Standards in medical device quality system regulations ensure that devices are safe and reliable for both patients and doctors. These regulations, set out by the Food and Drug Administration, can be perceived as serious barriers to the generation of invention and true innovations, inhibiting devices from entering the market which make tangible, positive change. In this first part of MIDI Innovation Vault™ season two, MIDI co-owner Chris Montalbano expounds upon the company’s strategy for navigating the tepid waters of FDA regulations.
Paradigm Shift in Viewing FDA Guidance
Often, developers see medical regulatory design controls and risk management as a limit to innovative potential. Particularly, FDA QSR and ISO 13485 which impose stringent guidelines upon medical device developers that can be arduous to navigate, discouraging them from truly pushing the limits of their innovative abilities. The FDA not only wants to see that device requirements are met, but that companies integrate regulatory processes into their “essential DNA,” recording them carefully within an effective QMS, or Quality Management System. Additionally, it expects that the QMS has a manual pointing to a wide range of standard operating procedures or SOPs, demonstrating your product realization methodology.
A paradigm shift in this arena, Chris asserts, is necessary for the continuation of innovation in the field, whereby MIDI’s goal is to shift perceptions to view FDA prescriptions as conducive to innovation rather than a roadblock to progress. As he explains, the FDA provides recommendations, also known as FDA guidance, regarding how regulatory processes, design controls, and risk management, should be approached and navigated during the development process. At MIDI, this guidance is integrated into a carefully outlined Innovation Roadmap which they refer to as the DevelopmentDNA™ approach, comprising a highly effective medical device development platform sure to produce innovation. In this series, we will break down each major stop on the Innovation Roadmap, examining the activities deployed in each step that produce innovation while consistently complying with FDA QSR and ISO 13485 regulations.
Before we can examine the stops on this roadmap, however, we must define what innovation means to MIDI as it relates to medical device development. According to Chris, device innovation “is the process of translating an invention into a device,” taking that device into commercialization where it becomes a product that benefits users. Innovation in this field, he states, must have four specific features. First, the device must satisfy a specific market or user need, either by addressing a yet unsolved problem or through the augmentation of an existing product, improving the degree to which a need is satisfied. Second, it must be reproducible at a reasonable cost that is easily accepted by the market. Third, it should be effective both in functional performance as well as ease of use, which can often have a positive influence on the efficacy of devices. Finally, and most importantly, the device must be safe for all parties involved in its use, in the medical arena referring to healthcare providers and patients.
Stops Along the Way
With the DevelopmentDNA™ approach, clients receive support as they develop their device to meet these conditions while ensuring that necessary safety precautions are taken at every step. The Innovation Roadmap has three major stops along the way; where a device begins on the map is dependent on its level of maturity and its progress in the journey from market concept to market delivery. If a device is entirely novel, it will need to hit each major stop on the map beginning with the first: market exploration and opportunity discovery. If the device is a reiteration of or improvement upon an existing device, whether it be the company’s own or that of a competitor, it will have already satisfied Stop 1 and will begin the process at Stop 2, entailing technology innovations including the R&D process. Provided that a device is an enhancement on an existing product already found in clinical practice, making little alterations to technology or clinical application, then Stops 1 and 2 have likely been satisfied. These devices begin at Stop 3, commercialization and implementation, in which they are prepared for the market.
MIDI is a second-generation owned medical device development firm with over forty-five years’ experience in the industry, supporting clients throughout the development process. Using their DevelopmentDNA™ approach, they infuse innovation and competitive differentiation into their client’s endeavors, supported by their team of engineers and usability experts tied to industrial designers. Utilizing this approach, their team evaluates and crafts responses to the functional, safety, business, and cost to manufacturer requirements of what MIDI refers to as “the golden standard approach,” which is partnered with rapid, AGILE development under the MIDI Quality 1st™ Umbrella. This series will illustrate this process, giving an inside look at the MIDI client experience.
Stayed tuned as we begin our journey on the DevelopmentDNA™ innovation roadmap in the next installment of MIDI Innovation Vault™, in which Stop 1, Market Exploration and Opportunity Discovery, will be deconstructed and examined in detail.