Invisible gorillas and detection of adverse events in medical device trials

What is easier to detect in your study – Slow-moving or fast moving deviations? This post considers human frailty and strengths. We recently performed a retrospective study of the efficacy of  Flaskdata.io automated study monitoring in orthopedic trials. An important consideration was the ability to monitor patients who had received an implant and were on […]

Medical device clinical trials – not for the faint of heart

Patients in medical device clinical trials are on their phones.  On their phones for WhatsApp and for monitoring chronic conditions and reporting outcomes at home, at work and in the middle of a call to their friends. Medtech developers are looking to make their product development process as effective as  possible and are facing conflicting requirements when it […]

Important EDC features for medical device clinical trials

Medidata Rave and its CTMS companion product iMedidata are a far more comprehensive solution than OpenClinica but when you choose EDC software for medical device clinical trials, you enter a realm of unique requirements involving connectivity, security, privacy, API integration and specific interfaces to hardware. Electronic data capture software (EDC software) systems have demonstrated that […]

Integrating mHealth in medical device clinical trials

Introduction mHealth evolved largely an application for developing countries, due to the rapid growth of mobile phone penetration in low-income nations. But mHealth is now a game-changer for clinical trials, enabling electronic patient reported outcomes and integration with medical devices using standard hardware and mobile operating systems. There are 3 key use cases of mHealth […]

How to secure your data in mobile medical device clinical trials

So you are getting ready to run medical device clinical trials with your mobile medical app or a medical appliance that is connected to the Internet via Wifi in the patient’s home network. How do you secure your device and your cloud systems and how do you comply with the HIPAA Security Rule that is a […]

Homeostasis and medical device clinical trials

Danny talks about how to strike a good balance between people and technology for monitoring medical device clinical trials. Are real-time alerts too much of a good thing for monitoring your study? Maybe real-time alerts for patient compliance in medtech studies is just a fad – a fad just like WhatsApp. I had a conversation […]

People, not digital for supporting patients in medical device clinical trials

1 in 7 American adults live alone Medical device clinical trials are performed under conditions that are near to real-life use by the patient. That means that a medical device for monitoring cardiovascular (CV) risk, CHF (congestive heart failure) and other cardiac disorders is used by a subject in medical device clinical trial at home […]

Why healthcare IoT devices need data monitoring

Use of healthcare IoT devices for sensing patient vital signs  enables fast and cost-effective remote monitoring of patient safety and data quality – however the challenges start after collecting the data. Healthcare IoT for sensing patient state is not a panacea. Monitoring of data you collect in your clinical trial using healthcare IoT requires up-front […]

The best alternative to paper in medical device clinical trials

There is an urban legend that paper is cheaper than EDC $1000/subject for paper-based data management (the going rate in Israel)  is a lucrative business for small CROs, independent data managers and biostatisticians, but $1000/subject is not the same as “total cost of ownership” or TCO. The TCO of doing a clinical trial for an […]

Why medical IoT is outside your comfort zone

Connected medical devices or (medical IoT – Internet of Things) outnumber people. This is an article David wrote about 1.5 years ago. It is a good general introduction for the layman to the challenges of developing connected medical devices in clinical trials but it is not a technical treatment and doesn’t get into the really […]