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1MED: Transforming the CRO Services with Diligence

Enrico Perfler of 1MED

Not more than a decade ago, Contract Research Organisations were known only for conducting clinical trials and lab services. It has now evolved to cater to broader service areas like data analytics, drug development, and the like.

Increasing investment by pharmaceutical companies for research and development, the rising number of clinical trials and increase in rare diseases have led to the growth of CRO. Globalization and technological advances in the medical field have added to the impetus.

CROs are known for efficient deliverance in clinical trial management services for pharmaceutical, biotech and medical device companies.

The Covid-19 pandemic has seen more pharmaceutical companies associate with CROs for R&D and this market is only expected to grow. As per recent research, the CRO market is projected to grow at a compound annual growth rate of more than 10 % by 2026.

One CRO that has been making waves in the market for its clinical and regulatory development is the Switzerland-based 1MED. It provides all the services that are required for the research and development of medical devices. It also offers post-market assistance.

Enrico Perfler, CEO of 1MED, shared his cognizance of the biotechnology and medical sector in the following interview.

Please brief our audience about 1MED, its mission, and the key aspects of its stronghold within the contract research niche.

1MED is a CRO focused on assisting medical device companies in facing the complexity associated with the development of medical devices in compliance with MDR by providing support from a strategic, regulatory, quality, and clinical point of view, with a cross-functional approach.

1MED services can encompass all phases of the medical device development lifecycle, starting from pre-clinical phases (device concept, device design, and prototyping, bench testing, etc.), through clinical phases (first-in-human studies, pivotal studies, etc.) to post-market activities to monitor device safety and performance when used in real-world (market surveillance and vigilance, post-market clinical follow-up, etc.).

1MED mission, especially towards SMEs, is training them to ensure a clear understanding of regulatory requirements and their implications, assisting them, and partnering with them to develop sustainable products against the industry’s constraints, mainly identified as the time to market and funds required for thorough development.

1MED thrives on working with companies that value innovation and want to make an impact and a difference in setting patient’s clinical needs at the centre of their innovation.

In 2020, we were listed among the TOP 10 consulting service companies in Europe by PharmaTech Outlook. But the most important recognition for us is the trust we have been capable of building with our clients and with the hospitals and private institutions we collaborate to develop innovative products.

Tell us more about the offerings which make 1MED stand out from the competition?

1MED was born to create a Contract Research Organization able to talk on a technical level with medical device manufacturers and to fully understand the technologies that lie behind the product itself.

Working with international and start-up companies on new product developments and interacting with EU Competent Authorities and Notified Bodies allowed us to understand that, often, hurtles during the approval processes for innovative medical devices are mainly due to the lack of understanding of the technology and of the benefit that such technology, in the end, may have for patients.

Our approach allowed us to support the certification of more than 300 different medical devices with a success rate of 100% in the last seven years.

What is your opinion on the impact of the current pandemic on the global CRO vertical, and what challenges did 1MED face during the initial phase of the pandemic?

COVID-19 pandemic changed multiple aspects of our life; one of these was limited access to healthcare institutions for non-COVID-19 patients. This caused a drop in emergency department visits, hospitalizations, and delay in surgeries for a considerable number of patients.

As a consequence, there was a halt in patient enrolment in most of the clinical trials that were non-COVID-19 related. Also, ordinary activities with clinical sites (e.g., qualification visits or monitoring visits) were significantly reduced.

With continuous development in technologies such as AI and big data, what is your prediction about the future of the CRO vertical?

Recent European Regulations require medical device manufacturers to generate clinical data not only in the pre-market phase for obtaining market clearance (i.e., CE-mark) but also in the post-market phase to confirm their product’s risk/benefit profile for certification maintenance.

In this regard, real-world data is a key and digital solution based on machine learning, big data are helpful for analysing a huge quantity of data. 1MED is investing in digitalization and artificial intelligence by developing IT tools to capture clinical data and simplify its management.

As an established leader, what would be your advice to the budding entrepreneurs and enthusiasts aspiring to venture into the contract research niche?

Both as market trends and regulation-wise, patient’s benefit is becoming the core of the innovation: research and development of new medical devices should only have a positive impact on patient’s benefit concerning the standard of care, setting profits, not as the main push for innovation.

All stakeholders of the MedTech industry have to become more aware of the ongoing paradigm shift that puts the patient at the centre. The most important message that I would like to convey is that the research and development of new medical technologies in the future should be socially and economically sustainable.

Only effective products will be allowed to enter the market, adding value to the supply chain. If products are effective, this also reflects on the national healthcare system, which will be able to guarantee better, faster, and more cost-effective cures with a lower overall impact on the costs of the given treatments, also reducing overall hospitalization rates.

How do you envision scaling 1MED’s operations and offerings in 2021?

To be competitive and to fulfil patient’s needs, in this dynamic industry, we always need to be up to date and very well trained about ongoing main issues and topics that come up daily. 1MED is reinforcing its MDR and IVDR team to satisfy the increased demand for clinical studies and regulatory services.

At the same time, the development of proprietary IT tools for clinical study management and real-world data analysis is key for supporting our growth as well as the acquisition of strategic target companies to accelerate our market penetration in Europe.

About the leader

Founder and CEO of 1MED, Enrico Perfler, has over 15 years of consolidated expertise in the MedTech industry. His recognized competence in regulatory affairs is proven by his active participation in regulatory working groups at national and international levels.

Enrico Perfler is a serial entrepreneur who has founded, managed, and invested in several MedTech start-up companies. He is also an author of internationally granted patents for cardiovascular medical devices and in-vitro tissue engineered models.




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