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Articles written by Kathie Zipp

5 Tips Startups Need to Know for Success

by Kathie Zipp | 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 Zipp | 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 Zipp | 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 Zipp | 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 Zipp | 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 Zipp | 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 Zipp | 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 Zipp | 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 Zipp | 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 Zipp | 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 Zipp | 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 Zipp | Jan 2020

Directional change and scope creep are inevitable in product development. However, their effects can be minimized through a systematic approach. ... Read more »