July 2018 | Volume 1

Here's what they said about OEM/supplier relationships, quality agreements, regulatory oversight and continuous improvement efforts.

Mr. Floyd, Stryker's Group President of Orthopaedics, oversaw Stryker's purchase of Mako Surgical in 2013--one year after joining the company. T imothy Scannell takes over business operations.
an OMTEC 2012 panel discussion moderated by David Floyd

Take ownership and make them impactful. Management Reviews can  complement any business model and be instrumental toward strategic business decisions.

View by capability:

> Sterilization (12)
> Testing (55)
> IP/Legal (5)

View by region:

> Asia (15)
> Europe (40)
> USA (222)
> Global (263)

Zimmer Biomet reiterated that none of FDA's observations identified specific performance issues with particular products, and that all products continue to be manufactured in the facility.

If cleared by FDA, NUsurface would be the first "artificial meniscus." The implant has been used in Europe under the CE Mark since 2008 and in Israel since 2011.

Regulation 21 CFR Part 820.30(i) outlines FDA's requirements for design changes, but is unclear about planning and inputs. These elements need to be addressed and documented during any device design changes and efforts. We provide a list of steps to follow.

Experts from USDM Life Sciences, Matrix IT and AHRMM provided guidance on compliance and implementation alongside product development. The presentation is available for download. 
Advice from an IP expert before you take a meeting with a third party. The goal is to ensure that an inventor's invention will remain a valuable asset to him or her, and that the secrets surrounding the invention are kept safe.