EU MDR planning is a classic project management activity to identify what has to be done, in what order, by whom and by when, and how progress will be monitored. Every project will vary...it's not possible to create one implementation plan applicable to all organizations.
This paper offers guidance... Read more »
Public-company announcements, as well as conversations we’ve had with members of industry, indicate that manufacturers continue to push toward commercializing coatings that prevent surgical infections and that productive conversations are taking place with regulators.... Read more »
Avalign is a precision manufacturer of implants, instruments, cutting tools, specialty instruments and cases/trays.... Read more »
The companies highlighted here (either brand new or new to us) represent all five major market segments and comprise a broad geographical mix: Denmark, Finland, Israel, Italy, The Netherlands and the United States.... Read more »
David Kay, M.D., a foot/ankle surgeon, shares what he see in his crystal ball regarding plates, biologics and total ankle replacement: "We have a lot of unfinished work. Observe and listen to surgeons, sterile processing, material handlers and supervisors. Suspend your view of the world to see the p... Read more »
Considering surgical techniques, regulations and technologies together as a whole, expect to see significant changes in orthopaedics over the next decade. Here we present seven shifts that OEMs should consider when choosing new product development initiatives.... Read more »
The software company is being recognized for its efficiency, strategic alignment and commitment.... Read more »
Dr. Kornelis Poelstra's researcn shows that molybdenum-rhenium (MoRe) offers greater strength in smaller implants compared to cobalt-chrome, titanium and stainless steel.... Read more »
New coating equipment will be utilized as well as new cleaning facilities in its coating center... Read more »
The merger expands Arcamed’s capabilities to include contract manufacturing of instruments and implants.... Read more »
Oxford Performance Materials says that study results reveal superior antibacterial properties of PEKK structures compared to PEEK surfaces.... Read more »
The study also shows the bioinductive implant increases tendon thickness for intermediate- to high-grade partial thickness tears.... Read more »
The combined company – called JTL America – will offer expanded mechanical and analytical testing capabilities for the orthopaedic and automotive industries.... Read more »
Computational modeling and simulation (CM&S) can revolutionize medical devices by accelerating innovation and providing evidence of long-term safety.... Read more »
Lima Corporate reaches 100,000 implant milestone for SMR shoulder system since launch in 2002.... Read more »
Surgical assistance technologies and services to track episodes of care have dominated joint reconstruction product development conversations in recent years, as players seek to innovate in a space that already claims highly successful procedures and implants.... Read more »
The company seeks to leverage new facilities and an advanced technology portfolio to serve orthopaedic and other industries. ... Read more »
An international team of researchers developed a scaffold that could prevent or kill MRSA and support bone tissue formation.... Read more »
The transaction positions HD Surgical as one of the largest U.S. manufacturers of forged and machined instrumentation.... Read more »
The unknowns of additive manufacturing have held up some companies from fully committing to its adoption. But, this hasn’t stopped them from progressing and making significant investments. Here's some action from the last few months.... Read more »
During 2015, the company invested $1.7 million in a 15,000-square-foot facility and supported the creation of 15 new jobs.... Read more »
The orthopaedic industry has become more invested in additive manufacturing, as demonstrated by product launches, partnerships and FDA’s recent guidance document on the technology. But, what do surgeons think about it?... Read more »
Companies with simpler products like arthroscopes and surgical instruments could consider a regulatory route that doesn't start with FDA and instead utilize the Third Party Review program. The benefits to doing so include speeding time to market and saving time and resources for more complex 510(k) ... Read more »
Invibio, the first company to sell implant-grade polyetheretherketone or PEEK, agreed to settle Federal Trade Commission (FTC) charges that it violated antitrust law by using long-term, exclusive contracts to maintain a market monopoly.... Read more »
Thomas “Toney” Russell, M.D., an orthopaedic trauma surgeon and President and CEO of Innovision, developed the N-force fixation platform to meet his own clinical needs in optimal fixation of fractures in the extremities and pelvis. The N-force system was a massive regulatory endeavor for a surge... Read more »
Coatings and surface treatments that encourage bony ingrowth are as popular now as ever. The technologies that allow for such growth, however, are changing. As additive-manufactured implants and nanotechnology allow for new forms of coatings, companies are starting to experiment with these technolog... Read more »
Evonik has invested in the start-up company SYNOSTE and now holds a minority share in the medical device company based in Düsseldorf, Germany and Helsinki, Finland. SYNOSTE, founded in 2012, has developed an implant for minimally invasive treatment of leg length discrepancy that is manufactured... Read more »
Orthopaedic manufacturers and their supplier partners are adopting different strategies for how materials are surface treated and manufactured in order to enhance device performance.... Read more »
Richard Hurley, M.D., pictures a world where surgeons actually design and 3D print implants in their office. To achieve this, he started Conceptualiz Inc. in 2012.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
For orthopaedic device manufacturers, new concerns are cropping up during the device testing process due to regulatory changes and the emergence of new materials and technologies in the industry.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
New technology has increased the use of custom implants and instruments in orthopaedics. Consider these factors if you're thinking about incorporating custom implants into your portfolio.... Read more »
Of 2015 OMTEC exhibitors, nearly 20 percent have presented their solutions at the conference since its early days. Discover who these companies are and what they bring to OMTEC year after year.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Mark Augusti of Integra LifeSciences discusses the company’s recent developments, including the creation of an independent spine company, SeaSpine.... Read more »
FDA issued its final rule requiring medical device manufacturers to assign and label products with UDIs more than a year ago. However, many questions remain for orthopaedic and spine manufacturers.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Spine surgeons discuss trends that excite them, their biggest challenges when using devices and what they want you to know when working with them to collectively improve spinal care.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »
