Medical Devices: Engineering s Contributions to the Quality of Life

Transcription

1 Medical Devices: Engineering s Contributions to the Quality of Life Guna Selvaduray San Jose State University inemi Medical Electronics Workshop Santa Clara, California May 4 5, 2011

2 Presentation Outline Background Overview of SJSU Program in Biomedical Devices Driving Forces for medical device development Issues in Biocompatibility G. Selvaduray - SJSU 2

3 Biomedical SJSU Graduate program: Created in consultation with industry professionals Respond to employment needs of medical device companies in the Bay Area Interdisciplinary program with emphasis on practical knowledge and skills Case studies; industry speakers; field trips to medical device companies Communications skills seamlessly integrated Written reports; PowerPoint and Poster presentations G. Selvaduray - SJSU 3

4 Requirements B.S. in engineering, chemistry or physics Pre requisites based on B.S. degree Biomedical Devices Core Physiology for Engineers (Engr 177) Engineering Biomechanics (ME 267) Biomaterials (MatE 175) Biomedical Devices Principles & Design (Engr 272) Regulatory, Clinical & Manufacturing Aspects of Medical Devices (Engr 274) Project/thesis applied design problem/research G. Selvaduray - SJSU 4

5 Faculty Research Areas Maryam Mobed Miremadi Encapsulation of biological cells; regenerative medicine Mallika Keralapura Ultrasound imaging; cancer diagnostics Len Wesley Bioinformatics John Lee Microfluidics, MEMS applications Guna Selvaduray Surface modifications & biocompatibility Fatigue of wires and tubes G. Selvaduray - SJSU 5

6 Biomedical Devices Engineered products Designed by multi disciplinary teams, including non engineers, e.g., human factors, regulatory affairs, quality Need to work, and communicate, with life sciences professionals, e.g., biologists, physicians, etc. Customer: Physician Operating environment: Human body Regulated by Food & Drug Administration G. Selvaduray - SJSU 6

7 Driving Forces Societal Aging and more affluent population Greater demand for, and awareness of, better quality of life Preventive therapies Health care cost containment Technological Improved technological capabilities Optics & fiber optics Miniaturization of electronics Micro fabrication Imaging technologies IT Improvements Nano, nano, nano G. Selvaduray - SJSU Many others 7

8 Biocompatibility 1 The ability of a material to perform with an appropriate host response in a specific application Examples of appropriate host response : Resistance to blood clotting Resistance to bacterial colonization Uncomplicated healing Biocompatibility depends on the purpose and location of the implant G. Selvaduray - SJSU 8

9 Biocompatibility 2 Bioactive material: one that elicits a specific biological response at the interface of the material, resulting in the formation of a bond between the tissues and the material Bioinert material: one that elicits minimal biological response Bioresorbable material: One that is (gradually) replaced by normal tissues, thereby excluding possible long term effects G. Selvaduray - SJSU 9

10 Biocompatibility 3 Tests need to be application and tissuespecific Dominated by surface characteristics, e.g., roughness, porosity, charge, chemistry, surface tension (of the solid), texture, subsurface grain structure, wettability, etc. G. Selvaduray - SJSU 10

11 Biocompatibility 4 Biocompatibility testing can be long drawn out and complicated: in vitro, in vivo, animal models, clinical trials Barriers to overcome Reliable methods for accelerated testing Ability to predict, a priori, biocompatibility before lab testing G. Selvaduray - SJSU 11

12 Recent Advancements Robotic surgical systems Drug delivery to targeted areas Patient centric devices Artificial bone Embedded chips for health monitoring Telemedicine Many others G. Selvaduray - SJSU 12

13 Thank you very much Questions? G. Selvaduray - SJSU 13