The healthcare industry has changed dramatically over the past 25 years, and medical device manufacturers are facing increased economic pressures. “Hospitals are no longer willing to let any product through the door at any price; payers are pushing back; and insurance companies are pushing back,” says Christopher Scifert, PhD, engineering manager at Orchid Design (Memphis). “A lot of companies are losing the ability to spend a ton of money developing their products, because they have to find more efficient and cheaper ways to do it in order to preserve their profit margin.”
Increased examination from FDA has introduced bigger hurdles in the regulatory environment. As a result, manufacturers must have a strong upfront strategy, especially in the areas of testing and marketing claims. So how are companies dealing? According to Scifert, they’re implementing methods to accelerate the design process and make it more efficient. They’re also adopting lean practices such as Six Sigma.
Scifert, who has expertise in orthopaedic biomechanics, is chairing a conference session at this year’s OrthoTec conference on June 7. The panel, “Robust Processes that Enable Better Product Design,” will focus on four key areas:
- Healthcare economics. —“Increasing pressures from hospitals and payers are forcing companies to drop prices and get their [products] to market cheaper so they can sell it for [less],” says Scifert. This section will discuss tools (such as design for manufacturing) that companies are using to do address this issue.
- Regulatory strategy. FDA has much higher expectations concerning product testing and marketing claims, and having the data to back up all claims. Companies must reassess the type of testing they conduct early in the design process.
- Lean sigma approach to design engineering. Design for six sigma and lean sigma approaches enables a more efficient and repeatable design process. Many of the major orthopaedic companies are adopting lean Six Sigma.
- Computational analysis. It is expensive and time consuming for a company to make a prototype of every design concept and physically test each concept. “Using the computer in a virtual simulation helps companies short-cut their design process, because they can very quickly run through design iterations and test them virtually before they every make a part,” says Scifert. The panel will discuss ways that companies can take advantage of available technologies such as finite element analysis, multibody dynamics, and kinematic software.
A Q&A will follow the panel, so you’ll have a chance to ask the experts what they think about your challenges.
What Scifert wants attendees to take away from the panel: “Everything is getting more challenging. Companies need to be more prepared to adopt different and new tools and thought processes to adapt to those challenges. Companies that don’t will fall behind. I hope to give them a set of tools and thought processes that they may be able to look at using in adapting to current changes in the market.”
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