In­no­va­tion fast-track?

FDA pro­gram aims to speed de­vice ap­proval

Modern Healthcare - - THE WEEK IN HEALTHCARE - Jaimy Lee

The Food and Drug Ad­min­is­tra­tion is shep­herd­ing some promis­ing med­i­cal de­vices to mar­ket, but it’s un­clear whether the ini­tia­tive will sat­isfy the in­dus­try’s com­plaints that the agency’s re­views are slow and un­pre­dictable.

The FDA’S In­no­va­tion Path­way pro­gram, launched in 2011, matches the mak­ers of “break­through” de­vices with an FDA case man­ager in an ef­fort to re­duce the time and cost it takes for a com­pany to bring a de­vice to mar­ket.

The FDA has two goals: shorten the time from con­cept to mar­ket, and trans­form the re­la­tion­ship be­tween the FDA and in­dus­try, said Me­gan Moy­na­han, act­ing as­so­ci­ate di­rec­tor for tech­nol­ogy and in­no­va­tion in FDA’S Cen­ter for De­vices and Ra­di­o­log­i­cal Health.

“It will stretch the bounds of our un­der­stand­ing of the sci­ence and the reg­u­la­tion,” Moy­na­han said.

Four de­vices have been se­lected to par­tici- pate in the pro­gram, in­clud­ing the three prod­ucts used to treat end-stage re­nal dis­ease that were an­nounced last week as the lat­est In­no­va­tion Path­way par­tic­i­pants.

The de­vices in­clude a dial­y­sis-ac­cess graft de­vice that al­lows clin­i­cians to se­lec­tively con­trol blood flow, which was de­vel­oped by Greenville, S.C. de­vice­maker Creati­vasc Med­i­cal; a wear­able ar­ti­fi­cial kid­ney de­vel­oped by Blood Pu­rifi­ca­tion Tech­nolo­gies in Bev­erly Hills, Calif.; and an im­plantable ar­ti­fi­cial kid­ney de­vel­oped by a re­searcher at the Univer­sity of Cal­i­for­nia at San Fran­cisco.

Shuvo Roy, a bio­engi­neer and pro­fes­sor at the UCSF School of Phar­macy, and Dr. Wil­liam Fis­sell, a nephrol­o­gist at the Cleve­land Clinic, in­vented the im­plantable ar­ti­fi­cial kid­ney.

The de­vice is unique in that it is im­planted, pro­vides con­tin­u­ous ther­apy and re­quires surgery. Roy said that while in­vestors have shown in­ter­est in the de­vice, many have con­cerns about the ef­fort needed to get the de­vice through the FDA’S strin­gent pre­mar­ket ap­proval process for novel prod­ucts.

“How will you ad­dress the reg­u­la­tory is­sues that will come up? How will the FDA han­dle this?” are the ques­tions Roy said he hears most from po­ten­tial in­vestors.

The de­vice has re­ceived about $4.5 mil­lion from gov­ern­ment grants and pri­vate phi­lan­thropists so far, and it needs an es­ti­mated $20 mil­lion to get the prod­uct through the first clin­i­cal trial, which has an ex­pected start date in 2017.

Shuvo Roy, a bio­engi­neer and pro­fes­sor at the UCSF School of Phar­macy, is de­vel­op­ing an im­plantable ar­ti­fi­cial kid­ney.

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