The current tide of the digital revolution is directed by technology, guiding every sector and carving a world filled with better opportunities. Amongst many, the healthcare segment is also flourished with a cluster of advantages that are technology-mediated.
In this list, the first beneficiary is the MedTech sector. This particular healthcare segment has been booming and is expected to rise with a CAGR of 5.5 percent by 2029. This development has provided multiple innovations with the resilient endeavors of visionary leaders. In contemporary times, healthcare visionary leaders are enhancing the fruits of research and facilitating the needed direction in order to strengthen the medical sector in a better way.
Infusing expertise, creativity, and innovation in the MedTech segment is an inspiring healthcare leader—Maria Nyakern. She is the Founder of AKRN Scientific Consulting S.L. She has clubbed her childhood passion of becoming a doctor and her interest in clinical research to showerhe medical community with a trustworthy platform. Along her journey, she has also been successful in providing clinical and regulatory services for Medical Device and diagnostic manufacturing companies.
Maria strongly believes that working in clinical research enables the Doctors and healthcare community to evaluate their practice objectively and be involved in advancing the medical discipline. Furthering ahead, she is found inspiring fellow women professionals of the field to rise above and gift the care sector with quality skills and expertise.
Let us dive further into her leadership tale and learn how it is transforming the MedTech industry!
An Inspiring Tale
As a child, Maria wanted to be a doctor, but in her late teens, she became more interested in science, technology, engineering, and maths (STEM). She loved reading biographies about great scientists and scientific discoveries and was inspired by female scientists like Rosalind Franklin, Emilie du Chatelet, and Lise Meitner.
Her interest in medical research awakened during her last year of undergraduate studies in molecular biology at Stockholm University in Sweden. She took a course in advanced cell biology led by Professor Uno Lindberg, who later became a very enlightening supervisor during her final degree project and motivated her to pursue a research career, followed by her doctoral studies.
She exclaims, “That was an exciting time in my life!”
After finishing her doctoral studies in Stockholm in 2003, Dr Nyakern spent a few years pursuing academic research in Bologna, Italy. Later, in 2006 she moved to Brussels and started to work in clinical research at a global medical device company.
Expressing her research interest, she says, “I was fascinated by the world of clinical research and realized how it is necessary to develop new treatments for different diseases and conditions that occur in humans. Applied clinical research is the foundation of evidence-based medical practice. I felt inspired to be part of setting up and coordinating clinical trials to answer critical scientific questions and get proof that the new treatment works and is safe.”
Over the following years, she was immersed in the world of clinical investigations and understood the scientific standards that are required to protect patients and produce reliable scientific results. Enlightening further, she informs, “The clinical investigation is one of the last steps of a long and often quite tedious research and development process. Understanding the connectivity of R&D and clinical research inspired me to pursue science, technology, and engineering.”
Hence, she encourages everyone to think broadly about what research actually is.
She puts, “Those who work in healthcare often feel that they are asked to help others in need. Some of the benefits come from knowing that you are contributing to the science and the art of medicine and that you have the tools to question and test different approaches objectively. Everyone has a role in supporting research—many will contribute to research, and some will be research leaders.”
For her being in healthcare is not just a career – it’s a calling!
Spearheading Dream into Reality
After working in academic research in Sweden and Italy, Dr Nyakern did spend about ten years at different global medical device companies and startups located in Europe. Later, she founded AKRN Scientific Consulting (AKRN).
Along the way, she got to know the work of several outstanding women pioneers, some running their own research labs or startups and some working with the corporate industry. She notes, “This was incredibly inspiring, and I knew that one day, I wanted to start a women-owned business that could promote the excellent work of like-minded women professionals of the MedTech industry.”
Therefore, in 2017, when Maria established herself as a clinical consultant in Madrid, she started facilitating opportunities for other talented scientists, especially female scientists, and initiated to establish a life-science consulting business based on the ethics and values she consistently applied in her own profession as a clinical research scientist.
Hence, AKRN Scientific Consulting was born.
Apart from the extensive experience that Maria brought with her, she feels that being a female leader introduced a more empathetic and nurturing perspective to AKRN. This helped her in the decision-making that drove diverse perceptions, contributing to opinions that made a well-rounded outcome.
Maria made specific efforts to develop good female leaders as she feels that they are not only strong mentors but also often pillars of the community. She shares, “For women, the leadership journey is not linear, and we must deal with obstacles along the way, and I really believe in helping women who want to achieve more.”
As her career and life progressed, she was motivated by an aspiration to provide problem-based learning opportunities to talented professionals of AKRN. She says, “I wanted to make learning approachable, engaging, and fun, and I think I have been successful in this. I established a training program that consciously worked on providing various opportunities to continue and develop the employee’s critical thinking skills that are so valuable for problem-solving and planning, and holistically executing clinical research.”
Expressing further, she adds, “I worked with all the hired staff and focused on setting up a milieu that promoted and facilitated the reasoning skills required to solve given problems successfully.”
Maria has also set up training programs that educate young scientists to enter the rewarding world of medical device clinical research. Her scientific training gave her the perfect terrain to develop resilience and not give up. Maria notes that she has seldom found a clear route in life. Instead, she had to forge her own way most of the time. She started in science, continued into clinical research, and developed enthusiastically into an entrepreneur and business leader.
Maria’s inspiring story reflects a famous philosophy—When life offers you an opportunity, do not turn it down. Reminiscing about her journey, she says, “I always took any opportunity that came my way with both hands. It has been a very intense decade with long nights, missed holidays, and sacrifices along the way, but I believe you must do what grabs your interest.”
Maria is an inspiring leader, and she is steadily seeking to drive the field of clinical research consulting services forward. She says, “I am entirely convinced that the future lies with young talent. And I hope I can be part of shaping it in the way I believe is right.”
Dr Nyakern has put these values into her brainchild – AKRN, since its inception. The company has experienced fast and steady organic growth, both in employees, clients, and projects, and has been able to establish itself in the European market quickly. Maria, with her innovative leadership skills, has demonstrated to the AKRN’s potential clients that Maria’s company possesses the skills and insights that are useful at every stage of the project development cycle.
Under Dr Nyakern’s guidance and experience, AKRN was acquired by a US-based global medical device company—CRO NAMSA in the year 2022. It is interesting to note that the acquisition occurred even before the completion of five years of its foundation. Such has been the impact of Maria’s leadership. This acquisition will allow NAMSA to expand its expertise and ability to meet the growing demand for safe, efficient clinical development and commercialization services for medical devices.
AKRN is a medical device CRO with specific expertise in European medical device law that develops and conducts clinical investigations and performance studies in compliance with the requirements outlined in the medical device regulations EU MDR 2017/745 and EU IVDR 2017/746.
She informs, “We have an excellent track record of meeting short turnaround times, which is extremely important for medical device startups during the development phase.”
This helps AKRN to facilitate its services when one needs to reach critical clinical milestones that can demonstrate a new technology’s value and guarantee the subsequent financing round. The AKRN team has specific competence in devices in the cardiovascular therapeutic space and aims to be the most experienced and knowledgeable European CRO in this field today.
The core of AKRN’s business has been to set up and manage medical device clinical investigations according to Good Clinical Practice (GCP) for medical devices and the ISO standard 14155:2020. Maria’s medical and clinical research background has ensured that clinical trials are set up and executed according to good clinical practice and has always been the cornerstone of her leadership.
As a parcel of their basket of service offerings, her team also supports manufacturers with several important regulatory and technical documents, including Clinical Evaluation Reports (CER), Performance Evaluation Reports (PER), Summary of Safety and Clinical Performance (SSCP), and more.
Along with its top offerings, AKRN consultants help companies transition their device development from the medical device and IVD directives (MDD and IVDD) to the recent European regulations EU MDR 2017/745 and EU IVDR 2017/746. Also, they provide guidance on implementing a medical device quality management system as per to ISO 13485:2016.
Optimizing Regulatory Services for Clients
AKRN’s services are grounded in medicine and science and assist its MedTech clients and partners in moving from medical discovery into clinical development, commercialization, and post-market follow-up.
Its multidisciplinary team comprises research specialists and clinical professionals having higher scientific knowledge obtained from Ph.D., Pharm.D., and Masters in Clinical Research programs. Such strength of its high level of scientific and clinical expertise helps the company to optimize and offer services in a cost-conscious and diligent manner that are highly valued by AKRN’s clients.
AKRN experience covers a wide range of medical device therapeutic areas, including neuroscience and cardiovascular devices. Additionally, the organization is highly fluent in more than ten European languages, which is very important to master when working in a European setting and with competent national authorities and ethics committees.
This multidisciplinary team is also able to offer a single point of contact, with the benefit of strong senior management support, which facilitates working with SMEs and MedTech partners that need both “boots on the ground” and executive strategy and support. She proudly says, “Our team has proven to have solid knowledge in the clinical research industry, with specific insights and expertise in the European MedTech setting that can help our clients meet their goals.
“That, combined with a genuine passion for medical device technology and supporting small and emerging MedTech manufacturers and startups!”
She feels that her clients and partners view her organization as trusted and valued advisors in clinical investigations, regulatory development, and CE-mark strategic consulting.
Women and the Medtech Industry
On a broader spectrum, gender inequality is not a MedTech-specific challenge. The female ratio of CEOs and founders in startup verticals in medicine and technology is less than 20%, which is in line with most other startup sectors. In contrast, as per the World Health Organization, women account for 70% of the global health and social care workforce.
She opines that gender inequality leads to a severe lack of focus on women’s health issues in medical research. So, it is clear that the industry needs to innovate for women and needs more innovation by women in healthcare.
Maria mentions that supporting emerging female leaders is the key, particularly while the world still has few role models. Education, Coaching and Mentoring, and having allies is critical, and the industry must highlight how ‘female’ leadership can complement the traditional, more male leadership.
Maria shares, “As a business owner and entrepreneur, I’ve had the opportunity to support women’s growth and persuade them to take chances and try new roles. I feel humbled to see how well my audience has responded and its impact, ushering more women into the medical device industry. Because as important as it is to have a pipeline and role models, we also need allies that encourage you to strive for more and say, Of course, it should be Me!”
She is personally inspired by the capacity and leadership shown by the talented women in her organization. AKRN has many young female role models within the company. All across AKRN and NAMSA, women in leadership positions are a living testament to the many ways women are lighting the way.
An Advice to Excel
In the interview interaction, Maria opinionated on the significance of providing entrepreneurs with funding, coaching, mentoring, and business support to develop their ideas.
She says, “As an entrepreneur, you also need courage and tenacity to provide arguments about why someone should invest in you and your business idea.”
Maria is also a defender of being “Humbitious,” a term coined by the executive coach and distinguished Trinity University professor Dr. Amer Kaissi that speaks about finding the right match between being humble and ambitious. She brings to notice the way in which Dr. Kaissi shatters the common myths about leadership being an ego-driven game and talks about the power of low-ego and high-drive leadership.
Her advice to people is to reach out to others for help and not be afraid or ashamed to connect with those business leaders who inspire them. She says, “Send them an email, connect with them on LinkedIn, or ask a mutual contact for an introduction. Good leaders are always willing to give you their time and guide you to succeed.”
Dr Nyakern is passionate about supporting budding entrepreneurs and making the path easier for others. She delivers a powerful message that says, “My leadership story started as a young girl without industry connections, mentors, or allies. All I had was a powerful desire to achieve and prove myself. My tenacity and courage helped me get to where I am today.”
Path for the Future
By partnering with NAMSA, AKRN aspires to continue increasing its presence globally and in Europe. With the expanded expertise of the combined organizations, they believe that the organization will serve as the world’s leading CRO for cardiovascular research services.
Maria proceeds to inform that the acquisition of AKRN by NAMSA will increase their global scale and will help them serve MedTech clients across 19 locations throughout APAC, Europe, North America, and South America.
As the worldwide leader in the medical device testing industry since 1967, NAMSA’s complete continuum development services help clients overcome development hurdles, mitigate concerns and streamline commercialization efforts.
Highlighting the importance of changing dynamics of healthcare worldwide, Dr Nyakern explains, “As we prepare for future health challenges, we know there will be no single solution or answer. That’s why we must keep building our team today, with people from all backgrounds and experiences — including, but not limited to, brilliant women — so that the innovation reflects all of us and a healthier future with more robust health systems and a renewed and refocused cross-sector collective of new leaders.”
“At AKRN, now a part of NAMSA, we will continue working to be the first and most trusted MedTech CRO in Spain, Europe, and beyond,” concludes Dr Maria Nyakern.
Awards and Accolades
The European Association of Economy and Competitiveness awarded Maria Nyakern with the Isaac Peral National Prize for Research, Science, and Innovation 2022 to recognize the research work carried out by AKRN.
The European Association and its jury recognized the success of AKRN as a medical device CRO and Dr Nyakern’scapacity for “entrepreneurial leadership within the European framework.”