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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 little unique among other consulting service companies we are familiar with,” said Russ King.

“Yes, we have the regulatory and quality experience and expertise our clients need. But what differentiates MethodSense is our strong staff of biomedical engineers and technologists who not only understand the regulations but very quickly become technical experts on the products we support,” he continued.

CEO Rita King adds, “The second and very critical differentiator is our people-focused approach to clients. MethodSense invests in understanding the client, the client’s culture and individual team members. Through this understanding and coupled with our regulatory and technical skills, we deliver services to meet the client’s specific needs.”

Russ King stated, “Finally, MethodSense’s leadership includes a great deal of business experience which results in a culture and philosophy that is critical to our clients – namely that our goal cannot merely be an output of quality documentation but must include the active support of our client’s business goals.”

In the service of their client’s goals, MethodSense principally provides services around the entire life cycle of medical and combination devices which include:

  • Regulatory Assessments and Roadmaps for FDA approval or CE mark acquisition
  • Quality Management Systems in compliance with global Quality Management Regulations such as 21 CFR Part 820 or ISO 13485
  • Risk file development and management for ISO 14971 or GMP compliance as well as support with IEC 60601-1 medical device safety certification preparation and management
  • Human Factors / Human Engineering or Usability studies
  • Product validation services and product verification support
  • Product submissions to regulators such as FDA product clearance or CE mark acquisition
  • Post-product approval support products around quality assurance and regulatory affairs, which includes extensive training programs.

“We should also mention our SaaS content management services with InfoStrength that helps maintain for our clients the organisation, compliance and auditability regulators expect,” Russ King explained.

Can you tell us more about regulatory compliance and why it’s important?

“Let’s remember that regulators like the FDA have one principle mission – the safety and efficacy of the products used to treat medical conditions,” said Russ King. “Regulations for the life sciences are designed to create a framework and practices that result in the creation and manufacture of safe and effective products.”

He adds, “If a regulator like the FDA finds that a medical device, biotech and pharmaceutical company did not create a product in a manner that complies with regulations or fails to manufacture a product in a way that complies with regulations, then the regulator can conclude that the product may not be safe or may not perform as promised. This situation influences the business position of the company – whether they can or can’t sell their product.”

“We should see regulatory compliance is a critical enabler, rather than a barrier, for medical device, biotech or pharmaceutical companies to sell their products and keep selling their products,” said King. MethodSense’s primary mission is to help clients successfully position themselves to sell their products and to meet their regulatory obligations.

Can you give us a couple of examples of your problem-solving expertise?

MethodSense has attracted clients that have had difficulty achieving FDA clearance for their products.

According to Rita King, “In one case, the FDA indicated during an initial pre-submission combination product meeting that product clearance would not happen because of a number of safety hurdles they perceived as insurmountable. Seven pre-submission meetings later, after meticulous technical planning and plan execution to demonstrate the safety of the device, a 510(k) was submitted. The FDA was convinced that the product was safe, and product clearance was awarded.”

In another case, a client saw two submissions rejected by the FDA, and the client’s response to the second rejection was that they loudly and negatively blamed the FDA for incompetence.

“After we got involved, we realised that the client did not understand how the FDA operated, what FDA language meant or FDA product concerns which were reasonable based on the previous submissions,” said Rita King.

MethodSense successfully educated the client about the FDA and helped them think of, and interact with, the FDA in a positive way. Going forward, with MethodSense leading communications, the FDA had the opportunity to be positive – and was. The product application was rewritten to address the FDA’s needs, and the company received product clearance.

Rita King continued, “There are typically two crucial dimensions to problem-solving that are intertwined – a ‘technical’ and a ‘people’ dimension. Most consulting firms in our arena focus on the technical aspects of a client project, or what the appropriate document must do or say.”

“We’ve never seen a product successful that did not also involve the success of the people involved. So we consistently look for the opportunity to support the personal success of everyone,” she added.

In the examples above, the companies we served and the people we were able to help, won. However, so too did the FDA and public in general which saw the introduction of new medical device products that were both safe and effective.

What are the key issues in global medical and pharmaceutical regulation right now?

According to MethodSense, regulatory change is the most important issue. “We see this in our practice particularly in the arena of medical devices and combination products,” said Rtia King. “The changes we see are often hard on our clients, and they rely on us to stay abreast of those changes and help them manage the impact of the changes on their company.”

She continued, “We see the most influential currents of change along two fronts. The first is that we are experiencing rather significant regulatory changes which include in the EU the new Medical Device Regulation and ISO 13485: 2016, which has stretched thin the responsiveness of Notified Bodies and consequently has created significant urgencies inside medical device companies.”

In the US, the FDA has, in general, tightened up its review processes with a renewed critical eye on software with new digital health initiatives, cybersecurity and artificial intelligence.

Russ King adds, “Second, there are technological advances in the medical device and combination device sectors – for example, predictive analytics and artificial intelligence – which are forcing regulators to assess whether they are correctly managing these changes in a way that best protects the public.”

The rapid scale of technological change and the challenges this poses for regulation is where most of our activity and learning is right now. And also, trying to drive a steady course in the face changing political and economic winds is very difficult for all parties.

“But I am absolutely confident that we are best placed to navigate this new terrain,” said Russ King. “We look forward to the helping companies bring exciting new medical devices and combination products to market.”

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