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About Challenges Of Using Combination Products


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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