Is innovation a good thing ? Is being the first one to develop, advantageous? Do forerunners deserve royalty payments?
All these are the questions that are been raised by medtech innovators who according to recent Harvard study, do not get incentivised, but rather billed for the extra effort they put in to develop innovative technologies.
Study from Harvard Business School outlines that device that undergoes high risk PMA pathway are charged higher and take extra time in comparison to there follow on version. The delay cost is as high as USD 6.7 million ,a cost over USD 94 million that a company shells out for high risk PMA approval , claims study results.
The research study was published in Aug 2015 HBSWEEK copy.
According to study first high risk medical device which contains likes of stent , aortic heart valve as device types take 34% higher time in comparison to follow on versions. These stats demotivate players like Medtronic , BSC and others to innovate, as innovation bears no extra benefits for an organization which spends millions and billions to make a product patient ready, all for betterment of healthcare ecosystem.
Parallel pharma industry on other hand always favors innovators, with biopharma given a special privilege of bio-betters. Only in certain cases like para 4 innovators take a back stand , primarily because patients immediate need and affordability are made a priorities over rewards.
Regulatory authorities agree to the fallback, outlining they have been performing outstanding in protecting front but not in promoting. And hence they claim of adding on speedy checks & approvals across various regulatory amendments to address the need of the hour. Under recent regulatory introduction, namely 21st century cures act , speedy pathway clause is structured just to answer the same issue.
Innovation in healthcare are to address the unanswered questions of patients, and if they are getting impacted by some glitches at regulatory level, it’s an issue that needs to be looked into with shear priority.
All we can hope is that FDA lives up to its claims and provide patients world wide with better innovative devices. After all, we all want a better healthcare ecosystem that banks on preventing rather than curing.