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The new FDA cybersecurity law prohibits a company from selling a connected medical device until the company proves it has a plan to monitor, update and fix the device in the field, should any security vulnerabilities arise. Moreover, the FDA now has the authority to force companies to comply, even for already commercialized devices. If you want to know how that translates to practical actions needed to be taken by medical device companies, read here.

Legacy medical devices “can’t jump” to homes. The issue here is similar to Tesla vs. the car industry. It took the car industry a decade to realize that pushing an electric engine into a legacy car can not begin to scratch the surface of the potential benefits realized by Tesla when they re-architected the electric car from scratch. An emerging architecture, "Cloud-Native medical device", is the key to the future of home care.

Partnering with Amazon Web Services has been an essential part of BioT’s product maturity. Working together, we became quite close and were recently asked to write a blog about our collaboration. We enjoyed sharing both our technological use of AWS as well as details about our commercial relationship, which got a serious upgrade recently after being accepted into the AWS ISV Accelerate Program, connecting independent software vendors to the AWS Sales organization. Read the full version here >>

2022 has been an exciting year for the medical device market. 2023 promises to be just as exciting. In this blog, our CEO Daniel Adler shares insights from our work in 2022 and predictions for the upcoming year.

The development boom in software-embedded medical devices, together with off-the-shelf software, presents the MedTech industry a supportive environment for creating complex software systems. While this is undoubtedly an important boost for the healthcare industry, regulatory bodies, like the FDA, scramble to keep up with emerging medical architecture. Learn how the Association for the Advancement of Medical Instrumentation (AAMI) created a task group, providing a visible path for achieving and maintaining validation.

The medical device industry is moving towards a connected care model with IoMT. This is creating an increased role for device manufacturers in the reimbursement process. With the ability to accurately measure how and when a device is used manufacturers have access to key information needed for RPM and RTM CPT billing. In this blog, we explore how reimbursement strategy affects product adoption and why.

Spring 2022 was a busy season for medical device-related conferences. We were delighted to meet with partners around the world and hear first hand what’s driving their device development. Meeting with device manufacturers at conferences also gives us a unique opportunity to ‘take the pulse’ of the device industry, and identify key trends in the industry. In this blog, we share our latest insights.

Failure to regulatory changes can result in fines and penalties for manufacturers, as well as loss of market access. With the introduction of the new Medical Device Regulation (MDR), and the pending In Vitro Diagnostics Regulation (IVDR), the regulatory landscape in the EU has undergone tremendous change. Learn the challenges facing manufacturers and how to reduce the burden of compliance.

Software as a medical device (or SaMD) is one of the fastest growing sectors in healthcare. We explore what it means for software to be considered a medical device in and of itself. Learn the advantages to SaMD, the regulatory requirements, and challenges facing manufacturers.

Patient adherence to prescribed treatment plans is a significant healthcare challenge. Even when a patient’s life may depend upon their correctly following a treatment plan, there are still many who fail to do so. This is true for both pharmaceuticals and medical device-based treatments. The causes of non-adherence are multifaceted but thankfully so are the solutions. We explore the role that the internet of medical things (IoMT) and connected care solutions play in improving patient adherence.

Regulation does not need to slow down the pace of innovation. We explore how companies can navigate the transition fulfilling regulatory requirements without impeding innovation. Learn how cloud-based software can quickly respond to fast-changing market conditions and new regulatory requirements eliminating the need for medical device companies to constantly invest in education, development and regulation.

It will come as no surprise to any medical device company that medical technology is forever changing. Advancements and new innovations have become a constant. Because of that, it’s imperative for companies to stay on top of any and all medical technology, or MedTech, news, best practices, and regulations. We’ve compiled our list of the top 15 news sites and blogs that any medical device company should keep their eye on.

The following list of medical device resources doesn’t come close to covering all that is out there, but each offers up good information, sometimes in a slightly different way. Here are our top picks.

Making the leap from stand-alone medical devices to connected devices is required, as the Healthcare world is already in the midst of this shift. Learn what are the many aspects and challenges to consider when embarking upon this change.

The U.S. healthcare IoT market is expected to reach $155.8 billion by 2027, signaling a rapid increase in the adoption of this technology. What are the benefits of using IoT in healthcare? What are the challenges? Here are answers and some use cases that illustrate what connected health solutions can really do

Connected IoMT devices are the answer to many of the challenges posed by the new EU MDR regulations. But in order to use them to their fullest potential, organizations will need specialized medical device platforms to manage the data these technologies are constantly generating.

With technologies such as medical IoT devices becoming commonplace in medical settings, home-based care is emerging as an important part of the global health ecosystem. At the same time, patient engagement is increasingly recognized as a key part of quality healthcare practices.

Your choice of remote patient monitoring platform impacts its success. How can you bring this promising technology into your own medical facility?

If you currently use connected medical devices or plan to, here are five tips that will help you manage your medical device cybersecurity obligations.

This guide will outline what you need to know about reimbursement for remote patient monitoring in 2021, including the implications of these new changes.

The speed of which the connectivity technology is being adopted makes it all the more important for clinicians to find an IoMT platform thatworks for them. These are the four challenges that you are most likely to face when attempting to implement an IoMT platform at your own healthcare facility.

Medical IoT devices have the potential to vastly improve the quality of care of patients, but they will need the help of 5G technology. Healthcare providers will be able to achieve excellent results for many patients while also increasing access to health services, improving convenience, and building a store of knowledge for future study.

Let’s review a few of the biggest benefits of medical device connectivity and how connected medical devices are reshaping patient care.

Learn about some fascinating IoT use cases in healthcare and why they’re so effective at improving healthcare management goals