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As a head of the product development organization (i.e. Engineering, Marketing, Manufacturing, or Quality) in the Medical Device Industry, what are the top five issues that keep you up at night?
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As originally asked by Robert Stathopulos.
I continue to be troubled by the poor outcomes demonstrated by medical product development organizations in producing new product winners. Industry surveys optimistically tout that about 1 in 8 projects yield new products that meet or exceed sales projections that justified those projects.
Improvements since the 1976 FDA medical device legislation have been incremental, but no breakthrough has been achieved. Disciplines like project management, stage-gate development, voice of the customer, and quality function deployment, among others, have clearly added to ‘good product development practices’ (or GPDP).
But how can the typical product development organization — Engineering, Marketing, Manufacturing, Quality, Clinical, Regulatory — improve its hit rate from 1:8 to 1:2? To address this question, I would like to ask Vice Presidents or Directors involved in Medical Device Development what are the key issues they continually face that affect the outcome of their product development organization.
I am a former Director of Product Development for several global medical device manufacturers, and currently advise medical device start-up ventures, in getting their ‘first product’ out of development and into production. Streamlining medical device development has been a life-long quest.
We did constantly invest in test development and fault detection as well but when dealing with consumer electronics with 6 month development and 6 month sales cycles it was crucial to get things right and win the shelf space. Once your on the planogram its easier to keep it, just deliver a better, cheaper and more attractive product 6 months later (which is often sold before kicking off the program). Much of this has not applied to Medical Devices but maybe it should….or will.
What about a screen for the feasibility phase, where technical as well as commercial feasibility are challenged? What about a screen for the prototype development phase, where performance and reliability are challenged? What about a screen for the clinical development phase, where usability and clinical claims are challenged? What about a screen for the process development phase, where cost and quality claims are challenged?
David W Bertoni
What has evolved out of this over the last decade are intelligent data driven systems that quickly validate concepts, fault detect, transfer knowledge and evaluate product quality. I think the Medical device industry has reached an inflection point and requires these types of solutions due to increasing market and regulatory pressures. The good news is the industry is far behind and as a result will be able to take advantage of the experience, lessons learned and work product of other industries. Some of the larger Medical Device firms operate in multiple industries and are already adapting cross-industry solutions to meet the current and future challenges.
As Jeff says, ‘failing quickly’ is more effective than ‘trying to make it go no matter what happens’. Unfortunately, good business sense is often overshadowed by executive ego and fear of being wrong.
I also like what Tina is saying. There is a very real inflexibility in development commitments that are made. Since most product development programs take years to complete, the market and customer change, and that change is often ignored rather than integrated into the ongoing program. Some new products are dead before they are launched because the market has evolved.
Or when introducing a proven product into a new market. Who would have thought that your product could be delivered via bicycle or rickshaw in a rainstorm in Asia.
Tim — It seems standard practice that too many projects are being pursued simultaneously. One or two high-impact new products are always worth more than five or six me-to or line extension products. In addition, I think that many device manufacturers under-estimate the efforts required to maintain the product lines that they produce, which drains their Manufacturing resources and often draws in R&D.
Mike — You are right on about hidden or unanticipated risk. Though no one can anticipate what could go haywire in new product development, thorough planning and risk assessment will always uncover blind spots that need to be investigated further. The most frustrating experience I’ve ever had is the appearance of a major design or performance issue that should have anticipated and planned for.
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