Medical devices play an essential role in saving lives, treating diseases, and improving the quality of life for millions of people worldwide. The process of designing, developing, and manufacturing medical devices is a complex and intricate one that requires careful planning, attention to detail, and a holistic approach.
The Journey from Concept to Commercialization
One common misconception in medical device design and development is that the process follows a linear path. After all, this type of approach makes sense at a high level. It is easy to understand and follow, like planning a trip, or traveling from point A to point B using a map.
Taking a closer look into the logistics of planning a successful vacation gives us a better metaphor for what safe, successful development entails.
Planning for Practical Issues
When we travel, we often rely on maps to guide us to our destination. However, maps don't consider the possibility of taking a wrong turn or encountering unforeseen obstacles, like construction, a flat tire, or inclement weather.
Similarly, in medical device design and development, a linear approach is limiting and insufficient in addressing unforeseen problems, especially when we cannot control the stimuli. Just as we plan for hazards when we travel, we must plan for present and future possible risks in medical device development.
The Unpredictable Human Element
A holistic approach to medical device development involves concurrent planning and testing. Yet planning and testing must include considering the unpredictability of human factors both in design and development, all the way through to use cases and security.
The goal is to develop a solution that anticipates every reasonably foreseeable issue. Directions exist to be followed, but we've all taken a wrong turn or veered away from the path at one point or another.
Therefore, during medical device design and development, there are three sets of human factors to consider: the design process, the end users, and security factors.
Humans in the Design Process
When designing a medical device, it's crucial to consider your device's intended function. In doing this, it's tempting to want to add all the “bells and whistles.” Although this is positively rooted in wanting the device to be the next world-changing invention, this mindset also leads to overengineering or overdesigning your device.
Keeping the end user in mind–considering functionality and ease of use–calls for focusing on the intended purpose of your device, and often, that means simplifying and streamlining rather than adding.
Safeguarding the End User
Focusing on the intended purpose means focusing on your device's end users. Will physicians or healthcare professionals easily adopt its use? If they are considered throughout development, then the directions, design, and function have a better chance of solving their patients' needs.
Consider, also, the patient! This is where lives will be changed. Just as with physicians and medical professionals, if the design and directions for use are clear and easily followed, the chances of misuse diminish. However, that chance is ever present, so identifying, considering, and mitigating those risks during development allows for a majority of those issues to be solved before the user is ever involved.
Cybersecurity: The Not-So-Positive Human Element
In discussing your device's risk factors and end-use cases, there is an element that is ever-evolving and unfortunately must always be considered: the ones who do not have the patients' best interest in mind.
These days, while most humans are doing their best to further technology and see its progress used to protect people's health, there is a dark side to consider. Cybersecurity issues lie around every corner in medical device development. Software vulnerabilities can lead to cyber attacks days, months, or even years after manufacturing.
Therefore, while your device is in the design and development phase, cybersecurity risks must be identified and mitigated.
Planning for All Unforeseen Issues
In medical device design, we must think through and plan for possible failures and account for problem scenarios through risk identification and management.
Solving for reasonably-foreseeable misuse, cybersecurity incidents, postmarket support, and end-of-support scenarios means aligning the medical device design and development process with factors that are applicable now or in the short term and also with possible issues down the line.
It's important to begin with the end in mind. Know where you're going and have a specific plan to fulfill a need for end-users, understand how your best intentions might still go awry even if they're perfectly realized, and simultaneously consider the technical intricacies of medical device design and development.
Velentium's Approach to Your Medical Device's Journey
Velentium emphasizes holistic solutions from inception to end-of-support, considering present timelines and future concerns concurrently. When considered comprehensively, approaching medical device design and development with a linear mindset is immediately setting it up for disaster.
A more comprehensive approach to medical device development may seem as though it is overthinking the process in the beginning (like contingency planning for your vacation), but that forethought creates less costly, more sustainable solutions for manufacturers and end users alike.
Medical devices are more than just products. They are life-saving tools that must be designed, developed, and manufactured with a future-focused approach. It's important to begin with the end in mind, to know where you're going (or where you could end up), and to have a thorough plan to fulfill a specific need while considering the intricacies of medical device manufacturing.
Contact us if you’re ready to explore what a holistic approach toward commercialization looks like for your medical device concept.
