Although 61% of decision-makers at healthcare organizations said their firms invested at least $100 million in digital transformation initiatives over the past year, 65% of those respondents said their firms have translated less than half of those investments into tangible business value. These numbers highlight the challenges of digital transformation with data siloes posing the biggest threat to success.
IoT is a key factor in patient-focused digital transformation. The technology enhances precision lab equipment and operations, providing greater clarity of medical data, streamlining experimentation and fueling industrial automation.
The Investigational New Drug (IND) application and the New Drug Application (NDA) stages are critical milestones in drug development, but they are different applications. Developers and sponsors must understand which application requires which data and when. Here we highlight strategies, hurdles and data required for successful drug development from IND to NDA.
Software validation is a critical tool used to assure the quality of device software and software automated operations, including labeling. Software validation can increase the usability and reliability of the device and label, resulting in decreased failure rates, fewer recalls and corrective actions, less risk to patients and users, and reduced liability to device manufacturers.
Implementing a hybrid work environment with R&D teams yields significant benefits but also presents challenges. In this article, we explore how to achieve successful R&D programs within the context of hybrid environments and share key strategies and best practices to effectively navigate the challenges, including the safeguarding of sensitive information and data.
Digital vehicle reimbursement solutions not only ensure fair compensation for employees, but also aid companies in managing costs.
As the proliferation of wearable healthcare devices expands in terms of application and availability, they’re also becoming smaller and more powerful. In turn, testing and validation in the design phase is becoming increasingly complex.
While the MedTech industry continues to face significant challenges related to regulatory requirements, cybersecurity issues, recalls and lawsuits, leaders in the industry are navigating and overcoming these areas to push innovation forward like never before.
Traditional screening tests suffer from a range of challenges. From logistical barriers to concerns regarding accuracy and reliability, achieving accurate diagnosis is frequently arduous. Imagine a revolutionary approach where early disease screening becomes as simple as collecting a breath sample. Thanks to cutting-edge sensor technology and advanced artificial intelligence, this vision is now on the brink of realization.
Post-market surveillance plays a critical role in the UK’s medical device regulatory framework. Manufacturers must prioritize establishing a comprehensive PMS system, developing clear and organized PMS plans, and promptly reporting incidents and corrective actions.
