About Challenges Of Using
Combination products have numerous
advantages but convergent technologies also have many perceived
risks. Industry experts recommend avoiding combination products
unless there are no alternatives.
Converging genomics, diagnostics and
therapies lead to personalized medicine but many hurdles
scientific, regulatory, financial etc. must be overcome.
Another issue is changing regulatory
environment. Historically medical devices and pharmaceutical
sectors are operated under different sets of regulations in most
developed countries. Regulators are now reviewing existing
regulatory pathways as great number of innovative combination
products appear on the market and in R&D pipeline offering
challenges for any regulatory agency because of differing views of
timelines, policies, development cycles and multiplicity of
configurations. The normal review paradigm is difficult to apply
to combination products because of their interactions.
The third is product development
path wherein integration of research stage combination
technologies & product development program is risky and tends to
entail higher development and manufacturing costs. In addition,
using components from disciplines not part of the core business
require complex management structures and collaboration with
unfamiliar business partners. This complexity, combined with
higher costs of regulatory compliance, slows the introduction and
increases the entry costs of new technologies.
Final concern is patient compliance.
The drug-eluting stent is one such example where patients who
receive stents without a drug coating have an occlusion of the
vessel within 6 months, whereas rest enosis rates for patients
with drug-eluting stents are in the low single digits. However,
current drug-eluting stent treatments require long-term
anti-platelet therapy—an offlabel use for drug manufacturers. The
result may be problems with patient compliance and an increased
risk of heart attacks.
It should thus be emphasized that
adoption of convergent technologies and their increasing benefits
will be accompanied by emergence of new risks.
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