Whether you had an “Aha!” moment that you quickly jotted down on a diner napkin, or you have been dreaming up a medical device in your mind for years, there is power in your personal connection to a concept.
That connection is the driving force for the entire journey to commercialization. First, throughout the process, you need a holistic progression that transcends the “nuts and bolts” of your medical device concept. After all, that only accounts for part of your device’s story. Secondly, your idea must be considered in terms of the changes it will bring to the medical device world. Finally, and most importantly, your device must be considered in relation to the practical needs of each end user.
Let’s explore where and how to begin your medical device’s journey, from concept to commercialization, in terms of these three perspectives.
Your Medical Device Concept: Connecting to the Need
It is vital to connect the original need for your concept to each step in the design and development process from the onset. With that need in mind, several standards, guardrails, and processes exist to ensure that this connection is properly made, such as developing Use Profiles, formulating Requirements, and executing a Test Plan (to name just a few).
Compliance and adherence to these processes can seem exhausting at first. However, keeping the project in perspective—knowing that holistic development of your device directly impacts its ability to deliver quality patient care—allows your connection to the need to be the compass that keeps every detail of your project on-course and on-mission.
Medical Device Development: Connecting the Need to the Ideal Solution
Fulfilling a need and developing the best solution are not always the same thing. If you need to get across town, fulfilling that need could mean walking there. However, is that the best solution? Most likely not.
The first option, although it fulfills the need, does not properly consider several factors, such as time, risks, or available technology. The same is true, at a more detailed level of course, for medical device development.
Your device’s concept will require several design iterations and tweaks before arriving at the ideal solution for its end users, and that is an important aspect of the development process. Your project deserves the opportunity to be as effective and safe as possible for its end users, so taking time in the process to connect the need to the ideal solution ensures that every stakeholder is considered.
Medical Device Compliance: Connecting to Your Solution
As you move forward with navigating the process, you will quickly notice that there are several regulatory compliance and safety standards that your device must meet along the way.
The sheer volume of rules, regulations, and documentation can often feel overwhelming and restrictive. However, a shift in perspective allows us to consider them as necessary “guardrails.”
These guardrails serve a vital purpose. They verify that, throughout its design, development, testing, manufacturing, commercialization, and even through to its end-of-life, your device is proven safe and effective, and serves its intended purpose with minimal risk.
Think of it like driving on a long, winding road. It’s true that the guardrails may obstruct a bit of your view. With that perspective, you may become frustrated and fail to see that they also keep you from veering off the path and risking a dangerous—even fatal—accident.
Standards and regulations in the medical device industry act as the guardrails on the path through your device’s lifecycle. Becoming preoccupied with their presence only distracts from appreciating their purpose.
Connecting to Purpose: Change the World
Velentium provides comprehensive services, from ideation and prototyping to testing and manufacturing, all the way to postmarket and end-of-support.
Our goal is to guide you on the path from napkin sketch to finished product, and beyond. We ensure that your device is ready for market, and most importantly, ready to make a real impact on patients’ lives.
We understand that bringing a medical device to market can be an exciting, yet daunting task, which is why Velentium is here to help. We provide holistic solutions throughout your device’s lifecycle, and we want to be a part of your journey to change the world.
This is the Value of Velentium.
Contact us today to learn more about how we can support you in bringing your idea to life.