The medical device sector grows rapidly and, according to Medical Device Regulation (EU) 2017/745 (hereinafter: MDR), covers a very wide group of products – from simple devices to high-technology machines using artificial intelligence. Regardless of the product complexity, MDR emphasises issues related to the quality, safety and performance of each medical device. Therefore, manufacturers face huge challenges: from end user`s expectations to safety, regulatory and quality requirements.
How to make a medical device development successful?
Developing a medical device to meet all requirements and successfully bringing it to market is a complex process that requires dedicated work from a multidisciplinary team. This process can be streamlined into seven key stages, which every manufacturer should consider:
Stage 1: Idea and Risk Analysis
Everything starts with an idea for a new medical device. However, no matter how groundbreaking the product may seem, it is important to adopt an objective perspective and perform a comprehensive evaluation. Therefore, it is crucial to consider the intended use of the medical device, the intended patient population, customer needs and expectations, potential profitability of the products, and different market requirements, as well as identify any similar or equivalent medical devices that are already available. Gathering this information is essential to conduct a risk analysis which will be a continuous process accompanying the medical device throughout its life cycle.
Stage 2: Medical Device Conceptualization and Regulatory Compliance
During the second stage of medical device development, which focuses on conceptualization, gathering of regulatory requirements such as those related to Quality Management System (QMS), as well as investigating intellectual property rights, is essential. In this step, it is also important to assess the financial feasibility and viability of the project. To ensure a thorough assessment, the collaborative involvement of designers and engineers, lawyers and healthcare experts may be required.
Stage 3: Design and Development
The subsequent phase involves the design of medical devices (drawings, specifications, materials selections and more) as well as the prototype development. Moreover, multiple studies are conducted to ensure the medical device meets various requirements and standards. It is typical during this stage to encounter problems with the operation of the product, which may necessitate updates to the risk analysis and a re-evaluation of the regulatory strategy.
Stage 4: Pre-clinical Testing
At this stage, the device undergoes a series of studies, including bench testing and in-vitro and in-vivo studies. The scope of testing varies depending on the nature of body contact and duration of exposure. Therefore, for specific medical devices, different sets of tests are necessary. This could include assessments of cytotoxicity, sensitization, irritation or intracutaneous reactivity, systematic and/ or subchronic toxicity, genotoxicity, implantation or haemocompatibility.
Stage 5: Clinical Trials
In Europe, the requirement for clinical trials depends on the device’s risk level. Generally, high-risk and innovative medical devices are required to conduct clinical studies. The main purpose of these clinical trials is to establish the medical device’s performance and safety. Completing these studies successfully is crucial for receiving regulatory approval.
Stage 6: Regulatory Approval
Once data have been collected, the manufacturer must demonstrate compliance with the MDR. For low-risk medical devices (such as class I devices that are non-sterile and without a measuring function), the manufacturer performs the conformity assessment independently. For devices that fall under higher risk classes, the involvement of a Notified Body in the conformity assessment procedure is obligatory. At this step, technical documentation (which details all information about the medical device, from the device’s description and specification to the verification and validation data of the product) is verified. Receiving successful approval allows the medical device to bear the “CE mark” and indicates that the product is ready to enter the market.
Stage 7: Market Launch and Post-Market Activities. Success?
MDR’s successful approval is not the end of the journey. Large-scale production begins a new stage of the medical device life cycle – continuous verification of its safety and performance. The post-market surveillance (PMS) system covered in the MDR requires proactive and reactive monitoring of the medical device. These continuous activities are crucial to identify any emerging issues, introduce important improvements and influence the shaping of final medical device success.
Be better! Tips for Navigating Your Medical Device to Commercial Success
- Center your strategy on user needs in both planning and design phases
- Conduct thorough market analysis
- Maintain detailed documentation and perform extensive testing
- Perform proper in-depth risk analysis
- Maintain compliance with regulatory requirements
- Prioritize accuracy and avoid the rush
- Ensure a structured, logical and well-documented process of technology transfer
- Adopt a collaborative multidisciplinary approach
- Leverage the assistance of external industry experts and consulting professionals
As evident, medical device development is a complex process which can present numerous challenges. The seven unique stages outlined above may serve as a navigational tool, shedding light on the array of difficulties and opportunities a manufacturer will face. Despite the complexities, it is undoubtedly a worth making the effort to take the first step towards the development and introduction to the market of new medical devices that contribute to our better health.
Our expertise
Interested to learn more about medical devices? You may like to read our articles: Medical Device Regulation – Regulatory aspects and Clinical Evaluation Report – grounds for clinical evaluation of medical devices).
If you need support in introducing a medical device to the market, SciencePharma will be glad to help you. Our experienced team will be happy to provide comprehensive solutions tailored to your specific needs and accelerate your product development process. We have been supporting our clients in introducing medical devices to the market, clinical and non-clinical trials, contact with Notified Body and much more! Do not hesitate to contact us!