Choosing the Right API for Your Medical Device
Cloud-based solutions for data storage is not a recent innovation. A relatively new concept in medical devices is storing data in the cloud. Given the mission-critical task of protecting and managing that data, some medical device developers may consider “build your own” solutions as the best approach. This post gives an overview of what to […]
Update on Clinical Decision Support Systems
Technology is revolutionizing healthcare, yet the road to revolution can be bumpy at times. New technologies are blurring the lines between medical devices as gadgets and Software as Medical Device (SaMD). What’s more, healthcare providers face cognitive overload from device complexity and an increase in patient data. At the same time, the demand for indi
Fast Healthcare Interoperability Resources (FHIR), What It Is and Why You Should Care
In the 1960s record keeping began to shift from handwritten notes on paper charts to transcribed information into electronic healthcare records or EHR. At its inception, EHR was so expensive only the government and large healthcare organizations could afford the transition. The arrival of the internet created a demand for sharing EHR, as well as […]
Trends driving demand for advanced medical devices for outpatient care.
The healthcare industry is undergoing a significant transformation, driven by various factors such as the need for cost savings and a shortage of personnel. As a result, advanced medical devices are increasingly vital in providing efficient and effective care in outpatient settings. Let’s take a closest look at the key trends driving the demand for [&hell
How to Proactively Manage Risk for Advanced Medical Device Manufacturers
Advanced medical devices are revolutionizing patient outcomes by providing innovative solutions to challenging conditions. Even so, regulatory agencies and advanced medical device companies are fully aware that devices can pose significant patient risks in the product life cycle from faulty design, development, or manufacturing. Proactively managing risk is cru
FDA Cybersecurity Guidance
The Internet of Things (IoT) has revolutionized healthcare for several years. The challenge is that connected devices send data across networks to databases, all of which may be vulnerable to cyber attacks if they are not adequately secured. Advanced medical devices also need to be maintained and updated. Some aging devices represent technical debt for [&hellip
Software Bill of Materials for Advanced Medical Device Development
It’s hard to imagine the world of medical technology before computers when medical devices were tangible gadgets everyone could see and touch. Enter the computer age, which quickly led to using software in medical device development. Software innovation continues to increase with significant growth in the Software as Medical Device (SaMD) sector. Understa
Five Women-Led FemTech Startups
For centuries, women have had a different experience with healthcare systems than men. In recent years, we are seeing a growing awareness of the global female healthcare gap that reflects gender disparities in health outcomes and access to healthcare services. This gap exists for several reasons, including systemic barriers limiting women’s access to heal
2023 Funding Environment for Medical Device Startups
Medical device startups are an essential industry in the US and worldwide. From improving patient outcomes to high-value job creation, these startups are responsible for driving innovation and advancing healthcare. It’s no secret that we are facing a period of economic uncertainty. Some sources predict the US will enter a recession as the Fed prioritizes
Software as a Medical Device (SaMD) Update
Startups in the Software as a Medical Device (SaMD) industry have a unique opportunity to revolutionize how health care providers and patients access and use medical devices. As part of the digital technology revolution, SaMDs are challenging the conventional definitions and regulatory processes for traditional medical devices. In this post, we offer a top-leve
