Originally Aired - Thursday, September 26 • 11:00 AM - 11:45 AM Eastern Time (US & Canada)
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Location: Conference Room 52A
Title: Don’t Develop Your Device Twice: Planning for the Next Generation, and the Next, and the Next….
Event Type: Master Class Conference
The development of a new medical device usually involves a standard set of steps that must include a risk assessment to ensure patient safety, product performance, and business success. These steps cover the complete evolution of the design, starting from identification of the clinical need and patient population size through to building and implementing a regulatory plan, validation of the technology through suitable clinical or benchtop studies and finally release to market. The development process must also include relevant prototyping, performance specification selection, identification of source materials and selection of manufacturing processes suitable for the technology and the price point.
In today’s medical device market, particularly in newer technologies, the first generation device is rarely the last iteration of the device, and keeping an eye on the demands of the regulatory and reimbursement environment at the concept phase is critical for success now and in the future. In this presentation, we will discuss the unique forces that the regulated medical device environment exerts on the development of a new device, and how those forces need to be addressed early and often in the development cycle to de-risk final launch and reduce the probability of repeat or redundant design cycles.
Design of the first generation device can often requiring considering aspects well outside the conventional ideation phase very early on in the process. We have frequently found that startups or early adopters fail to consider the regulatory and market pressures that they will encounter after they have completed their design, forcing a redesign or re-filing late in the development process. At the same time, without a next generation mindset to the design of the first generation, any change to a first generation medical device already cleared by regulatory agencies may force a costly re-evaluation of risk, particularly biocompatibility risk. Deceptively simple changes, such as a change in sterilization, can have profound impact on the materials of composition as well as a vastly changed biocompatibility risk assessment. A thorough evaluation and understanding of the materials and manufacturing process used in the first generation technology can reduce cost and timing for both the current, and next generation solutions, particularly when performed in the concept phase, well before manufacturing.
One example of design change in a second generation product is the raw material source. If a manufacturer is building a device with a polypropylene component manufactured by a third party, there are increasing pressures to find second raw material sources for supply chain resilience, or onshoring. If the medical device manufacturer has detailed information about the alternative resin, the molding conditions used by the third party, and the processing chemicals used in manufacturing the component, a risk assessment of the biocompatibility and performance risk can be performed at reasonable costs and short timelines. If this information is not known, a more costly and time consuming extractables study may be needed. Planning for this resin source change possibility up front, by either selecting resins that are relatively freely available, or considering the second source as initial development is in process, can drastically reduce costs and timing. A second example of design change involves sterilization. Currently there is increased scrutiny of ethylene oxide as a sterilization modality. This scrutiny is forcing vendors to examine alternative approaches but, for polymer materials in particular, this choice can profoundly impact the performance of the device. Selection in advance of materials that can be subjected to a variety of sterilization modalities provides increased flexibility should the next generation device need to consider alternatives to the first generation, or external force require a sterilization change on an existing product.
Planning for future designs in advance, and considering these issues during initial development, can increase up-front costs. Accumulating this information may appear to increase cost-to-market during the first generation development. This presentation discusses this approach and considers that by planning ahead and considering the pressures on the product that are separate from the “engineering” of the device, one can reduce overall cost and time to market during the development of the first generation device and, to a large extent, de-risk and reduce costs and time in the next generation technology.
