Bits of Interest


AAMI International Conference on Medical Device Standards and Regulations

AAMI will be hosting an International Conference on Medical Device Standards and Regulations on March 22 and 23rd in Arlington VA  To see more information on go to http://www.aami.org/isc

ASTM workshop on Coatings for Medical Devices in in November

Workshop on Coatings for the Medical Industry - November 6, 2018


Coatings are becoming a more prevalent issue in medical devices. The need to strategize about upcoming needs in the development of coatings for the medical industry is important so that they don’t become stalled in their development and approval or problematic in their deployment.  This workshop will help create a strategy for developing coating standards and specifications that will augment the pending ISO TC 150 coatings document (ISO 17327)


Abstracts are being accepted until March 2nd for this workshop which will be held in Washington DC just before the ASTM F04 (Medical and Surgical Devices and Materials) fall committee meeting. 


Abstract should be no more than 300 words and submitted to the Workshop Corresponding Chair - Gary Fischman at gfischman@futurestrategysolutions.com no later than March 2nd, 2018.


The meeting is anticipated to have five speaking sessions and a poster area.  These will included:

  • Introduction to Coatings and ISO 17327 (the new ISO coatings standard)
  • Coatings for hard tissue interfaces
  • Coatings for soft tissue interfaces
  • Coatings for blood tissue interfaces
  • Path forward


Organizers


  • Gary Fischman - Future Strategy Solutions and Covalent Coating Technologies
  • Ryan Syskey - Exponent
  • Parimal Bapat - Orchid Biocoat
  • Jill Baxter - Depuy-Synthes
  • Kevin Tingey - WL Gore
  • Hany Demian - US Food and Drug Administration
  • Hani Haider - University of Nebraska Medical Center
  • Byron Hayes - WL Gore


We look forward to seeing you there.





Covalent Coating Technologies

Covalent Coating Technologies is a small, start-up coatings developer and manufacturer.  We have IP on a glass ceramic on titanium biofriendly coating as well as experience developing coatings and management of coatings operations.  


Covalent Coating Technologies

C5 vs Ceramtec

Through September 2016 Dr. Fischman served as an expert witness on behalf of C5 (Coorstek) with respect to their ability to sell CeraSurf ceramic implants.  After an 11 day trial, the case was ruled in C5’s favor by Judge R. Brooke Jackson of the US District Court for the District of Colorado. 

With a large number of citations directed towards Dr. Fischman’s testimony, Judge Jackson concluded that different from CeramTec’s argument  the color pink in Biolox Delta is “Functional” and arises from the inclusion of chromium in the zirconia toughened alumina composite.


© Future Strategy Solutions 2015