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 […]
The great ripoff of SDV in medical device studies
Question Are you still doing 100% SDV in your medical device clinical trial? Here are some facts from medical device clinical trials: 30% of your study budget is for monitoring and 50% of monitoring is for SDV For a $1M study – you are spending $150k for SDV. What do you get for your $150K? […]
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 medical device studies need business controls
There are some interesting analogies between cyber security and medical device clinical trials from a risk management perspective. Both areas are complex, vulnerable to human exploits and may result in loss of data. Medical device trials are not exempt from unexpected human behavior. Despite this concern, I find it significant that guidance for remote-risk-based monitoring […]
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 2 most common mistakes in Clinical Research Data Management
Another survey piece that David wrote about common mistakes in clinical data management and some basic controls to stay from the common issues. Use automated monitoring to empower people We are all human. As much as we would like to rely on technology to automate every sector of clinical trial research, we still need the […]
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 […]
Using AI to assure patient compliance in heart failure patients
Can AI be used to help patients with heart failure? Each year cardiovascular disease (CVD) causes 3.9 million deaths in Europe and over 1.8 million deaths in the European Union (EU). CVD accounts for 45% of all deaths in Europe and 37% of all deaths in the EU. In 2015, almost 49 million people were […]
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 […]
