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When patient selection is key

How a leading global device company successfully uses digital review processes to launch a new TMVI system

In our first blog post, Uwe Gladbach, a biomedical engineer and Head of ClinFlows, gives us an introduction to how digital review processes can help companies from the medical sector in the area of structural heart disease. Specifically, how this can be used to launch new treatments and medical devices cross-locationally and saving time while meeting GDPR requirements. In this article, he discusses the challenges that stakeholders face when launching a new transcatheter mitral valve implantation (TMVI) system in cross-locational settings. He explains how these complex processes can be realized by using customized web-based solutions. He gives a practical step-by-step example on a digital review process and stimulates some thoughts on data privacy aspects.

How to leverage the precious medical expertise gained during clinical studies

When developing breakthrough treatment modalities for the clinical market, conducting clinical studies and trials represents an essential aspect of the process. During the different study phases, increasing numbers of patients are enrolled, and the number of participating sites increases. But still, the expertise, handling a new device by implanting physicians, is only carefully built and remains limited to the participating physicians. Furthermore, it typically starts with more straightforward cases before more anatomically or clinically complex cases are approached. Hospitals that have not participated in the early clinical trials have to build their expertise once the product is launched to the market and need to become trained to be able to handle a new device correctly and treat patients successfully. Especially in TMVI, it is crucial to select the right patients, as well as selecting the correct size for the implanted valve. Medical companies undertake enormous efforts during the product launch to support physicians to build up their skills regarding patient selection, the treatment procedure, and the handling of new devices. One of the challenges they face during these processes is that they need to continuously communicate with physicians and hospitals across the globe as well as to review patient data and DICOM images to give advice.

Extensive experience of clinical specialists and proctors plays a vital role in the success of a product launch

Now you may ask yourself, why is it so important for experts of medical companies to review all the data and images and give advice to hospitals and physicians when launching new treatments or products? Well, the answer is simple; because of their extensive and precious expertise and knowledge that is indispensable for a successful product launch, for the training of everyone involved, and, in the end, for the successful treatment of the patient.

Let me give you an example:

During last year’s PCR congress in Paris, I was talking to a clinical imaging analyst from one of the major clinical device companies who is very valued by his colleagues. During his professional career, he has been present during uncountable procedures and has contributed to a great number of successful launches and introductions of new treatments like TAVI or recent TMVR interventions. Now, on a daily basis, he reviews and measures TAVI/TMVR cases from countries all over the world and gives advice to physicians and hospitals. When being asked how many cases he had already reviewed so far, he replied: “Probably more than 10,000.” This extensive experience definitely makes him an expert in this field and enables him to give advice that many stakeholders, and patients can benefit from. We are proud that he is a seasoned user of our decidemedical platform.

From CD/DVD courier shipments to safe and efficient online processes

About ten years ago, I had a discussion with a Clinical Director from the TAVI industry, who had the task of building and organizing an infrastructure to manage the review of about 3,000 TAVI cases on an annual basis in Europe. With his team, he started reviewing CDs/DVDs of Echocardiographs, Angios, and CT images that he had received via courier shipments – you remember those plastic bag envelopes? Documenting the receipt and status of review in Excel sheets – you can imagine how time-consuming that was.

I remember thinking that there needs to be an easier way to exchange clinical data and medical images, so that sites receive a reply from medical experts more quickly and safely. So we came up with ClinFlows and started to provide our online service allowing sites to upload their medical DICOM images, (which can sometimes be volumes of several gigabytes) online via our platform decidemedical. Since then, the digital workflow and platform capabilities have evolved as browser technology has continuously progressed, offering new features and programming possibilities.

Today, our solutions enable all stakeholders of clinical projects and studies to easily exchange pseudonymized clinical data, evaluate and review them, and to communicate with each other. Thus, they can finally benefit from remote expertise and launch new products and treatment options much quicker and easier than they used to in the past.

In practice: Step-by-step-example of a digital review process of the product launch of a new TMVI system

But how does this work? Let’s make this more practical.

In a project for a global leading medical device company that recently started to launch a new transcatheter mitral valve implantation (TMVI) system, we realized a customized workflow on our platform DecideMedical, which is used by hospitals in 87 countries worldwide. The task was to set up a workflow that allows review of several thousand cases per year while being in line with GDPR. As well as involving the industry partner with its administrative team, the Field Clinical Specialist (FCS), external medical proctors (physicians) and the sites uploading their clinical cases. Now, the working process is as follows:

  1. Site creates an account. The administrative team sends an access code to the site, allowing the heart team at the hospital to create an account on decidemedical and to create and submit cases to the project.
  2. Enter the clinical data. The site enters clinical data and uploads echocardiographs in DICOM format and submits the case to the expert team (FCS) of the medical device company. DICOM headers are automatically de-identified during upload. The experts are automatically notified by email when a new case is submitted.
  3. Review the data. The FCS responsible reviews the data (preview or download) and informs the site if the case is or is not eligible for TMVI and asks the site to continue with providing CT imaging. When the site adds the multiphase CT imaging, the expert is notified and downloads the CTs from DecideMedical and runs an analysis on a specialized image analyzing software, like 3Mensio (Esaote).
  4. Get the expertise of a medical proctor. Optionally, the FCS can push the case to one of their medical proctors to receive his or her opinion assisting in the review process. The proctor is notified automatically by DecideMedical when a case is available for review, and the proctor can respond to the FCS within DecideMedical.
  5. Receive a final judgement. Based on the review outcome, the FCS sends the final reply and judgment about the patient’s eligibility for the treatment back to the site, which is notified about the availability of the review by email.

Thanks to web-solutions the patient is ready for treatment within hours

This review process can be carried out – depending on the party’s availability – in just hours. Hence, the patient can probably be treated the same or next day. The hospital can now proceed with the intervention, considering the opinion of the reviewer. Of course, at all times, the treating physician remains responsible.

Embedded discussion tools enhance the communication between the parties and store all case information centrally and safely.

We are convinced the time is over for sending CDs via couriers or having field force personnel from the industry picking up CDs at the hospital by car. We know it still happens… it’s like picking up paper letters by hand instead of using email. Obviously, this is very inefficient and not regulatory-compliant at all.

Watch out and protect patient privacy in line with GDPR

Talking of which, since May 2018, the General Data Protection Regulation (GDPR) has been in force, especially protecting the privacy of EU patients.

GDPR is worth a separate article and will be covered on this blog in more detail in the near future. However, I would like to give you some food for thought about dealing with patient data.

  • Are you aware of the fact that you are not allowed to forward patient data to anyone if the patient has not provided and signed their informed consent? And do you know which information the consent form must contain?
  • Do you know the difference between the “anonymization” and “pseudonymization” of data and the consequences with regard to GDPR?
  • Do you know about DICOM headers and its difference to burned in annotations on DICOM data?
  • Do you know in which country your patient data is stored and that the USA is a third-party country with regard to data storage according to GDPR, leading to certain requirements?

Yes, we know, these regulatory questions can be quite confusing and demanding, but please be cautious about them. Physicians, medical experts, as well as the different stakeholders of the medical device industry dealing with sensitive health data, must understand their role and be aware of their legal responsibilities and consequences.

Exchanging sensitive data within seconds can be done – while meeting GDPR requirements

We love the field of new treatment options with its tremendous drive for innovation, with wonderful, passionate people and a mature clinical study culture. And we work ambitiously to make the development of new, innovative, and helpful treatments as easy and fast as possible.

That’s why our online tools allow us to configure the required and individual workflows needed for the various clinical projects and to work in compliance with the GDPR. ClinFlows, as a data processor, provides the certified IT infrastructure, is ISO 9001 certified, and has been successfully audited by numerous companies.

We are excited and grateful that due to these reasons, our services are used all over the globe and connect the clinical community for the patient’s benefit.

And to conclude this article, I would like to promise you one thing. We will keep on doing what we love the most. That is supporting the launch of new treatment modalities and breakthrough technologies, by making the workflow of clinical studies and proctoring projects in multiple market segments, easier, faster, and regulatory-compliant.

About the author:

Uwe Gladbach is a biomedical engineer, who started his career as a perfusionist in open-heart surgery back in the 90s. Over more than 25 years, he gained experience in the medical device industry in various positions, covering clinical research as well as sales and operations in global positions. Uwe is the CEO and founder of ClinFlows.