David Blicq dblicq@rrc.mb.ca (update 01/04/2010) DIRECTORY I BIO I NOTICE BOARD
Biomedical Devices
"Health products" can include an enormous range of materials, all of which impact upon human health. Biomedical devices are m
aterials (natural or synthetic) that interact (in a variety of ways) with biological systems to replace, improve or repair specified physiological conditions.
Although often used for medical applications, "biomedical products" also describes many other elements, including fermentation-produced enzymes and pharmaceutical products, diagnostics (like gene chips / arrays), novel biomaterials etc. Although these materials and technologies may seem to be significantly different they all involve the interaction between biological systems and manufactured (or other) technologies. The use of biomedical devices and therapies continues to rise dramatically and transcends the normal definitions of biological and medical sciences.
Biomedical devices and Biomimicry
The linkage between biomedical devices and biomimicry / biomimetics is critical. Biomedical devices seek to supplement, replace, or even repair tissues, organs, bone structures, or correct pathological conditions. In all of these cases biomimicry is absolutely critical: materials must be immunologically inert, must imitate complex biological systems flawlessly and perform better than the natural original components.
Scope of Health Products and Medical Devices Worldwide
Health products represent a $300 billion industry worldwide (a fairly conservative estimate). Table 1.0 describes some of the distribution data.
Table 1.0 Common Medical Devices
| Device | Numbers |
| Catheter | 300,000,000 |
| Contact lenses | 75,000,000 |
| Renal dialyzers | 25,000,000 |
| Intraocular lenses | 7,000,000 |
| Stent (cardio) | >2,000,000 |
| Replace hip / knee | 1,000,000 |
| Dental implant | 500,000 |
| Vascular graft | 400,000 |
| Breast implant | 300,000 |
| Pacemaker | 200,000 |
| Heart valve | 200,000 |
| left ventricle devices | 100,000 |
Skill Sets
Biomedical device science brings together researchers from diverse academic backgrounds.
Experts from diverse disciplines must communicate clearly with professionals from a wide range of fields. Example professionals include:.
- Bioengineers
- Chemists
- Chemical engineers
- Electrical engineers
- Mechanical engineer
- Materials scientist / specialist
- Biologists / Zoologists
- Microbiologists
- Practitioners / Physicians
- Veterinarians
- Bioethicist
- IP (intellectual property) protection specialists / Legal professionals
- Regulatory specialists
- Funding Organizations / Venture capitalists
Core Issues for Biomedical Device Development:
Toxicology (direct and indirect) - such as toxic leachates from polymers being degraded by the host's immune system) must be studied and validated to establish safety thresholds for all materials
Compatibility / Biocompatibility - the extent t
o which a material integrates with an organic system, from a lack of significant immunological response to successful re-cellularization and incorporation
Healing processes can be significantly affected by the presence of foreign materials which illicit an antigenic response
Site-related issues - toxicological and immunogenic response may differ greatly depending not only on the nature of the health product but are also greatly affected by the nature and required function of the tissue / organ systems involved
Mechanical requirements - the mechanical functions of the medical device are critical - needing to emulate numerous bio-physical properties such as elasticity, tensile strength, etc.)
Performance requirements - biomedical devices must
perform within specified tolerances for a consistently predictable length of time. The implications of having a stent or pacemaker fail prematurely can have lethal consequences
Regulatory requirements - all biomedical devices must adhere to strict regulatory requirements which establish controls for personnel, safety, efficacy, and validation. These requirements typically require millions of dollars in developmental research to ensure core criteria are addressed satisfactorily
