Minnesota Chapter of ASM International

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May 19th Annual Symposium "Medical Devices"

Wednesday, May 19th, 2021 VIRTUAL SYMPOSIUM

1:00 p.m. – 4:00 p.m.

ASM Minnesota Chapter invites  you to the virtual 2021 Symposium on “Medical Devices.” Five speakers will present their expertise in medical devices: prospects, challenges, materials, alternatives, product liability, and failure analysis. Register online at www.mnasm.org by Tuesday, May 18th to receive the meeting link. Registrants will receive the symposium meeting link by email on Tuesday, May 18th. Certificates for Professional Development Hours (3) are available after the symposium. The symposium schedule, speakers, and abstracts are as follows:

 

1:00 p.m.            Welcome

 

1:05 p.m.            Dr. Deepak Kalaskar, Associate Professor of Bioengineering, University College London Division of Surgery and Interventional Sciences

“3D printing in Healthcare: Prospects and Challenges”

In this lecture, we will describe the overview of 3D printing in Healthcare applications. Mainly focusing on opportunities and challenges offered by this new technology for healthcare applications. The talk will also describe our novel research in design and development of personalized devices, implants and bioprinted tissues.

 

1:40 p.m.            Adam Griebel , Senior Research & Development Engineer, Fort Wayne Metals “Wire-Based Materials R&D at Fort Wayne Metals”

Fort Wayne Metals is constantly seeking to use our knowledge to put new solutions into the hands of our customers. This presentation will highlight several areas of active development, including magnesium alloys for absorbable devices, a Nitinol alternative for nickel-sensitive patients, and new guidewire materials with improved combinations of stiffness and elasticity.

 

2:15 p.m.            Break

 

2:30 p.m.            Seth Humphrys, Materials Engineering Manager and Nick Stepka, Senior Materials Engineer, Medtronic Neuromodulation

“Hazardous Materials Justification for Cobalt Containing Alloys”

The European Union Medical Device Regulation (EU MDR) has indicated that cobalt [Co] will be designated as a category 1B CMR (Carcinogen/Mutagen/Reprotox) as of October 2021. The foundation of this designation centers largely on evaluation of effects of metallic cobalt exposure CAS No 7440-48-4; EC No 231-158-0 rather than cobalt as an alloying element in common engineering metals. The regulation requires that invasive devices containing  cobalt in concentration above 0.1% weight by weight are labeled in the Instructions for Use (IFU).

 

Medtronic Neuromodulation commonly uses MP35N (see composition in Table 1) as conductor wires and electrical contacts for permanently implanted leads, extensions and neurostimulators due to excellent mechanical properties and corrosion resistance. Typically the MP35N components are not directly tissue contacting in the use case because they are covered by multiple layers of polymer insulation. However, these components are not inside of a hermetic enclosure and fluid ingress may occur. Therefore, Medtronic Neuromodulation has developed Hazardous Materials Justification documents for MP35N in accordance with GSPR 10.4.2.

 

Table 1: MP35N % Element Composition (w/w)

Cobalt

Nickel

Chromium

Molybdenum

Balance

35

20

0


Additionally, Medtronic Neuromodulation employs a variety of stainless steel components, many of which are short term use (<24 hours); examples include: needles, introducer cannulas, and tunneling tools. Many common grades of Stainless Steel (e.g. 304L, 316L, etc.) do not actively control cobalt as an impurity element, and may contain cobalt on the order of 0.1-0.8% (w/w). ASTM F138-2019 has added a maximum of 0.1%, however; this only applies to 316L grades of stainless steel. When engaging suppliers, it has not been straightforward to source stainless steel with reduced cobalt levels. A similar hazardous materials justification document has been developed for stainless steels at Medtronic Neuromodulation.

 

A review of the hazardous materials justification documents outlines the required steps to rationalize cobalt containing materials from both a materials science and toxicological perspective based on internally generated data and literature in the public domain. However, there is an existential need to consider the development of new alloy systems that meet the requirements of new regulations while also delivering the required performance metrics such as mechanical properties, corrosion resistance, radiopacity, electrical properties, MRI compatibility, manufacturability and weldability.

 

3:05 p.m.            Dr. Mallika Kamarajugadda, Senior Principal Scientist, Medtronic

“Ethylene Oxide (EO) sterilization alternatives for medical device applications”

For over four decades, EO (Ethylene oxide) sterilization has been the dominant mode of sterilization in the medical device industry. Ever since EO was moved to the list of known carcinogens in the late 1990’s, there has been increased scrutiny over its usage as a sterilant.  Alternative methods for sterilization have emerged and these efforts have gained momentum recently. New regulations being considered in both the US and Europe as well as the recent closure of 5 EO facilities have added additional incentives to shift the market away from EO as the primary form of sterilization. This presentation will give an overview of the alternative sterilization technologies that are currently being considered for medical device applications.

 

3:40 p.m.            Ronald J. Parrington, P.E., FASM , Engineering Systems, Inc. (ESi)

“Product Liability and Failure Analysis”

Failure analysis is a valuable tool in litigation involving product liability.  The legal and technical definitions of product liability are reviewed.  Root causes of product failures can be categorized as: (1) physical; (2) human; and/or (3) latent (systemic), or by the stage in the product life cycle (material, design, manufacture, and/or service) where the cause of failure originated.  Failure analysis is used to identify the physical cause(s) of failure (distortion, fracture, wear, and/or corrosion), as well as human and latent roots.  The process of failure analysis is outlined and case histories of failure analysis are illustrated with numerous photographs, fractographs, and photomicrographs.

Location Virtual Meeting


Attendees

Ronald J. Parrington
Ronald J. ParringtonEngineering Systems
Ryan Haase
Ryan HaaseMEE
Brian Berg
Brian BergBoston Scientific
John Newman
John NewmanPhysical Electronics
Al Swiglo
Al SwigloSwiglo Metallurgical
Ethan Ambroziak
Ethan AmbroziakBoston Scientific
William Wolf
William WolfMedtronic
Charly Arkens
Charly ArkensElement St. Paul
Heather Remore
Heather RemoreBoston Scientific
Lester Engel
Lester EngelEngel Metallurgical,
Lori LaVanier
Lori LaVanierEurofins EAG
Fay Raisanen
Fay RaisanenMedtronic
Farida Kasumzade
Farida KasumzadeMax Consulting
Kyle Clark
Kyle ClarkMedtronic
Joel DeKock
Joel DeKockPreco, Inc.
Brent Fogal
Brent FogalPolaris
Mark Jacques
Mark JacquesIHC/Lake Region Medi
Jeffrey Pfaendtner
Jeffrey PfaendtnerKP Engineering
Jeffrey Helgerson
Jeffrey HelgersonBaxter
Mark Weiss
Mark WeissESi - Engineering Sy
Hugh Robinson
Hugh RobinsonESI
Dehua Yang
Dehua YangEbatco
Jay Anderson
Jay AndersonElement Materials Te
Larry Hanke
Larry HankeMaterials Evaluation
Nick Stepka
Nick StepkaMedtronic
Brian Manor
Brian ManorBoston Scientific
Mallika
Mallika Medtronic
Michael Bissen
Michael BissenAbbott
Dennis Braun (unconfirmed)
Dennis BraunCommScope
Tom Steigauf (unconfirmed)
Tom SteigaufMedtronic
PANKAJ GUPTA (unconfirmed)
PANKAJ GUPTAAbbott
AttendeeAttendee NameCompany Name