Thanks! You've successfully subscribed to the BONEZONE®/OMTEC® Monthly eNewsletter!

Please take a moment to tell us more about yourself and help us keep unwanted emails out of your inbox.

Choose one or more mailing lists:
BONEZONE/OMTEC Monthly eNewsletter
OMTEC Conference Updates
Advertising/Sponsorship Opportunities
Exhibiting Opportunities
* Indicates a required field.

Articles written by Kim Snell

Process Validation Requires that You First Determine Scope

by Kim Snell | Sep 2019

What is the current industry thinking on process validation? Our Ask the Experts series posed to the question to Carolyn Guthrie, Director of Regulatory Affairs and Quality Assurance, Kapstone Medical. ... Read more »

Complaints and Clinical Evaluations: What Reporting Actions Should You Take?

by Kim Snell | Sep 2019

Regulatory and quality orthopedic professionals offer advice on ways that they would manage the gray areas of complaint reporting and clinical evaluation writing. ... Read more »

Computational Modeling Gets Boost from ASME Standard, FDA Science Priority

by Kim Snell | Sep 2019

A new standard and FDA’s regulatory science priorities focus on computational modeling & simulation, which provide indication that orthopedic device professionals should look to understand and leverage the tool's benefits. ... Read more »

3 Testing Companies Advise How to Handle Evolving Requirements

by Kim Snell | Aug 2019

Orthopedic device companies should proactively ask FDA and other regulatory bodies about important testing requirements and changes to regulations and standards. ... Read more »

A Solid Quality System Will Help You Adapt to Changing Regulations

by Kim Snell | Jul 2019

Incorporate sound quality management systems into the production of new products and processes so that regulations become guiding principles for continued growth as opposed to hurdles that companies fear. ... Read more »

Materials are the Next Frontier for Orthopedics, Surgeon Says

by Kim Snell | Jul 2019

True advancements in orthopedics will come from new materials, specifically those that emphasize infection prevention and bone healing, says Dr. Gordon Donald, The spine surgeon, who has dedicated his career to coatings and materials development, shares his view of the future. ... Read more »

Orthopedic Pediatric Companies Receive Funding from Pitch Competition

by Kim Snell | May 2019

Orthopedic pediatric care gained recognition with a funding pitch competition that granted five winners $50,000 to support commercialization. ... Read more »

Orthopedic Coatings Expected to Rapidly Evolve, Says Surgeon

by Kim Snell | Apr 2019

“One of the most important and interesting technological developments in the realm of orthopedic devices is the creation of multifunctional coatings,” says Stuart B. Goodman, M.D., orthopedic surgeon and professor at Stanford. ... Read more »

AdvaMed Names Stryker CEO Kevin Lobo Chairman of the Board

by Kim Snell | Apr 2019

AdvaMed named Kevin Lobo, CEO of Stryker, Chairman of the association’s Board of Directors. Lobo's plans during his two-year chairmanship include: patient advocacy, developing pathways to approval and reimbursement for emerging medical technologies and promoting diversity in the industry. ... Read more »