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Perspectives on First Step in Design, Part II

Tue, 06/05/2012 - 12:54pm

Once a new medical device idea is formulated, what is the critical first step to help ensure its success through to market launch?

Jerry Brightbill
Program Manager, Product Development, Vention Medical

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After the idea is formulated, it is essential to evaluate it in clinically relevant tests.The objective of this effort is to set technical direction and to identify technical risks.

After holding a brainstorm session with experienced engineers,the design team should select the best one or two concepts to build and test.The team should consider manufacturability, risk, reliability and cost in this selection process.Engineers should emphasize developing a prototype that evaluates the most significant unknowns. For example, if designing a stent delivery system with a novel stent releasing method, an engineering team should focus more on developing the releasing mechanism, and less on creating a fully functional ergonomic handle.This strategy helps identify and overcome critical challenges before considerable time and money is spent, and it postpones development of lower risk items to a later stage.

By creating and testing multiple prototypes early in the program, the development team can determine technical direction promptly and can address challenging design aspects early.Once the group obtains acceptable test results, they can proceed to the risk analysis, design refinement, verification and transfer phases.


Marc Dubreuil
Director, Business Development, Farm

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A device should be evaluated at the earliest step possible to determine market success and capital preservation. An idea must be vetted by multiple users who can provide non-biased feedback on performance, usability and anticipated adoption. The best devices are those that create maximum clinical benefit with minimal cultural change. Getting input early can help drive investor commitments and save time, energy and money developing a less than viable market opportunity.

Conducting formative, evaluative and summative testing throughout the development process allows us to test validity and user interest in the device. Early concepts, storyboards, animations and prototypes can be used to do preference testing, bench testing and usability testing—even the FDA is on the right track when they require that we incorporate users in the development process. By getting feedback from a large number of potential users with a wide range of experience, we can determine the applicability of the product for a particular market.

When we can combine technology’s cost benefits with device usability to increase adoption, success can be achieved in the marketplace. And by involving users throughout the development process, you’ll receive the endorsement of the FDA as well.


Nick Lukianov
Director, Business Development, Avnet Electronics Marketing, Americas

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To help ensure the success of a device through to market launch, the first step is comprised of the comparison, trade off analysis and intersection of two fundamental planning exercises; device scope and profitability.

First, a device specification must be developed that includes definition of the end-use model, fundamental device operational requirements and technical specifications, availability of volume production ready technologies, extent of clinical trial requirements, regulatory hurdles, reimbursement potential, and all associated product lifecycle costs. In parallel, business plan modeling must be completed with regard to target markets, geographies; traditional vs. emerging markets; economies of scale and cost of sales.

Based on the fact that the majority of medical device manufacturers are in the business with a profit motive, the intersection of these two vectors will either provide motivation to move beyond the first step or to have a potentially useful diagnostic device or therapeutic tool languish on the shelf of “great ideas that could have been.”


Daniel Santos
Engineering Manager for Pro-Dex, Inc

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Once Engineering, RA/QA, Manufacturing, Procurement, and Business Development have collectively evaluated the device’s life-cycle—from project feasibility all the way through release— the critical first step is for the design engineer to coordinate with an in-house prototype machinist to ensure Design for Manufacturing.

Feedback from a knowledgeable, highly-skilled prototype machinist, even when the prototype is just a computer-generated model, can offer valuable insight into how to design the device so that it is easier to manufacture and more efficient to assemble.

Without the prototype machinist’s critical perspective, the design engineer is unlikely to know whether or not the design concept is compatible with in-house machining capabilities, if the components or materials will make the device costly or time-consuming to produce, or if features in the design (or lack thereof) will impede assembly.

Collaboration between the design engineer and the prototype machinist will expose many of these issues early in the design process (ideally before the first design drawing is released), allowing for prompt resolution and accelerated time to market.


Eric Loh
CEO, EPI Mobile Health Solutions Pte Ltd.

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The critical first step to ensure its success is to learn what the market needs and demands are. Sufficient time and resources must always be dedicated to know and understand the consumer market and the likelihood of them using the medical device.While one often considers an innovative idea as a disruptive creation – one that drives the market to behave in a certain manner – it needs not always be the case! By spending a considerable amount of time to know the market and understand the market needs and hence, address these needs by incorporating innovative solutions into the medical products, we are able to ensure that the medical device is something that is in demand. Knowing the market is both a critical first step and a continual process. The market is ever-changing and target markets may change over time. It is important that all aspects of the market are considered and researched thoroughly to ensure that the medical device will be a success through to market launch.

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