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Oct 30, 2014

How to Design for Compliance: Tips for Getting (and Keeping) Your New Product on the Market


Successful product development requires the orchestration 
of multiple complex systems and processes, sometimes 
requiring worldwide coordination.
by Lisa Weeks, Communications Specialist, MasterControl


Having a great product does not guarantee success. The road from concept initiation to commercial release is a long and arduous one. Success depends upon not only understanding the new product development process, but also the FDA submission process, and the complex interplay between the two. Many companies underestimate the value of a carefully thought-out submission strategy. They focus solely on product development and treat the approval process as an afterthought. Others are so eager to get their product to market, they rush the design and testing processes and end up with a product that’s dogged by costly delays or, worse, unmarketable.

Successful product development requires the orchestration of multiple complex systems and processes, including design control, compliance management, and risk analysis/assessment and design and process validation. Is your company’s new product development program equipped to handle all of these elements in an environment that’s constantly changing due to new technologies, regulations and competitive activity? Few are.

Design for Compliance

According to the FDA, nearly half of all product recalls are due to faulty design in manufacturing processes. Some products don’t even make it that far. In the medical device industry, for example, close to 75% of all first-time 510k applications are initially rejected, creating costly delays (2). So, how can you guarantee that your new product development system is designed to produce products that not only perform as designed, but also conform to the highest regulatory standards? First, you must understand how regulators expect you to develop and implement design controls, then you must be able to transfer product design to manufacturing, and eventually to market. In short, you must design for compliance. 


Five-Phase Design and Development Process Based on Best Practices

But what does it mean to design for compliance? To design for compliance means to take a systems approach to new product development. All elements, from design concept to commercial product, must support and build on each other in order for you to get—and keep—your products on the market. According to Walt Murray (1), director of MasterControl’s quality and compliance consulting division (QCC for short), which specializes in new product development and acceptance services, including submissions assistance, designing for compliance requires you to adopt a five-phase, best-practice-based  process. An in-depth look at all of the phases is a topic for another post, but here’s an overview:
  • Phase 1: Design Requirements & Planning. Critical components: project plan, design requirements and preliminary hazard analysis (PHA) and feasibility.
  • Phase 2: Design & Development. Critical components: design specifications, initial traceability matrix and concept prototype(s).
  • Phase 3: Design Verification. Critical components: Design verification and testing protocols and piloting and design verification report.
  • Phase 4: Design Transfer.  Critical components: Design transfer specifications, process/equipment validations and actual production units’ checklist (batch records).
  • Phase 5: Design Validation. Critical components: Concurrent validation protocols and reports, completed traceability matrix, and event management.

“The five-phase process can help you evaluate and, if necessary, dramatically improve your new product development system—or any element relating to that system. While the phases are essentially the same for every organization, the way they interact, as well as the specific phases, procedures and skills required, should be customized to meet your company needs,” said Murray.


“You Don’t Know What You Don’t Know”

As I mentioned earlier, few companies are equipped with the time and/or resources to thoroughly evaluate their current new product design and development program for compliance—or to develop a program from scratch. But it’s more than a lack of time and resources.

“Most regulated companies that I’ve worked with—and this is true whether it’s a two-person start-up or a global manufacturer with thousands of employees worldwide—simply don’t know what they don’t know,” said Murray.

This statement seems like a no-brainer, but think about it. Most of us take knowledge for granted; we assume that we (or our employees or suppliers) know more than we really do. This isn’t always a problem. For example, most of us can get by just fine not knowing how to perform brain surgery, but not knowing how to write an SOP, or a compelling substantial equivalence argument in a 510k submission, can get us into hot water or, at the very least, cost us valuable time to market.  My point being, make sure the things you don’t know aren’t the things that could put your business at risk. But how do you know what you don’t know when you don’t … well ... know?


Benefits of a Streamlined New Product Development Process
 
None of us can be expected to know everything, and when you’re working in a regulated environment, there’s A LOT to know. And the more time you devote to learning what you don’t know, for example, the less time you have to focus on your core business objectives.

“In my experience, companies approach new product development in one of two ways,” said Murray. "Some employ too many gates or checkpoints, which drags out the decision-making process, as well as the time it takes to get their products to market. Others do the exact opposite; they “wing it,” which causes them to skip checkpoints and up with a product that’s ultimately unmarketable. Neither approach works.”

So, what does work? According to Murray, new product success hinges upon developing a sustainable process that is comprehensive, but also efficient, and based on the complexity and risk-level of the project. While this is no easy task, it’s well worth the effort. Developing and implementing a new product strategy that aligns with your business, marketing and organizational goals will yield many benefits and competitive advantages:  improved cycle time; better product quality; improved resource utilization; enhanced brand equity; fewer customer complaints and recalls; a more streamlined, successful submission process; and, above all, a higher product success rate.

For more information about MasterControl QCC’s new product development and acceptance services, click here.

Sources:

(1)   Walt Murray, the director of MasterControl’s Quality and Compliance Consulting (QCC), is a specialist in the quality and regulatory professions with more than 25 years’ experience to his credit, working with nationally-recognized organizations including Aventis-Pasteur, Merck, Pfizer, Stryker, USANA, Del Monte Foods and the American Red Cross National Labs. He is certified in quality systems auditing, problem solving and process control using Six Sigma principles that support lean enterprise, including kaizen improvement and advanced planning principles. His extensive audit experience covers several industries, and he has successfully brought several medical device companies to full registration under the ISO process model standard. Murray has also worked extensively in risk and supplier management. To learn more about Walt Murray and QCC, go to: http://www.mastercontrol.com/quality-management-software/quality-control/compliance-consulting.html?lne=lkey

(2)   “Simplifying Substantial Equivalence in FDA Premarket Notifications,” Med Device Online, September 10, 2104 (Podcast). Available from the Internet: http://www.meddeviceonline.com/doc/simplifying-substantial-equivalence-in-fda-premarket-notifications-0001

Lisa Weeks, a marketing communications specialist at MasterControl, writes extensively about technology, the life sciences industry, and other regulated environments. Her two decades of marketing and advertising experience include work with McNeil Pharmaceuticals, SAP AG, SCA Mölnlycke Health Care, Crozer-Keystone Health Systems, and NovaCare Rehabilitation/Select Med. 




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