Best Practices for Medical Product Design & Documentation

Here’s a challenge I see quite often while we’re on a client project involving mechanical design or CAD work. ?Does this familiar?

Someone is tasked with designing a new sub-assembly or component for an existing product.? As they get underway their work on face value gets the company to a conclusion where the design/ drawing is technically complete. As such, this person is able to check the proverbial box for ‘task completed’ and move on to the next assignment.? While the work may have technically been completed, it often is done in a fashion which causes all sorts of problems down the road for the company, including other employees working on the same project within the same organization as well as their external suppliers.?

How is it someone can complete a design project satisfactory on the surface yet problems arise down the road with that very same design, which had been previously approved?

Answer: the devil is in the details, or lack thereof, to be more specific.

The reason why companies and or their respective employees experience this is because they aren’t following a formal and documented ‘gold standard’ for their product design practices.? Simply put, they lack discipline with design fundamentals.

As a result of a lack of design standards (and perhaps training) employees are left to decide for themselves how to complete a task which may get them to the finish line but the approach, process and details along the way can have wild variances and interpretations.

While this may be commonplace and old news to many of you reading this article, the reality is the actual practice of designing a product with repeatable ‘gold standards’ is anything but common sense or consistent in the workplace.? When our approach to design is fast and loose we experience the following:

• Design intent isn’t captured
• Formatting and documentation inconsistencies or it’s wrong all together
• Future efforts to utilize the design for other applications can’t be leverage causing rework
• Models can’t be adjusted or revised easily because the initial designer didn’t put enough thought into their work to think ahead about future changes which may need to take place; the design is static rather than being parametrically driven
• Confidence in the model and the overall design is tarnish
• The company losses time and market opportunity which translates into lost revenue and market share attainment

When these issues show up it causes companies to reinvest dollars and resources into their work in order to move the project forward to get it to a point of where it can be properly advanced along the product development life cycle.? This reinvestment is unnecessary and a huge time suck.? We see this a lot when a medical device OEM has a contract manufacturer (CM) do some of their design work.? In more times than I can count the work which is produced in this scenario is rough, limited with detail and documentation, almost never parametrically driven, and close to useless in other scenarios.? Don’t fall for the trap of “we just need drawings.”? While that may be the case in the moment, this will almost always cause you more work and funds down the road.

For these reasons it’s vital companies implement a ‘gold standard’ in their design work which their employees and suppliers follow to ensure the work each party is facilitating makes it to the finish line in the same format, intent and approach.? This unification of process increases the likelihood design work is done correctly while also ensuring future usage of said designs doesn’t require additional unnecessary iterations or complete redesigns.

If implementing a ‘gold standard’ for your design and product development practices could be a benefit to your team or company, here are some of the key points to consider:

1. Documented processes with consistent templates and forms
2. Develop a systematic way to capture tribal/ legacy knowledge
3. Utilize a centralized database (PLM) for product data storage (tools like UpChain, Arena and Windchill)This will help with traceability and legacy data
4. Developing consistent design techniques like:sketches constrained,design for manufacturing (DFM),simplified features which are in systematic order,building relations to create predictability,organize your?feature manager trees,design intent documentation
5. Drive dimension (model dimensions) used in drawing (ease in updating documentation)
6. Implement a system of checks and balances to ensure work is done properly and in accordance with company processes and policies
7. Ensure there are consistent discussion, training and guidance focused on designing with the future in mind

Example below: A well laid out Solidworks Assembly Feature Manager Design Tree

If you, and or your company, lacks a ‘gold standard’ for your product design efforts you are inevitably wasting time and resources.? This also has a direct correlation to a suppliers’ ability to help with outsourced work causing the overall project to be more challenging and lengthier than necessary (prototyping, manufacturing, etc.)? While this isn’t a fun realization there is hope!?

Here’s how to fix it.?

Start right away by developing a best practice plan. ?This will help you and your team form an outline for what design practices and approaches are ideal for your product and technology, which aren’t, etc. From there setup a review plan to provide feedback on all work performed. Once the infrastructure of your new gold standard system is established you’ll want to asses the skills of your team and develop a training program which can be offered to both new and existing employees.

Square-1 Engineering , a medical device consulting firm, provides end to end technical project services to companies which design, develop and or manufacture life science products.? We utilize a unique approach in helping our customers complete their projects by combining the best of technical consulting services (hands on engineering & RAQA compliance) with technical training programs focused on building powerhouse teams AND GETTING WORK DONE!