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Regulating Medical Devices Shapes Industry for the Better

Regulating Medical Devices Shapes Industry for the Better

This article originally appeared in Business Worldwide magazine. It’s fashionable to be anti-regulation in business today. But sometimes regulation is central to how a sector operates. We talk to Rita King, CEO of MethodSense and Russ King, President of MethodSense about why regulation of medical device, biotech and pharma companies is so critical. Most devices and innovations need to go through a complex system of regulatory approval. In order to obtain market entry, some argue that regulatory agencies like the US-based Food and Drug Administration (FDA) are too zealous, preventing or delaying life-saving innovations from entering the market. Richard Williams, an affiliated scholar at the Mercatus Center at George Mason University, cites an example where three medical devices submitted for approval took nine years to process. He argues that it costs on average $24 million to manage FDA requirements. “A mid-1970s law,” he argues, “requires virtually every medical device—and improvements to existing devices—to endure a slow, expensive, uncertain approval process, ill-suited to 21st-century technology. The Food and Drug Administration (FDA), which grants such approval, has an ageing structure and culture that adds extra layers of discouragement to would-be innovators.” But what are the benefits of regulation, and how can pharma and tech companies manage the process of compliance more smoothly? MethodSense is a company that exists to assist companies with FDA and other regulatory agencies to obtain market entry for their medical device products. We talked to Rita King, CEO of MethodSense, and Russ King, President of MethodSense, about what they do and why regulation matters. What kinds of services do you provide as a company? “MethodSense’s consulting service approach is a...
MethodSense Inc. CEO WiMethodSense Inc. CEO Wins Global Leadershipns Global Leadership Award with Business Worldwide Magazine

MethodSense Inc. CEO WiMethodSense Inc. CEO Wins Global Leadershipns Global Leadership Award with Business Worldwide Magazine

We are pleased to announce that CEO Rita King was named “Healthcare CEO of the Year – USA” by Business Worldwide Magazine. Full text of the press release is below… LONDON, October 4, 2018 /PRNewswire. The chief executive of life science consulting firm MethodSense has gained global recognition for outstanding leadership in the Business Worldwide Magazine (BWM) 2018 CEO Awards. Rita King was named ‘Healthcare CEO of the Year –USA‘ for her sterling work at the helm of the North Carolina-based company. The 2018 Business Worldwide CEO Awards identify and honour the Most Respected C-level executives across the globe from a variety of different sectors. Unlike many business awards that focus on the overall achievements of specific companies, the approach here is to focus instead on the personalities at their helm, inspiring others to achieve similar successes. MethodSense offers life science and medical device regulatory compliance; guiding medical device, biotech and pharmaceutical companies and supporting them through the commercialisation process and beyond. It’s an industry that’s notoriously difficult to navigate, with many submissions taking years to be approved by regulatory bodies like the Food and Drug Administration (FDA). Through their comprehensive methods, MethodSense assists in all aspects of regulation, compliance and commercialization efforts. MethodSense seeks to simplify the process of bringing, or keeping, a medical device or combination product to market, enabling them to commercialize their innovations. In a career spanning more than 26 years, Rita King has garnered an impressive international reputation as a regulatory expert. She has participated in numerous national and international committees and is a founding member of the Underwriters Laboratories team. A highly sought-after speaker, her thoughts on...
CV Magazine Names Regulatory Strategist Female CEO of the Year

CV Magazine Names Regulatory Strategist Female CEO of the Year

  Our CEO and Regulatory Strategist, Rita King, was recognized as Female CEO of the Year 2016 by CV Magazine. In addition to the award, CV Magazine conducted an in-depth interview with Rita to find out more about her success leading up to and in her current role at MethodSense. CV Magazine: Tell me about your business and your ongoing strategy? Rita King: MethodSense is both a consulting and product development firm. I initially created the company to help large life science companies manage critical information subject to regulatory oversight. We evolved further with the development of InfoStrength, a regulatory compliant information management software we designed, after extensive market research, expressly for life science companies. In order to facilitate the quality and regulatory requirements of our clients, my team created this software solution specifically geared toward maintaining compliance throughout the lifecycle of a business, from product design and development through commercialization. Most software in the industry was not intuitive and was cumbersome to use. My goal was to develop a product that would require little to no training for the users, yet still meet life science company requirements. As the software gained traction, client demand for hands on quality and regulatory support, in addition to the software, grew. MethodSense’s consultants use their critical thinking skills and industry experience to guide medical device manufacturers through worldwide commercialization. Since 2012, the consulting aspect of the business has grown considerably. This growth has enabled us to expand our services with expertise in quality compliance, regulatory strategies, software validation, human factors and usability engineering, risk management and other services for US and global...