BIOEN 5301: Introduction to Modern Biomaterials Patrick A. Tresco - Principal Instructor Office Hours: MWF 10-11:30 -108D BPRB or by appointment Phone: 581-8873 Email: Patrick.Tresco@utah.edu Frequently, presenters must deliver material of a technical nature to an audience unfamiliar with the topic or vocabulary. The material may be complex or heavy with detail. To present technical material effectively, use the following guidelines from Dale Carnegie Training®.   Consider the amount of time available and prepare to organize your material. Narrow your topic. Divide your presentation into clear segments. Follow a logical progression. Maintain your focus throughout. Close the presentation with a summary, repetition of the key steps, or a logical conclusion. Keep your audience in mind at all times. For example, be sure data is clear and information is relevant. Keep the level of detail and vocabulary appropriate for the audience. Use visuals to support key points or steps. Keep alert to the needs of your listeners, and you will have a more receptive audience. 9/20/2018

What is a biomaterial? 9/20/2018

Definition: Biomaterial Any material of natural or of synthetic origin that comes in contact with tissue, blood or biological fluids, and intended for use in prosthetic, diagnostic, therapeutic or storage applications without adversely affecting the living organism and its components. In your opening, establish the relevancy of the topic to the audience. Give a brief preview of the presentation and establish value for the listeners. Take into account your audience’s interest and expertise in the topic when choosing your vocabulary, examples, and illustrations. Focus on the importance of the topic to your audience, and you will have more attentive listeners. 9/20/2018

Therapeutic Devices in Orthopedics Approximately 245,000 knee replacements are done annually in the United States, and this number is expected to grow rapidly as the population ages. 9/20/2018

Applications in Dentistry 9/20/2018

Catheters About 50,000 substitute heart valves are implanted annually in the United States, and this number is also growing. At present, the leading mechanical valve design has been implanted in more than one million patients worldwide. In total, the prosthetics industry exceeds $10B annually and is expected to grow rapidly in the next few decades; the orthopedics industry alone has been growing steadily at 10% annually. 9/20/2018

In Ophthalomolgy 9/20/2018

In Nephrology 9/20/2018

In Drug Delivery 9/20/2018

Future Applications- Tissue Replacement 9/20/2018

Where are the biomaterials? 9/20/2018

Would you have considered these items biomaterials? 9/20/2018

Biomaterials Represent a Broad Range of Products Medical devices include a broad range of products from simple tongue depressors to sophisticated programmable pacemakers with micro-chip technology. Medical devices include in vitro diagnostic products, such as general purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology. Certain electronic radiation emitting products with medical application and claims meet the definition of medical device. Examples include diagnostic ultrasound products, x-ray machines and medical lasers. 9/20/2018

General Applications of Biomaterials Storage of fluids, tissues, and other biological products Diagnosis Monitoring Therapy 9/20/2018

Definition: Biomaterial -FDA "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, 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 intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary 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 primary intended purposes." 9/20/2018

The Food and Drug Administration (www.fda.gov) Regulates: Food-Foodborne Illness, Nutrition, Dietary Supplements… Drugs-Prescription, Over-the-Counter, Generic…. Medical Devices -Pacemakers, Contact Lenses, Hearing Aids… Animal Feed and Drugs-Livestock, Pets … Cosmetics-Safety, Labeling….. Radiation Emitting Products-Cell Phones, Lasers, Microwaves….. 9/20/2018

CDRH- Center for Devices and Radiologic Health (www.fda.gov/cdrh/ ) Responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. CDRH also regulates radiation emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions. 9/20/2018

Classification of Medical Devices Based on the duration of the device use, invasiveness and risk to the user. Class I devices: crutches, bedpans, tongue depressors, adhesive bandages etc. –minimal invasiveness, does not contact the user internally. Class II devices: hearing aids, blood pumps, catheters, contact lens, electrodes etc. –higher degree of invasiveness and risk, but relatively short duration. Class III devices: cardiac pacemakers, intrauterine devices, intraocular lenses, heart valves, orthopedic implants, etc. -considerably more invasive and can pose immense risk to the user-implantables. 9/20/2018

BIOMATERIAL OR MEDICAL DEVICE? It is important to know that the FDA neither approves materials nor maintains a list of approved materials Although FDA recognizes that many of the currently available biomaterials have vast utility in the fabrication of medical devices, the properties and safety of these materials must be carefully assessed with respect to the specific application in question and its degree of patient contact. An important principle in the safety assessment of medical devices is that a material that was found to be safe for one intended use in a device might not be safe in a device intended for a different use. Accurate characterization is an essential step in selecting a material for a medical device, but ultimately the final assessment must be performed on the finished product, under actual use conditions. 9/20/2018

Biomaterials Research in Industry is dominated as much by the regulatory approval process and submission requirements as by the physical, mechanical, and chemical properties of the medical device. 9/20/2018

Biological Response to Contact with Materials A study of the molecular and cellular events that follow contact with biological fluids or tissues whether in vitro or in vivo from initial contact to the eventual culmination of the response. 9/20/2018

Biocompatibility A general term meaning that a biomaterial, device or construct can be brought into direct contact with living tissue without: causing a harmful tissue reaction (pain, swelling or necrosis) that could compromise function; causing a systemic toxic reaction; or having tumorigenic potential. 9/20/2018

Manufacture of a Medical Device One of the first steps involves the selection of suitable biocompatible materials. This is an essential step because the types of tests required for evaluation of a device depend on the physical and chemical nature of its materials in addition to the nature of the device's exposure to the body. A specific material may appear suitable on the basis of its physical properties, cost, and availability, but might contain toxic chemical components. Therefore, it is advisable to screen the candidate materials at an early stage to eliminate those that are toxic, and select those that are sufficiently biocompatible or nontoxic for their intended use. Chemical constituents and potential extractables should be identified and quantitated for overall safety assessment of the device. 9/20/2018

Biocompatibility Testing is performed to determine the potential toxicity resulting from contact of the device with the body. The device materials should not—either directly or through the release of their material constituents—produce adverse local or systemic effects, be carcinogenic, or produce adverse reproductive and developmental effects. Therefore, evaluation of any new device intended for human use requires data from systematic testing to ensure that the benefits provided by the final product will exceed any potential risks posed by device materials. 9/20/2018

Biocompatibility testing include procedures designed to evaluate: cytotoxicity; acute, subchronic, and chronic toxicity; irritation to skin, eyes, and mucosal surfaces; sensitization; hemocompatibility; short-term implantation effects; genotoxicity; carcinogenicity; and effects on reproduction, including developmental effects. 9/20/2018

Biomaterials Science is an Interdisciplinary Affair Biomaterialists include physical scientists, engineers, dentists, biological scientists, surgeons, and veterinary practitioners in industry, government, clinical specialties, and academic settings. 9/20/2018

Biomaterials Scientists study the interactions of natural and synthetic substances and implanted devices with living cells, their components, and complexes such as tissues and organs. 9/20/2018

Biomaterials Engineers develop and characterize the materials used to measure, restore and improve physiologic function, and enhance survival and quality of life. 9/20/2018

The Society For Biomaterials A professional society which promotes advances in all phases of materials research and development by encouragement of cooperative educational programs, clinical applications, and professional standards in the biomaterials field. Internationally recognized leaders in the biomaterials field participate in the Society and sponsored events. (www.biomaterials.org) 9/20/2018

Relevant Biomaterials Journals Journal of Biomedical Materials Research Biomaterials Journal of Biomaterials Science. Polymer Edition Journal of Biomaterials Applications Journal of Materials Science: Materials in Medicine 9/20/2018

Relevant Websites Biomaterials Network (www.biomat.net) Medical Device Information (www.devicelink.com) Medical Materials Engineering reference (www.engineeringreference.com) United States Patents and Trademarks Office (www.uspto.gov) General search-Google (www.google.com) MEDLINE-(www.ncbi.nih.gov/entrez/query.fcgi) 9/20/2018

Where can I find information about medical devices? www.nlm.nih.gov/services/meddevice.html Just a few of the sites are: - Medical Device Link's Suppliers Page at http://www.devicelink.com/company/ - MEDMarket Network's Internet Medical Products Guide at http://www.medmarket.com/index.cfm?id=product_guide - Yahoo! listing of Medical Equipment Companies at http://dir.yahoo.com/Business_and_Economy/Companies/Health/Medical_Equipment/ - Yahoo! listing of Biomedical Device Manufacturers at http://dir.yahoo.com/Business_and_Economy/Companies/Biomedicine/Device_Manufacturers/ 9/20/2018