Medical device prototype development is different from other types of prototyping because of the additional regulatory hurdles to be considered. While some devices will require a lot of agency approvals, others are less restrictive and easier to bring to the market. While creators won’t have to worry as much about these hurdles at the prototyping stage, it is an essential component in proving the concept and potentially patenting it.
The process of medical device prototyping will depend on the level of risk perceived in the product. For that reason, it’s more challenging to prototype something intended for use inside the patient’s body as opposed to something designed for educational purposes only. In either case, the prototype isn’t just about proving the concept. It’s also about highlighting the safety and efficacy of the product.
Three Steps of Medical Device Prototype Development
Medical device prototype development is a bit more complex than standard product development, so guidelines aid in creating a clear outline that works to build a strategy for eventual FDA approval and mass-market use.
#1: Establish the User Profile
Before prototype development, it’s crucial to establish a clear user profile for the product. The profile helps the developer better understand whether it’s a feasible option for their target market and gauge the cost of product development. It also helps them lay the groundwork for clinical tests later on, as they’re looking for a pool of candidates who can test the device. The user profile should include:
- The age, sex and physical condition of the end-user
- If used for a specific illness, the stage of the illness
- Whether it is a palliative option or one designed to slow or cure a condition
- The current solutions available to the patient
A robust user profile will help device makers fully understand whether their solution is practical for the treatment of the condition. It will also help them in the next step, assessing the risk level of the device.
#2: Assess the risk level
Medical devices come in three categories of risk. Understanding what risk level the product falls into will help the creator prepare the best possible prototype to submit for seeking approval later.
- Class I – This is the lowest risk level. It is designed for items like medical instruments, which may be used on patients but aren’t invasive.
- Class II – Class II devices are typically low risk internal and external devices that patients might depend on, like syringes or wheelchairs.
- Class III – Class III devices present the highest risk to patients and, as a result, are heavily regulated. This category includes items like stents, pacemakers, and other instruments meant for long-term, in-body use.
The risk level matters in prototype development because devices that fall under these categories will often have to be prototyped in the actual materials intended for use with patients. The prototype itself will have to act as a replica for the actual product.
#3: Peer Review the Concept
Having someone in the same field review the concept in the prototype stage can help the creator recognize any barriers or improvements they can implement. Of course, at this stage, it’s wise to have any peer-reviewers sign non-disclosure agreements to prevent the risk of intellectual property theft later.
That peer reviewer can also help the creator understand whether their concept is truly a novel one worthy of patenting, or if it’s too close to something on the market to be worth pursuing. It’s not uncommon for medical professionals to discover very similar solutions to issues. A peer review can help them identify potential conflicts before too much is spent on a redundant product.
The Importance of Partnering with Experts
Medical device prototype development is not something that should be outsourced to a general prototype creator in some overseas market. The creator must have a first-hand relationship with whoever is building the product. It’s equally vital that the medical device prototype creator has extensive experience building similar products. Through that, they’ll be able to offer insight that can help clear regulatory issues later on.
An experienced partner who understands the industry is the best possible resource to have in medical device prototype development. With their insight, creators can better understand the market, risk, and potential conflicts they’ll face through the project. It’s the single best way to control costs and effectively manage the creation of a product as they attempt to navigate the regulations and restrictions along the way.
PRL’s engineers have dozens of manufacturing options available to help you solve any challenge facing your product: CNC machining, custom tooling, 3D printing, thermoplastic molding, reverse engineering, and more. No matter what stage your product is currently at, we can create it and optimize it for manufacturing.