On this week’s podcast, part 2 of our multi-part Medtech Insight feature series on the appraisal of manufacturing capability and maturity – “Medtech’s Next Top Maturity Model” – is discussed. Author Shawn M. Schmitt explains what happens when a device-maker is appraised using the Capability Maturity Model Integration (CMMI) model and method, from the first intake calls to the last day of the assessment, when the final appraisal results are given to a firm.
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Roche’s scanners have been integrated with PathAI’s AISight Dx system. The system’s FDA-cleared PCCP allows new components to be validated and integrated without additional FDA clearance. Eric Walk, chief medical officer, hints at future biopharma companion diagnostic collaborations.
A proposed rule from Medicare would impact essential devices for many beneficiaries. AdvaMed says the rule would reduce incentives for companies to innovate and criticizes CMS for not providing the necessary information stakeholders need to fully understand the proposal’s implications.
Just ahead of its 28th meeting, the International Medical Device Regulators Forum has released a summary of the global uptake of its documents.
Political and regulatory pressures make revising the EU’s medtech regulations a tricky balancing act, two renowned medtech experts, Erik Vollebregt and Bassil Akra told Medtech Insight during a recent interview.
Roche’s scanners have been integrated with PathAI’s AISight Dx system. The system’s FDA-cleared PCCP allows new components to be validated and integrated without additional FDA clearance. Eric Walk, chief medical officer, hints at future biopharma companion diagnostic collaborations.
Dutch insulin pump maker ViCentra secured $85m to scale European manufacturing, preparing for the 2026 launch of its thinner, lighter Kaleido 2 pump and push into US market. CEO Tom Arnold said the pump has more than 3,500 users in Europe and expects “tens of thousands” in the next 18 months.
A proposed rule from Medicare would impact essential devices for many beneficiaries. AdvaMed says the rule would reduce incentives for companies to innovate and criticizes CMS for not providing the necessary information stakeholders need to fully understand the proposal’s implications.
