According to the FDA, a medical device is defined as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory… intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals.”
Because medical devices can be life-changing, it’s important to get medical devices from inception to production as quickly as possible. When you decide you’re ready to bring your medical device to market, it’s best to start with a medical device consultant. Here’s why.
1. Knowledge of the process.
If you have a great idea for a medical device but don’t have the knowledge to move it forward, you may end up with just that — an idea.
A design team will work with you as a partner to help you progress from the idea stage all the way to testing and manufacturing. You won’t have to worry and wonder because you’ll have an expert leading the way.
2. Experience with diverse startups.
If it’s your first time planning for the development of a medical device, you may have no idea where to start. Fortunately, a consultant will.
Not only will they have the knowledge to move you from one step to the next until, eventually, your medical device launches, but they can use their previous experience, FDA knowledge, and industry relationships to ensure your product’s success.
3. Understanding the terminology.
Unless you’ve already brought a medical device to market, you may find yourself overwhelmed by the terminology used during the medical device development process. You can always study up on the terminology, but unless you know how to directly apply the terminology throughout the process, it’s not very much help.
A medical device expert is well-versed in medical device terminology, so they can expertly guide you through the process, explaining everything as you go.
4. Identifing ways to reduce risk.
A great idea can’t be translated into a great product if there are endless risks associated with it. Many medical devices have caused injury and even death to those who have used them. If you’re uncertain about the risks associated with your medical device, then you may be hesitant to launch it, and your idea may never get turned into reality.
A consultant can help prevent this from happening. They’ll reduce risk by identifying and managing your product’s potential risks and hazards to users and patients so you can safely get your medical device to market.
5. Getting your product to market.
Turning your idea for a medical device into a marketable product isn’t easy. Even if you have an incredible idea, that idea won’t go anywhere if you don’t have access to an experienced professional who can help you turn that idea into a tangible product. It’s about more than just developing a prototype and hoping you can sell it.
For a successful product launch, you have to understand the engineering, business, legal, and regulatory requirements behind it. If you don’t, then it’s best to partner with a consultant who can lead the way.
A Free Resource: Get Your Medical Device Roadmap
It's a complicated market. For some opening guidance you can get a medical device roadmap by scheduling a free consultation with C3 Medical Device Consulting.
About C3 Medical Device Consulting
Finding the right partner to bring your medical device to life is hard. At C3 Medical Device Consulting, we provide the plan and people you need so you can feel confident in your product’s success. To connect with us, follow us on LinkedIn!