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EU Allows Notified Bodies to Conduct Audits Remotely

Posted in Legal, Clinical & Regulatory | Jan 2021

While remote auditing will be conducted on a case-by-case basis, Notified Bodies and members of industry expect the shift could ease the backlog created by MDR and COVID.

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8 Tips for Startups on Successful Execution

Posted in Business Critical | Jan 2021

Orthopedic startups should follow these eight tips for successful business execution.

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FDA 510(k) Recap: First Orthopedic Clearances

Posted in Legal, Clinical & Regulatory | Jan 2021

This month’s recap informs you of companies entering the major orthopedic market segments with their first product clearance. The six companies we chose to highlight received their clearance within the last quarter of 2020. Geographically, they span the U.S., Australia and Italy.

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FDA Releases AI Action Plan for Medical Devices

Posted in Legal, Clinical & Regulatory | Jan 2021

FDA’s five-point plan outlines the Agency’s thoughts on a tailored regulatory framework, good machine learning practices, patient approaches, technology biases and real world performance.

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Infographic: 3 Top Orthopedic Trends for 2021

Posted in Business Critical | Jan 2021

As we consider 2021 trends, an increase in enabling technology adoption, procedure shifts to ASCs and M&A activity top the list.

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Additive, AI, Digital Health Noted in FDA’s 2021 Science Report

Posted in Legal, Clinical & Regulatory | Jan 2021

FDA published its Focus Areas of Regulatory Science report, prioritizing research across the strategic initiatives of data, increasing choice and competition through innovation and empowering patients.

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Sensors Gain Spotlight in 3 Recent Orthopedic Announcements

Posted in Business Critical | Jan 2021

Stryker and Exactech acquired new technology, while Canary Medical received new funding. The three companies will utilize tools in joint replacement, including intraoperative feedback, implanted sensors and wearables.

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SUPPLIER DIRECTORY

BD - Business/Strategy Co...	CP - Component Parts
DS - Delivery Systems	ED - Economic Development
EM - Equipment/Machinery ...	FA - Financial Services/S...
IMP - Implant Manufacturin...	INST - Instrument Manufactu...
INSU - Insurance/Risk Manag...	IP - Intellectual Propert...
LA - Laser Processing	LO - Logistics
PA - Packaging	PD - Product Development
RA - Raw Materials Provid...	RG - Regulatory/Quality/C...

Legal, Clinical & Regulatory

MDR Experts Share How to Succ...

Notified Body representatives and regulatory consultants provided an update on MDR compliance at OSMA's summer meeting. We review the advice around significant change, legacy devices, economic suppliers and more. ...

By Sharon Starowicz Oct 2020

Voice of Industry

The Future of Instruments is ...

We spoke with instrument suppliers Intech, MedTorque, N2 Biomedical and Pacific Instruments to find out what is top of mind for their customers and learn how they’re helping orthopedic companies develop innovative solutions for better patient outcomes. Robotics, outpatient procedures and single-use instruments were among common themes. &nbs ...

By Heather Tunstall Sep 2020

Business Critical

5 Tips Startups Need to Know ...

Nimble startups remain critical to driving market innovation in orthopedics. To experience success, companies need to time the market, focus heavily on product development and develop a strong pipeline. ...

By Kathie Zipp Sep 2020

Research & Development

3D Printing and Robotics Lead...

OEMs and consultants said the primary market opportunities in China will be tied to advanced technology, including systems that aid surgeries and implant surface structures. ...

By Carolyn LaWell Sep 2020

Supply Chain Management

DFM: A Vital Supply Chain Per...

Using a thorough supplier risk assessment during DFM is critical in creating a robust supply chain that can prevail in both ideal and non-ideal conditions. ...

By Edward Jaeck Sep 2020

Voice of Industry

Infographic: CEOs Talk Busine...

COVID-19 has inspired orthopedic companies to rethink their business practices and strategies, from cultural tenets to surgeon correspondence. ...

By BONEZONE Aug 2020

Supplier News

Send us your news.

January 27, 2021 | Promotions at Precision Medical Technologies/Precision Medical Industries

The sister companies have made a number of senior management promotions to transition the day to day operations of both businesses. ... Read more »

January 27, 2021 | SITES Medical and Mach Medical Officially Open New Headquarters

The facility houses a high velocity, single piece flow manufacturing capability which can help orthopedic OEMs reduce inventory by up to 83% and cost of goods by 48%. ... Read more »

January 27, 2021 | Stratasys Enhances Digital Anatomy 3D Printer

The Digital Anatomy 3D printer enables physicians to practice inserting screws with biomechanical realism similar to a human anatomy. ... Read more »

January 26, 2021 | Cretex Companies Announces Leadership Transition

Cretex Companies announces new leaders at its helm. ... Read more »

January 26, 2021 | Placon Granted Worldstar Award for Packaging

Placon has been announced as the WorldStar award winner in the medical and pharmaceutical category for the second consecutive year. ... Read more »

January 12, 2021 | Precision ADM Appoints Pablo Batista as Vice President, Engineering and Operations

Precision ADM has its roots in the orthopedic medical device industry and has developed an Advanced Digital Manufacturing® process which includes design, engineering and manufacturing. ... Read more »

January 12, 2021 | ARCH Global Precision Acquires LISI Medical Jeropa

A subsidiary of LISI Medical, the Jeropa plant is a leading contract manufacturer of high-precision medical implants, instruments, and other devices serving orthopedic and other market segments. ... Read more »

January 11, 2021 | Sydney University and GE Additive Partner to Drive Australian Manufacturing

The partnership is formed to advance additive manufacturing technologies. ... Read more »

January 11, 2021 | Packaging Provider Nelipak Appoints Pat Chambliss as Chief Executive Officer

Nelipak Healthcare Packaging is a global manufacturer of custom-designed rigid and flexible healthcare packaging used for Class II and Class III medical devices. ... Read more »

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Webinars and White Papers

White Paper | Finishing 3D Printed Devices with MATRIX MCD Apatitic Abrasive

The emergence of additive manufacturing technologies into orthopedics has been transformative, advancing device intricacy and performance while offering patient-specific solutions. While 3D print resolution has steadily advanced during this evolution, post-processing is often a necessity to remove s...

Webinars and White Papers

White Paper | Nano-engineered Titanium Coatings Improve Osseo-Integration and Anti-Microbial Properties of Implants

By Nader Kalkhoran Interest and demand are growing for nano-engineered titanium coatings and surface treatments to improve the performance of PEEK- and metal-based implants used for orthopedic and spinal device applications. Recent work has demonstrated that highly-adherent nano-structured thin tit...

Webinars and White Papers

White Paper | How to Choose the Right Bioresorbable Polymer and Technology for Your 3D-Printed Implant

The combination of 3D printing technologies with bioresorbable medical polymers represents a cutting-edge approach to enable patient-specific implants that can be printed rapidly for reconstructive surgeries and other orthopedic applications. This paper reviews the suitability of bioresorbable polym...

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