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When developing a camera-based medical device, there are a number of considerations that must be accounted for prior to moving too deep into the medical device development process.
After the base requirements are considered, when dealing with an imaging device, you must align the camera sensor that will capture the image to the device that will generate the image.
At a foundational level, a company’s ability to connect wires to a camera sensor is the starting point. Once those wires are connected to the sensor, a question you will want to ask yourself is “what capabilities does the company have to generate an image and subsequently recognize if the image is good or not”.
THE IMAGING SYSTEM
As with every medical device that generates information, there must be a piece of equipment that provides feedback. For example, when delivering fluids to a patient via a catheter, pumps provide feedback and data. Electrocardiography (ECG) is a test that has historically been used in hospitals to evaluate the heart via plastic patches and a corresponding information relay system. However, with advancements in technology, ECG information is now being made available to consumers through wearables or wrist worn devices.
We developed the PREVOYANCE® camera assembly to support engineers who are incorporating camera sensors into the next generation of imaging devices as well as medical devices that have historically not had camera modules or been camera based. While working with these engineers, I discovered the need to support every imaging device with the corresponding system to project the image.
Within the medical imaging space, there are several names for the piece of equipment where the imaging is generated “to” or “through”. You may have heard the equipment referred to as a Camera Control Unit or CCU, Video Processing Unit or VPU, an Image Signal Processor or ISP, and maybe other derivates and abbreviations that mean the same thing.
SINGLE-USE CAMERA-BASED DEVICE, USELESS WITHOUT A SYSTEM
When developing a camera-based medical device, there are a number of considerations that must be accounted for prior to moving too deep into the medical device development process.
To start, there are many of the standard considerations that go into all medical device product developments, including the human use scenarios, use case scenarios, and the associated exterior raw materials that will be designed into the device to meet the medical application’s requirements.
After the base requirements are considered, when dealing with an imaging device, you must align the camera sensor that will capture the image to the device that will generate the image. We have previously written about Optics, Lighting, Cable Assemblies, and Working Channels, so we won’t dig any deeper into any of those areas, but suggest you audit those pieces of content if interested in learning more.
For the purpose of this blog, we’ll continue to expound upon the creation of a complete imaging system.
GENERATING AN IMAGE
When considering your joint development and manufacturing partner, one of the factors that is key to consider, is the partner’s ability to generate and support the actual image.
At a foundational level, a company’s ability to connect wires to a camera sensor is the starting point. Once those wires are connected to the sensor, a question you will want to ask yourself is “what capabilities does the company have to generate an image and subsequently recognize if the image is good or not”.
Some development partners rely on external engineering firms to support the design and development of the image for the single use camera-based devices they are helping develop.
When interviewing and analyzing a possible development and manufacturing partner for your camera-based device, consider evaluating their ability to demonstrate their understanding of the following aspects of generating an image; color adjustment, LED brightness, light targeting (wide vs narrow aggregate picture), edge brightness, sharpness, and automatic gain control. Next, it is important to understand if they are supporting these aspects of image quality with internal resources or external support.
SYSTEM LEVEL REGULATORY SUPPORT
Once you have identified a joint development partner who has the ability to support your single use camera-based device technically from the engineering perspective through all the stages of medical device development, and you have evaluated and validated the company’s ability to support generating the image, the next step is to discuss regulatory support.
Submission of a product for regulatory approval occurs when a camera-based device is connected to a device that generates an image. This imaging system is what the regulatory submission will be based on.
When considering a medical device development partner from the regulatory perspective, confirm the company’s quality management system and ISO 13485 certification.
Discuss what controls are in place, such as methods for maintaining general controls, including good manufacturing practices, labeling, and applicable registration and listing.
Recognize that, as the customer, you will need to determine the classification of the “Imaging System” in conjunction with the FDA, EMA, or any other international registries device class and regulatory controls (for example Class I, II, or III).
If your manufacturing partner is providing and supporting the CCU/ISP and the camera-based device, it is the responsibility of you as the customer to complete the validation, certification, and approval from the FDA, EMA, or any other international registries prior to use in human procedures.
CONCLUSION
Choosing a joint development partner who has the mechanical design and development skillset, can support the highly technical image processing, and support your regulatory needs is critical to minimize time required to bring a product to market.
Consider other devices you are currently producing, when you are reliant on two or more companies that participate in the system level aspects of the device, how challenging it can be to get all the partners participating and engaging at the same time.
A vertically integrated single source to support the complete system increases the opportunity for short-term and long-term success.