Velentium’s slogan for medical device engineering is “Your IP. Designed and Built.” We offer a selection of services that represents the entire lifecycle of a device, from feasibility assessment support, to secure development and design, verification and validation solutions, submissions and regulatory approval assistance, manufacturing, postmarket surveillance, and EOL support. Our engineers, developers, SMEs, manufacturing technicians, and production managers who support these services work together continuously: they aren’t segregated by project stage.
Having production engineers working side-by-side with concept designers gives us an unusual vantage point on both the design and manufacturing processes. In this series, for which we are joined by Production Manager Devin Carroll and Technical Manager Soumendu Bhattacharya, we aim to share some of our insights.
Device designs are “released,” or transferred to manufacturing, in one of two main scenarios. In Scenario A, the device has been designed for manufacturing starting from the Concept phase. In this scenario, manufacturing considerations are taken into account for proof-of-concept designs and prototyping. This is the preferred / ideal scenario, for reasons we’ll discuss in more detail in future posts. Devices developed this way are set up for the smoothest, fastest transition into production, and are less likely to encounter unexpected delays and expenses. However, business considerations around budget and timetable early on in development can make Scenario A less practical in the short run.
Then there’s Scenario B, in which the design is evaluated and adapted for manufacturing after the concept has been proved with functioning prototypes. Depending on the device, its use cases, and the test types required, adaptation may take place prior to initial low-batch prototype runs, or between prototyping and high-volume production. Certain aspects of the design should not be changed at this point, for practical reasons -- specifically, no changes can be introduced which might impact the device’s essential clinical functions or performance without significant implications for the regulatory approval process. But other aspects may be able to be changed, and may need to be changed, to optimize the design for production at high volumes. This might include swapping out a component for its equivalent on the BOM, designating a different component supplier or new backup supplier, or streamlining the assembly process. The need for these changes will generally be driven by practical considerations -- for example, to address availability shortfalls for a particular component, cybersecurity or quality concerns for a particular supplier, or to cut down on manufacturing costs by making an assembly process more efficient.
(Of course, any such change must be governed by a design control process similar to that which governed development up to this point).
Reading a high-level description of these scenarios can make the choice between A and B seem clear, even obvious. Why not take manufacturing concerns into account right from the early stages of development? Isn’t it more practical to always take the “Scenario A” approach for a device you intend to bring to market through mass production? Well actually -- no, it isn’t always more practical. Many devices start out as R&D projects, with a mandate to prove the efficacy of a core concept on a tight schedule and budget. Introducing manufacturing concerns too soon might be a premature complication and expense that an R&D project simply can’t afford, if it is to succeed.
Our next posts in this series will dive into these scenarios in more depth. We’ll discuss their pros and cons to bring further clarity to the decision about when to introduce manufacturing concerns into the design process.