre­ate ef­fi­cien­cies in bring­ing new, in­no­va­tive de­vices to mar­ket. Re­al­iz­ing bet­ter pa­tient care from th­ese new de­vices should not be hob­bled by reg­u­la­tory in­ef­fi­cien­cies, es­pe­cially when more and more health min­istries them­selves are pro­vid­ing seed fund­ing to foster di­ag­nos­tics de­vel­op­ment and growth.

“We are in­volved with the reg­u­la­tors to shape the reg­u­la­tions as tech­nol­ogy is mov­ing at such a fast pace that we be­lieve that reg­u­la­tions and the providers of the tech­nol­ogy and de­vices needed to work in tan­dem. There is still lack of mo­bile in­fra­struc­ture in more re­mote ar­eas of APAC. Con­sumer and provider con­fi­dence in pro­vi­sion of se­cure data net­works,” adds Kuldeep Singh.

Alexis En adds, “Some emerg­ing mar­kets do not yet reg­u­late the im­por­ta­tion of home med­i­cal de­vices (such as home blood pres­sure mon­i­tors and neb­u­liz­ers). This means that the mar­ket is flooded with low cost, but un­val­i­dated prod­ucts. This im­pedes con­sumer aware­ness of the need for ac­cu­rate di­ag­nos­tics and by ex­ten­sion bet­ter man­age­ment of their health. Om­ron is mak­ing on­go­ing ef­forts with rel­e­vant au­thor­i­ties to im­prove reg­u­la­tory frame­works and bet­ter pro­tect and sup­port the health of peo­ple in th­ese ar­eas of the world.”

Dr Sid­ney Yee, CEO, Di­ag­nos­tics De­vel­op­ment Hub (DxD Hub) and Ex­ec­u­tive Vice Pres­i­dent, In­cu­ba­tion & Startup Man­age­ment Di­vi­sion, Sin­ga­pore says, “The im­por­tance of global reg­u­la­tory har­mo­niza­tion in the field of di­ag­nos­tics has long been ac­knowl­edged. How­ever, the rapid tech­no­log­i­cal in­no­va­tion that char­ac­ter­izes the IVD in­dus­try is out­pac­ing cur­rent reg­u­la­tory frame­works. Safety to pa­tients and ev­i­dence is cru­cial. While in­no­va­tion is im­por­tant, we prob­a­bly also need to have a safety test of th­ese in­no­va­tions with­out hav­ing to be in­cum­bent by a lot of th­ese pro­cesses that have been put down by years. Some­times, in­no­va­tions dis­rupt the stan­dard process. For reg­u­la­tors to deal with in­no­va­tions, an in­no­va­tion sand­box might be help­ful which will also deal with the reg­u­la­tory chal­lenges.”

Em­pha­siz­ing on the grad­ual shift to­wards early de­tec­tion, thanks to sen­sor tech­nol­ogy and wear­ables, Tan adds, “Cur­rent trends point to­ward a fo­cus on on­col­ogy, car­dio­vas­cu­lar dis­ease and di­a­betes, with an emerg­ing fo­cus on men­tal health con­di­tions. This will add to the del­uge of health­care data - which in turn will drive ad­vance­ments and adop­tion of data sci­ence and artificial in­tel­li­gence (AI) to or­ga­nize and

glean ac­tion­able in­sights from the data. Ul­ti­mately this should ben­e­fit in­di­vid­ual pa­tients through faster di­ag­no­sis and tar­geted ther­a­pies based on their ge­netic makeup.”

“Med­i­cal di­ag­nos­tics will be­come more con­sumer aka pa­tient fo­cus – and start in­cor­po­rat­ing the IoT into its de­liv­ery. We are also driv­ing for AI to en­hance what we have now along­side re­mote care mod­els to re­alise bet­ter health­care. Reg­u­la­tory wise it needs to take the form of a gov­er­nance struc­ture which is still flex­i­ble enough to en­able in­no­va­tion to oc­cur. In­fra­struc­ture is al­ready mak­ing its ways into the fur­ther reaches of any ge­og­ra­phy with that the abil­ity for pa­tients to ac­cess care mod­els not pre­vi­ously avail­able. One of the big­gest ad­vances over the next decade will be achiev­ing greater lev­els of di­ag­nos­tic pre­ci­sion at the in­di­vid­ual level by be­ing able to cap­ture and process mul­ti­ple ob­jec­tives and pa­tient re­ported vari­ables in the con­text of the en­vi­ron­ment in which the per­son lives us­ing ma­chine learn­ing.

This will in turn give rise to the other sig­nif­i­cant ad­vance­ments in the next decade. Also, the us­age of di­ag­nos­tic pre­ci­sion to gen­er­ate per­son­alised pre­scrip­tions of care that have a demon­stra­ble health ben­e­fit. To scale th­ese new ad­vances, the med­i­cal di­ag­nos­tic in­dus­try and its part­ners will need to com­pen­sate/in­cen­tivise and in­sure peo­ple for use of per­sonal data and be will­ing to risk share for out­comes,” Kuldeep con­cludes.

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