SIBF Special Event: Surfaces and Blood Compatibility
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6/22/2016
When: Wednesday, June 22, 2016
5:30-8:00pm
Where: Medtronic Operational Headquarters
710 Medtronic Parkway NE
Use “Visitors Entrance” on level P3 through the parking garage
Minneapolis, Minnesota  55432
United States

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The Surfaces in Biomaterials Foundation would like to invite you to a special Surface Science Networking Open House located at the Medtronic Operational Headquarters in Fridley, MN. Attendee registration is free, but we do ask that you RSVP so that we may plan accordingly.


Location Information

Medtronic Operational Headquarters
710 Medtronic Parkway NE
Minneapolis, Minnesota 55432
Note: Please enter the building through the “Visitors Entrance” on level P3 through the parking garage.

 

Schedule of Events

5:30pm – 6:30pm Social Hour with Refreshments, Lab Tours, Vendor Displays

6:30pm – 6:45pm Event Welcome

6:45pm – 7:15pm "ISO10993 Part 4 2016: The Latest Changes Taking us into the 21st Century of Blood Compatibility Assessment" with Michael Wolf, Senior Principal Scientist and Technical Fellow at Medtronic 

7:20pm – 7:50pm "Surface Analysis of Biomaterials" with Anna Belu, Senior Principal Scientist and Technical Fellow at Medtronic

8:00pm Closing Remarks

 

"ISO10993 Part 4 2016: The Latest Changes Taking us into the 21st Century of Blood Compatibility Assessment"

Abstract
For guidance on demonstrating basic safety in the area of blood compatibility of new medical devices (or component changes in existing medical devices), manufacturers look to the ISO 10993-Part 4 standard for basic considerations and requirements. Medical device applications involving contact with patient blood are bewilderingly diverse. They can be fleetingly brief to permanent (e.g., syringe needles vs. vascular stents), involve indirect or direct blood contact (or both!, e.g., a parenteral nutrition bag vs. a blood oxygenator), encompass simple to complex geometries (e.g., smooth vs. rough or complicated surfaces), and present remarkably different levels of risk (e.g., venous devices used with anticoagulation vs. arterial devices used with no anticoagulation; some in the brain!). Thus, the Œselection of tests for interactions with blood¹ as the Part 4 title denotes, remains an unavoidably variable and critical task for demonstrating device/patient safety.

 

Recently the ISO 10993-Part 4 standard finished a lengthy revision process and is currently in the ŒFinal Draft International Standard¹ (FDIS) stage. This means that it is likely to be accepted and published as the new standard in the 2016-2017 timeframe, and will not likely receive another significant revision until around 2020. At this presentation the major changes will be reviewed along with a decision tree offered for the important area of testing materials and devices for thrombogenic properties.

 

Biography
Michael F. Wolf is a Senior Principal Scientist and Technical Fellow at Medtronic. Wolf received B.S. degrees in Biochemistry and Chemical Engineering from the University of Wisconsin-Madison and an M.S. degree in Biomedical Engineering from the University of Minnesota. At the UWM and UMN his studies focused on biomaterials science, pathobiology, and endothelial cell seeding. Now approaching his 28th year at Medtronic, Wolf has worked widely in the area of characterizing and improving how blood- and vascular tissue-contacting devices/materials interact with the body, using both in vitro and in vivo models. This work has covered device areas such as CPB equipment, mechanical heart valves, vascular grafts, stents, and cardiac pacing and hemodynamic sensors. For more than a decade, Wolf has also been active in development of standards for medical devices. He has served as subject matter expert, chairperson, and convener (presently) to the ISO TC/194 working group focused on ISO 10993 Biological evaluation of medical devices - Part 4: selection of tests for interactions with blood. Wolf is an inventor on eight patents and author or co-author on twenty peer-reviewed publications and four book chapters.


 

"Surface Analysis of Biomaterials"

Abstract
When surface analysis meets biocompatibility a lot questions arise that are still unanswered. Surface analysis can¹t be used to prove biocompatibility but it can be used to gain insight into what the biology is interacting with and how it is responding to it. Likewise, surface analysis can be used to gain insight into how biomaterials perform in areas which are important in the manufacturing of medical devices. Surface analysis tools are excellent for evaluating surface modification treatments, coatings, cleanliness, and contamination. The characterization results can give insight into potential for material performance in areas such as drug delivery, adhesion, lubricity, welding, corrosion, and even biointeractions.

 

The focus of this presentation will be on surface science in a medical device industrial environment. Several examples of surface characterization of biomaterials will be presented using analytical tools such as TOF-SIMS, XPS, confocal Raman microscopy, IR, SEM, SPM, interferometry, and ellipsometry. The role of surface analysis will be discussed in regards to the development of new devices, manufacturing of devices, performance of finished devices, in vitro and in vivo testing of biomaterials, and gaining regulatory approval of devices.

 

Biography
Anna Belu is a Senior Principal Scientist and Technical Fellow at Medtronic in Corporate Science and Technology, where she leads the Microscopy and Surface Analysis team. Belu¹s scientific and research interests include biomaterials, biointerfaces, surface modification, surface analysis, failure analysis, microscopy, imaging, molecular characterization of materials, and medical devices. Belu has over 40 publications and has given many invited talks and tutorials in the fields of surface analysis and biomaterials. Belu received her B.S. in chemistry from Denison University in Ohio, her Ph.D. in analytical chemistry from the University of North Carolina, and has completed postdoctoral work at the University of Washington in the Department of Bioengineering. She was a Staff Scientist at Physical Electronics for four years and has been with Medtronic for the past 14 years. Belu has held leadership positions with several technical organizations including AVS, the Society for Biomaterials, and the Surfaces in Biomaterials Foundation. She currently serves on the Advisory Board for the Characterization Facility at the University of Minnesota. Belu is Editor of the journal Biointerphases.

 


Thank You, Sponsors!

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Interested In Showcasing Your Company?

 

We invite you to help support the Surfaces in Biomaterials Foundation’s Networking Open House with a display table at the event.

 

The sponsorship includes:

  • Opportunity to network directly with industrial, academic, clinical, & regulatory members.
  • Company logo on event signage.
  • Table at the event to display collateral materials.
  • Company listing on the website.

Find more information about Sponsor Registration here!

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