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.

medical device clinical trials - leap of faith into it

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.

 

 

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.

100X faster to deviation detection in medical device studies.

Patient compliance automation on the flaskdata.io platform for a medical device clinical trial is 100X faster than manual monitoring. Automated compliance monitoring analytics and real-time alerts let you focus your site monitoring visits on work with the PI and site coordinators to take total ownership and have the right training and tools to meet their patient recruitment and patient compliance goals.

Integrating mHealth in medical device clinical trials

patient compliance in medical clinical device 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 in medical device clinical trials:

1. ePRO – patient reported outcomes using smartphone apps that integrate with EDC APIs

2. As a mediation layer for medical devices, enabling a medical device to obtain connectivity to the EDC by communicating with a mobile app over BLE (blue tooth low energy).

3. As a mobile medical device in its own right

Why Android is the biggest selling medical device in the world

After a short marketing review of why Android is already the biggest selling medical device in the world, I’ll review FDA requirements for clearing mobile medical devices which need to be taken into account before bringing mHealth (mobile medical apps) into your connected medical device clinical trial.

Connected medical device vendors moving into clinical trials need to consider the regulatory requirements in advance since they are in a near-real-life situation with patients during their trials and will probably be using a similar configuration in post-marketing.

The marketing stats

In 2016, publishers of mobile health apps brought to market 100,000 more apps, a 57% increase over 2015. This brought the total to 259,000 health apps globally available to consumers, according to new study mHealth App Developer Economics 2016 conducted by health research group Research 2 Guidance. By 2017  there were 325,000 mobile health apps available online and Android is now the leading mHealth platform

With its global popularity and a large developer community – Android is a natural choice as a tool for data management in your clinical trial or as middleware for your connected medical device.

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What makes mHealth apps flavorgasmic?

mhealth

When eating food so good that you let out an involuntary moan, usually the first bite; also as an adjective – flavorgasmic. November 30, 2008 Urban Word of the Day

I downloaded this unbelievable healthcare app yesterday for my iPhone that helps me monitor my father’s health remotely. I swear when I clicked the first page I had a total flavorgasm.

Still wondering why mobile monitoring apps are having a tough time mainstreaming?

Read on.

The 80-20 rule is alive and kicking when it comes to apps – 80 percent of the apps you downloaded, you don’t use more than a couple of times and pretty soon they just lay fallow on your phone until you get around to removing them.

This is validated by examining my own usage of apps I’ve installed on my Android devices. The $99/year subscription I purchased for Epocrates is not being used, because frankly the Epocrates UI sucks and it annoys me because they have so much hype and I so wanted Epocrates to be useful for me.

In our previous post on how to do successful remote monitoring of patients in your clinical trials – we noted that technologies that mainstream became a unobtrusive part  of our lives.

Some mobile apps are a part of my daily life routine and are used frequently. This is a totally non-surprising conclusion. In my case, the iRealbook is part of my daily practice schedule on tenor sax and clarinet and I look forward to trying new rhythms – even if it’s frustrating, you can always bail out of Fast Jazz 3 and try Jazz Waltz 1 with a single finger swipe and click.

Life is sweet. But – you still have to consistenly practice – being good on a musical instrument is like anything else, it requires consistentency. 15′ of long tones / day is better than 1.5 hours once/week.

So – we can see that the first 2 critical success factors for any app, especially a mobile healthcare app for monitoring your health or health of your family members, which includes remote monitoring for risks and activity – are

1. How well the healthcare app fits into your daily routine

2. How simple and easy it is to use.

Relevance and ease of use are necessary conditions for using mobile healthcare apps – but are they sufficient conditions? Will you have a flavorgasm after the first bite and then a week later totally forget that you downloaded the U.S. Preventive Medicine Macaw  app for health and fitness app designed to personally monitor your health by assessing your health risks and tracking your daily activity.

I downloaded the Macaw app when it first came out in 2012 and found the registration process surpringly easy and quick. After I fired up the app, I was confronted with a lot of screens and data. The first bite was great, but it was too much of a good thing. 3 years later I’m not even sure they’re still in business.

Moving on.

Capzule PHR for the iPad is a fabulous app for personal healthcare records management. It is beautiful and has lots of features – but from my personal perspective it has a big show-stopper: It is buzz-word compliant in the biggest way – it’s all about sharing and templates, Wifi, scanning documents to multi-page PDF files, QR codes and text forms,password protection, edit records, transfer files etc ad nauseum.

If Capzule PHR is so good for your health, then why do they spend so much time talking about the technology in order to sell it to you?  

If Macaw was relevant but non user-friendly, Capzule PHR was really user-sexy but non-relevant with it’s top-heavy technology focus and the amount of data it collects.

In our post 5 things that make hit healthcare apps – we talk about adding value to patients, doctors and caregivers and fill out the picture with the 5 most important things that a mobile app must have in order to be really sticky and not just flavorgasmic.