Graphic By Amanda Pedersen
In an effort to push for a focus on quality over compliance, enhanced transparency, and better stakeholder engagement, FDA and the Medical Device Innovation Consortium (MDIC), a public-private partnership focused on regulatory science, created a program now in its pilot phase known as the Case for Quality program.
The project paved the way for the Medical Device Discovery Appraisal Program (MDDAP), an FDA program that aims to elevate the focus of all medical device companies from baseline regulatory compliance to sustained practices that can advance medical device quality and safety to achieve better patient outcomes. The idea is to foster a new level of collaboration between the agency and the industry to create a Case for Quality movement.
Mark Rutkiewicz, vice president of quality at Innovize, one of the first companies to participate in the pilot program, has managed medical device company processes and has designed quality management systems for more than 30 years, and has written two books on the subject of implementing efficient compliance processes using virtually any tool out there.
Rutkiewicz recently spoke with MD+DI about how the new MDDAP program will help companies focus on practices that can accelerate the process of bringing technologies to market, while also helping companies save time and money on FDA approvals.
MD+DI: For starters, can you talk a little about FDA’s Medical Device Discovery Appraisal Program and why Innovize decided to sign up for it? What was your experience as one of the first companies to go through the pilot assessments?
Rutkiewicz: I have been in the medical device industry for over 30 years and at six different companies. At each company, I always saw the waste in the way companies set up their quality systems. Paper processes are simply converted to electronic systems, not re-designed to take advantage of new technologies or best practices. One-off compliance issues or regulatory changes are fixed with Band-Aid solutions. Being an electrical engineer, I always felt the need to redesign business processes to make them more efficient. I ended up rebuilding the quality systems at each company I worked. While at Innovize, I volunteered for the Case for Quality project at the MDIC. I was one of the first team members on the Maturity Model team. This team’s results lead directly to the FDA MDDAP initiative.
At each of the companies where I rebuilt the quality system, I felt I was making it more compliant and easier for people to do their work. The business process improvements had a significant bottom-line impact. Specifically, people were more productive, reduced product issues and felt they were doing real work and not feeding the bureaucracy. I believed the company was at a higher maturity level than other companies, but could I prove it?
On the Case for Quality team, I learned details of the CMMI assessment schema and felt it could prove my business process improvements were the right ones. I decided to put my money where my mouth is and volunteered for Innovize to have the proof of concept assessment done in June 2016 with FDA watching on a video feed. The CMMI assessment, which is the basis for the MDDAP, was similar to the kinds of assessments I performed when determining how to redesign quality systems. The plus with CMMI is that it is scalable, documented, and measurable. FDA loved the idea and it showed them you could get into the real company issues, not just proving compliance.
MD+DI: How important do you think this program could be when it comes to driving quality improvements for medical devices, and how does the program help accelerate time to market for companies?
Rutkiewicz: The idea behind the MDDAP is that it is like a coach helping you get better for the game, while FDA QSIT inspections are referees judging how well you are playing the game and penalizing you for breaking the rules. Most companies work to make sure they pass FDA inspections, but it is really on a superficial level, getting the right information to FDA no matter how difficult or expensive it is to retrieve.
The MDDAP requires companies to stay on a continuous improvement path; there is not an end. You need to keep improving your processes and the assessments eventually need to show that you are achieving higher maturity levels.
Like I said earlier, I did the same type of improvements at other companies and they paid high dividends. These higher maturity-level business processes allowed us to improve product quality, our product development times were cut in half and product changes throughput productivity improved 1000%. The MDDAP assessment asks people throughout the company how they do their job, but with a bent toward leading them toward better practices. The problem is many people do not know what the highest maturity level looks like and how you would work in it.
I have a textbook coming out that can specifically show people how to implement tools and procedures to achieve best practices independent of the tools they use. We can talk all day about what device companies should do, but nobody has, before now, explained exactly how to design and implement efficient, compliant processes using any tool out there.
MD+DI: What are some keys the program looks for when trying to identify efficient implementation of design controls? How crucial do you think these elements are in the process of bringing a device to market?
Rutkiewicz: The MDDAP is currently focused on the manufacturing side and not design controls, but the practice areas assessed do touch significantly into design controls. The CMMI assessments were originally designed around the best practices in getting military projects successfully completed on time, on budget. The concept of design controls is not part of CMMI; instead, think project management best practices. The assessment has specific practice areas, including planning, monitoring and control, requirements management, configuration management, managing performance and measurement, and implementation infrastructure. Doing these foundational tasks better will improve your product development cycle time, instead of assigning more resources and having people work longer hours.
MD+DI: What are the incentives and other upsides offered by the MDDAP program? Why do you think more companies should consider enrolling in the program?
Rutkiewicz: FDA has offered some nice incentives to companies participating in MDDAP. The first incentive is the elimination of periodic QSIT inspections. This in itself pays the cost of having the assessment performed. The second is the elimination of a manufacturing site change transfer inspection to sites that are in the MDDAP program. The third is the elimination of pre-PMA inspections if you already have PMA products. Lastly, the big one, you can bundle products and changes into one 30-day Change Notice and FDA will accept it immediately, and you can implement immediately.
These incentives will help sell the program to the leadership team, but there is a more inherent benefit FDA believes will occur. The company leadership team must make a commitment to continually improve their business process and practices. The CMMI assessments are about making management more open and transparent. The highest maturity levels only affect the way management makes decisions. This level of improvement will make many in management uncomfortable. A mature company puts controls into the business processes and doesn’t rely on micro-management to ensure quality across all aspects of the business.
MD+DI: Do you think there are any improvements to the program that could be made to further benefit medical device companies or otherwise improve the process of device development?
Rutkiewicz: CMMI is currently administering the MDDAP program and they are learning how medical device companies work. The biggest issue is terminology (they come from a software development quality perspective) and not the model they use because the practices in the CMMI model are universal. As the assessors learn the terminology and understand the scope of the regulations and standards, the challenge will be to link the assessment into actionable plans.
The regulations and standards tell us what needs to be done, which is the rulebook. The CMMI assessment is coaching us to be able to deal with all scenarios. The problem is, there is no playbook or blueprint to follow to build the right kind of quality system to make the best products in the fastest time. The MDDAP/CMMI assessments need to better align with best-practice medical device business processes. My consiliso textbook provides the blueprint for standardizing medical device company business processes as well.
MD+DI: As a company that has gone through pilot assessments, how much time do you think this program has saved your company, and do you think it will help other companies save time without compromising the development of their device?
Rutkiewicz: The MDDAP assessment validated the quality improvement journey we already started. Innovize spends about 1% of revenue on quality improvement and business process changes annually; this investment more than pays for itself with improved product quality and faster change management. For other companies, it will provide a fresh perspective and an incentive to stay on the continuous improvement path, but it will really help more established companies.
I do not think small startup companies should use this assessment and then try and figure out how to improve their processes. Their primary goal should be to get the product to market, but they do need to follow a proven, compliant blueprint for the design of their quality system. We train engineers how to design and manufacture products, and others on how to run a business, but until now we have not, in the medical device industry, had a playbook for how to marry innovation, producing safe and effective products, and running a complex company subject to various regulations in every market.
MD+DI: Finally, in a broad sense, do you think this program will be successful in terms of company participation, as well as ultimately bringing devices to the market faster? Are there any companies that wouldn’t stand to benefit from enrolling in the program?
Rutkiewicz: I do think many companies will use the MDDAP program to support their ongoing improvement initiatives. FDA does not allow companies with no history or with systemic compliance issues to enroll in this program. The companies that do not want to invest in improving their processes or provide a transparent management process will ultimately fail in this program because change must occur in order to survive in this industry. Those companies will, eventually, also fall by the wayside as better-designed, more mature businesses (not just products) provide too much competition in the marketplace.