1MED
Chart a Customised Regulatory Pathway to Success

The implementation of the new medical devices regulation (MDR) and in vitro diagnostic regulation (IVDR) has reshaped global medical device manufacturing and pharmaceutical markets by increasing the technical complexity and costs of introducing new products. With no “grandfathering” process in place where existing medical devices on the market were, until now, considered safe by default, companies will now have to submit clinical data, conduct a comprehensive post-market real-world surveillance and reporting, and utilise packaging that enables device tracking from manufacturer to patient. Consequently, as fast approval time is a critical factor for its success, bottlenecks caused by the new regulations are becoming increasingly problematic for companies as they scramble to evaluate and prioritise existing and future products. At this juncture, recognised as a high-quality and reliable outsourced provider, 1MED is helping medical devices, biotechnology, and pharmaceutical companies address the prevalent challenges they face today.

1MED specialises in supporting the commercialisation of new medical technologies and products by providing customised regulatory strategies, clinical trial management, and quality assurance services across all phases of the medical device development lifecycle. “We provide our clients with the right tools and plan of action to transform a time-consuming and complex approvalprocess into a streamlined and cost-efficient process by guaranteeing quality and conformity to the latest regulatory requirements,” explains Enrico Perfler, CEO of 1MED.

In the current scenario, there are more than 500,000 medical devices currently on the EU market that will have to be re-certified under the latest compliance rules, which require more substantial clinical evidence than previous directives. A recent survey of medical device manufacturers highlighted that most respondents cited increased costs, lack of clarity, shortage of notified bodies, and disruption caused by the COVID-19 pandemic as their most challenging barriers towards compliance. Headquartered in Agno, Switzerland, 1MED primarily serves the European market. Its unique cross-functional approach has been instrumental in the certification and CE-mark maintenance of more than 500 different medical devices, with a 100 per cent product approval rate to date. The company works closely with its clients from the concept and preclinical phases through clinical phases to post-market activities to obtain timely product certification, supporting the growth and development of businesses from a strategic, regulatory, quality, and clinical perspective.

Increase Value in Every Step of Regulatory and Clinical Development

“We are a full-service CRO with a strong focus and technical know-how on medical devices, in vitro diagnostics and pharmaceuticals sector,” states Perfler.

Since its establishment in 2014, 1MED has served as a collaborative partner that tailors its CRO services to suit a client’s business goals, timeframe, and budget. Over the years, the company has built its unique expertise on medical devices and IVD regulations based on the current paradigm shift where the patient benefit is at the centre of development. As per the current regulations, medical device manufacturers are mandated to prove the clinical benefit of their medical devices compared to the current state-of-the-art. To this end, 1MED has created a service pipeline capable of integrating complementary solutions and strategic partnerships in compliance with applicable regulatory requirements. Through the company’s extensive partner network with European notified bodies, research institutes and laboratories, it offers the competencies, reliability and network of big CROs while maintaining the accessibility, responsiveness and costs of a small-medium company. In addition, 1MED’s multidisciplinary team of experts whose in-depth knowledge of regulatory and clinical trials’ requirements across international borders enables fast-market access while ensuring continuous improvement, scalability and customisation to maximise the cost-effective use of resources.

We are a full-service CRO with a strong focus and technical knowhow on medical devices, in vitro diagnostics and the pharmaceuticals sector

Whether providing turn-key clinical development services or supporting a client’s specific need, 1MED helps design and execute all phases of a product’s lifecycle, from preclinical assessment and pre-market clinical trials to CE marking and post-market surveillance activities. The company’s experts help define the suitable pathway to assess a medical device’s safety and performance characteristics and solve rising issues whilst never losing focus on the study’s primary objective to achieve their regulatory goals. “To obtain reliable results, it’s important that every step is a precursor of the previous. As a result of this robust and pragmatic process, we boast a high approval rate from notified bodies,” comments Perfler. Considering profitability, development cycles, and cost concerns, 1MED translates European and International regulations of medical device regulations into concrete customised regulatory strategies to bring products to the market.

For instance, the revised MDR specifies new rules for substance-based devices which are absorbed or locally dispersed by the human body. There is a need to evaluate a medical device composed of such substances or a combination of substances for absorption, distribution, metabolism and excretion (ADME).

In such cases, 1MED helps clients establish the need for specific verification studies to be performed according to the new directives.

Through its partnership with its sister company, 1LAB, the company can design and conduct customised tests to investigate the potential for local and systemic absorption. Using its in-depth experience and understanding of their clinical research and the everdynamic regulatory environment, 1MED helps clients achieve certification whilst saving time and resources.

Build a Future-Proof Mindset

The fundamental shifts in medical device sales and servicing, brought on by the combination of an increasingly digital world and the impact of the pandemic, are here to stay. As companies transition to generating value via data through their devices, stakeholders can expect renewed scrutiny and increasing pressure on real-time data collection and management. “We want to disseminate our technical know-how and develop state-of-the-art digital tools in order to empower the clients in dealing directly with regulatory issues,” elucidates Perfler.

With the support of its digital tools(1FILE and 1Survey), 1MED’s regulatory Intelligence department ensures up-todate compliance with regulatory requirements, constantly adapting its approach and documentation accordingly to help clients maintain continuous regulatory compliance. The 1File and 1Survey tools are both designed to accelerate the process of re-certifying legacy devices. While the 1File streamlines the process of technical documentation, assembling and maintaining reports in compliance with regulatory requirements, the 1Survey aids in the collection of post-market clinical data and surveillance report activities to help stay ahead of the regulatory curve. Furthermore, 1MED helps clients with tailor-made on-site and off-site training programs that focus their specific needs on MDR and IVDR related quality aspects.

The coming years represent an opportunity for medical devices, biotechnology, and pharmaceutical companies to secure a significant market share as they migrate to new regulations. Nonetheless, with each new regulation comes additional complexity that puts more constraints on managing day-to-day tasks. As companies evaluate current and future compliance needs, they must build strong partnerships to add expertise and capabilities to enable them to enter the market faster and more competitively. This is where 1MED has illustrated its proficiency by helping medical device manufacturers predict new requirements and develop practical regulatory strategies. With the regulations set in place, 1MED will no doubt play a pivotal role in easing the transition and helping companies secure a place as leading providers of medical devices.