
Maria Nyåkern, Ph.D.
Dr. Maria Nyåkern is a pioneering force in the medical device industry. As a consultant and entrepreneur she has been instrumental in carving a niche for herself in the MedTech sector.
Nyåkern bridges her Swedish heritage, inspired by resilience and ingenuity and strong entrepreneurial roots, with Spain's growing reputation as a dynamic hub for artificial intelligence and technological innovation. Spain's investment in digital transformation, combined with a skilled workforce and thriving startup ecosystem, creates fertile ground for advancing AI-driven solutions in healthcare and beyond.
Her academic foundation in science from Stockholm University laid the groundwork for a career defined by leadership and a commitment to advancing B-2-B solutions in MedTech. In 2017, Dr. Nyåkern founded AKRN Scientific Consulting, a Madrid-based Contract Research Organization (CRO) specializing in clinical research and regulatory consulting for medical devices and in vitro diagnostics. Under her leadership, AKRN played a pivotal role during the COVID-19 pandemic, addressing the global demand for clinical consulting services. Its success led to its acquisition by NAMSA in 2022, a testament to its transformative impact on the MedTech industry.
Continuing her entrepreneurial journey, she established Nyåkern Nexus Investments, focusing on strategic investments in emerging medical technologies and innovative startups. Alongside this, she founded ACR Consulting, which provides tailored staffing solutions and consultancy services in clinical and regulatory operations.
Dr. Nyåkern is a sought-after international speaker on MedTech innovation, clinical research, and AI in healthcare. She serves as an adjunct faculty member at IE University, where she is collaborating with IE University to design and develop courses focused on medical device development and regulatory pathways, reflecting her commitment to fostering the next generation of MedTech leaders.
As a Swedish representative on the ISO technical committee for the ISO 14155 standard, Dr. Nyåkern plays a role in advancing global guidelines for clinical investigations of medical devices. This standard ensures that clinical trials for medical devices meet the highest ethical and scientific standards, safeguarding patient safety and producing reliable data for regulatory purposes.
Dr. Nyåkern is also a member of the Scientific Advisory Group (SAG) for Artificial Intelligence in healthcare. In this role, she contributes to evaluating how AI regulation and advancements will reshape clinical evaluation practices for medical devices, ensuring that innovation is aligned with safety, efficacy, and ethical considerations.
Her contributions extend beyond academia and consulting; she is a valued board member for organizations driving healthcare innovation and sustainability. Recognized for her dedication to science and technology, she was awarded the Isaac Peral National Prize for Research, Science, and Innovation in 2022.
Dr. Nyåkern’s journey reflects a deep commitment to building bridges between innovation, technology, and humanity.
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