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Orchid Blog

How to Develop Your Next Orthopedic Product with Smart Design

Posted: Monday, September 23, 2019

Did you know that approximately 75% of the cost of a medical device product is in the actual design (materials and geometry) and only 25% of the cost is in the process (and, maybe, geographically where the product is made)? The industry is becoming increasingly more aware of this, which is why Design for Manufacturing (DFM) is a term that you may have seen trending in our market. DFM means incorporating an understanding of the manufacturing processes into the design of a product, which can reduce costs and increase time to market. To take it a step further, including inspection methods into the design phase (Design for Inspection, or DFI) can also dramatically reduce costs. In an industry with increased pricing pressures, leveraging design to reduce costs and time to market is smart, so incorporating DFM and DFI is smart design.

Background on Costs and Processes in the Orthopedic Industry

While the trauma, extremities and total joint market segments have significant pricing pressures, the orthopedic and spine segments have historically had significant margins. In the past, costs may have been a secondary consideration, and OEMs would design products first, then make up for costs in the marketplace.

In addition, the compliance side of the orthopedic industry wasn’t always as challenging as it is today. The focus was on speed-to-market. So, companies worried about getting products to market first and looked for ways to squeeze cost out later. Today, it is too difficult to make those kind of changes after a product is on the market. This is true particularly for implants, while design changes on instruments are a little bit more flexible.

With the changing environment, the thought process around product design is evolving. Now, design engineers have to think about more than adding function, reliability and quality – they also need to be thinking about designing for manufacturability and inspection.

Smart Design: Integrating Product and Process Development

I think of DFM as the integration of product development and process development into one common activity. Without DFM or DFI, OEMs will typically complete the product design, freeze it, send it out for quoting and choose the lowest bid. The pitfall with this method is that the lowest quote may not be as low as the product can potentially be manufactured if DFM and DFI are done concurrently.

A design input should be more than just what you need the product to do, it should also include what it needs to cost to manufacture.

At Orchid, we work more with our customers during the design process now, and they’re discussing how much the products need to cost in order for them to be successful as a business. As a result, we are able to drive the project toward early development, as well as developing cost requirements before the design is even started.

Design for Inspection (DFI)

While many OEMs are understanding the benefits of incorporating DFM,. A lot of times, people don’t understand that a fundamental in the development of the manufacturing process has to be metrology, or design for inspection. How are you going to measure the part and how is the drawing going to tell you to measure it? The cost of manufacturing always includes some cost of inspection.

The traditional approach has been just to inspect more, so the manufacturers are doing things that provide a lot more inspection data. With the compliance side of our business becoming a larger factor in our industry, design for inspection is just as important as design for manufacturing.

Orthopedic DFM Trends

There is an increased interest in reducing the cost of instruments. The easiest way to do that is to simplify and reduce the features of the product design that have evolved over time. There is a challenge with OEMs being willing to reduce functionality or reducing bells and whistles on their instruments, and at the same time to get the cost out. The marketing teams never want to get rid of anything that’s already there. Simplification has to come into play, and we have to accept it as one of the criteria to reduce costs. That is always a balance.

There are also many new advancement tools and software programs emerging to help with DFM. CAD software is getting more advanced and starting to integrate DFM capability within it, and they are all starting to move toward simulating manufacturing processes where, you can design something, push a button, and the software will tell you if where the hot spots are that are causing problems. If you have a pocket that is too deep for that endmill diameter, or if the project turns into a 5-axis project vs. 3-axis, the software will tell you.

Barriers to Smart Design

There are some OEMs that have misunderstandings when it comes to DFM and DFI and still think you should pick your supplier after the design is done. That is not progressive thinking. There are some very large companies with purchasing departments that do not encourage engineers to talk to any suppliers. At times, the decisions are driven through attempts to get the cost out with competitive quoting, rather than utilizing engineering to build cost out of the design by partnering with a supplier and utilizing DFM and DFI. I think there is a lot of misunderstanding still in the industry with that kind of thinking.

When OEMs do approach the process design concurrently with the product design, their product launch becomes much more predictable. The company can feel more confident in the costs and variables associated with the processes and save both time and money by incorporating those inputs up-front. It just makes sense to invest more time and thought into the planning process – it’s smart design!

     By Steve Maguire, General Manager, Orchid Design