why a medical device is now the biggest risk in your clinical trial
Of all of the connections brought about by the Internet of Things, nothing is more frightening than the notion of an unsecured medical device. The magnitude of risk associated with medical devices and the Internet of Things is a gripping proposition with 67% of medical device makers expecting an attack on their devices while only […]
The key is not first to eSource, the key is smart to market
This post is not for the Pfizers, Novartis, Merck and GSK giants of the life science industry. Its for the innovators, the smaller, creative life science companies that are challenged by the costs, the regulatory load and complexity of executing a clinical trial. This post is dedicated to the startup entrepreneurs of the world. Building an EDC […]
An attack modeling approach to medical device clinical trials
What does taking off your shoes and belt in the airport have in common with risk assessment in clinical trials? Today we talk about the drawbacks of traditional risk assessment and propose an alternative approach to clinical trial risk assessment that is based on data and considering plausible attacks on your trial as opposed to fixed protocols and […]
5 ways to reduce costs and accelerate medical device clinical trials
Time is money The economic model of a multi-center clinical trial is based on a commercial biotech/biomed/pharma company sponsoring and funding clinical research in order to prove efficacy and or safety of a new drug or medical device. In fact, although the sponsor has the most at stake by far, in clinical trials, sponsors and […]
5 critical factors in choosing software for clinical data management
Here are some practical guidelines to selecting an EDC system. Some basic blocking and tackling. Always good. EDC not paper Electronic data capture (EDC) systems are basically the standard for clinical trial data management. To put it simply, the old-school process of using a paper case report form (CRF) and then uploading it into an […]
5 key questions for choosing clinical data management software
Pricing from the big EDC vendors is complex and confusing and the overlap between CRO clinical data management services and their EDC solutions locks you into a proprietary system of high-costs and expensive professional services. The non-transparency of the clinical data management market As the CEO of an innovative biomed or biotech company doing clinical trials, […]
What is more important – patient safety or hospital IT?
What is more important – patient safety or the health of the enterprise hospital Windows network? What is more important – writing secure code or installing an anti-virus? A threat analysis was performed on a medical device used in intensive care units. The threat analysis used the PTA (Practical threat analysis) methodology. Our analysis considered […]
The chasm between FDA regulatory and cyber security
When a Risk Analysis is not a Risk analysis Superficially at least, there is not a lot of difference between a threat analysis that is part of a software/hardware security assessment and a risk analysis (or hazard analysis) that is performed by a medical device company as part of their submission to the FDA. […]
3 things a medical device vendor must do for security incident response
You are VP R&D or CEO or regulatory and compliance officer at a medical device company. Your medical devices measure something (blood sugar, urine analysis, facial anomalies, you name it…). The medical device interfaces to a mobile app that provides a User Interface and transfers patient data to a cloud application using RESTful services over HTTPS. Sound familiar? […]
Invisible gorillas and clinical trial monitoring
Danny Lieberman Invisible gorillas and detection of severe adverse events. This weekly episode considers human frailty and strengths. We recently performed a retrospective study of the efficacy of the FlaskData.io tools for remote study monitoring in orthopedic trials. An important consideration was the ability to monitor patients who had received an implant and were on a […]
