Medical Device Design

Creating Cutting-Edge Solutions For Health Issues

A medical device is an instrument, preventative device, or piece of diagnostic equipment used to treat medical conditions. A device might require approval by the FDA, or other regulatory body, to prove its safety, effectiveness, and user-friendliness. While there are rules and regulations that need to be followed for your product to be approved, there are still a lot of unique devices you can create.

Designing medical devices is intensive, especially to ensure success throughout the process. Medical device designers must closely monitor various aspects, including health regulations and user experience. Every stage, from initial design to final usage, requires careful tracking and adjustment.

Examples Of Common Medical Devices Designed For Daily Use

Medical device design doesn’t just exist within the bounds of a doctor’s office. Many medical devices are designed to be easily used by the average person, as medical problems don’t just happen at doctor’s offices. Items like band-aids and contact lenses are considered medical devices and extremely helpful to many due to their availability.

Here are some examples of medical devices you’ve likely encountered in your day-to-day life:

Hearing Aids

This device is essentially a noise amplifier small enough to fit in your ear. Designers have carefully incorporated a microphone, speaker, and battery into the space of a single earbud. Modern digitized hearing aids can also be adjusted for different environments, and many offer compatibility with smartphones.

Insulin Pumps

Insulin pumps are designed to help monitor and stabilize the insulin levels of people with diabetes. These pumps use intravenous devices to both monitor and stabilize levels of insulin. This helps keep blood sugar levels where they need to be without much input from the person.

Wearable Fitness Monitors

Monitoring fitness progress was challenging until products like the Fitbit and the Apple Watch were created. These pieces of technology are designed to track heart rate, sleep patterns, and many other metrics so that the everyday person has that information at their fingertips. While not technically classified as medical devices by the FDA, the information can help many people track their general wellness without affecting their health.

Pacemakers

Pacemakers are devices that are surgically installed inside a patient’s chest to help keep your heart beating at the same rhythm. These devices send small pulses of electricity to prompt the heart to beat normally. While not used by everyone, pacemakers are carefully designed for constant use.

These devices are incredible examples of how a device can help with the day-to-day health of average people. However, these devices barely scratch the surface, as many medical devices like MRI machines or stethoscopes need trained professionals to be utilized correctly and aren’t common outside a medical office. Each of these devices needed a team to design and create it.

Design Controls In Medical Device Design

One of the most significant parts of medical device development is ensuring the designs comply with FDA rulings. Regulations held by bodies like the FDA, Health Canada, and the European Commission want to ensure devices are safe for public use. If a medical device is successful and valuable, it will be used widely. If there are significant malfunctions or design flaws, or if it doesn’t adhere to regulations, the device must either go through revisions or be scrapped.

The guidelines for design controls outlined by different regulating bodies provide a framework for the design approach. Successfully implementing this system requires a wide variety of professionals from both technical and non-technical backgrounds. These guidelines cover everything from initial design phases to distribution.

Many regulating bodies worldwide follow ISO 13485. However, the FDA uses a different clause when regulating medical devices: FDA 21 CFR 820.30. Before designing a medical device, it is crucial to get familiar with these regulations.

Design Controls In Medical Device Design

FDA Classifications For Medical Devices

Medical devices are classified to denote the general level of safety when using them. These classes are differentiated through numbers. The lower the class, the safer it is for general use. However, higher-class devices tend to be much more risky because of their role in potentially life-saving treatments.

A class I medical device is extremely low-risk. This means that even if the person in charge misuses them, there is an extremely low chance of causing more harm to the patient. These devices are more straightforward in their design and usage. Examples of these devices include bandages, non-electrical wheelchairs, and hearing aids. This class of device is usually relatively easy to get on the market, as it is rare for these items to be integral in life-saving care.

While starting the process, remember the different classes of medical devices. Having an idea of what class it will be in beforehand will make the design process go much more smoothly.

Class II devices have a higher risk associated with their use. These devices are more difficult to use, but their malfunction still has a low risk of causing significant harm to the patient. The vast majority of medical devices are put into this classification. Some examples of class II devices include infusion pumps for intravenous medication, contact lenses, and syringes. Hearing aids can also be considered to be class II.

Class III medical devices are the riskiest for patients' health, but they are often the most important. Items like pacemakers, defibrillators, and implanted prosthetics are all considered class III devices. These devices are risky, though, as the FDA's special controls are not enough to ensure the safety of their users.

Phases Of Medical Device Development

The details of the process will look incredibly different from device to device, but the overarching process usually stays the same. We generally use a three-phase model to design and manufacture medical devices.

While having a vision for a device is integral, medical device development is more than just a vision. Getting a design off a piece of paper and into the world is essential to ensuring its success, as this process can significantly affect the device’s final form.

The Medical Device Design Company You Need

Designing a medical device is an intense process requiring various individuals' help. Without a good team backing your project, the likelihood of it being FDA-approved is extremely low. That’s why Gecco Vision offers professional medical product development services. Our team has the skill, experience, and diverse perspectives to ensure your device is FDA-approved, easy to use, and successful. Call our office today to get your product’s design process started.

Once the idea has been settled, it’s time to begin conceptualizing it through sketches and renderings. This part of the process is the most creative. Tweaks must be made throughout each iteration until a final design is chosen and sent to be prototyped. By the end of phase 1, the product’s design and functionality should be finalized.

The initial phase of medical device development is challenging but also exhilarating. Throughout this phase, creativity is vital.

This phase covers several different steps, starting with generating the idea. Although this may seem simple, ideation requires us to think through the design and use problem-solving to ensure that the product's vision can be brought into reality. Knowing the product’s desired use and the need it fulfills will greatly aid us throughout the design phases.

Phase 1: Concept Development and Ideation

Now that the ‘what’ of the design is finalized, it’s time to start exploring how the product will look throughout manufacturing and widespread use. Near-constant communication with the designers makes it as refined as possible. Validation of components, product engineering, and construction and testing of functional prototypes are all critical parts of this phase.

It’s important to align the design with the intended product manufacturing process throughout this part of the project. The device functioning as designed isn’t the only thing that matters, as manufacturing capabilities, limitations and costs are an important part of the device’s success when on the market. By the end of this phase, the prototype should be ready to send to manufacturing.

Phase 2: Detail Designing and Development

Once the prototype is finalized, manufacturing can start. How this looks can differ from device to device, as some designs may require the team to redesign details to optimize the manufacturing process. Finding the right manufacturer is also key, as some places will try to cut corners at the cost of the original vision of the product.