The advent of the COVID-19 pandemic has created uncertainty and delays in procedures, but hospitals and surgeons still need a steady supply of product, meaning that the orthopedics industry must keep innovating. One thing is certain, 2020 will be a turbulent year for procedure demand. Early on, analysts predicted that because many orthopedic procedures are elective, they would be postponed to help free up space for critically ill patients. While the recovery of orthopedic procedures has begun more quickly than analysts initially expected, it seems likely it will take longer than expected to reach full recovery as we look into 2021. June ordering patterns were already much higher than May, but the quicker recovery may indicate a second decline (W-shaped) versus a sharp decline followed by a quick recovery (V-shaped).
Procedure bans have begun to be lifted, and some governmental bodies are beginning to allow outpatient procedures. At the same time, as and where more cases of COVID-19 have arisen, some states and countries have needed to reinstate bans.
How can OEMs and CMOs ensure an uninterrupted product availability for surgeons and hospitals once these procedures get rescheduled? Here are four considerations:
- Stay connected. Keeping an eye on trends in the news, maintaining regular conversations with your customers, and informing your suppliers will help you gain a better understanding of anticipated demand for the year and create an evolving plan to meet the needs of the industry.
- Maintain a steady supply. A sharp increase in demand when procedures get rescheduled could potentially put unmanageable strain on the supply chain, and contract manufacturers will not be able to keep up with the increased demand from the orders. Maintaining a steady supply now with an informed view of the year will prepare us for a spike in demand later.
- Be ready when patients need you the most. As patients’ procedures are delayed, surgeons are looking for temporary ways to ease their pain, and their need for orthopedic surgery will have intensified. Ensure that you don’t miss a surgery due to lack of product on the shelf.
- Ensure a steady new product pipeline. The pandemic shouldn’t stop innovation — our patients still need us. By planning and staying ahead of the curve, you can avoid the bottleneck in the development and manufacturing process and avoid delays in obtaining product.
Developing Products Amid the Pandemic
Approximately 75 percent of the cost of a medical device product is in the actual design (materials and geometry), and only about 25 percent of the cost is in the process. The industry is becoming increasingly more aware of costs during the current COVID-19 pandemic, which is why design for manufacturing (DFM) is a term that is even more relevant in our market today.
DFM means incorporating an understanding of the manufacturing processes into the design of a product, which can reduce costs and 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. Incorporating DFM and DFI is smart design.
Costs and Processes in the Orthopedic Industry
Reducing costs associated with development and manufacture of orthopedic medical devices helps companies drive up their margins. Significant pricing pressures exist not just for trauma and extremities market segments now but also for the orthopedic and spine segments, which have historically always 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 had typically been on speed to market. As a result, companies focused on getting products to market quickly as a top priority and cost wasn’t a primary driver. The result is designs and manufacturing processes that lead to reduced margins and competitiveness. At the same time, it is too difficult to make changes after a product is on the market. This is especially the case for implants, while design changes on instruments are tied to significant costs.
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 and to a target price that is becoming increasingly competitive.
There is an increased interest in reducing the cost associated with instrumentation. One way to do this is to simplify designs, while retaining needed functionality. Attention however must also be given to instrument life and maintenance as well as reprocessing and distribution costs. Making sure these requirements are correctly specified and met up front will reduce costs later on.
Integrating Product and Process Development
Without DFM, the design is frozen and sent out for quoting, avoiding design optimization that results from incorporating manufacturing feedback. The result is that the product margin is often not nearly as competitive as it should be. Designing to a target price is becoming more and more crucial to ensure a business’s success.
DFM often involves the integration of product development and process development into one common activity. It always involves a close collaboration between manufacturing and design experts. Orchid, for example, is a vertically integrated company that can work to support OEMs as they transition their designs into manufacturing.
Orchid Design works with customers during the design process and at the same time with its manufacturing experts. Doing these activities early on and in parallel doesn’t have to take any longer if planned into the project appropriately. The result is always reduced project, manufacturing, and process costs. And it helps drive the project toward early successful commercialization.
Design for Inspection. While many OEMs understand the benefits of incorporating DFM, DFI is often overlooked. Consider how the part is to be inspected and how the drawing or solid model should be completed to enable or simplify inspection. The cost of manufacturing always includes some cost associated with inspection. The traditional approach has been just to inspect more, so the manufacturers are doing things that provide a lot more inspection data. Again, this drives up costs unnecessarily, pushing margins down. With the compliance side of business becoming a larger factor in the orthopedics industry, design for inspection is just as important as design for manufacturing.
Smart Design. Consider involving your supplier early on in the design process. Encourage engineers to talk to suppliers during the earliest phases of the project. Identify target costs and lean on engineering and manufacturing expertise to drive the excessive cost out of the system by partnering with a supplier that expertly utilizes DFM and DFI.
By approaching both the process design and the product design concurrently, product launch dates become much more predictable. The project team will feel more confident in their decisions made regarding the product and the associated processes. This is smart design!
This article was written by Charlie Wing, Director of Engineering, Orchid Design, Orchid Orthopedic Solutions, Holt, MI. For more information, visit here .