Biomedical Engineering Reference
In-Depth Information
4. Future questions may be raised that could result in re-evaluation
of the premarket approval decision. Although the statutory basis
for such re-review is unclear, it will readily come about in the
face of reports of clinical problems related to device design or
composition.
Standardization
Once a new biomaterial, or any other new material, for that matter, has
entered into commercial use, it is desirable that its composition and
properties become standardized. Such standardization does not infringe
patented protection or proprietary rights but makes the material avail-
able as a part of the device designer's armamentarium. Furthermore,
standardization of materials tends to produce a focus on a narrower
range of materials rather than constant innovation for the sake of differ-
ence, yielding more rapid recognition of a particular material's strengths
and weaknesses in various applications. A wide number of organiza-
tions are active in standardization of medical and surgical materials and
devices, with the ASTM (Philadelphia) taking the lead role in standard-
ization of evaluation methods for biomaterials in the United States and
Table 15.4
General timeline for new biomaterial
introduction
Begin:
Concept
Material design
End of Year 1:
Trial fabrication
In vitro
tests, engineering characterization
Year 2:
Acute
in vivo
tests
Begin chronic in vivo
tests
Year 3:
Year 4:
Begin device design
Complete chronic in vivo
tests
Year 5:
Complete device design
Engineering tests of device
Year 6:
Initial patient trials (“custom device”)
Design protocol/apply for IDE
Year 7:
Begin clinical trial
Year 8:
Year 9:
Complete clinical trial
(2-year follow-up)
Year 10:
Apply for premarket approval
Release of biomaterial for first indications
Year 11:
Begin standardization, continue postintroduction
surveillance (if required)
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