Teetering on the precipice of medical device/digital health clinical trials
Danny teeters on the edge of the precipice of privacy and security. Step on the brakes not on the gas and don’t look down. Take a 500m leap of faith into the chasm of medical device clinical trials. Validate digital therapeutics. Venture into uncharted territory of medical cannabis trials.
At some stage in my “let’s do something different and risky” life after leaving the safety of Intel culture, I stumbled into cybersecurity.
Cybersecurity and privacy for medical devices
I started helping Israeli medical device and digital Health startups with privacy and security consulting. We built and analysed medical device threat models. The threat analysis approach succeeded in helping people improve their systems and privacy compliance.
Over time, the threat analysis methodology that was developed was adopted by thousands of security analysts globally – PTA Technologies.
Well-known digital health companies like Earlysense, Zebra Medical , Elminda, Dario Health, Tytocare, Intendu, as well as larger players like Biosense all worked with me on their HIPAA and FDA Cyber compliance posture at one point or another.
Compliance is a continuous process
I did not do this on my own. I owe these opportunities to my friend and colleague Mike Zeevi from Softquest Systems.
Over time, I figured out what works and how to comply with standards – HIPAA, FDA and GDPR. This came from real-life implementations and FDA submissions. I got hands-on in compliance audits with large US healthcare organisations like BC/BS Dignity Health.
Development practices for connected medical device and digital health apps
Many startups in the digital health and medical IoT space make 3 mistakes when engineering their systems.
1) First they Google. 2) Then they Guess. 3) Then they DIY when the Guesses Fail.
Flaskdata transforms the clinical trial experience for patients, sponsors, CROs, and research sites. Designed as a unified data platform, Flaskdata creates a single source of truth from API calls, mobile, cloud, wearables, medical IoT, patient ePRO and EDC from research sites.
Outcompete with automation
Flaskdata.io automates detection and response to protect your patients and the integrity of your clinical data.
Unlike other solutions, FlaskData provides immediate observability to exceptions and missing events instead of recommendations to review paper source documents.
The FlaskData platform collects, detects and prioritizes issues in your clinical data and responds with high fidelity alerts to your patients and clinical teams. Automated detection and response helps you achieve same day delivery of valid data.
Some companies add an additional step: “Contract to a Software House that Talks Big” and then DIY or switch contractors.
This is a costly and risky pattern. As Jim McCarthy says –
More people have ascended bodily into heaven than have shipped great software on time.
– Jim McCarthy, Dynamics of Software Development by Jim McCarthy, Denis Gilbert
For Israeli digital health startups, there is an additional risk. This is the risk of not having an organisational memory. Youth has energy, hip viewpoints and updated expertise on latest technology. Who knew that a similar technology failed 30 years ago before you were born?
Build versus buy for digital health platforms
Digital health startups face 2 challenges. The first is an engineering challenge. The second is a validation challenge.
AWS cloud services have changed the way we engineer connected medical devices and digital health apps.
However, you need to factor in the cost and time requirements for a slew of additional activities. You need reliable DevOps, application integration, data integration, performance, configuration management, security, privacy, compliance and risk management.
The validation challenge is about clinical trials. About 4 years ago, we saw that our medical device customers wanted cheaper and faster ways to collect, monitor and analyse clinical trial data.
Building the product yourself and building a digital clinical trial systems is neither simple nor cheap. Resorting to paper studies to save money, turns short-term savings into long-term losses in time and data quality.
The solution – full-stack digital clinical trial platform
I joined forces with Jenya and we took a strange and wonderful decision to help Israeli medical device companies run clinical trials in the cloud.
This is what Flaskdata.io – patient compliance automation for medical device studies does. We provide a full-stack 21 CFR, HIPAA, GDPR compliant platform for collecting and monitoring data from investigators, patients and devices. Organisations like Theranica Therapeutics and Weizmann Institute all trust our platform for their human research. Today, Flaskdata.io helps site coordinators and clinical trial manager assure patient compliance using real-time alerts and trends at over 300 sites globally.
We work hard to bring modern technology to our customers instead of paper and save time and money.
Platform as a Service offerings like IBM Watson digital health has an amazing set of tools. You have to build your own product, integrate, test, secure, verify and validate.
By comparison, validated Software as a Service platform like Flaskdata.io enables you to get started immediately. You can design data collection using visual UI and integrate the open Flask API for medical devices. Check out our Swagger here.
There is a free tier that enables very early stage startups to start running pilots for free. And yes, we support, English, Hebrew and Chinese.
Give us a shot – you will not be sorry.