In order to try and help avoid this, Design Director Mark and Design Development Engineer Luke, discuss the process and importance of conducting feasibility studies as part of the medical device development process:
“Each year, 30,000 new consumer products are launched – and 95% of them fail.” – Clayton Christensen (Harvard Business School). Further studies have found that around 75% of these failures are due to organisational reasons whether that be feasibility, viability, or time to market… This highlights the importance of a stage dedicated to the exploration and mitigation of risks at an early point in the design!
We have first-hand experience of clients approaching us with projects that have failed as a result of not undertaking feasibility studies and therefore recommend it as an essential stage, where costs and technical risks can be considered. The concept can then be updated, or alternatively, it may be determined that it’s time to pause the project before further investment is made.
The scope of a feasibility study can extend to encompass many aspects, including social, organisational, operational, and ethical/environmental studies but, for the purpose of this blog, we will be focusing on those most commonly associated with NPD; commercial & technical.
A feasibility study in new product or device development is an analysis of the likelihood that a product will be successful in returning a profit, within the desired timeframe. By investigating the technical and commercial risks, the likelihood of success is much improved. Fully developing a design without investigating these areas can be costly further down the line, resulting in unexpected costs and delayed launch dates:
Are tooling costs within the available budget? Can the parts be manufactured and assembled at a cost that allows the product to be sold at an acceptable price, and return the desired amount of profit?
Can the parts be manufactured easily, using the suggested processes and materials? Can it be assembled easily? Does the concept work effectively in the real world?
A dedicated feasibility stage usually occurs once a detailed concept CAD model has been developed. The bill of materials generated from such a model provides a solid base in which to consult with suppliers, source proprietary components, and therefore adequately assess the feasibility.
To some extent, an experienced engineer is able to design with cost and manufacturability in mind, however, at the concept stage it is particularly important to avoid placing heavy restrictions on creativity or unnecessarily limiting the design. The goal of the concept design stage is to freely explore different options for a product and the main focus should not be on feasibility.
The concept CAD models are used to start discussions with tool makers and produce engineering drawings with critical dimensions or tolerances shown. We would be looking to obtain all costs relating to the production of the components, including bespoke tooling and part costs including finishes or secondary operations. Material selection can have an impact on tool and part costs, as well as potential supply chain issues, so selecting the right materials for the technical requirements of the product and understanding costs is important. Lead times should be requested from all manufacturers/suppliers, as this will influence product launch plans.
If possible, discuss the assembly of the product with the company that will carry out the work, to ensure that they have the necessary skills, tools, space and availability. If the product will be installed, speak to typical installation teams to find out what is best practice and understand the difficulties they might face.
Prototyping the design at this stage can help highlight functional, ergonomic and human factors risks that wouldn’t be obvious by looking at the design on a screen.
Time is money, so if the product is over-complicated or difficult to manufacture/assemble/install, it could add significant and unnecessary costs to the product and its development. Its well worth taking the time to assess these things as early as possible to understand these challenges and design them out. If you would like further advice or assistance with conducting a feasibility study or, a wider device development programme, please get in touch.
Design Director
Mark ensures that projects are delivered on time and are suitably resourced to guarantee quality of output. Mark is heavily involved in our design services, having a wealth of experience in healthcare devices, trainer devices, IVD’s, and inhalation.
Mark holds a Bachelor’s Degree in Product Design along with 20 years’ experience working on a wide range of design projects.
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