Every medical device on the market once began as a simple idea crafted to solve a problem. Despite the best intentions of every device developer, many of these ideas fail to reach their potential given the challenging road from original concept to delivered product. This is why crafting a quality design plan has become a crucial element to success for device developers, as it helps us define what needs to be done, when it needs to be done, and who will actually do it.
These days, a proper design plan can provide developers with a step-by-step roadmap for medical device creation, ensuring that no detail goes unnoticed. Unfortunately, there are many different ways a design plan can fail, which often leads to failure before development barely gets off the ground.
Walt Murray, a quality management and regulatory affairs specialist, has seen the best and worst when it comes to design plans. Murray has worked as an independent expert for major medical device companies around the world, consulting on a variety of different design plans across the medical device realm. Murray is certified in quality and environmental systems auditing with more than 30 years' experience working with many titans of the medtech industry including Johnson & Johnson, Pfizer, Merck, and Stryker.
Murray will be speaking at the conference at MD&M Minneapolis November 1, discussing all the do’s and don’ts of successful design plans during his talk, “The Role a Design Plan Plays in Technical Transfer.”
Ahead of his discussion, Murray decided to sit down and speak with MD+DI to discuss the basics of a quality design plan and the various roles and responsibilities needed to create and carry out a successful design plan. He also decided to share a few tips that design teams can use to avoid lengthy setbacks that can slow or even completely derail development altogether. Don't miss his talk for even more guidance.
MD+DI: For starters, can you talk a little about the basics of a successful design plan, and the role it can play in the process of product delivery? How crucial is it to craft a meticulous and precise design plan?
Murray: The plan has several aspects to it that validates the full commitment of the team described in the deployment of the plan. In project management terms, key task points are outlined (review phase-gates) along with the documents that must satisfy those tasks. Therefore, it is important as to who is the project manager (not a member of the active team) in driving all critical aspects of the plan, which include: (1) phases are complete and the DHF [device history file] is populated; (2) the MA [market authorization] submission for regulatory approval is also part of the DHF and is meeting its detail and timeline; (3) the RMF [risk management file] is populated as part of the DHF and has completed all risk-based assessment and analysis before the completion of the design and development phase; (4) design transfer is approved by review of the validation phase and the technical transfer occurs as the result of a bonified DMR [device master record] approval by manufacturing; (5) the key freeze points have final technical documentation (design-product-operational freeze) in the DHF; (6) formal closure of the DHF under predetermined description in the design plan has been completed and is under control by the appropriate medium used to store it.
MD+DI: What are some of the roles and responsibilities of the drivers of the design plan? How can they effectively keep design teams on track from start to finish?
Murray: First, the assignment of the project manager who, irrespective of other chores, must keep the DP [design plan] tasks deployed for the plan. Second, the interface team must be confirmed from a predesignated list of roles necessary to complete the phase tasks and the final phase review. Third, an independent QA auditor should audit each completed phase to ensure the plan and its documentation are populating the DHF. No one-party team member can control the key components of the plan—they must all be equally collaborating. This is driven by the project manager in conjunction with the auditor.
MD+DI: What are some common mistakes or miscues that can often lead design teams down the wrong path, and how can teams work to avoid some of these mistakes?
Murray: If the design plan is followed (like a roadmap), then there shouldn’t be any wrong turns. Mistakes can have a process for a fix; however, miscues are a failure to follow the plan. The key is the predetermined documentation and interfacing that must occur. Poor calculated timing for inputs by the team leads to premature deadlines where things are often rushed and signed off without due process. Much worse is the presumption of approving items that need team collaboration. The design plan is designed to eliminate such risks, which is why an independent project manager and auditor can keep things on track.
MD+DI: How important is it to define any and all risks involved in the design process? What role does documentation play when it comes to the process of validation?
Murray: The risk aspect of a design project is the most crucial aspect of the project charter. Realistic, transparents barriers, assumptions, and commitments must be laid out. Product and process risks are well outlined by tools for analysis and assessment. This early component of risk can use a SFMEA [system failure mode effect analysis] system to capture these risks. Don’t take systematic risk lightly. They can become the root cause of consternation for the design plan and can cause frustration and even covert work within the design plan. Validation is critical, yet the most apprehensive component phase of design control. It should be anticipated that issues will arise from this phase. It is also the final due diligence component of identifying risks, failures, improvements, and opportunities unseen during verification of product ‘freeze.’ How these issues are handled does not have to be a go or no-go scenario, although some will have high-risk consequences if not addressed. It does help to avoid recalls or even market withdrawals, so documentation such as well thought-out protocols, methods of analysis, and results are all crucial. The 2011 process validation guideline from FDA has taken much of this into account. The new qualification process is PD-PPQ-P&PC (not IQ/OQ/PQ) [process design-process qualification-product & process control verification not installation qualification/operational qualification/performance qualification].
MD+DI: What are a few tips that you could share with design teams to help them stay on track during the development process and avoid getting held up or sidetracked on the way toward the finished product?
Murray: The first would be to allow for unforeseen circumstances. Second would be to use good forms and ticklists to keep interfacing reviews on task. Third would be to be transparent, but not over-analytical about risk-based thinking. Lastly, use a formal risk-based factual decision making model to help avoid groupthink.
MD+DI: Finally, in your years of experience, would you say there are still things you’re learning about crafting an effective design plan? What are some of the recent lessons you’ve learned that could help design teams in today’s world of device development?
Murray: The most important is the intimate involvement of management as a peacemaker/decision-enabler in the approval of the overall design control procedure. If necessary, have the top (most influential) executive be a CAPA owner where this process comes under great scrutiny, as necessary improvements will be needed for it to be successful.
Please attend the MD&M Minneapolis November 1 session, “The Role a Design Plan Plays in Technical Transfer.”