A Guide to the Medical Device Development Process
Research indicates that 75% of medical device start-up companies fail. As with all product development, failure to understand what is required in terms of development input/output, and planning properly will most likely place you into this 75%.
Navigating the world of medical regulations and certification paths, which every new medical device must pass or at least match to reference products available on the market, is a daunting task. Device development targeted at global markets has become more feasible due to the recent alignment and adoption of EU MDR, FDA and EU regulations, and are now a much closer match than they were previously. This is actually a positive advancement especially for the case with regard to quality system requirements and conformance with harmonized standards.
For those that are interested, the FDA’s classification system is based upon device risk, with Class I (low risk) and Class II (moderate risk) mostly falling under the 510(k) path to realization. The 510(k) process requires manufacturers to demonstrate that their new device is substantially equivalent in safety and effectiveness to a similar, legally marketed device already on the market, known as a predicate device. Class III devices, on the other hand, are classified as high risk and require the Pre-Market Approval (PMA) pathway, which involves providing extensive validation data to prove the risk-benefit profile of the device.
In contrast, the EU MDR has four device categories and five risk-based classifications. A link to the guideline can be found here: MDCG 2021-24.
Developing a medical device is a complex and highly regulated journey. It requires careful planning, efficiency, expertise, and adherence to industry standards. Whether you’re launching a new product or refining an existing device, understanding the medical device development process is essential to ensure compliance, quality, and market success while maintaining an efficient workflow that optimizes resources and timelines.
Steps in the Medical Device Development Process:
1. Concept and Feasibility
Successful medical products begin with a good idea that usually addresses a specific clinical need, a gap in technology, or extends new technologies into the field. At this stage, we explore potential concepts and assess viability from both a technical and clinical perspective. This includes defining what the device needs to do, researching the market, and identifying any potential early roadblocks. An essential part of this feasibility study is classifying the device based on its risk to the patient, as this classification is critical in determining the process rigor requirements. By taking the time to do this thorough evaluation, we make sure that our time and resources are focused on an idea that has the potential to succeed.
2. Design and Development Planning
The next step is to create a roadmap for design and development. This covers everything from timelines and budgets to resources and regulatory requirements. A well-organized plan helps us stay on track and ensures that each design decision aligns with the project goals.
3. Design Input and Specifications
During this phase, we define the device’s functional and user requirements based on user needs, industry standards, and regulatory guidelines. These specifications cover everything from dimensions to safety features and help ensure that the final product does what it is supposed to do. At Pegmatis, we work closely with our clients to make sure the requirements are clear, measurable, and feasible.
4. Design Output and Initial Development of Medical Device
Once we’ve defined what the device needs to do, we move into the product development phase where the vision begins to take shape. This is where we develop the actual device, translating conceptual ideas into a functional design that aligns with the defined requirements. At Pegmatis, our approach starts with a solution hypothesis, which sets the foundation for a structured design strategy. This phase includes detailed planning to ensure that time and budgetary constraints are met, emphasizing project management and careful allocation of resources. The aim here is to build a robust framework that supports the later stages of development.
The development of the product may include hardware design, firmware development, and software development. Our team is highly talented and knowledgeable, equipped to design a wide range of medical devices. Whether the device requires sensors, specialized firmware, or other cutting-edge technologies, we ensure that all components work seamlessly together to solve the targeted problem effectively. This end-to-end approach enables us to create innovative and reliable medical solutions tailored to meet industry standards as well as the needs of patients and medical staff.
5. Prototyping and Risk Mitigation
Prototyping is a pivotal part of our process. Once a product is designed, we create prototypes to validate our solution hypothesis and address potential risks early. This includes assessing usability, performance, and other technical aspects that could impact the final product. Our interactive process often involves multiple overlapping threads, where iterative prototypes help refine the solution. By focusing on resolving risks early, we enhance the likelihood of success and streamline further development stages. Through this method, Pegmatis ensures that potential challenges are managed proactively, aligning with both the technical and business objectives.
6. Verification and Validation
Verification and validation are critical steps to ensuring the device works as intended and meets all requirements. The verification phase allows us to confirm that our design matches the specifications. Validation confirms that the device meets user needs and applicable regulatory standards. This phase includes rigorous testing, from bench tests to usability trials to ensure the device is both safe and effective.
7. Regulatory Submission and Approval
Once the device is fully tested and validated, it’s time to seek regulatory approval. Requirements do vary by region; at Pegmatis, we provide the necessary documentation to meet local standards. Navigating the regulatory landscape can be quite complex, but our team at Pegmatis is experienced in product development for highly regulated industries. We are here to ensure the process goes as smoothly as possible.
8. Manufacturing and Commercialization of Medical Device
Once the device is approved, it is ready for production. We work with manufacturing partners to ensure that each produced unit meets the same high standards as the prototype. This phase also includes finalizing packaging, distribution, and marketing plans. We work with clients to create a seamless transition from design to production so that your team is set up for success.
By moving through each phase of developing a medical device with intention, companies can create safe, effective devices that make a real difference in healthcare. At Pegmatis, we guide our clients every step of the way, combining our expertise with a hands-on approach to deliver a product that meets the highest standards. If you’re looking to outsource the medical device development process, get in touch with our team today to talk about your next project.
