Medical Device Resourcesby Marjorie Greer

June 14th, 2010

Marjorie Greer• 13+ years with Abbott Vascular

• Abbott Vascular is part of Abbott Laboratories

• Abbott Vascular specializes in developing & manufacturing devices for the coronary and endovascular areas of the body

• Work with all divisions of Abbott Vascular (R&D, Marketing, Regulatory, Clinical, etc.) worldwide

Medical Devices Defined

• Medical device vs drug– Drug is considered a product that produces a

chemical reaction in the body– Medical devices are products that affect a

human or animal that does not have a chemical reaction in the body

• X Ray machines• Knee/hip replacements• Pacemakers• In vitro laboratory equipment

What this means

• Multiple components to think about– Biological – Engineering/Materials– Marketing– Regulatory Affairs

Engineering

• Some medical devices have multiple parts that need to be put together, and also are the same people who manufacture the device

• Devices can be put together by:– Lasers– Sauter– Bonding– Adhesive– Injection molded

Engineering References

• Thomas Net (www.thomasnet.com), was Thomas Register

• Industrial search engine• Can search for parts and materials, can narrow it down

by state, has been around for over 100 years• One downside-companies are not included

automatically, have to contact Thomas net• An example-an employee needs to make a injection

mold, and they come to you to find out what companies serve Louisiana

• Answer-A company in Pennsylvania serves the state

Engineering-References

• Rules and guidelines have to be met for medical devices within the United States– ASTMs (American Society for Testing and Materials) (

http://www.astm.org/ )• Standard Specification and Test Methods for Metallic Bone Staples • Standard Specification for Polysulfone Resin for Medical

Applications • Standard Guide for Accelerated Aging of Sterile Barrier Systems for

Medical Devices

– AAMI’s (Association for the Advancement of Medical Instrumentation) (http://www.aami.org/ )

• Biological evaluation of medical devices— Part 15: Identification and quantification of degradation products from metals and alloys

• A Compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices

Engineering-References

• Rules and guidelines have to be met for medical devices within Europe– ISO (International Standards Organization)

• Orthopaedic Joint Prostheses Part 6: Method for Determination of Endurance Properties of Stemmed Femoral Components of Hip Joint Prostheses Without Application of Torsion

• Biological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramics

• Welding and allied processes - Classification of geometric imperfections in metallic materials - Part 1 : fusion welding

Materials

• Medical devices are made of different materials

– Gold– Platinum– Magnesium– Ceramic– Stainless steel– Plastic

• A common theme for searches is-what kinds of allergic reaction comes with a material?

Materials-References

• ASMs (Association of Society of Materials)-Essential tool (http://products.asminternational.org/matinfo/index.jsp)

– ASM Handbooks online– Failure analysis center– Alloy center online

Materials-References

• ASM’s materials for medical devices database (http://products.asminternational.org/meddev/index.aspx) – Cardiovascular– Orthopedic– Dental and Neurological-in production– Can identify which materials is what mechanical

design– Can compare different materials, coatings, and

processes

Materials-References

• IEEE (www.ieee.org) – Members are for collaboration on technologies that

benefit humanity, such as:• Computing• Robotics• Electrical Engineering• Biotechnology

– Conferences, books, journals include titles such as:• IEEE Transactions on device and material reliability• IEEE Transactions on biomedical engineering• IEEE Transactions on nanotechnology

Marketing• Devices are relatively new compared to drugs• Nothing out there quite like Thomson Pharma (yet)

– For cardiovascular device area, there is www.cvpipeline.com • 7 sectors only (Atrial fibrillation, CRM, regeneration, Drug eluting stents, etc)• Includes searching by product, company, trials, IP)

• Online free newsletters– Medical Device and Diagnostic Industry online newsletter

(http://www.mddionline.com/) • Have to read where the start-ups get their funding from:

– Start Up journal– In Vivo journal– Medtech Insight journal (all published from Elsevier Business

Intelligence)– Clinica Medtech Intelligence (published by Informa Healthcare)

Regulatory• Devices have a different regulatory process to go through than

Drugs• Stages are:

– R&D Phase– Pre clinical phase– Clinical – Pre market approval (PMA) or 510 (k)s

• http://www.fda.gov/MedicalDevices/default.htm • Medical Device Reporting - 21 CFR Part 803• Incidents in which a device may have caused or contributed to a

death or serious injury must to be reported to FDA under the Medical Device Reporting program. In addition, certain malfunctions must also be reported. The MDR regulation is a mechanism for FDA and manufacturers to identify and monitor significant adverse events involving medical devices. The goals of the regulation are to detect and correct problems in a timely manner.

Regulatory

• The Sheets– For Medical, it’s the Gray Sheet and the Silver Sheet

(published by Elsevier Business Intelligence)

• Medical device websites– Idrac (http://www.idrac.com/)

• International website, both pharma and medical device• Includes the language the documents are originally in

– Medical Device Today (http://www.medicaldevicestoday.com/regulatory/)

• Has highlights from the Gray Sheet, Silver Sheet, In Vivo, Start Up, and Strategic Transactions)

Medical device - Current/future challenges

• Medical devices have a fast growing segment of combination products (drugs/devices)– Drug Eluting stents one example

• Challenges– Regulatory-CDRH AND CDER Reviewed– Chemistry of Drugs and Materials– Chemistry of Drugs and Polymer

Some vendors here at SLA

• ASM International=Booth 1622

• ASTM International=Booth 1606

• Elsevier Business Intelligence=Booth 1232

• IEEE=Booth 1303

• Informa Healthcare=Booth 634

Medical devices wrap-up

• Contact Information– Marjorie Greer– Marjorie.greer@av.abbott.com