Patient-administered healthcare is one of the fastest-growing segments in the medtech industry. When the patient becomes the operator, usability requirements are vastly different than those of trained clinicians, which elevates considerations in the design process.
The only constant today is change itself.
The long-awaited part 23 of ISO 10993, the series of standards governing Biological Evaluation of Medical Devices, was published in January 2021. It was the first to introduce validated methods for in-vitro irritation tests. This article reviews the latest developments and identifies the cases in which manufacturers can avoid animal experiments.
Understanding EU MDR and IVDR: The goal of EU MDR and IVDR is to ensure safety by asking manufacturers to provide evidence that their products are safe (disclosing any risks), effective (performing as expected), and state of the art (compared to industry benchmarks).
As more healthcare activities take place from home, passive continuous monitoring solutions and new technology such as artificial intelligence will be critical to communications between providers and patients. In addition, new solutions that offer overnight monitoring will play a crucial role in helping to fill the gaps, particularly in assessing patient deterioration or changes in health conditions. The pandemic has forever changed the trajectory of healthcare and specifically virtual care.
EU regulations require manufacturers of medical devices and systems prove the single-fault safety of their products. However, it is not clearly defined in detail how to comply with these requirements. This article explains which technical and legal requirements apply and which aspects should be considered during development.
This article discusses simple optical designs and common imaging techniques used in microfluidic enabled platforms. It will also suggest key elements to consider when deciding which optical set-up to employ for a given microfluidic application.
The market dynamics for telehealth and virtual care continue to evolve, and virtual care ecosystem players must understand how consumers have experienced these changes to better position themselves and design their solutions.
Intensive chemistry requirements are creating massive data sets of chemicals, all of which need to be assessed for biological safety. This deluge of data is making equivocal results far more common than ever before. Fortunately, manufacturers can take steps to mitigate risk and support the safety of their products.
The mHealth industry is rapidly disrupting traditional healthcare delivery by leveraging the power of mobile communication technologies and wearable devices.
