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 […]
Prevention Strategies for Cybersecurity Attacks on Advanced Medical Devices
Healthcare data security has been a concern since the early days of electronic health records. Over time, healthcare delivery organizations (HDOs) built up huge databases of patient data. When the internet arrived on the scene, those databases became lucrative targets for hacking. Today, the growth of connected medical devices is further straining early systems
Pros and Cons of Outsourcing for Advanced Medical Device Development
Many global factors are converging to increase the demand for advanced medical devices in the next decade. At the same time, industry stakeholders know that taking a medical device from concept to market is a very expensive and complex process. Not surprisingly, outsourcing is emerging as an important option for advanced medical device development. Grandview [&
