Muvr Labs Brings Wearable Technology to Joint Replacement Recovery
by Heather Tunstall | Jan 2020
Startup Muvr Labs seeks to deliver a recovery solution that includes wearable devices, measuring and monitoring tools and greater interaction among the surgeon, physical therapist and patient. ... Read more »
ISO 14971 Update Recognized by FDA, Aligned with EU MDR on Risk Management
by Heather Tunstall | Jan 2020
The medical device risk management standard was updated to better align with changes in medical device regulations around the world. The standard emphasizes postmarket surveillance, is recognized by FDA and aligns with EU MDR requirements. ... Read more »
5 Questions on Engineering, Extremities and Experience with Paragon 28's CTO
by Heather Tunstall | Jan 2020
Not everyone can credit a decades-long career to their dog. But Frank Bono, CTO and CO-Founder of Paragon 28, Inc. does exactly that. He shares what he learned at startups, offers advice for the next generation of engineer hires and shares his thoughts on extremities reconstruction, the last orthope ... Read more »
Executive Interview: Carmell Therapeutics on its Controlled Degradable Biologic
by Heather Tunstall | Dec 2019
Carmell Therapeutics' proprietary process binds and cross-links regenerative factors in lyophilized platelet-enriched plasma into solid and semi-solid plasma-based materials to accelerate healing in bone, tendon and wound care. The company is waiting on IND clearance before starting its pivotal tria ... Read more »
3 FDA Actions to Reduce Ethylene Oxide Sterilization
by Heather Tunstall | Dec 2019
FDA has prioritized the reduction of ethylene oxide to sterilize medical devices. Recent announcements from the agency provide orthopedic manufacturers insight into how and why they should consider adopting new sterilization processes. ... Read more »
Knee and Spine Osteoarthritis Ripe Areas for New Orthobiologic Products
by Heather Tunstall | Dec 2019
Dr. Steven Sampson, Founder of the well-known TOBI Symposium, shares his take on the state of regenerative medicine and the important areas of focus in the coming years. ... Read more »
Orthopedic OEMs Seek to Outsource More Design Work
by Heather Tunstall | Dec 2019
Suppliers and design firms are expanding their capabilities in anticipation of orthopedic device manufacturers outsourcing more product development work. We spoke with four companies about what type of product development work they're increasingly being asked to do and why they think outsourcing of ... Read more »
Orthopedic Industry Investors Talk Funding Trends
by Heather Tunstall | Nov 2019
Smart tools and technologies that increase supply chain or operating room efficiencies are on investors’ shortlists for deploying capital in the musculoskeletal space. ... Read more »
Design for Manufacturing: An Engineer’s Guide to Machine Tools
by Heather Tunstall | Nov 2019
This guide provides basic knowledge of how the drill press, mill, lathe, EDM and cutting tools operate, as well as strengths and limitations of each technology to help improve engineers’ designs. ... Read more »
Pristine Surgical Enters Sports Med Market with Single-Use Surgical Imaging System
by Heather Tunstall | Nov 2019
Pristine Surgical is expected to launch to market an arthroscope that includes a single-use digital imaging platform in the first half of 2020. The company's technology includes inventory management capabilities, patient engagement tools, pre- and post-op communications and training compon ... Read more »
FDA 510(k) Success Dependent upon Pre-submission Planning
by Heather Tunstall | Nov 2019
How should you prepare for FDA 510(k) submissions in 2020? Start with a thorough understanding of the testing and verification and validation work you need to complete prior to submission. ... Read more »
4 Key Elements of Design Controls
by Heather Tunstall | Nov 2019
Design controls require an integrated and complex process that includes inputs and outputs, reviews, verification and validation, as well as design transfer. We provide a primer on four important elements during design development. ... Read more »
FDA Announces Advisory Panel, Releases Report on Metal Implants
by Heather Tunstall | Oct 2019
FDA says gaps exist in both knowledge and the available tools that are necessary to understand and assess biological responses to metal implants in clinical and regulatory contexts. In acknowledging these challenges, FDA scheduled an Immunology Devices Panel Advisory Committee meeting and published ... Read more »
Inventory Management Requires New Tracking Technology and Old-Fashioned Communication
by Heather Tunstall | Oct 2019
Arthrex and Ortho Development share how their people and technology have evolved to meet inventory management demands. ... Read more »
X-BOLT Introduces New Hip Fracture Concept
by Heather Tunstall | Sep 2019
X-BOLT Orthopaedics addresses the issue of screw cutout in hip fracture repair with technology that replaces the lag screw for femoral head fixation. Studies indicate that the system significantly reduces the reoperation rate. ... Read more »
Vallum’s Nanotechnology Addresses PEEK’s Hydrophobic and Bioinert Shortcomings
by Heather Tunstall | Sep 2019
Numerous spine companies manipulate PEEK to promote osseointegration with interbody devices, but Vallum believes they are the only one addressing the hydrophobic and bioinert drawbacks of the polymer material. ... Read more »
Logistics Software: Tools to Track Your Orthopedic Devices and Instruments
by Heather Tunstall | Sep 2019
Keeping track of orthopedic devices and instruments throughout the supply chain is a challenge, as manufacturers strive to reduce sedentary inventory and improve transparency across all communications and touch-points. ... Read more »
Orthopedic Taskforce Collaborates on Welding Specification
by Heather Tunstall | Sep 2019
A taskforce comprised of orthopedic competitors and partners is working to create a welding engineering specification, focusing on instruments and an educational component. ... Read more »
CoorsTek Acquisition Positions UnitedCoatings as a Top Supplier
by Heather Tunstall | Aug 2019
The purchase of CoorsTek Medical allowed UnitedCoatings Group to expand design and supply chain services and traditional manufacturing capabilities, establishing the company as a fully-integrated contract manufacturer. ... Read more »
HAPPE Spine to Develop Strong, Porous, Bioactive Spinal Fusion Implants
by Heather Tunstall | Aug 2019
Startup HAPPE Spine is rethinking the way that PEEK and hydroxyapatite are manufactured together to make an interbody that maintains load-bearing strength and facilitates osteointegration and radiolucency. ... Read more »
Xenco Medical Takes a Single-Use, Pre-Loaded Approach to Spinal Implants
by Heather Tunstall | Aug 2019
In an effort to curb infections and sterile processing inefficiencies, Xeno Medical has developed a new material and rethought manufacturing and packaging for its spinal implants. ... Read more »
David Hovda on Innovation, Startups and Artificial Disc Replacement
by Heather Tunstall | Jun 2019
The CEO of Simplify Medical, David Hovda, shares how he got from the U.S. Navy to orthopedics, lessons he learned along the way and his vision for cervical disc replacement. ... Read more »
Onkos Surgical’s Personalized Approach to Treating Musculoskeletal Cancers
by Heather Tunstall | Jun 2019
Onkos Surgical targets underserved oncology surgical market with an expanding portfolio of implants and technology. ... Read more »
Embody Develops Biointegrative Collagen-based Implant for Soft Tissue Injuries
by Heather Tunstall | Jun 2019
Embody utilizes a novel additive manufacturing process to develop its Tapestry biomaterial. The company anticipates commercial launch in 2020 for its Achilles and rotator cuff scaffolds and a 2022 timeline for ACL repair. ... Read more »
How to Boost Employee Engagement
by Heather Tunstall | Apr 2019
David Jensen, CEO of Strategic Business Systems and seasoned orthopedic executive, believes that a positive culture and employee engagement go hand-in-hand. One doesn’t necessarily lead to the other, but they are mutually dependent on one another. But, how do you get there? ... Read more »
Zimmer Biomet Details the Ways They Manage Supplier Risk
by Heather Tunstall | Apr 2019
Zimmer Biomet’s supplier risk management program bolsters resiliency throughout their supply chain. More than two years into the initiative, Zimmer Biomet and their supplier, Precision Edge, share insight into how the program works and the lessons they’ve learned. ... Read more »
