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
Meet Top 6 Companies in Medical Device Security Services
As medical device technology advances, so does the need for robust security measures to protect patient data and prevent unauthorized access. All stakeholders in the advanced medical device space know that the news is not good. According to The HIPAA Journal, in 2018 healthcare data breaches of 500 or more records had a rate of […]
Medtech: Collaboration is King in Post-Covid World
Collaboration in MedTech drives performance.
Overview of Electronic Data Capture for Advanced Medical Device Design and Development
For centuries, record-keeping productivity depended on the number of humans writing down data at any given time. Clay tablets in museums and huge archive rooms filled with aging paper folders show us the limits of pre-electronic data storage. When computers and the internet began to go mainstream in the 1980s, one of the promises of […]
Managing Downside Risks After Launch – Post Market Best Practices for Connected Medical Devices
When advanced medical device (AMD) startups are in the thick of device design and development, getting to market is the light at the end of the tunnel. While Go To Market (GTM) approval is a huge milestone, a market launch is simply the start of an even longer marathon that doesn’t end until the device […]
