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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 Named Top 25 Life Science Technology Vendors

MethodSense Named Top 25 Life Science Technology Vendors

CIO Applications recognizes MethodSense as Top Life Science Technology Vendors Amidst technological innovations, regulatory changes, and increased reliance on patient-centric models, there seems to be a multitude of growth opportunities for life sciences companies. Life sciences undoubtedly remain one of the industries that see rapid technological evolution ahead of them. Even though life sciences has been considered a slow adopter of technology over the years, the future of the industry looks better— with companies adopting new age patient care technologies. Not just that, companies in the life sciences sector today are automating their routine tasks with a vision to invest their time in innovating and creating new business models that are more progressive and patient-centric. From digitizing the way they generate reports to their appointment schedules models and further, post-discharge care, everything is being transformed, which clearly indicates a better future for both—and these companies will need the support of top life science technology vendors. To help these life sciences players partner with trusted technology companies, CIO Applications featured a list of “Top 25 Life Sciences Technology Vendors – 2017.” The list includes the top life science technology vendors that offer groundbreaking solutions to healthcare providers and help streamline their processes. CIO Applications selected MethodSense as a premier consultant in the medical sciences, MethodSense, based in Research Triangle Park, NC. MethodSense helps clients tackle compliance-related challenges. The company also offers InfoStrength—a regulatory compliance information management software—to augment its consulting services and to ensure requirements are met during projects and product development cycles. Rita King, CEO and Senior Regulatory Consultant, explains, “Our platform enables our clients to safely and securely...
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...

How the 21st Century Cures Act Impacts Medical Device Software

There has been a lot of discussion surrounding medical device software and how it should be regulated. Concern about software of this nature will continue to rise to the forefront of conversations because there will be an increasing number of these products in the marketplace. The 21st Century Cures Act specifically addresses which types of medical device software will be exempt from regulation. Section 3060, Clarifying Medical Software Regulation, identifies five categories of medical software that will not be regulated as medical devices by the FDA due to their potential low level of risk to patients. The software categories that may be excluded from device regulation include: Administrative & Operational Software: that provides administrative support of a healthcare facility, such as that for appointment scheduling, health benefit eligibility and processing financial records. While this software is included in the provision, it was not considered a medical device to begin with. Wellness Apps: for maintaining or encouraging a healthy lifestyle that is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition. This is consistent with FDA’s General Wellness and Mobile Medical Applications guidance documents. Electronic Patient Record Software: provided that it is only intended to transfer, store, convert formats or display the equivalent of a medical chart. There are some caveats to this exception, however: Records must be created, stored, transferred or reviewed by healthcare professionals; Records must be part of health information technology certified under section 3001(c)(5) of the Public Health Service Act; and The software must not be intended to interpret or analyze patient data or images for the diagnosis, cure, mitigation, prevention, or...
Human Factors Engineering for Medical Devices

Human Factors Engineering for Medical Devices

In February 2016, the FDA released a guidance entitled, “Applying Human Factors and Usability Engineering to Medical Devices.” The intention of this document, in combination with IEC 62366-1:2015 Part 1: Application of usability engineering to medical devices, is to maximize the safety and effectiveness of devices for intended users, use and use environments. Its purpose is to direct manufacturers to ensure their device user interface has been designed in a manner that will either eliminate or reduce use errors to the greatest extent possible by taking the user, user interface and use environment into consideration during design and development. Human Factors Engineering applies the knowledge of human behaviors, abilities and limitations to the design of the medical device interface. To get a handle on Human Factors Engineering, which you might also hear referred to as Usability Engineering, there are a few terms you should be aware of: User Interface: includes all parts of the device a user will see, hear and touch, including packaging, labeling, training, physical controls and display elements Use Error: a user action – or lack of action – that was different from what the manufacturer expected and could result in harm Critical Task: a task that, if performed incorrectly or not at all, could cause harm to the patient or user The FDA is now requiring several types of device manufacturers (as described in the FDA draft guidance, “List of Highest Priority Devices for Human Factors Review”) to conduct Human Factors Validation Testing. As an industry, we will see an increasing number of manufacturers required to conduct these studies, especially as more devices are available...