Rick's Story
You already did the hard part. You created a world-changing device. Now’s the time for me to work through the design process and bring you closer to production by –
- Creating a product built for production in an FDA-environment, and,
- Working with your manufacturers to make production rapid, robust, and affordable.
I’m sure I can help you. Let’s talk and discover precisely how.
So, what could possibly go wrong?
Theoretically, nothing. Or anything.
Most innovators, and their design crew, know how to do their prospective tasks, know what their medical device or other product is supposed to do, and recognize whether it is doing its intended purpose.
So, what are some things that could go wrong?
- Design for Manufacture (DFM) is something that appears easy, but misapplied DFM, or lack of DFM, can bring development to a full stop.
- For instance, a product may be nearly complete when a critical dimension is causing everything not to function because the product of fabricating tolerances, material change over time and machine setting choices were not factored correctly into the design.
- Development can be stopped dead because there was too much information on a drawing for a post-release FAI (First Article Inspection).
- Critical dimensions may appear straightforward, but the resulting geometry may present inspection problems. If the dimension cannot be confirmed by measurement, then Quality Control may have to sign off on the feature using other, inferior criteria, resulting in subsequent quality issues being hidden. I leave the resulting issues and lost production time (or worse) to your imagination.
- Not all contracts are created equal. A developer can actually lose control over their IP (intellectual property), which can cause all manner of chaos, including the need to reinvent, or at least recreate, all of their design data.
- Miscommunication between departments can create product requirements which are physically impossible, but which will still consume months of development time, and waste hundreds of engineering hours, until they are discovered.
- Young companies can create their own regulatory issues unintentionally, such as having their document of record residing within the Product Data Management of their solid modelling software (SolidWorks, Pro/ENGINEER). This can seriously impair revision generation, not to mention the burden of validating the CAD (computer aided design) software. But if your designer is familiar with the broad FDA requirements, the problem can be easily avoided.
- Finally, a designer can (1) be in “over their head” with respect to the demands of a task, but (2) not quite experienced enough to know that this is true.
- You can even have a designer or engineer who has no idea that their design will not function, such as, (1) An electrical engineer specifying or designing a mechanical component, or (2) A mechanical part or assembly designed by, say, an industrial designer and not someone with an engineering education and experience.
But these are design-related problems.
You may also see that —
- Development time is a busy time. Clouds of emails, texts, and other communications can result in the Client having one timeline, but the Designer having quite a different timeline. This can lead to an unexpected and anxious phone call.
- The very same thing can happen with project design costs, resulting in some very unpleasant communication at the end of the month.
- Not only that but design details may be misunderstood, wasting time and resources, resulting in another one of those unpleasant communications.
The BIG question
I can answer that pretty quickly.
Yes, these things can happen in product development, singly or in combination.
Yes, and I have observed every single one of these things, at least once.
Yes, and I have seen some stranger things also, but aren't these trouble enough?
Mission