7 questions to Evidencio CEO Rob Mentink about their medical algorithm platform

Interview conducted by Beni Hirt, Decomplix CEO

Why build a marketplace for medical algorithms and clinical decision support tools? Or in other words: What needs of the healthcare industry does Evidencio address?

Evidencio’s creation of a marketplace for CE-certified medical algorithms serves several strategic and practical purposes, each aimed at enhancing the accessibility, reliability, and integration of these tools into the healthcare sector. The core underlying reasons are:

1. Streamlining Access to Certified Tools: By hosting a dedicated platform for CE-certified medical algorithms, Evidencio makes it easier for healthcare professionals to find and access tools that have already met stringent European Union regulatory standards. 
2. Enhancing Collaboration and Innovation: The marketplace acts as a hub for innovation by bringing together developers, clinicians, and researchers. This fosters a cycle of feedback and improvement, driving further innovation in medical predictive modeling.
3. Ensuring Quality and Compliance: By facilitating the distribution of CE-certified algorithms, the Evidencio marketplace ensures that all offerings adhere to high standards of quality and legal requirements, assuring both the end-users and developers. This helps in maintaining trust and reliability in the use of these advanced digital health solutions.
4. Facilitating Adoption and Integration: With a marketplace that features a wide range of vetted, ready-to-use algorithms, healthcare facilities can more easily integrate these tools into their existing systems. This reduces the barriers to adoption, such as compatibility and interoperability issues.
5. Supporting Regulatory Navigation: The marketplace not only offers a platform for selling developer’s algorithms but also provides support through Evidencio’s services in achieving and maintaining CE certification. This is crucial for smaller developers or startups that might lack the resources to manage regulatory affairs independently.

In summary, Evidencio’s marketplace for CE-certified medical algorithms is designed to advance the implementation of trustworthy medical technologies in healthcare settings, promoting safer patient outcomes and catalyzing the broader adoption of predictive analytics in medicine.

What types of algorithms can Evidencio cover as a legal manufacturer?

Evidencio can cover a broad range of medical algorithms. There are a couple of ways to slice this. From a clinical use perspective:

• Diagnostic Algorithms: These algorithms assist healthcare professionals in diagnosing diseases by analyzing patient data, symptoms, and test results. Diagnostic tools might use artificial intelligence (AI) to interpret images, recognize patterns, or predict disease presence based on historical data.
• Predictive Algorithms: Such algorithms forecast the likelihood of a disease or medical event, such as heart attacks or strokes, based on patient health data and risk factors. Predictive modeling is crucial in preventive medicine and helps in tailoring individual care plans.
• Treatment Recommendation Algorithms: These tools analyze medical data to suggest treatment options. For example, they might recommend a specific drug based on a patient’s genetic makeup or predict how well a patient will respond to a particular treatment regimen.
• Prognostic Algorithms: Prognostic tools predict the outcome of a disease or the likelihood of a recurrence. They are valuable in planning long-term treatment strategies and in informing patients about their recovery prospects.
• Risk Assessment Tools: These algorithms calculate the risk of developing a condition or experiencing a medical event. They are often used in settings like cardiovascular health, to estimate the risk of developing heart disease, or in surgery, to assess the risk of postoperative complications.
• Personalized Medicine Algorithms: These involve algorithms that help in customizing healthcare, with decisions, practices, and products being tailored to the individual patient. This often involves complex algorithms that can analyze genetic, environmental, and lifestyle factors to optimize healthcare outcomes.
• Monitoring Algorithms: Tools designed for the continuous monitoring of patients, especially those with chronic conditions. These algorithms can analyze data from wearable devices, alert healthcare providers to changes in a patient’s condition, and recommend adjustments in care remotely.

From a risk perspective, Evidencio focuses its services on Class IIa MDR medical devices, and Class B IVDR devices. Higher Risk algorithms can potentially be onboarded too, but these require a different (longer and more costly) process as the current Evidencio ‘fast-track’ for Class IIa / Class B devices.

From a technical perspective, Evidencio supports a broad range of algorithm technologies, such as Statistical models and calculators, e.g. Logistic Regressions, Cox Regression, Custom formulas, etc. as well as Machine Learning algorithms based on e.g. OSAsense, Patient-monitoring & Altering in Vivica.

What about wearables that provide input to medical device software (MDSW)? Can Evidencio take on the legal manufacturer role too?

Yes, but limited to the algorithms. Evidencio usually focuses on Software only and does not take hardware certifications into scope.

Why should an algorithm innovator go with an MDSW legal manufacturer instead of “Doing it yourself”? Key benefits?

The most important benefits are:

1. Time to market: If the intended purpose, evidence and risk profile allow an algorithm to be classified as a Class IIa medical device, Evidencio is typically able to get it to market in 9-12 months. As opposed to 2 or more years if you do it yourself.
2. Cost: Since he reuses Evidencio’s infrastructure and QMS, the cost of certification is usually significantly lower than 50% compared to doing it himself.

Which aspect of the platform/service do your customers value the most?

Price, speed, and (international) market access.

How long does onboarding take until an algorithm is CE-certified?

Evidencio uses a 2-step process. We start with a ‘pre-assessment’. In this step, we assess the:

• Algorithm, its math, implementation, etc. for compatibility with the Evidencio platform
• Intended purpose: medical claims, intended users, etc.
• Clinical evidence: availability and quality thereof, and to which extent it covers the medical claims maid in the device’s intended purpose description

The pre-assessment phase normally takes 4-6 weeks. It produces a report which, if positive, is subsequently used to determine whether a.o. the clinical evaluation plan, algo onboarding steps, etc. 

Suppose the algorithm fits our Class IIa fast track. In that case, the CE mark is obtained 6-9 months after initiation of the certification phase. This is always pending Notified Body approval of course.

Last, what is Evidencio’s collaboration model with Decomplix?

Evidencio partners with Decomplix to provide customers in the DACH area with local support and consulting. Decomplix can performpre-assessments and develop the needed technical documentation for customers under Evidencio’s QMS. We see Decomplix also as a reseller of our service to scale the Evidencio platform.