MARACA International is a specialised consulting company from Belgium. We provide specialised regulatory, quality and medical/clinical services to our clients worldwide. Hence, the name of MARACA, which stands for medical affairs (MA), regulatory affairs (RA) and clinical affairs (CA).
MARACA supports medical device (MD) and in-vitro diagnostic device (IVD) companies to bring their devices to the European and US markets. We also support pharma companies for combination products and companion diagnostic devices, as well as the development of medical device software applications (MDSW) and the development of laboratory devices. MARACA can also act as an expert for notified bodies, competent authorities, or MD committees.
Provided by our network of experts, our services can be customised or cover the overall management of the company’s regulatory and clinical departments.
Who is Dr Luc Van Hove?
Luc Van Hove is a clinical study physician with more than 25-years’ experience in MD, IVD, diagnostics development, clinical study management and device registrations.
Before founding MARACA in 2017, Luc previously worked for more than 20 years as a clinical and regulatory expert for IVD companies in Europe and the US. He was also the medical director for 15 years at Abbott Laboratories and had worldwide medical, clinical, and regulatory responsibilities for all diagnostic products. Luc jointed thereafter small US and European biotech companies to lead their clinical and regulatory departments as senior director, vice-president or chief medical officer.
A board-certified Clinical Pathologist in Belgium, he studied at the KULeuven to achieve his medical degree, his PhD in tumour immunology and his medical speciality as Klinisch Bioloog. During these years, he was also a Fellow of the Belgian National Fund for Scientific Research (NFWO) with his oncology research and advanced to Associated Professor. Luc published more than 150 papers, many in the oncology field and more recently in Molecular Diagnostics. He is awarded by the American Association for Clinical Chemistry (AACC) and by Abbott Laboratories.
What is MARACA’s mission and vision?
Luc explains MARACA’s mission ‘is to improve patient and clients lives with durable service’. The MARACA collaboration is a partnership and we are committed to delivering service excellence.
“Our vision is to provide best-in-class regulatory, quality and clinical services to MD and IVD device manufacturers, clinical laboratories, pharma companies and notified bodies”.
What are the key values MARACA International stands for?
“MARACA stands for superior regulatory and clinical knowledge transfer, brought with passion, flexibility, a customer-focus, durability, creativity, efficiency and empathy,” says Luc.
“Indeed, we are realising your device dream whereof you will reap the rewards. You can feel our passion in every contact. We will provide you with a total experience which is unique, creative and will lead to surprising solutions for your device submissions. An honest, collaborative proposal, without worries for our customers we stand for,” says our CEO.
How is MARACA International seen in the business community?
Our high-quality services are recognised by the industry. It resulted in an AI Acquisition International certificate from the voice of modern business with a 2018 Global Excellence Award as Recognized Leader in Quality Control Services – Belgium and in 2020 the certificate of Best 2020 Global Excellence Award for Best Clinical and Regulatory Consultancy 2020 – Belgium.
What is the focus of MARACA International?
Luc explains that MARACA is currently especially focused on supporting medical device and IVD companies with the introduction of nanotechnology-based devices to the European and American markets. MARACA became the regulatory partner of the European Open Innovation Test Bed for the introduction of nanotechnology-based MDs, called Safe-N-Medtech.
“MARACA is developing an SME roadmap for the introduction of nanotechnology-based MD to the European market. Nanoparticle (NP) containing MDs need to follow the same regulatory path as the other MDs. But there are additional specific requirements for NP-based MD due to the new specific risks which NP could pose to the patient, the user or the environment. Therefore, additional specific biological toxicity studies need to be performed. For some of these NP devices, special competent authority permission will be required and there can be additional labelling requirements needed for these devices.”
MARACA has organised a scientific session at the upcoming Regulatory Affairs Professionals Society (RAPS) European Convergence meeting in Brussels 26-28 October 2020. This session reviews regulatory hurdles to overcome to introduce nanotechnology-based IVD and MDs to the EU Market, as a Safe-N-Medtech concern. We will review the hurdles which NP devices have to tackle and what support the Safenmt consortium can offer to overcome these challenges.
Is MARACA impacted by the COVID-19 pandemic?
Indeed, MARACA is impacted by the Covid-19 pandemic. There is no travelling anymore so we now all communicate with virtual meetings. Businesses will be very different post-pandemic. Luc was already preparing for a future pandemic while he was worked at Biocartis. The pandemic demonstrated how underfunded our preparedness was at the European level. Europe has no Emergency Authorization pathway to bring devices to the market in an emergency. The result was major chaos and an uncontrolled release to the EU market of subpar Personal Protective materials, ventilators, and Covid-19 tests. The European Commission recognised this alarming situation and opened a call for Covid-19 device accelerations. MARACA responded to that call by participating in several efforts to bring compliant MD and Covid-19 tests to the market as fast as possible.
What is unique in the service of MARACA?
MARACA offers a unique service as Medical Practitioner, which includes:
- Physician input and review of the product design
- Advisor in the development of Companion diagnostic products
- Risk management review for patient impact
- Health Hazard assessment of a complaint for patient impact
- Benefit – Risk summary development and signing as Medical Practitioner
- Clinical evidence development from literature review and signing as Medical Practitioner
- Assessment of clinical evidence in the Performance evaluation report
- Clinical performance study protocol development and synopsis as Medical Practitioner
- Statistical analysis plan with endpoints for clinical performance study
- Physician representation with Notified Bodies, FDA and competent authorities