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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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FDA’s New Draft Guidance on Cybersecurity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 In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device lifecycle.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 ...

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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 ...

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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, ...

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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, ...

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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 ...

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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 ...

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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, ...

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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 ...

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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 ...

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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 ...

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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 ...

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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, ...

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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, ...

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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 ...

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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, ...

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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...

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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 ...

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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 ...

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FDA’s Evolving Regulatory Stance For SaMDs, Wearables, Digital Health & DTx

The FDA’s Center for Devices and Radiological Health (CDRH) issued a new policy on April 14, 2020, in an effort to maintain a patient-centric approach to the COVID-19 public health crisis titled Enforcement Policy ...

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Digital Health Apps & SaMD – Incorporating Privacy In Design & Development

John Giantsidis, president, CyberActa, Inc. wrote in the current issue of “meddeviceonline”: Technologies like artificial intelligence (AI) and digital health have made a positive impact in expanding access to healthcare ...

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What Do Artificial Intelligence And Continuous Validation Have In Common?

Kathleen Warner, Ph.D., RCM Technologies wrote in the current issue of MedTechIntelligence: “In 2011, the Center for Devices and Radiological Health (CDRH) initiated the Case for Quality, which provided guidance on how software ...

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AI in MedTech – Risks and Opportunities

An increasing number of medical devices incorporate artificial intelligence (AI) capabilities to support therapeutic and diagnostic applications. In spite of the risks connected with this innovative technology, the applicable regulatory framework does not specify any requirements ...

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MedSysCon Medizintechnik GmbH – Cybersecurity

Securing Medical Devices: What is Really Needed?

Medical device manufacturers continue to develop new, highly sophisticated and increasingly connected products. These products offer a wide range of benefits: Improved treatments, more precise diagnostics, better patient monitoring, automated control, and central reporting ...

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MedSysCon Medizintechnik GmbH – ISO 14971:2019, Risk management

ISO 14971:2019 — Clarifying Benefit, Risk, & Benefit-Risk

Discussion of the term “benefit” first appeared in the first edition of ISO 14971, which appeared in 2000. The requirement of controlling risk allowed the use of “benefit” as an alternative method of releasing a product when a residual risk was evaluated as “unacceptable.” ...

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MedSysCon Medizintechnik GmbH, PMS, postmarket surveillance

A Systems Approach to Postmarket Surveillance

Jayet Moon, author of the book “Foundations of Quality Risk Management”, wrote in a Guest Column of Med Device Online: “As the central focus of the EU’s Medical Device Regulations (MDR), postmarket surveillance (PMS) and its related processes and subsystems ...

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