Design for Manufacturability’s Impact When Deployed Early in the Medical Device Product Development Process

​At the forefront of the medical device new product development (NPD) process we typically find a list of considerations we’re trying to address within our product all while coming up with a solution which meets marketplace needs. Talk to anyone in R&D, or downstream marketing for that matter, and you’ll commonly hear the list of ‘needs’ for a new product can seem never-ending.

What you may find surprising is how often design for manufacturability (DFM) is not considered in the beginning of the development process.  DFM is an important, and often overlooked, part of product development which involves designing a product in a way which makes it easier and more cost-effective to manufacture commercially.

While embedding DFM into the process early seems like a logical part of the process, what plays out in reality is an NPD process that is focused on creativity and validating a technology yet can lack appreciation for the future state of the product and it’s foray into the market.  

So why is it companies may overlook incorporating DFM into the development process?

For starters, many of us who design products on the front end, have little perspective, or perhaps no perspective on what it takes to actually produce a scalable product on the back end.  Unless you’ve worked on a manufacturing floor or you’ve walked through an entire new product introduction (NPI) cycle, it’s easy to misunderstand all which goes into producing a product to bring to market.  

The design process also requires creativity and ingenuity in order to find new approaches, break common perceptions of technology capabilities, etc.  It’s about ideation!  Unfortunately thinking down the road about how it will be built for commercial purposes is “someone else’s problem”. 

To illustrate this point let’s look towards the automotive industry at a product we all know, which also happens to be a heavily regulated industry, like the medical device industry. 

If you have ever been to a large-scale automotive show, like the LA Auto Show in Los Angeles, CA, what you’ll see are concept cars on display to wow the eyes and entice the senses.  Ironically, if those same concept cars ever got to production, you’ll find their characteristics which made the vehicle look incredible are often diluted down to features and benefits which consumers will accept and are cost efficient to produce. 

Case in point, the two images below shows a 2010 Chevy Volt electric vehicle.  

​The top image is the concept vehicle – sleek, sophisticated, sharp lines, aggressive character and eye catching.  Almost resembles a sports car.  The bottom image is the production vehicle – commuter extraordinaire with features which are dull, less angular and more consistent with a car which will be manufactured by the hundreds of thousands. 

Concept vehicles have their place though – mostly to show off a company’s capabilities and satisfy egos.  They just aren’t practical on scale.  The truth is if Chevy produced at volume the concept version the average consumer wouldn’t be able to afford it.  As a result, they round out the features, slap some plastic on it and Walla you’ve got a commuter vehicle fit for the masses at a price point which coincides with high volume sales. 

The medical device industry is no different.  While industrial design is playing a much larger role today with device design, the fact of the matter is our industry struggles at times with over engineering products just like the auto industry.  This can lead to a company losing sight of what the end user needs and wants, as well as if it can actually be manufactured to meet reimbursements.

It’s for these reasons it’s important to consider design for manufacturing from the very beginning of the design process.  If you do so, you stand to experience the following:

1. Cost Reduction: DFM helps identify and eliminate potential manufacturing challenges and inefficiencies early in the design phase. By addressing these issues upfront, you can avoid costly design changes and rework later in the process.
2. Faster Time to Market: Efficient and streamlined manufacturing processes result in quicker production cycles. Considering DFM from the start can help you get your product to market faster, gaining a competitive edge and capturing market opportunities more swiftly.
3. Improved Quality and Reliability: A design optimized for manufacturability tends to produce more consistent and reliable products. Minimizing manufacturing complexities and potential error sources can lead to higher product quality and fewer defects.
4. Prototype Development: Prototyping is a vital step in medical device development. DFM principles can help create prototypes that closely resemble the final manufactured product, allowing for more accurate testing and validation.
5. Better Use of Materials: Designing with manufacturing in mind allows for the efficient use of materials. This can reduce material waste and decrease overall production costs. Additionally, it may have environmental benefits by reducing resource consumption and waste generation.
6. Scalability: If your product design is easily manufacturable, it can be scaled up or down more effectively to meet changes in demand. This flexibility is crucial in today's dynamic business environment.
7. Regulatory Compliance: By considering DFM from the beginning, you can design with these requirements in mind, reducing the risk of compliance issues later on.  (think about standards like ISO 13485, 14001 and 14971
8. Enhanced Innovation: Designing for manufacturability doesn't mean sacrificing innovation. In fact, it can encourage creativity by pushing designers to find innovative solutions that are also efficient and cost-effective to manufacture.
9. Minimizing Risk: Addressing manufacturability issues early reduces the risk of encountering unexpected problems during production, which can lead to delays, increased costs, and potential product recalls.

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Considering DFM from the beginning of the design process is crucial for optimizing the manufacturing process, reducing costs, improving product quality, and ensuring a smoother path to market. It ultimately results in a more competitive and successful product with potential less risk downstream.

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​The quickest way to overcome a business challenge is to get help from those who are experienced in besting your beast!  The team at Square-1 Engineering is comprised of a variety of medical device technical and project management professionals who are subject matter experts in the areas of NPD, Quality, Compliance and Manufacturing Engineering.  Learn more about how we can solve your work and project problems today to get you back on track!

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