We are proud to announce the creation of a new division within NDA, focusing on advice and support to companies facing increasing regulatory challenges in the device space.
The new medical device division is led by Dr. Tina Amini, formerly Head of Notified Body and Certification Authority at LRQA, and aims to support drug development and medical device companies under pressure from increased regulatory requirements.
Recent scientific advances and improvements in enabling technologies have opened new avenues for convergence among medicines, diagnostics, and devices. The medical technology industry continues to be one of the most diverse and innovative sectors.
Many innovative pharmaceutical and biotech companies find that their medicinal products rely on appropriate diagnostics or delivery systems operating under a different regulatory framework. Major shifts in regulatory requirements have put increased pressure on traditional medical technology companies to sustain growth and profitability.
The increased scrutiny by regulators on both sides of the Atlantic, most recently embodied in the new European Medical Device Regulation (MDR), has created challenges for these companies to achieve marketing approvals and certifications, as well as to remain competitive.
The increased dependence on sophisticated diagnostics for patient stratification, along with the convergence of the fields through advanced combination products creates new scientific and regulatory challenges – how do you assess this product? Is it a device or a medicine?
“It is clear that the impact of different types of medical technologies, including software, on drug development and other crucial medical interventions is enormous”, comments Johan Strömquist, CEO
NDA. “With the promise of big data and AI, as well as stratification of patients down to the genome level, this is a trend that will only continue to expand.”
He continues:
“We see that even the regulators are struggling to understand the convergence of these new technologies and it is in such areas where clear advice and guidance is most valuable to innovative companies. With the creation of the NDA Medical Device Division, we are taking a crucial step to formally move into this area to partner with our clients on the medical device aspects of their development programs as well.”
NDA Group’s ambition to leverage synergies between drugs and devices has provided the company with a special focus for the new division. The challenges associated with borderline classifications, drug / device combinations and in-vitro diagnostics are core points for the new division.
Dr. Tina Amini, Division Director, Medical Devices, comments:
“The clear focus for us is to support companies with the medical device aspects of their development program to enable access to the market for the medicines that these products enable. NDA Group’s excellence in the field of medicines is now complemented by an impressive understanding of the regulations surrounding medical devices on both sides of the Atlantic.”
She continues:
“Being able to work with one partner to address the regulatory development challenges for both the drug aspects and the device aspects of their product is going to be a game changer for many companies. This will expedite faster access to market and will create great efficiencies compared to trying to manage and coordinate multiple vendors. When you pair that up with the unprecedented experience and expertise of the NDA team you’ve got an unmatched resource that will be able to make a huge difference in getting the right products to market as quickly as possible.”
Learn more about our new Medical Device Services here
or
Contact us now to talk about how we can support your team.
