It is time to discard the old thinking of “drug and/or device,” and to begin focusing on the goal of developing complete therapeutic systems.
Most of FDA’s senior leadership overseeing device regulation has been replaced since 2002, shifting an organization that was perceived as unresponsive and reclusive to one that strives to be interactive and front-facing.
To grasp the opportunities offered by underserved patient populations, medtechs must invest in risk by embedding resources in emerging market regions, locate and hire local talent, and break barriers related to intellectual property, local regulations, and policies.
I spoke with Craig Thompson, MD, SVP/CMO of Boston Scientific’s Interventional Cardiology unit, about TAVR costs, benefits, and market drivers, as well as Boston Scientific’s Lotus valve system.
If, as most believe, the future of the medical device industry will be determined by emerging markets, manufacturers need to embrace the idea of needs-driven local innovation for unmet medical needs.
Last week, we spoke with the CEO and founder of Biotricity, Waqaas Al-Siddiq, about physician concerns due to a lack of clear delineation between medical grade vs fitness/lifestyle devices. In Part 2 of my discussion with Al-Siddiq, we explore some of the trends and market evolutions that will affect the wearable device industry in the next five years.
How is medtech to help consumers and physicians differentiate between medical-grade and lifestyle devices? I spoke to Waqaas Al-Siddiq, co-founder and CEO of Biotricity, a start-up healthcare company delivering remote biometric monitoring solutions. Al-Siddiq shared his thoughts on this issue, and how his company has addressed them.
While the American Association of Clinical Chemistry event’s 68th installment featured various brilliant minds and plenty of discussion regarding industry trends, new product launches, and retooled service offerings from medical diagnostics makers, there were three consistent themes that resonated throughout.
Beyond addressing an unmet medical need, diagnostics device makers serving the home point-of-care (POC) market must satisfy both the care provider and the patient if a product is to succeed. Add to that the challenge of keeping pace with the evolution of telehealth and mobile health platforms, and the uncertainty of new technology — specifically, that it doesn’t always deliver on its promise of a trouble-free solution.
Windgap Medical's wet/dry epinephrine delivery device is in its third generation of prototype development, and the company has fought through the gauntlet of outsourcing decisions. Here, CEO Chris Stepanian discusses outsourcing methodology, including which functions to outsource, vetting of potential partners, and more.