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.
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.
This is a post David wrote a while back and it still seems relevant. If you would have asked me 2 years ago – I would have told you that in 2018, no one would be doing paper medical device clinical trials the same way that no one does paper accounting. I would have thought that logic would prevail considering the advantage of using automation and technology instead of using your Chief science officer to manually enter data into Excel.
Medical science is the foundation for innovative medical devices. Taking medical science and developing a medical device product requires translating basic science into technology. This is self-evident.
So why do so many innovative medical device vendors conduct their clinical trials using paper? Damn if I know. Using paper for medical device clinical trials is somewhere between penny-wise and pound foolish and plain dumb.
Every year, 20,000 clinical trials are performed. An electronic data capture (EDC) system is quickly becoming adopted as the modern standard for monitoring in clinical trials. EDC solves the problems that are inherent to traditional, paper-based methods of data capture. During medical device clinical studies, the accessibility to real-time data capture and storage during conduction is key to performing a study that is cost efficient, and effective in generating results.
Paper-based = slow and costly
EDC = quick and efficient
Do not forget these simple equations, as they should become your mantra.
As seen below, the number of medical device clinical trials conducted is like the global population; it only keeps increasing. The pressure is on for product developers to conduct studies in the most expedient fashion possible, and collecting data that is not only pertinent and useful, but is clean and devoid of doubt concerning its accuracy.
Thanks to technological advances (read: EDC), on-site monitoring and clumsy, paper-based data storage are going the way of the dodo bird. The use of EDC as a basis for automating patient compliance during medical device clinical trials is quickly developing as more an more medical devices become connected via mobile and home wireless networks.
Paper-based data capture systems are irrelevant for connected medical clinical trials.
90% of drug development costs are invested in clinical trial conduction. EDC systems facilitate automation of patient compliance during the duration of the medical device trial. And while not every medical device trial uses connectivity and automated patient compliance monitoring, there is an increasing understanding that the direction is digital and not paper.
The majority of the public values clinical trials for the healthcare industry, as seen below. Implementing an EDC system for medical device clinical trial monitoring has proven to reduce study costs by 59%. So, ask yourself, what are you waiting for?
As seen above, the value of clinical trials is understood by the public, and as clinical trials continue to grow in scope of variables and number of participants, they require a more efficient means of data capture in order to cut the costs involved in monitoring. EDC systems provide exactly that. Here we will touch upon why an EDC system is becoming an essential for clean and efficient risk-based monitoring in clinical trials.
Medical device monitoring data is available in real-time
Using an EDC system affords the opportunity for study monitors to receive data entered by clinicians as soon as it is collected. By using hand held devices, such as a tablet, that are logged into an EDC system, makes risk-based monitoring a breeze. No longer does one need to record data on a clipboard, and then duplicate the same data into an on-site hard drive. This means that monitors are getting their hands on information the second it is captured.
Simply put, the faster that you get data into the hands of your monitors, the greater the efficiency of the study.
Increased study efficiency through cloud notifications
Recently, for the past 20 years or so, medical device clinical trials have been substantially increasing in scale and complexity as they continue to become more valued and salient as a means of biomedical development. Often, they involve a sizable number of people responsible for entering data, and study monitors assigned the task of monitoring specific variables and patient compliance to the protocol.
An EDC system automates the appropriate delivery of fresh and high-quality data from investigational sites, patients and connected medical devices. Whoever needs to receive whatever data variables from a clinician are notified in their personal account via the cloud. Not only does cloud-based EDC keep monitors informed in real time, but the organization and delivery properties ensure that the right monitors are receiving the right data, increasing efficiency in increasingly complex studies.
When data is entered after capture, an EDC system can automate from the entry user the delivery of data to the assigned monitor. Email alerts can also be integrated into the EDC system, so that whenever data is entered for review by a monitor, they are informed even if they are not logged into the EDC system.
Reduced monitor travel costs with remote compliance monitoring
Not only does using EDC keep monitors informed of new captured data as soon as it happens, reducing subject risks, but monitors can perform their tasks from abroad, saving travel time and expenses. The features of using a cloud-based EDC system are nearly endless, but the decentralizing of on-site data monitoring is one of its greatest boons.
Monitors that work from home going to be willing to receive lower salaries, and people are generally happier when they can work from home. Your study will save time and money by an increased retention rate in monitor personnel, that are willing to work with a clinical trial sponsor, study after study.
Further, and this is a benefit from remote monitoring of your medical device clinical trial that most would not think of, consider reduced human traffic at your study site. The less people you have at your study site the better, as there is simply less for on-site study managers to focus on. This is a minor benefit of an EDC system, compared to the speed of data delivery with EDC, but a benefit nonetheless.
Also consider that remote monitoring can allow the outsourcing of monitors. If your study site is located in California, but there’s a team of specialists in India, willing to perform exceptional quality of monitoring for lower salaries, of course you are not going to fly them over to work for you; cost prohibitive. If you are using the standard on-site monitoring method that comes with paper-based systems, your resources are limited to only those that can geographically travel to your study site.
Cleaner, consistent data submission to monitors
EDC systems can use a study-specific standardized data collection form, reducing errors in collection and delivery to monitors. Consistency is key to running a smooth, hassle-free medical device clinical trial. By using standardized electronic data collection forms, your study will erase the possibility for inconsistent data submission from data managers to monitors.
Paper-based data capture systems may seem familiar and comfortable to clinicians, and making the transition to an EDC system may seem like a plunge into unknown territory, but the data is plainly cleaner when conducting a study with EDC. The deficit of errors and omissions that are caused by implementing EDC are a tremendous ROI for your study. Consider the following:
For example, in a paper-based system, data is recorded by hand, and even something as seemingly trivial as handwriting comes into play and can muddle data. Not every clinician will have the best penmanship, so this opportunity to corrupt data is entirely circumvented by using an EDC system.
A more frequent, and damaging, corruption of data that occurs when using the standard paper-based system are data errors and omissions when recording data. People make mistakes, for whatever reason. It is natural, and bound to happen. Say, for instance, that you have a subject XY-1001-9, for which the clinician is collecting data; it is very easy to write YX-1001-9, XY-101-9 or XY-1010-9 if a clinician is distracted, or maybe just operating on little sleep from the previous night.
By working with an EDC system with standardized data collection forms, the above scenarios are entirely avoided. That being said, standardized forms are not going to write themselves. During the planning stage of your study, devote time to organizing and developing the standardized form model you are going to use for each subject in your study to reduce errors and omissions. In the long run, your ROI will go through the roof.
However, even in an EDC system, mistakes can be made. No system is entirely error-proof, especially when being implemented for the very first time. When a mistake inevitably does happen, it is far less of a headache to solve and prevent from recurring using an EDC system. For starters, FDA compliance adherence measures should already be in place at the hands of the EDC software vendor. As compliance standards are modified by the FDA, they can be updated in the EDC system without a hitch. When data entry errors occur, they can be addressed by programming the software to recognize proper form entries.
Another feature of EDC systems for reducing errors and omissions is data entry recognition standards. Remember the subject number examples? If you write something down on paper, there is no real way to tell if you got it right the first time, than somebody else telling you who has noticed that you have made a mistake, and then correcting it themselves. Every field of the EDC user interface can be programmed to recognize whether the data entered was in the proper format, and whether any fields were skipped or not submitted.
An EDC system also reaps tangible data capture benefits for studies using subject-submitted data. Many subjects are not experts in clinical trial data management and entry, and unless you are conducting a study into only a single variable, patient submitted data, which saves time and costs, is an impractical approach to collecting study data. However, whilst being cloud-based, EDC allows any subject with a smartphone, tablet or computer the ability to submit data, at the very moment it is noticed and measured, mitigating subject risks and saving on study personnel expenses.
For user submitted data, the standardized data collection form with checks in place for data submission ensures that the subject will not make a mistake when submitting data. You will be able to get by and hire less clinicians for future studies, a further cost saver of EDC.
Facilitating future medical device studies
After you take the plunge (and please do, ASAP) into EDC and forego paper-based data capture, the benefits will be noticed immediately for your next clinical trial. Not only will every facet of your data capture and monitoring be smooth sailing, but think of the future studies you will be sponsoring, and how they will benefit.
Not only does EDC facilitate the aforementioned features, but after you and your study personnel (and subjects if applicable) are trained and familiarized with the use of the EDC system you have chosen, future studies will be up and running faster than you can say “outdated, paper-based data capture.”
EDC systems significantly cut the time spent during the planning and preparation phases of a medical device clinical trial. Consider how while you are planning the variables and factors to be measured, you can instantly enter them into the software, saving time and money that would otherwise be spent on designing paper forms and making copies. EDC systems are flexible, and if study personnel is trained properly by the software vendor from the get go, require little maintenance for their design.
What are you waiting for?
Hopefully you now have a better understanding of how vital an EDC system is for an efficient medical device clinical trial, and how many headaches it alleviates for monitoring clinical trials. When you are looking for a vendor, ask how they can eliminate rework and detect problematic trends in real-time. Ask them if they require expensive third-party analytics and if they limit the number of users that can use risk-based monitoring tools and make sure they have a great training program. Enjoy your streamlined future studies.
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 their value is manifest for clinical trial efficiency and cost savings. Soon, medical device clinical trials will no longer be dependent upon paper-based systems at all. Paper is great for passing notes in class, but how often does that even happen anymore? Kids in school are more likely to use Snapchat or simply text each other.
As someone said recently – “millenials are off Facebook, adults still use email”.
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 planning and preparation but also the ability to respond to bad news and unexpected events.
In this article, Jenya Konikov-Rozenman surveys the 3 elements you need to implement to ensure success in use of healthcare IoT devices in your clinical trials.
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 human component to study, assess data, store it and make decisions based on captured research data. We cannot remove human study monitors and data managers entirely out of the equation.
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 innovative medical device vendor will include the time spent by the scientific staff preparing and reducing data, additional time by the data manager to clean the data and a large intangible cost of the delay to receive management reports of patient compliance, typically 2-3 months, if you are running a multi-site study with paper.
But beyond TCO, the most significant factor in a medical device vendor decision process is how fast can you get actionable intelligence on your patients and sites and CRO?
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 nasty things that can happen. If you are a software engineer with devops experience, you will want to pay attention to the part in the post that talks about validation.
We’ll leave the nasty stuff for another post.
Why bother with medical IoT? Coolness or Compliance?
Increasingly, connected medical devices are used for treating a wide variety of indications, from diabetes and blood pressure to migraine headaches. So the first reason is that its cool and fashionable to connect Apple watches to clinical trials.
The real reason to use medical IoT / connected medical devices in your trial is to collect data from the patient and ensure patient compliance to the clinical trial protocol. Use of medical IoT, wearables, watches and device apps can close the monitoring gap from weeks to seconds and make SDV a thing of the past.
Well – it certainly isn’t science and technology innovation or even the FDA.At a recent executive roundtable, according to Tufts University’s Center for the Study of Drug Development director and associate professor Ken Getz, it is that many pharma corporations and CROs have not yet fully embraced the newest, most efficient technologies, and this has been a huge problem in recent years.
More expensive. Riskier than ever.
“Drug development cycle times have not gotten faster, costs continue to increase, and drug development has become riskier than ever with only 11.8% of products that enter clinical testing receiving regulatory approval, about half the rate of the 1990s,” says Getz.
Which, of course, is true, as we in the clinical trial industry know that it takes about a decade for a drug to be developed and on average seven years for it to be tested before it makes it to market, and only if it gains regulatory approval. So, what would happen if clinical testing time could be shortened?
Jenya wrote a piece about the challenges of clinical trials operations change management for regulatory people who have to work with medical technology developers and I just had to write my own intro.
Frankly, its easier to talk about change for other people than for yourself. A lot easier. I have written here, here and here about the gaps between the stakeholders in medical device clinical trials – security, IT, engineering, product marketing ,regulatory affairs and medical device security to name a few.
Overlook change management at your own risk
Change management is a topic usually overlooked when medtech companies implement cloud EDC, and introduce medical IoT for collecting data from patients directly and use electronic source documents for their connected device/mobile medical app or device clinical trial.
In this post, Jenya talks about how to manage change during the transition from traditional medical device clinical trial data management to cloud technologies, remote monitoring, medical IoT and electronic source data.
There is a saying in American English dating back to the 1940’s – “Call me when you have a nickel in your pocket”. With limited budgets, small, innovative medical device vendors will be looking at the nickel in their pocket and thinking that they cannot afford a cloud EDC offering for clinical data management and opt for the paper default or the DIY option for monitoring. None of which are a particular good idea.