Perspectives on First Step in Design, Part I
Once a new medical device idea is formulated, what is the critical first step to help ensure its success through to market launch?
When you consider that a power supply is essential to electronics, it is amazing that so many designers wait until the end of the design process to design it in. The advantages achieved by considering the integration of the power system into a design ahead of time at the board level is pretty obvious, as last-minute changes can be catastrophically expensive. That still doesn’t mean that every engineer will do so, and even those that do may not consider all factors, such as getting rid of device operating heat or ensuring maximum use of available board space.
At larger scales, the issues do not go away simply because one can use an external power supply. The power supply’s performance and efficiency are still critical factors, as is the interface between the supply and device. Regulatory approvals and other-environment (from moisture to altitude) performance are important as well. This is especially critical to medical device creators working on battery-driven or remotely powered devices where every facet of the power system must be compliant.
Taking your product’s power supply into consideration at the beginning of the design process will pay off tremendous dividends in development time and device performance. In addition, getting the power supply vendor involved early ensures the solution will meet all the latest agency requirements, avoiding delays at later stages of development that can kill or significantly increase the cost of a product.
Managing Director, Industrial Design Consultancy
The crucial step is to identify the risks and potential difficulties in developing the idea through to launch. The detailed risk review should start with the user and market needs: "Does the device solve a significant patient and/or health system need?" Next are the technical risks, "Is it possible to develop new functions and overcome patents?" then regulatory risks, "Will the device get approval?" and finally commercial, "What will the final device and the development process cost?" The development programme should then focus on answering questions with the biggest risk.
Medical Device Leak Testing Technical Support Manager, USON
You know the market need and are ready to “go to the drawing board.” Before you put pencil to drawing board—or keyboard to CAD program—first identify the expertise you will need for market launch and assemble your entire team and have them ready for consultations from the start. This means both your in-house team and the outside experts in your supply chain.
From USON’s point of view, as a company that has helped medical device manufacturers cost effectively produce products with stringent leak rate requirements for nearly half a century, I can tell you that those who consider leak detector options and constraints or new possibilities for product design afforded by NDT innovations ahead of time come out ahead—with more efficient assemblies, shorter test cycle times, and lower production costs. Include leak test experts in your team and you may make different material choices. Careful consideration of leak test requirements to control heat or pressure during a weld assembly might have significant impact on the preferred subassembly or final design. Smarter companies take advantage of USON’s no-cost feasibility studies to clearly establish the number of test stations needed and/or production lines.
Donald L. Sweeney
Senior EMC Engineer & President, D.L.S. Electronic Systems Inc.
To ensure its success through to market launch, a newly formulated medical device will need an early stage design review, addressing electromagnetic compatibility and product safety requirements. This review is a critical first step because it eliminates regulatory compliance design flaws and identifies applicable standards early in the design phase, thereby eliminating costly changes during testing of the final product and delays in the delivery of the new device. This early stage design review will cover worldwide EMC and Safety directives, including FCC, CE, UL, CSA, FDA, IEC, CCC, and other government and regulatory agencies. This review will allow the device to meet regulatory compliance in a time-efficient, cost-saving way during final testing. We have found by addressing EMC and Product Safety requirements early in the design stage, we have saved many medical manufacturers the cost, frustration, and loss of time of trying to add fixes and design changes to a product that is out of limits or that requires Product Safety changes.
Head of Global Segment Medical and Pharmaceutical, BU Masterbatches Clariant
The critical first step has to be establishing clear design and regulatory criteria. This can be best achieved by bringing all parties of the manufacturing chain into the development process from the outset.
Consideration early-on of factors beyond device function is fundamental to a speedy and successful market launch. This means involving experts in discussion of the materials to be used, preferred color and desired performance features, production parameters (e.g., consequences of international manufacture), regulatory aspects, and the handling challenges throughout the device’s lifetime, such as sterilization methods and frequency of use. Identifying potential problem areas before they arise can avoid slowing down the development process or worse, subsequent market withdrawal. This is particularly important with the FDA challenging manufacturers to demonstrate that materials haven’t changed compared to an existing device, or there is no impact on extractables.
Such an approach is one that Clariant attaches great weight to in its customer relationships. From experience, we know that those customers that work with color and functional effects in the earliest stages of design enhance creative opportunities and have the best possible chance of meeting stringent regulatory requirements as well as cost targets. The result: faster time to market and a differentiated device.
Partner at Kalypso
One critical first step that many companies struggle with is proof of technical feasibility.
Why is early proof of technical feasibility so important?Simply stated, technology uncertainty adds risk to your project schedule. Companies can manage technology uncertainty by separating technology development (i.e., invention) from product development and building a technology assessment step into the front end of your product development process. In doing so, you can avoid entering full-scale development with unpredictable technologies that have not yet been reduced to practice. If too much “invention” is done during product development, the uncertain timing makes scheduling difficult, leading to missed launch windows.
Why do most companies struggle with proof of technical feasibility? Technical feasibility is a hard concept to define. The engineer being held accountable for a delivery schedule will have a completely different definition than the marketer who wants to get on with development. Therefore, it is important to have clear understanding and alignment. This is achieved by applying objective technology maturity criteria to quantify when a technology is ready for design. Performance values or thresholds are established upfront and assessed as the technology moves through its development toward the feasibility point.