
14Mar
The Buzz About Medical Device Cybersecurity in 2022 and Beyond
Medical device cybersecurity continues to create buzz, as the FBI issues a Private Industry Notification to health care providers outlining cybersecurity risks for medical devices. This follows FDA’s released Draft Guidance ...
Read more
17Feb
Top ten observations from 2022 in life sciences digital and analytics
Life sciences companies are making progress in adopting and deploying digital and analytics. But they can go further and faster by heeding some lessons from the past few years. Looking toward the new year is a good time ...
Read more
05Feb
The health benefits and business potential of digital therapeutics
Around the world, the burden of chronic disease is increasing at a rapid pace. Unfortunately, most of these conditions are irreversible and need to be managed through lifelong medication use. However, many patients ...
Read more
15Jan
The FDA & EU IVDR Regulatory Frameworks For IVD SaMD
Software that is qualified as an in vitro diagnostic medical device (known as SaMD IVD) is affected by the same requirements as other medical devices, which are governed by various FDA regulations and EU In Vitro Diagnostic (IVD) Regulation EU 2017/746. Therefore, ...
Read more
05Jan
GPT Applications in Healthcare?
Natural language computer applications are becoming increasingly sophisticated and, with the recent release of Generative Pre-trained Transformer 3, they could be deployed in healthcare-related contexts that have historically comprised ...
Read more
19Dec
IVD Software as a Medical Device (SaMD)
In recent years, software has been playing an increasingly critical role in the medical device world. Software with a medical intended use can be embedded as part of a medical device (and regulated as part of the device) or it can also be considered a medical device by itself ...
Read more
08Dec
Time extension for MDR transition
The EU Commission will present elements of a legislative proposal for a targeted amendment of the MDR and IVDR during the EPSCO Health Council on 9 December 2022. Those elements are based on the input received so far from national experts and stakeholders ...
Read more
30Nov
The promise of digital therapeutics
Investments in digital-therapeutics companies in the United States have grown by an average of 40 percent a year over the past seven years to reach more than $1 billion in 2018. Investors’ enthusiasm mirrors the growing demand for digital-therapeutic products ...
Read more
28Nov
What’s Wrong With Your Medtech R&D Department?
Larry Blankenship, director of Boulder iQ wrote in the current issue of www.meddeviceonline.com: “Voicing complaints about R&D departments in medical device companies is nothing new. Executives, staff members, and investors commonly ask, “What’s wrong with ...
Read more
23Nov
Five ways that life science companies can build tech talent
Life science organizations should have little difficulty attracting and retaining tech talent. The salaries that they offer are typically higher than those in other industries. The work—improving health and the quality of life ...
Read more
19Nov
FDA vs. Congress: The Software Showdown
September 2022 will be remembered as a seminal turning point in digital health in the U.S. It was not FDA’s concluding its Software Precertification Pilot program, where the FDA finally admitted and further validated our cGMPs for SaMD approach1 that a new legislative authority ...
Read more
14Nov
Are you Submission Ready?
Companies often come to us when they feel that they are ready to submit their medical device to the FDA for clearance or approval, but Medical Technology newcomers may not realize the amount of time and effort that truly goes into being “submission-ready.” It is important not to underestimate the large amount ...
Read more
10Nov
FDA’s New Draft Guidance on Cybersecurity
The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device lifecycle. There are several major changes ...
Read more
26Oct
Tips For Your Virtual Meetings With The FDA
In the past two years, the pandemic has kept sponsors developing drugs, biological products, and medical devices from meeting in person with FDA. Advisory committee meetings, workshops, and conferences have gone virtual, too. While some sponsors have hopes ...
Read more
21Oct
Medtech Cyber-Incidents – A Costlier Problem Than You Think
To help medtech companies understand their business-threatening cyber risks, we offer an infographic and related taxonomy classifying cyber risks into five categories of harmful events — operational interference, ...
Read more
17Sep
The 5 Common Medical Device Startup Challenges (& How To Overcome Them)
The medical device market is diverse, fast-moving, and powered by dynamic customer needs and ongoing demand. Anticipated to reach $734.39 billion by 2027, the market is a land of both opportunity and risk for enthusiastic, ...
Read more
23Jun
FDA Releases Guidance On Cybersecurity In Medical Devices
The digital revolution that resulted in the Internet of Things (IoT), Internet of Medical Things (IoMT), Software as a Medical Device (SaMD), and connected devices permeating the healthcare environment, both in the hospital ...
Read more
09Jun
Key Design Considerations For Digitally Connected Injectors
Digital health has become an integral part of clinical trials and the commercial patient support ecosystem. In the past two years, there has been a significant transformation in the way clinical trials are conducted, as well as how healthcare providers support patients ...
Read more
30Apr
Medical Device Interoperability
Medical device interoperability is the ability to safely, securely, and effectively exchange and use information among one or more devices, products, technologies, or systems. This exchanged information can be used in a variety of ways including display, ...
Read more
31Mar
How To Update my QMS for FDA QMSR Amendment Compliance?
Now that the FDA has officially announced its intention to harmonize and modernize 21 CFR Part 820 Quality Management System Regulation (QMSR) for medical devices, the question is: What do I need to do to my quality management system (QMS)? If your QMS is based on ...
Read more
18Mar
FDA Releases Guidance On Digital Health Data Acquisition In Clinical Investigations
Increasingly, digital health technologies (DHT) are becoming part of the conduct of clinical trials for pharmaceuticals and medical devices. They cover an extremely broad range of applications, including ingestible ...
Read more
11Feb
Nine Pitfalls To Avoid In Data Integrity
Part 11 compliance has been around for about 20 years,1 but still today I see confusion in the industry. While most elements have been implemented successfully, in part attributable to the array of great software available in the marketplace, there are still areas ...
Read more
15Jan
Advancing Patient Care With Wearable Medical Devices
While wearable medical devices1 offer the opportunity to monitor, diagnose, and deliver individualized care to patients, adoption by clinicians has yet to gain significant traction. However, the COVID-19 pandemic has raised awareness of wearables ...
Read more22Dec
MedSysCon – The faster way to medical device compliance
The regulatory and quality landscape for medical devices is constantly evolving. The mission of MedSysCon is to deliver specialized consultancy services for regulatory affairs and quality assurance, focused on the digital health industry. Our content and solution driven, ...
Read more26Nov
Make Your Medical Device Start-Up More Investable
A particularly tough challenge for medical device start-ups is that the executives tend to be the scientists and inventors of the device. When it comes to funding, you need to trade your inventor hats for business ones and learn to think like an investor. It’s not an easy task, ...
Read more
09Nov
Meet Hearables – The Next Revolutionary Medical Devices
Hearables, in-ear devices that use sensors to monitor health, are on the brink of becoming the next revolutionary technology. While in-ear devices have been around for decades in various iterations (used primarily for transmitting sound), the application of this technology ...
Read more
31Oct
Wearable Cardiac Monitoring
Cardiac monitoring is almost a standard feature of modern wearables but there are still opportunities to get better information and do more with the data. Seizing those opportunities could transform everything from medical care to athletic training and general well-being. Cardiac monitoring has been around for over 100 years, ...
Read more
15Oct
FDA’s Upcoming Computer Software Assurance Guidance
The medical device industry can benefit greatly by implementing CSA. In a recent European study1 on medical devices, AI application categories and types were researched and cited as producing data that can be collected and analyzed throughout the life cycle of the patient...
Read more
11Oct
DevOps: What It Is and Why It Matters
Though there are no surefire, “silver bullet” methods for improving IT efficiency, DevOps has yielded results that are hard to ignore. As its name suggests, DevOps combines software development and software operations principles with the goal of helping organizations ...
Read more
03Oct
UK seeks overhaul of AI, software as a medical device regs
The U.K.'s Medicines and Healthcare products Regulatory Agency is overhauling its regulations applying to software and artificial intelligence as a medical device. MHRA has developed a Software and AI as a Medical Device Change Programme it contends will provide ...
Read more