Spinal Fusion Device in Development Eliminates Bone Graft and Pedicle Screws
by Hannah Corcoran | Oct 2016
Researchers at The University of New South Wales developed a fusion device designed to stabilize the spine without bone graft or pedicle screws in single-level posterolateral fusion. ... Read more »
Focus: The Need for Innovation in Orthopaedics is Real
by Hannah Corcoran | Sep 2016
Challenges in orthopaedics have created new opportunities to innovate. Here, we look at two: delivery of care and manufacturing techniques. ... Read more »
New Trauma Technologies Emerge to Treat Infections
by Hannah Corcoran | Jul 2016
Infection control has been on the radar of various orthopaedic device companies, from start-up to top five. In the trauma market, technologies intended to minimize post-surgical infections are emerging as a potential solution to curb rising healthcare costs. ... Read more »
3 Points to Consider from the Long-Awaited EU Medical Device Regulations
by Hannah Corcoran | Jul 2016
The new EU Medical Device Regulations could make it tougher for orthopaedic device manufacturers to do business in Europe. ... Read more »
Surgeons Seek Muscle-Sparing Techniques in Arthroscopy/Soft Tissue Repair Market
by Hannah Corcoran | Apr 2016
Growth in the arthroscopy and soft tissue repair market is propelled by surgeon requests for devices that employ muscle- and tissue-sparing techniques to return patients to activity faster and with less pain. This is largely being driven by patients in this segment, particularly athletes and “week ... Read more »
AAOS 2016 Recap: Product Launches and Clearances
by Hannah Corcoran | Mar 2016
Industry trends such as bundled payments, additive manufacturing and robotics were hot topics at this year’s AAOS Annual Meeting. ... Read more »
Sports Medicine Surgeon Embraces Push for Value in Industry
by Hannah Corcoran | Mar 2016
Brett Sanders, M.D., created Tensor Surgical in 2012, a value-based sports medicine company. The focus of the company is to stay lean and increase revenue, while continuing to work on tunnel-specific devices for arthroscopic shoulder repair. ... Read more »
Speed and Production-Equivalency Lead Prototyping Demands
by Hannah Corcoran | Mar 2016
Prototyping is a critical factor in the design stage. Competition in the industry, regulatory guidelines, speed to market, production-equivalency and additive manufacturing are influencing the prototyping conversation. ... Read more »
Adaptive Designs Provide Clinical Trial Flexibility
by Hannah Corcoran | Dec 2015
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 »
What Does it Take to Innovate?
by Hannah Corcoran | Dec 2015
In a highly regulated, cost conscious industry, a roadmap to innovation is as important as the type of innovation itself. Companies large and small need to do the following to successfully meet market expectations: allocate money, leverage data and consult FDA. ... Read more »
A Look into Trauma Trends: Surgeon and Industry Perspective
by Hannah Corcoran | Dec 2015
According to surgeons and industry interviewed by BONEZONE, trends in trauma center on the rise in hip fractures, challenges of treating osteoporosis and pelvis fractures, the emergence and need for specialty plates and a place for biologics to enhance bone healing. ... Read more »
3D Printing, Cybersecurity Emerging Concerns for Device Manufacturers
by Hannah Corcoran | Nov 2015
Additive manufacturing and the domination of digital communication and information transfer pose new concerns for manufacturers. ... Read more »
Brazil Remains Among Top Ten Markets, Despite Economic Downturn
by Hannah Corcoran | Oct 2015
Claiming the 7th largest economy in the world and the largest in South America, Brazil is a force in the global medical device market. ... Read more »
The Fundamentals of a Human Factors Program
by Hannah Corcoran | Oct 2015
Prudent manufacturers already know that the deployment of human factors and usability engineering go beyond meeting regulatory requirements. Manufacturers can leverage their programs to cut costs, mitigate risks and understand how they stack up to competition in the market. ... Read more »
Surgeon Seeks to Market 3D Printed Implants on Demand
by Hannah Corcoran | Sep 2015
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 »
Demand to Reduce Consigned Inventory Leading to Instrumental Changes in OR
by Hannah Corcoran | Aug 2015
Device manufacturers increasingly seek to streamline their instrument inventories, due to top down demands for simpler, more cost-effective solutions. These requests have funneled down to their supplier partners, who have offered perspective on these industry changes. ... Read more »
New Factors Challenge Traditional Testing Requirements
by Hannah Corcoran | Aug 2015
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 »
Regulatory Expert Builds Web Tool to Assist Companies with 510(k)s
by Hannah Corcoran | Jul 2015
Frustrated with FDA’s 510(k) search function, Eric Eggers created kBLASTER to help companies simplify and speed their 510(k) submissions. ... Read more »
FDA Outlines Stance on ex-U.S. Clinical Data
by Hannah Corcoran | Jun 2015
In a recent draft guidance, FDA describes what device companies should consider when submitting OUS clinical data for regulatory approval in in the U.S. ... Read more »
New Supply Chain Models Shift Resources from Device Makers to 3PLs
by Hannah Corcoran | May 2015
Orthopaedic device manufacturers can benefit from outsourcing services such as inventory management, warehousing, order processing and shipping, thus freeing up internal resources to focus on R&D, manufacturing and sales. ... Read more »
New Software and Manufacturing Techniques Push Custom Implant Expansion
by Hannah Corcoran | May 2015
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 »
Suppliers Consolidate in Response to OEM M&A Activity
by Hannah Corcoran | Mar 2015
Suppliers in the orthopaedic industry are feeling the effects of consolidation at the OEM level. To grow in size and capabilities, suppliers are engaging in their own strategic activity to stay competitive. ... Read more »
Collaboration and Resources Needed to Close Skills Gap in the Orthopaedic Industry
by Hannah Corcoran | Mar 2015
It is often difficult for orthopaedic device manufacturers to fill certain positions, due to the technical requirements and high-level skills needed for the job. Collaboration among stakeholders is necessary to secure qualified workers. ... Read more »
Survey Finds Most Med Device Companies Have Positive Outlook for 2015; Same Challenges Remain
by Hannah Corcoran | Feb 2015
A recent survey published by Emergo Group suggests that medical device professionals feel confident about the industry’s climate in 2015, despite continual challenges in the areas of pricing and regulations. ... Read more »
CAPA+2, UDI and More: What to Expect from FDA in 2015
by Hannah Corcoran | Feb 2015
Ensure that you’re prepared for FDA’s 2015 plans. Keep your compliance in check with this expert perspective. ... Read more »
Conflict Minerals Due Diligence: Strategies for a Successful Second Filing
by Hannah Corcoran | Jan 2015
May 31, 2015 is the second filing deadline for the conflict minerals due diligence disclosure rules. Here are some key takeaways from last year’s filing and new strategies to improve your compliance process. ... Read more »
Trending Technology: Metal Injection Molding
by Hannah Corcoran | Dec 2014
Metal injection molding has garnered attention in the orthopaedic industry, due to the technology’s ability to produce complex shapes at high production rates and decreased costs. ... Read more »
Uncover Opportunities in Your Supply Chain Challenges
by Hannah Corcoran | Nov 2014
Overcome challenges in the orthopaedic device supply chain with these tips on how to leverage new technologies, enter new markets, form strategic partnerships and plan accordingly. ... Read more »
FDA Focuses on Properties and Biocompatibility of AM Medical Devices
by Hannah Corcoran | Nov 2014
Understand FDA’s current thinking on the regulatory process for additive manufactured devices. ... Read more »
FDA Surveillance Inspections and Warning Letters Decrease
by Hannah Corcoran | Nov 2014
A CDRH quality system data report offers insight into common observations from 2013. Familiarize yourself with these trends and action items to avoid quality issues. ... Read more »
FDA Addresses Custom Device Exemptions
by Hannah Corcoran | Nov 2014
FDA clarified changes to the Custom Device Exemption provision through a final guidance document. ... Read more »
Surgeons Share Spine Device Trends and Challenges
by Hannah Corcoran | Oct 2014
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 »
Experts Offer Strategies for Clinical Trial Execution and Outsourcing
by Hannah Corcoran | Sep 2014
Experts share their insights on best practices and strategies for conducting clinical trials inside and outside of the U.S., as well as ways to manage outsourcing of the process to a partner. ... Read more »
