MedTech Intelligence recently sat down with Peter O‘Blenis, CEO of Evidence Partners to discuss challenges reviewers face throughout their literature review process in the context of regulatory compliance, and to talk about the upcoming virtual event, Evidence Matters 2021.
To achieve success, a medical device startup must build a sophisticated data architecture specifically designed to deliver maximum value for its customers’ use cases. However, it’s extremely difficult to build such an architecture—especially given early-stage budget constraints. That’s why startups must wisely synch their data architecture spending with their funding rounds.
Automation handling with integrated controls can assist with laser marking for all shapes, sizes and materials used in the manufacture of medical devices. This approach can offer flexibility, along with the ultimate precision necessary, to support the UDI system, which provides a clear framework that defines the form in which information should be encoded on the device in accordance with its classification.
Modern technology has given rise to new legal questions. How does FDA regulate machine-learning computers that are changing so rapidly – given that the approved product may be drastically different than the product that ends up on the market? These questions arise from a lack of understanding of the complex nature of AI/ML-based SaMD, the opaqueness of the regulatory framework, and a dearth of relevant case law.
Medical devices and medical software are becoming increasingly connected to hospital networks, other medical devices or the Internet. As a result, manufacturers and developers are required to consider cybersecurity from the very early stages of development. This in turn necessitates comprehensive risk management along the entire lifecycle of a device.
Automating validation processes gives manufacturers the flexibility and capability to make changes, updates and re-validation, making it easier to upgrade or add new MES modules to their process. Simplifying the process through automation leads to faster ROI and time to market.
COVID-19 ushered in a fundamental change in how medicine is being delivered.
A review of common risks and pitfalls of incorporating artificial intelligence in medical devices and an overview of the regulatory framework.
A discussion with Peter Willemse about how configure, price, quote (CPQ) software can help medical device manufacturers deal with the nuances of everyday challenges and continue to drive revenue and increase profit margins.
Digital health tools and technology have the potential to dramatically improve the patient care experience, but the shift requires purposeful coordination and planned architecture.