Acquisition news, ISO changes, additive manufacturing updates and the ever-present topic of design controls topped the list of most-read BONEZONE articles in 2015—a pattern that mimicked 2014. In case you missed one of the major strategic announcements of the year or need a refresher on compliance initiatives and industry-shaping events, we’ve recapped the six most-read articles from last year.
1. Big Changes in ISO 13485: 2015?
Our summary of draft two of the new standard found that, no, you shouldn’t expect significant changes when it comes to updating and complying with ISO 13485. Author Rob Packard recommended companies that already have a quality system compliant with ISO 13485 and 21 CFR 820 should fast-track their transitions before implementation of the European Regulations takes place.
The final draft of the standard was still under a vote as of December 31, 2015 and is expected for release in early 2016, according to the last website update from ISO.
Gregory Howard, DEKRA Certification’s ISO 13485 Project Lead, will walk OMTEC 2016 attendees through compliance with the new standard. Mr. Howard is a quality expert with an extensive orthopaedic background (imds, Integra LifeSciences and Zimmer).
2. Tecomet CEO Describes M&A Drivers at Supplier Level
In one of the first articles of 2015, Tecomet CEO Bill Dow said, “You’ll continue to see consolidation among the bigger contract manufacturers, but just as importantly, with the thousands of smaller contract manufacturers that are going to have to find a bigger partner in this business space to maintain viability moving forward.”
His prediction proved to be accurate. Paragon Medical expanded its European operations with the purchase of Michael Bubolz’s medical device segment. Orchid Orthopedic Solutions enhanced its coatings business with the acquisitions of Alhenia and Cam Bioceramics’ Cam China facility. The largest transaction was Greatbatch’s acquisition of Lake Region Medical. Also, Onyx was purchased by Sweden-based Elos and Precision Engineered Products was purchased by NN Inc.
3. Three Spine Companies Implement New Manufacturing Strategies
NuVasive, Globus Medical and Alphatec Spine announced revised manufacturing strategies to strengthen operational and financial goals. Interestingly, each company is taking a different approach.
NuVasive plans to boost its in-house manufacturing from 30 percent to 100 percent. The California-headquartered company recently announced that it acquired a manufacturing site in Carrollton, Ohio that is about 30 miles the manufacturing facility it acquired in 2013.
Alphatec has taken the opposite approach. The company will outsource 100 percent of its manufacturing in an effort to focus on its core competencies of design and commercialization.
Globus acquired long-time supplier Branch Medical Group in order to bring more manufacturing in house. The company notes that its 2016 plans include increasing in-house manufacturing investments.
4. Zimmer Closes Biomet Acquisition
Fourteen months after the deal was announced, Zimmer Biomet became the second-largest player in the orthopaedic industry with an estimated 17 percent of market share. The $14 billion transaction allows the combined company to diversify its revenue mix, create cross-selling opportunities and improve global distribution channels. The combined company announced that it will operate with a $360 million R&D budget, double that of Zimmer’s previous spend.
5. Surgeon Seeks to Market 3D Printed Implants on Demand
Richard Hurley, M.D., predicts a future in which he designs and prints implants in his office. He started Conceptualiz, Inc. in 2012 to help realize his vision.
“There’s an evolution toward patient specific implants,” Dr. Hurley said. “As they are presently manufactured, they cannot be introduced to the mass market, because at six weeks to design and manufacture, the path to market is slow and costly. Another issue is that the engineers are doing all the design work and surgeons aren’t really involved. The solution we bring with our platform is that—because it’s all automated by the software and performed by the surgeon—time to market and cost is reduced significantly. Our method reduces this time to two weeks and reduces the cost by half.”
BONEZONE further discussed with Dr. Hurley the regulatory hurdles ahead and the OEM partnerships he seeks.
6. 8 Design Control Issues Found during FDA Investigations
FDA investigators evaluate a company’s process, methods and procedures to implement design control requirements. There are major issues that arise time and again due to companies’ lack of understanding of the role of design controls. Author John Gagliardi broke these issues down in the December issue of BONEZONE and he’ll do it again in an OMTEC 2016 education session.
Need a primer on design controls? Mr. Gagliardi’s 2010 article on the topic remains one of THE most-read BONEZONE articles year after year.