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When you think about orthopedic product development or manufacturing, many things come to mind—science, patients (and patience), materials, skill, knowledge, talent, quality, speed, cost, in addition to countless others.
September 16, 2014
By: Christopher Delporte
Pick your favorites. Where the orthopedic sector excels is in bringing all of these seemingly disparate variables together. The parts and materials that go into creating a titanium trauma screw, a state-of-the-art implant system or cutting-edge combination product, for example, don’t just physically go into the device itself. Resources in different forms are scattered throughout the process. It’s more than a supply chain of tangible goods moved from point A to point B, which are then put together and sent back out, that brings a medical device to market. It’s about bringing people with the right talents together. This issue’s machining and tooling feature (page 34)—a regular topic in our coverage of the orthopedic manufacturing space—is, in many ways, very literally about bringing parts together. But as Mark Crawford, contributing writer to ODT, outlines in this issue, what goes into the machining and tooling process isn’t nearly as cut-and-dry as it may appear. “OEMs are seeking efficiencies by contracting with ‘one-stop’ companies that also can handle secondary operations such as anodizing and laser engraving,” Crawford writes. “They also want partners who are skilled at machining complex parts or products from more challenging materials such as titanium, cobalt chrome, titanium and polyether-ether-ketone. Orthopedic OEMs, therefore, are eager to work with creative machine shops that can figure out how to streamline operations.” To continue the “bringing things together” theme, Managing Editor Michael Barbella’s feature on nanotechnology (page 52) not only delves into how current research of extreme miniaturization could transform medical device product offerings, but also outlines how two university engineers/professors working on separate projects and in different fields of study joined forces to achieve a cutting-edge breakthrough they may not have reached otherwise had their offices not been just a few doors apart. Associate Editor Ranica Arrowsmith explores the topic of testing (page 44). One of the experts she interviewed—an OEM biomedical engineer turned founder of a company that specializes in orthopedic device testing—tells ODT about constantly fighting a battle to find competent testing firms that specialize in orthopedics. She and others like her have become indispensable pieces of the puzzle in the product development process. “As a biomedical engineer and a person who’s started a small business, I understand there’s always a simpler, more efficient, safer way to get from point A to point B,” Dawn Lissy, founder and president of Empirical Technologies Corp., wrote in a recent blog. “Like so many entrepreneurs, I have experience streamlining processes and focusing on the fundamentals.” The Last Word column (page 66) looks at Medtronic Inc.’s proposed purchase of Ireland-based Covidien plc and how medical device companies are jumping on the bandwagon of “inversion”—buying foreign companies to reincorporate abroad to take advantage of lower tax rates. It’s a way to come together that U.S. lawmakers wish companies weren’t so quick to pursue. But, no shock here, they can’t get together to decide how to stop it. The White House has contemplated executive action but hasn’t set a timeline yet. On Sept. 2, White House Press Secretary Josh Earnest told reporters that if Congress refuses to act, the Obama administration is considering options to respond to “corporate deserters.” Inversion is legal, but the White House wants to make it tougher. Some experts suggest the administration and U.S. Department of the Treasury could make such deals less attractive by counting a company’s U.S.-issued debt as equity, making it more difficult for firms to achieve the necessary majority of foreign equity ownership required for an inversion deal. While many Democrats want to respond to inversions with specific legislation, Republicans and even former President Bill Clinton say that inversion deals are a symptom of a larger tax problem that requires comprehensive reform to resolve. President Obama says he’s open to reform, but it’s unlikely that anything substantive would happen on that front with midterm elections just weeks away. Sen. Bernie Sanders (I-Vt.) suggested that companies that do inversion deals should not be allowed to compete for federal contracts. Financial experts seem to think the inversion trend—2014 has been the busiest year on record for such deals—is slowing, as bigwigs begin to worry about possible government intervention, among other headaches. Inversions perhaps aren’t the best examples of medical technology firms coming together to achieve great things. But, as this (and I’d like to think every) issue of ODT illustrates, the orthopedic industry’s true grit comes from how it leverages a host of varied resources to achieve incredible results. Christopher Delporte Editorial Director
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