Manufacturing: Breaking It Down

Let’s say you have a medical device idea. You’ve done the exploration, research, market assessment, and you have a business strategy to bring your device to the market. You also have a variety of prototypes, starting with low-fidelity all the way to a functional prototype. You’re ready for manufacturing, but where do you start when manufacturing your device? Well, here are a few suggestions to consider when your project is ready for manufacturing.


First, let’s go over what medical device manufacturing consists of. Your device’s manufacturing process is really dependent on the requirements of your device and its intended medical use. It includes all aspects of the fabrication of a medical device, from designing a manufacturing process, sterilization, and packaging of a device for shipment. The manufacturing design should produce a visual aesthetic and function that aligns with the client’s expectations.


Now that we know what medical device manufacturing involves, here’s a list of four recommendations to consider when manufacturing.


Usability-

There are four important factors to think about when it comes to usability:

  • Effectiveness- It accurately supports users in completing intended tasks.

  • Efficiency - Users can perform tasks quickly and easily.

  • Engagement- Users find it pleasant to use and appropriate for its intended use.

  • Ease of use- Users can easily perform tasks without running into issues.

In order to ensure that your device achieves its full intended purpose and that it is competitive in the current market, device usability is very important.


Placement-

There are multiple ways a medical device can be placed in regards to the patient, including being affixed to the patient’s body. If the device is affixed, placement needs to be taken into account during ideation, design and production. It’s important to consider what specific adhesives will be used, as wear time, application time, specific temperatures, and other external factors will impact the withstanding of adhesive. You should also contemplate how movement of specific limbs or joints will affect where and how a device may be attached.

Regulations and Compliance-

For a medical device to be used for their intended medical application, it needs to be designed in compliance with regulatory and manufacturing standards. These regulations are issued to ensure safety and accountability for users of the device. There are specific policies that must be followed and the device must be certified before distribution.

Testing and Validation-

Again, a device must pass testing specific to its classification. This is to ensure safety and functionality intended for the device’s use on patients and for the user. For approval, you will need to submit a 510k form. Unfortunately, there is no “510k form” that you can simply fill out and send to the FDA. For submission, you must include the following:


  • Device classification

  • Predicate device(s)

  • Proposed labeling

  • Description of the device and specifications, including engineering drawings, photos, etc.

  • Performance data such as clinical testing

  • Sterilization information


The process of manufacturing is intense and it is often best to outsource to expert contract manufacturers. Fortunately, when working with Vita Group you don’t have to worry about finding an outsourced manufacturer. Vita Group has integrated manufacturing as part of our offered services. If you’re ready to take the next step in developing your medical device, book a call with Vita Group's COO, Jason Scherer, to learn more.

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