And understandably so – it is the ideas, the vision, the drive to bring your product to market that inspires most product development and has produced some of the world’s best innovation.
A product is only as good as the regulations it complies with, however – something that was shown by the initial surge of new products and technologies developed in response to the Covid-19 pandemic, many of which were restricted from use due to lack of necessary certification and approval.
Nailing down the requirements as robustly as possible at the beginning of the product development process is essential, and a failure to do so can have a critical impact on the project, even causing it to fail altogether. Meanwhile, changes after design ‘freezes’ lead to re-work, adding cost and delays.
So where should you start when it comes to the design process?
Improving your chance of success
If you begin by identifying the risks, regulations and standards associated with developing your product, you will significantly improve your chances of success. It is unlikely to be a straightforward process, but it is essential that these considerations are made at the beginning. There are countless risks associated with product development, such as missing a requirement, a concept failing verification and requiring re-work, finding out your design cannot be manufactured, or costs being too high based on anticipated volumes.
These issues are commonplace and can be managed. Diligence is the key and it is generally recommended to follow a stage-gated design review process. This is not exclusive though, and less formal design discussions and meetings in-between these formal reviews, typically with key stakeholders or subject matter experts, should always be captured and fed into the reviews.
These reviews are invaluable and should be held at pre-determined stages of the product development process, such as specification review, concept review and detailed design review. You should freeze the design after each review to ensure everyone is clear on the design intent, and to become aware of any costs and lead times from changes made outside of the process.
There are lots of tools that you can utilise in your product development journey. Methods such as the failure mode and effects analysis (FMEA) provide a comprehensive method of identifying design pitfalls. There are numerous technology qualification frameworks in existence too, the most commonly used being DNV RP-A203, and these outline structured approaches to help mature your product's technology readiness level.
Knowns and unknowns
With respect to risk, we can learn a lot from the ‘knowns and unknowns’ framework, made famous by former US defence secretary Donald Rumsfeld. Originating from Socratic philosophy and used robustly by NASA, the method allows us to categorise our challenges into four quadrants that vary according to severity – known knowns, known unknowns, unknown knowns and unknown unknowns.
Ideally you want to convert as many risks as possible into known knowns. Most of your challenges will begin as known unknowns, which you will be maturing and developing during the product development until they become de-risked known quantities, or known knowns. An example of a known unknown is a novel method of manufacturing or material that you wish to explore. If you become satisfied that it is useable and capable of meeting requirements it can upgraded to a known known.
Unknown knowns are risks that could have been identified during the project planning stage but were missed and then go on to negatively impact the project. These usually result from poor communication, whereby an error in a previous project was not reported and shared. This can be very frustrating because it is easily avoidable.
Unknown unknowns are the true surprises. These are the issues you were not able to envisage happening, such as production being halted because one of your suppliers goes into liquidation and the liquidator seizes the tooling which belongs to you. This category poses significant threat to the project. These issues require reactive handling and can be the costliest.
Looking at the risks, regulations and standards appropriate to your project can be daunting, and the experience of others can be beneficial in this regard. The NMIS design engineering team can help identify and capture product requirements, separating the essential from the ‘nice to have’. We can support with capturing these in a product design specification and using this as the basis for product development, ensuring the design concept adheres and can be verified to the identified codes and standards before developing for manufacture.
While it may be tempting to get straight to design, you can save a lot of time and money with the right diligence and groundwork.
Research has found that 97% of hardware start-ups fail. If you consider risks, regulations and standards from the starting line, you will have a much better chance of finishing the race.
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Content published by Professional Engineering does not necessarily represent the views of the Institution of Mechanical Engineers.