Health­care Reg­u­la­to­ry Com­pli­ance Chal­lenges for Med­ical Tech­nol­o­gy

One of the chal­lenges that the com­pa­ny is fac­ing is find­ing part­ners in the health ecosys­tem. The oth­er one is going through the health reg­u­la­to­ry process as each coun­try has its reg­u­la­to­ry author­i­ty. Sri Lanka’s reg­u­la­to­ry author­i­ty is cur­rent­ly review­ing the Jen­do sys­tem. Once the review is com­plet­ed, it will allow the com­mer­cial­iza­tion of the device. The com­pa­ny will also apply for the Unit­ed States Food and Drug Admin­is­tra­tion (FDA) approval, fol­lowed by oth­er coun­tries.

Jen­do Inno­va­tions is also in dis­cus­sion to estab­lish two busi­ness cen­ters out­side of Sri Lan­ka; one in Switzer­land, and the oth­er one in Sin­ga­pore. “Both coun­tries have a favor­able busi­ness envi­ron­ment, and growth oppor­tu­ni­ties,” accord­ing to Keerthi.

Tried and Test­ed on Patients to Pre­vent Heart Dis­ease

Jendo’s sys­tem is not com­mer­cial­ized yet but the device is already being used by hos­pi­tals and lab­o­ra­to­ry chains, and clin­i­cal­ly test­ed on over 800 patients.

Under the cur­rent busi­ness mod­el, the device will be sold at US$2,250 with an annu­al sub­scrip­tion fee of US$10,000. The test will be charged US$8. Accord­ing to Keerthi, “the screen­ing price is afford­able in com­par­i­son with oth­er estab­lished pro­ce­dures.”

The com­pa­ny swift­ly pro­ceed­ed to apply for a patent, first in Sri Lan­ka (pend­ing), then in the Unit­ed States (grant­ed: USPTO Patent 10,912,464 B2), and in Japan (Pend­ing), through the WIPO Patent Coop­er­a­tion Treaty (PCT).

Accord­ing to Keerthi, investors want to make sure the prod­ucts they invest in is ahead of the com­pe­ti­tion. “A patent is key to prov­ing the val­ue of your inven­tion and win­ning investors’ con­fi­dence,” he said.