COVID-19 demonstrated the power of rapid diagnostics on a global scale, but the path forward is still complex for in vitro diagnostics (IVD) developers and medtech leaders. This article outlines five factors to consider in order to enable efficient, smooth regulatory approval of your product.
Patients living with chronic skin conditions are increasingly turning to light-based therapy – known as phototherapy – as an alternative to topicals or biologics. Let's look at the different wavelengths of UV light used, as well as recent advances in UVB light sources to use in next-gen devices.
Medical device designers are increasingly challenged by the limits of what the materials at their disposal can do. How can device manufacturers begin to consider what the alternatives to standard materials might allow for in a given medical application? And what would that process look like?
It’s in your best interest to be as rigorous and thorough as possible when testing software that runs your medical device. If a device has a software issue/fault, the patient's life could be in danger.
Nuclear medicine, with its fusion of medical imaging and therapeutic techniques, is reshaping the way diseases are diagnosed, treated, and managed. Let’s look at key market drivers, market restraints, and emerging trends and technologies.
The buzz about artificial intelligence (AI) isn’t new, but it is becoming clear that the best innovators will bring AI into their teams. Working with AI doen't need to be intimidating, though. You can effectively put AI to work by following these four steps.
Biocompatibility testing is a regulatory safety requirement that assures a device and its components are compatible with the biologic environment in which the device will be used. Maintain your critical path to market with these tips.
With rampant competition in the medtech market, streamlining development processes lies in the ability to compress timing while maintaining the integrity of the final product. Let's look at how to do this.
Part 1 of this article series dived into the use of Agile methodology with a focus on the planning phase of a software development plan. This article dives further and discusses the phases of team structure and collaboration, defining requirements and product definition, software architecture, and more.
The EU's Medical Device Regulation, which entered into force in 2021, introduced new requirements for clinical and post-market data for medical devices in Europe. As an additional level of scrutiny for specific devices, the Clinical Evaluation Consultation Procedure ensures that notified bodies correctly assess the clinical data. Let's look at what we can learn from the expert panels' first published scientific opinions.