Breakthrough Technology: A Look at Orthopedic Companies with FDA Device Designation
by Kathie Taylor | Mar 2021
To keep a finger on the pulse of innovative orthopedic technologies close to entering or on the market, and to understand the hurdles they’ve cleared thus far, we highlight a dozen+ companies that have participated in FDA's Breakthrough Devices Program. ... Read more »
5 Considerations for Design for Manufacturing
by Kathie Taylor | Feb 2021
A well-planned DFM process can ensure function, reliability and quality so that orthopedic device companies meet their product goals. ... Read more »
8 Tips for Startups on Successful Execution
by Kathie Taylor | Jan 2021
Orthopedic startups should follow these eight tips for successful business execution. ... Read more »
Surgeons Share Lessons from 2020, Technology Predictions
by Kathie Taylor | Nov 2020
While 2020 brought unpredictability, it highlighted numerous opportunities for improvement of processes and technologies with digital tools, additive manufacturing and O.R. platforms. ... Read more »
3 DF(x) Elements to Follow for New Product Development
by Kathie Taylor | Nov 2020
A modern design for manufacturability approach forces orthopedic device companies to develop products aligned with customer needs and business needs. ... Read more »
Essential Steps to Proactively Improve Your Product Development Process
by Kathie Taylor | Nov 2020
In a perfect world, product development goes smoothly. However, we don’t live in a perfect world. Our imperfection is why a focus on process improvement to enhance our work product is worth R&D teams pursuing. ... Read more »
5 Tips Startups Need to Know for Success
by Kathie Taylor | Sep 2020
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. ... Read more »
4 Human Factors Practices that Lead to Successful FDA Submission
by Kathie Taylor | Sep 2020
Nearly 90% of FDA 510(k) submissions receive reviewer comments related to human factors engineering. While these four practices are likely not new to you, they serve as a refresher for what FDA is closely considering with your submission. ... Read more »
Additive Manufacturing Advancements to Boost Use in Orthopedics
by Kathie Taylor | Aug 2020
The additive manufacturing market is expected at a CAGR of +20% by 2024. The medical device industry, and orthopedics specifically, are expected to experience strong growth due to advancements in additive manufacturing technology and processes. ... Read more »
How to Create a Product Development Roadmap
by Kathie Taylor | Jul 2020
Product portfolio roadmapping is like taking a trip. Companies must decide where they're going and how they're going to get there in order to be successful. ... Read more »
Orteq Promotes Joint Preservation with Meniscus Implant
by Kathie Taylor | Jul 2020
Orteq’s ACTIfit received FDA Breakthrough Device Designation, an important milestone toward entering the U.S. knee market. ... Read more »
DiFusion Brings First Immuno-stealth Polymer to Orthopedic Market
by Kathie Taylor | Jun 2020
PEEK and titanium dominate the spinal fusion market—two materials with roots in the aerospace industry. DiFusion received FDA 510(k) clearance to market a spinal interbody made of ZFUZE, a new polymer engineered specifically for orthopedics. ... Read more »
Keys to an Effective Additive Manufacturing Quality System
by Kathie Taylor | Jun 2020
FDA and Stryker joined an additive manufacturing panel to discuss the importance of quality systems and industry and regulator collaboration. ... Read more »
Traditional Metals Meet Mainstream Adoption in Orthopedics
by Kathie Taylor | May 2020
Here’s a look at some of the leading metals in the orthopedic market and what’s pushing the development of new materials and manufacturing processes. ... Read more »
What Does the Next Generation of Total Ankles Need?
by Kathie Taylor | May 2020
Preoperative planning, surgical instrumentation and bony ingrowth are advancements that surgeon Alan Davis, M.D., says are a must for future total ankles. ... Read more »
How to Ensure a Well-Established Problem Definition
by Kathie Taylor | Apr 2020
Empathic design pushes product development teams to follow the user journey to gain a sense of the true problem they’re trying to fix. ... Read more »
Startups to Drive Polymer Innovation in the New Decade
by Kathie Taylor | Mar 2020
While the orthopedic device industry has changed its tune on metals vs. polymers over the last 20 years, the push for material innovation has remained. Entering a new decade, orthopedics is experiencing another wave of polymer innovation that provides greater design freedom and compatibility with th ... Read more »
How to Control Project Scope Creep
by Kathie Taylor | Jan 2020
Directional change and scope creep are inevitable in product development. However, their effects can be minimized through a systematic approach. ... Read more »
