The process for gathering clinical evidence is different for pharmaceuticals, medical devices, and biologics. Depending on the product, the manufacturer starts with very different information. Thus when working with a combination product, the manufacturer needs to think about chemistry, materials, and compatibility. Susan Alpert, principal of SFA Consulting, explains the complexity involved and how manufacturers of combination products should approach the process at the MedTech Intelligence Combination Products Conference in Washington, DC.
One of the biggest stumbling blocks for manufacturers, particularly those with legacy devices, is clinical evidence under IVDR. Carlos Galamba, former technical reviewer and current VP of Intelligence and Innovation at RQM+, discusses the challenges and opportunities of the more…
AI not only improves data collection and analysis, it impacts which products are engaged in clinical trials, determines necessary medical criteria, helps design the trials and can even choose the best participating facilities. The result is, organizations that leverage AI…
The FDA, in collaboration with the Clinical Trials Transformation Initiative (CTTI), is hosting a two-day virtual public workshop on increasing the enrollment of historically underrepresented populations in clinical studies and encouraging clinical study participation that reflects the prevalence of the…
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