Medical devices have played a critical role in revolutionizing healthcare and improving the quality of life for millions worldwide. And since this is a wide industry, they have different markets—hospitals, nursing facilities, private homes, and individual users on the go. They have become streamlined and smart, transmitting valuable information to a health provider in real-time.
Despite this sector evolving rapidly with innovation at its core, there is still a massive room for development. Just how big is it? In 2023, the income from medical devices is projected at $470B and $585 in 2027, with cardiology devices representing 17% of total sales. Many unmet needs must be monitored safely, cheaply, and reliably at a reasonable price.
This blog outlines crucial steps and factors in creating medical devices, ensuring they are safe, efficient, and ready for the market.
Stages Of Medical Device Design And Development
Medical devices, like other inventions, undergo many stages before they are ripe for the market. Developers can choose the long route or reduce the time to market with the help of experts. One way to minimize the concept-market time is to partner with medical device design consultants early. According to RBC Medical, mistakes during the conceptualization stage are costly.
Typically, the design and development of medical devices involve the following stages:
- Concept And Market Research
The process begins with identifying a clinical problem or an unmet need in the healthcare sector. For instance, for patients with metabolic disease syndrome who don’t have diabetes yet, what can be measured daily or weekly to alert the health provider that the condition is progressing?
During the ideation phase, inventors, engineers, and clinicians brainstorm ideas and potential solutions to address the problem. They examine existing devices or technologies, assess market needs, and consider the end user’s requirements, such as ease of use, reliability, access, and affordability.
Meanwhile, market research includes evaluating existing solutions and analyzing potential competitors. The goal is to clearly understand the market landscape and identify areas where innovative medical devices can make a difference.
In this stage, it is crucial to gather input from potential users, such as physicians, nurses, patients, and other stakeholders like regulators and payers. This feedback will help refine the concept so it aligns with the needs of the intended users.
Once a concept is generated, the next step is to evaluate its feasibility. This involves analyzing the project’s technical, regulatory, and financial aspects. A comprehensive feasibility analysis helps determine the concept’s viability and ensures the device can be designed, manufactured, and marketed effectively. It also helps identify potential risks, challenges, and mitigation strategies early in development.
- Design
The design phase involves creating a detailed specification for the device, including its functional, mechanical, and electrical requirements. The team should also consider usability, ergonomics, and aesthetics, as these can significantly impact the device’s acceptance and adoption by healthcare professionals and patients.
The development process usually involves several trials, with prototypes being built and tested to ensure the device meets its intended purpose. During this stage, it is essential to include end-users, as their feedback can help identify potential issues or areas for improvement. For instance, if the device is wearable, is it shockproof, heatproof, or waterproof?
- Regulatory Strategy and Compliance
Before beginning the design and development process, it is crucial to understand the applicable regulatory requirements and develop a strategy to achieve compliance. Why? Because failure to meet standards means that the product will never be marketed.
When creating a new product, keeping track of all the steps taken while designing, testing, and manufacturing is essential. This record, the Design History File (DHF), helps show that the developer followed all the rules. This record is needed during compliance and audit checks. Part of this process also involves figuring out how risky the product might be. This will dictate the level of scrutiny and the type of clinical data required for regulatory approval.
Different countries and regions have regulatory requirements and standards, such as the Food and Drug Administration (FDA) in the United States.
- Verification and Validation
Verification and validation (V&V) are essential steps in the medical device development process, ensuring that the device meets its design specifications and intended use. Verification involves confirming that the device meets its design requirements, while validation ensures that it fulfills its intended purpose in a real-world setting.
V&V activities typically involve a combination of bench testing, animal testing, and clinical trials. The complexity and duration of these tests depend on the device’s risk classification and the applicable regulatory requirements.
- Manufacturing And Quality Management
Once the device has been designed, tested, and validated, the next step is establishing a manufacturing process that can reliably produce high-quality products. This involves developing and documenting manufacturing procedures, selecting appropriate materials and suppliers, and implementing a robust quality management system (QMS).
The QMS should include procedures for ongoing quality control and monitoring and a system for addressing any non-conformances or defects. Regular audits and inspections are crucial for maintaining compliance with regulatory requirements and ensuring that the manufacturing process remains consistent and reliable.
The International Organization for Standardization (ISO), an organization without affiliations, has created ISO 13485:2016 specifically for the quality management systems of medical devices.
- Market Launch
After obtaining regulatory approval, the medical device can be launched in the market. This then involves developing a marketing strategy, establishing distribution channels, and training healthcare professionals on the correct use of the device.
- Post-Market Surveillance
Post-market surveillance happens after a medical device is approved and available for use. This ongoing monitoring helps ensure the device remains safe and effective for patients. It involves collecting and analyzing data about the device’s performance, potential side effects, and any issues arising during its use. This information helps identify problems, improve the device, and prevent safety issues.
Takeaways
While the market is huge for medical devices, going from a concept to a marketable product is complex, time-consuming, and expensive. Developers can do these processes by themselves, but those who want to get ahead in a competitive market can hire companies that are experienced and have a track record of launching medical devices successfully.