As per the potential and future of medical innovation, the establishment of a medical device involves the process of conceptualization, clinical deployment, testing, and regulation, along with the phases of product evolution encapsulating the risk and failure points by teams and innovators. This article emphasizes the importance of engaging experts for patient safety and successful adoption.

The extensive and intricate process of rendering a medical device usable and functional in a clinical and hospital environment involves an idea, designing, testing, and conforming to the statuary regulations. The probable and potential risk of a hospital device stems from the intricacy of the design and the technical expectations. The journey of innovations leading to the availability of medical devices for patient use hinges on understanding and defining this multi-phase process.

Understanding the Initial Idea and Identifying Needs

In the field of medical product development, the first step is to identify the true clinical need. Innovators need to evaluate if the new device will achieve benefits that are meaningfully different from the available options. This is a phase where partnering with a medical device development company can be very beneficial.

They have the engineering, user-centric design, and regulatory strategy to help shape a well-defined concept. This type of early collaboration can inform functionality, feasibility, and impact on the clinical setting.

A significant number of new medical device projects will be high-risk. For example, the systematic review about medical device development points out that 90 per cent of the time, prototype tests fail at their first attempt. This is indicative of the challenges involved in the development of a new design that is clinical in nature, meets safety criteria, and the other pressing requirements in clinical scenarios.

Research and Development Processes in Healthcare

Once the need is clarified, development and research can begin. Teams can analyze different available technologies, review the clinical workflows, and establish design requirements. They can then create and test prototypes under lab conditions, then adjust their design based on performance and received feedback.

All the while, product developers need to keep in mind the future production of the product, including the choice of materials, quality control, and the ability to scale production.

Medical device software is problematic. A recent McKinsey analysis shows 70 per cent of software recalls from medical devices relate to software and design issues. This shows that developing and validating the software requires the greatest effort. Establishing clear and thorough documentation, peer review, and validation testing processes can mitigate some of the software issues. Collaborative project management and regulatory-compliant software development are also key.

Navigating Regulatory Requirements and Safety Standards

Regulatory approvals are some of the most challenging requirements to meet for most medical device development teams. In the USA, the Food and Drug Administration (FDA) distributes regulatory oversight of medical devices along several pathways, depending on the device’s risk class. Developers are expected to prepare extensive documentation, perform preclinical testing, and sometimes conduct clinical feasibility testing.

FDA regulatory consultants provide evidence for when a clinical evaluation can or can’t begin, and at what evidence tier, the clinical evaluation process can be initiated. The FDA also supports early feasibility, which allows limited human exposure before having all design details finalized. This strategy allows for early design synthesis without extensive nonclinical testing.

Once something is approved, safety is always a concern. Reports of recalled devices by the FDA show that design flaws are the cause of almost 30 per cent of device recalls, including almost 50 per cent of the recalls that are deemed the most serious. This is a clear indication of the importance of having proper design input, risk mitigation, and validation throughout the life cycle of the device.

Prototyping and Testing for Real World Use

In this phase of the device life cycle, physical and/or software design prototypes undergo extensive evaluation and testing. Developers design device versions that are intended for clinical use and that can be utilized by the intended users, and will be tested for usability, reliability, and safety. This testing may involve bench testing, testing in mock clinical environments, and/or human factors evaluation.

Feedback from testing is used for improving the design, and/or for error reduction, enhanced performance, and/or to ensure that errors are not made in the normal use of the device in clinical practice. Design feedback may be needed to increase manufacturing efficiency and improve the quality of the finished device.

Prototypes allow early testing phases to show regulatory and clinical satisfaction. Prior to releasing a device to patients, human factor engineers assess usability to identify and mitigate risks. These studies validate the ability of potential users, in this case, clinicians, to use the device safely and appropriately within the use environment. Medical Device Innovation Consortium found a 40 per cent higher adoption in the clinic of devices that were tested in the real-world environment during development.

How Healthcare Solutions are Developed

From inception as an idea to concept development, then testing, and through the arduous process of regulation, the work that goes into the development of medical products and tools is assiduous and painstaking and a long one as well, considering the need to create safe and effective tools for providing care.

The pathway to innovation goes well beyond the need to stand out as unique or the need to offer up a ‘good idea.’ Getting the right partnerships together, having the ability to create and maintain structured development processes which emphasize safety, creates the opportunity to bring ‘good ideas’ to reality.

The pathway to creating and having new medical technologies delivered, distributed, and delivered to the clinical field is full of numerous technologies that are directed towards improving outcomes that are desired in the field of medicine.