1. University of Medicine and Dentistry of New Jersey John L. Ricci, Ph.D., Department of Orthopaedics History and Scope of Biomaterials J. L. Ricci, Ph.D. Department of Orthopaedics, UMDNJ

2. University of Medicine and Dentistry of New Jersey John L. Ricci, Ph.D., Department of Orthopaedics Biomaterials Characterization Website www.rci.rutgers.edu/~moghe/622.htm

3. University of Medicine and Dentistry of New Jersey John L. Ricci, Ph.D., Department of Orthopaedics What is a biomaterial? Who uses biomaterials?

4. University of Medicine and Dentistry of New Jersey John L. Ricci, Ph.D., Department of Orthopaedics Biomaterial — A biomaterial is a nonviable material used in a medical device intended to interact with biological systems.

5. University of Medicine and Dentistry of New Jersey John L. Ricci, Ph.D., Department of Orthopaedics Device — an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article. including any component, part, or accessary, which is... as defined in Medical Device Amendments of 1976

6. University of Medicine and Dentistry of New Jersey John L. Ricci, Ph.D., Department of Orthopaedics (1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

7. University of Medicine and Dentistry of New Jersey John L. Ricci, Ph.D., Department of Orthopaedics (3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes.

8. University of Medicine and Dentistry of New Jersey John L. Ricci, Ph.D., Department of Orthopaedics Examples of Devices prescription lenses and frames, hearing aids, intrauterine devices, surgical instruments, cardiac pacemakers, etc.

9. University of Medicine and Dentistry of New Jersey John L. Ricci, Ph.D., Department of Orthopaedics Biomaterial — A biomaterial is a nonviable material used in a medical device intended to interact with biological systems. (see biocompatibility)

10. University of Medicine and Dentistry of New Jersey John L. Ricci, Ph.D., Department of Orthopaedics Biocompatibility — The ability of a material to perform with an appropriate host response in a specific application.

11. University of Medicine and Dentistry of New Jersey John L. Ricci, Ph.D., Department of Orthopaedics Host Response — The response of the host organism (local and systemic) to the implanted material or device.

12. University of Medicine and Dentistry of New Jersey John L. Ricci, Ph.D., Department of Orthopaedics What are biomaterials used for? Dentistry, surgery, drug delivery...

13. University of Medicine and Dentistry of New Jersey John L. Ricci, Ph.D., Department of Orthopaedics Short -term implants Catheters (including balloon catheters) IVs

14. University of Medicine and Dentistry of New Jersey John L. Ricci, Ph.D., Department of Orthopaedics Long -term implants Dental fillings, caps, crowns... Opthalmic implants (lenses) Orthopaedic total joint replacements (hips, knees, fingers, shoulders, ankles) Pacemakers, defibrillators, etc... Cardiovascular stents

15. University of Medicine and Dentistry of New Jersey John L. Ricci, Ph.D., Department of Orthopaedics Federal Food and Drug Administration Regulation Federal Food, Drug, and Cosmetic Act of 1938 — Drug premarket approval, removal of fraudulent devices, proper labeling. Medical Device Amendments of 1976 — regulation of development, testing, production, distribution, and use. Three classes of devices, Class I (least regulated) to Class III (most regulated).

16. University of Medicine and Dentistry of New Jersey John L. Ricci, Ph.D., Department of Orthopaedics Safe Medical Devices Act of 1990 — expanded FDA authority in premarketing and postmarketing stages. Established tracking for some devices. Biomaterials Access Assurance Act of 1998 — limits liability of biomaterials suppliers.

17. University of Medicine and Dentistry of New Jersey John L. Ricci, Ph.D., Department of Orthopaedics Classes of Devices Class I — General controls. A device for which controls other than standards and premarket approval are sufficient to assure safety and effectiveness. Examples — dental floss, tongue depressor, surgeon’s glove

18. University of Medicine and Dentistry of New Jersey John L. Ricci, Ph.D., Department of Orthopaedics Class II — Performance Standards. General controls are insufficient but there is sufficient information for establishment of a performance standard. Examples — Oxygen mask, blood pressure cuff, ultrasound imager.

19. University of Medicine and Dentistry of New Jersey John L. Ricci, Ph.D., Department of Orthopaedics Class III — Premarket Approval (PMA). Insufficient information for reasonable safety and effectiveness, required to have approved premarket approval application. Examples — Intraocular lenses, replacement heart valves, most orthopaedic and dental implants.

20. University of Medicine and Dentistry of New Jersey John L. Ricci, Ph.D., Department of Orthopaedics Premarket notification for new or substantially modified devices — The 510(k) rule — substantial equivalence to a device already on the market prior to the 1976 amendments.

21. University of Medicine and Dentistry of New Jersey John L. Ricci, Ph.D., Department of Orthopaedics New devices — Premarket Approval (PMA) applications — nonclinical and clinical information establishing safety and effectiveness. Investigational Device Exemption (IDE) — needed to conduct clinical studies — nonsignificant or significant risk.

22. University of Medicine and Dentistry of New Jersey John L. Ricci, Ph.D., Department of Orthopaedics Voluntary Standards American Society for Testing and Materials Examples — ASTM F-4 committee — implant devices Materials — ASTM F75 standard for cast cobalt-chromium-molybdinum alloy Test Methods — ASTM D638M Test method for tensile properties of plastics

23. University of Medicine and Dentistry of New Jersey John L. Ricci, Ph.D., Department of Orthopaedics Additional Voluntary Standards AAMI — Association for Advancement of Medical Instrumentation ANSI — American National Standards Institute ISO — International Standards Organization

24. University of Medicine and Dentistry of New Jersey John L. Ricci, Ph.D., Department of Orthopaedics Biomaterials — A Historical View Four generations of devices

25. University of Medicine and Dentistry of New Jersey John L. Ricci, Ph.D., Department of Orthopaedics First Generation Implants “ad hoc” implants specified by physicians using common and borrowed materials most successes were accidental rather than by design

26. University of Medicine and Dentistry of New Jersey John L. Ricci, Ph.D., Department of Orthopaedics Examples — First Generation Implants gold fillings, wooden teeth, PMMA dental prosthesis steel, gold, ivory, etc., bone plates glass eyes and other body parts dacron and parachute cloth vascular implants

27. University of Medicine and Dentistry of New Jersey John L. Ricci, Ph.D., Department of Orthopaedics Examples — First generation Implants breast implants titanium dental implants plaster of paris bone cements

28. University of Medicine and Dentistry of New Jersey John L. Ricci, Ph.D., Department of Orthopaedics Second generation implants engineered implants using common and borrowed materials developed through collaborations of physicians and engineers built on first generation experiences used advances in materials science (from other fields)

29. University of Medicine and Dentistry of New Jersey John L. Ricci, Ph.D., Department of Orthopaedics Examples — Second generation implants titanium alloy dental and orthopaedic implants cobalt-chromium-molybdinum orthopaedic implants UHMW polyethylene bearing surfaces for total joint replacements heart valves and pacemakers

30. University of Medicine and Dentistry of New Jersey John L. Ricci, Ph.D., Department of Orthopaedics Examples — Second generation implants Most current implants fit this category Many represent second generation versions of first generation implants

31. University of Medicine and Dentistry of New Jersey John L. Ricci, Ph.D., Department of Orthopaedics Third generation implants bioengineered implants using bioengineered materials few examples on the market some modified and new polymeric devices many under development

32. University of Medicine and Dentistry of New Jersey John L. Ricci, Ph.D., Department of Orthopaedics Fourth generation implants tissue engineered implants designed to regrow rather than replace tissues Integra LifeSciences artificial skin Genzyme cartilage cell procedure some resorbable bone repair cements many new products under development — genetically engineered “biological” components (Genetics Institute and Creative Biomolecules BMPs)

33. University of Medicine and Dentistry of New Jersey John L. Ricci, Ph.D., Department of Orthopaedics Biomaterials Development and Marketing vs. Biomaterials Characterization market pressures for new materials and devices cost of development and characterization

34. University of Medicine and Dentistry of New Jersey John L. Ricci, Ph.D., Department of Orthopaedics Corporate biomaterials research characterization of new and licensed technologies for product development quality control (GMP)

35. University of Medicine and Dentistry of New Jersey John L. Ricci, Ph.D., Department of Orthopaedics Academic biomaterials research development of new materials and application of advanced materials to biomedical applications new tissue engineered materials technology transfer