By Jim Kasic and Peggy Fasano, Boulder iQ
As part of the FDA’s regulations, every medical device developer must establish a quality management system (QMS). In most cases, developers also must establish and use design controls, creating specific documentation and reviewing requirements throughout the process. Those include a design history file (DHF), verification and validation testing, and a device master record (DMR) on the release of the design to manufacturing. Most device companies include a phased product development process in their QMS, outlining specific requirements for each phase. QMS policies require, and strictly enforce, documented design and phase reviews before completing the DHF for that phase of the process. In many cases, these reviews serve as gatekeepers, allowing significant work on the following phase to begin only when the requirements of the previous phase have been met. The result is the well-known phase-gate approach to medical device development.
The resulting product development process often becomes cumbersome and slow – the exact opposite of what’s needed for products whose function is often essential to critical treatment or prevention of disease or chronic conditions. The good news is that there are ways to make dramatic improvements to the efficiency of the product development process while maintaining project phase controls. Speeding time to market within a controlled process is possible but requires thinking differently – thinking smarter – about the order of some steps in the process, focusing on the end result instead of each phase. This “think smart” approach does not skip any required steps. It simply eliminates the “gate” from traditional phase-gate thinking. The result: substantial time savings. In our experience, implementing the “think smart” approach with several hundred companies over 25 years, we have seen time savings of 10 to 60%, depending on the project. That translates to significant cost savings every step of the way.
Draft The Instructions For Use (IFU) In Phase 1
In most systems, writing the Instructions for Use (IFU) document for a device takes place toward the end of the development process when all relevant details are available. Instead, there’s a real advantage in drafting the IFU within the first phase of the development as part of the formative usability study (per ISO 62366).
To confirm that the development approach is sound, the formative usability study typically requires document sketches and presentation of concepts to potential users. Drafting the IFU up front saves serious time later on, as it helps the development team better understand the end use of the product. They then can conduct a simple in-service training session with users following the drafting of the IFU.
This approach has a double benefit. Users walk through how they will implement the device, and developers gain perspective and details about how their device will achieve key end goals – all before expending substantial time in development. And the resulting impact on the accuracy of the product requirements and specifications can be dramatic, ultimately reducing the number and depth of iterations during the design and testing processes.
Developers can then use information from the IFU – appropriately modified – with the resulting product requirements document and specifications to outline test protocols for engineering performance confirmation and verification and validation. Knowing how the design will be tested very early in the process helps streamline the design activities.
Prep The Table Of Contents First Versus Last
Following the “think smart” approach, it’s also possible to develop the table of contents for the DHF and 510(k) at the beginning of the development process. To do so, a company would create a file folder (electronic and/or physical) for each item in the table of contents and begin adding draft documents to them as early as possible.
As later phases near completion, developers will need far less time and effort to complete the DHF and portions of the 510(k) submission, since most of the work will already be done.
Draft Verification And Validation Plans Directly After The Product Requirements
Development of verification and validation plans is often listed as a step in a later phase of the development process. However, the reality is that they can be drafted as soon as the product requirements have been drafted, in Phase 1. The same holds true for other procedures and documents.
By understanding exactly which tests the product will need to undergo at the beginning of the development phase, the engineering team can design the product through the lens of the testing requirements, thereby assuring the product will pass the tests. In the process, they also might encounter a cost-prohibitive test, allowing them to change or shift a specific feature.
The plans, procedures, and documents will almost inevitably change through development and will require refinement for additional information and detail. But doing as much as possible, as soon as possible, provides a foundation that results in major time savings over the life of the development process.
Overcoming Implementation Challenges
Change can be hard for everyone, especially in a professional context where the same methodology – such as the FDA’s phase-gate approach – has been used for a significant period. Methods to shift an organization’s mindset do exist, however.
Putting the cart before the horse: A common challenge encountered in starting the IFU draft in Phase 1 is that product details are not available, since the product has not yet been designed. That’s the point: to be clear on the type of product to design so that it meets the needs of the market. To address the challenge, it’s important to talk with the product development team, including those from quality, engineering, and regulatory, at the beginning of the project. By explaining the entire process and including them in writing the IFU, they will better see the overall benefits and become invested in the modified process. They will gain a better understanding of the product, have more “skin in the game,” and know their overall role in the process.
“I’ll just have to redo it later”: A common refrain when implementing the “think smart” approach, the reality is that once the IFU, requirements, and specifications are in place, the developer can draft most of the documents that will be needed later by simply leaving blanks to fill in for the details. To complete each phase, review meetings should confirm the review and appropriate approval of all documents required for that phase. That does not mean that all documents must be prepared, in entirety, just before the review meetings in a massive time-consuming effort. Rather, by “thinking smart,” it’s possible to draft a large number of documents for future phases, ready for the addition of final details. As an added benefit to preparing documents early on, developers must carefully think about what each will require, thereby avoiding last-minute oversights or rushes to obtain information.
Personnel management: Another challenge can be managing schedules so that the right person is available to do needed work up front. While almost every project will have someone responsible for regulatory work at the beginning of a project, some shifting of schedules may be required. The key is to look at the overall time savings and the resulting decrease in number of days, weeks, and months to get a product to the market.
Templates And Project Management Tools
Each project and each product has its own unique characteristics. After all, product requirements and specifications for an IV pump and tubing set will be radically different from those of an electrosurgical generator and disposable surgical pencils. Templates, then, may be limited but still have value in establishing and completing the major required items.
Project management tools – including Microsoft Project, Playbook, Smartsheet, and Agile – do an excellent job of tracking activities. But they only help implement a specific way of proceeding along the development path. To use tools like these within the “think smart” approach, a design company would simply restructure the tasks and sprints to include early implementation of the IFU, test procedures, DHF and 510(k) submission document structures, and other tasks.
Efficient design depends on a deep understanding of user needs and testing requirements. Developing this understanding from the beginning, and documenting the understanding in appropriate required documents at the time, results in time and cost savings and the ability to introduce innovative products in advance of the competition.
In every field, significant advantages happen by challenging traditional thinking. Medical device development is no different. Thinking smart means thinking in ways specifically targeted to reducing time to market while maintaining quality and compliance.
About The Authors:
Jim Kasic is the founder and chairman of Boulder iQ. With more than 30 years of experience in the Class I, II, and III medical device industry, he holds more than 40 U.S. and international patients. His career includes experience with companies ranging from large multinational corporations to start-ups with a national and international scope. Kasic has served as president and CEO of Sophono, Inc., a multinational manufacturer and distributor of implantable hearing devices, which was acquired by Medtronic. He also was the president of OrthoWin, acquired by Zimmer-BioMed. He received a B.S. in physics and an M.S. in chemical/biological engineering from the University of Colorado, and an M.B.A. from the University of Phoenix. He can be reached at email@example.com or on LinkedIn.
Peggy Fasano is Chief Operating Officer at Boulder iQ. She is an expert in product development, project management, and engineering within the medical device and biotech industries. She has held the positions of senior consultant with Deloitte Consulting, managing director of the Deming Center Venture Fund, product development and engineer consultant for Boulder BioMed, and project manager and mechanical engineer for Sophono, Inc. She also has worked as a mechanical engineer and project manager at Polestar Technologies. Fasano holds a B.S. in mechanical engineering from Tufts University, and an M.B.A. from the University of Colorado. She can be reached at firstname.lastname@example.org or on LinkedIn.