The need for cleanroom manufacturing is increasing — and with it the need for reliable partners.
Medical devices, equipment and technology are becoming more complex every day. Part of the story is the increasing adoption of networked devices and the Internet of Medical Things. According to a recent Verified Market Research report, the global market for connected medical devices is projected to grow from $27.4 billion in 2020 to $136.8 billion by 2028. These devices will require more electronics and software than ever.
Of course, connectivity is only one reason for the increasing complexity of medical devices and equipment. Consider an advanced surgical system used in minimally invasive surgery. The system is composed of three different subsystems: the console for the imaging, the cart system and the hand piece, which includes a single-use-device. Each of these subsystems is complex in its own right, and each requires a variety of niche capabilities to produce.
As these complexities increase, so do the challenges of keeping everything compliant with the strict standards and regulatory requirements that apply to medical devices. One of the basic principles is that devices must be kept free of contamination throughout manufacturing. This means that many devices and components need to be produced within a bioburden-controlled environment. In other words, cleanroom manufacturing capabilities have a critical role to play in the design and manufacturing of today’s medical devices.
Understanding the cleanroom manufacturing process.
Cleanroom manufacturing is specialized work, and medical device manufacturers are more frequently realizing the need to work with partners who are specifically equipped to handle it. Medical device manufacturers remain competitive through the quality, safety and effectiveness of their devices. That means their cleanroom manufacturing process needs to support each of those goals: quality, safety and effectiveness.
Upfront planning is crucial, and needs to consider few things:
Class II and Class III medical device cleanroom requirements are strict.
Every manufacturer must guarantee that they have built their Class II and Class III medical devices in a controlled environment. There are strict hygiene and fitness-to-work requirements to ensure there is control of the materials and people entering the room. Manufacturers need to clear many hurdles to meet FDA medical device cleanroom requirements, and those requirements will differ from product to product.
The cleanroom manufacturing process is custom every time.
Because requirements differ depending on the product, there is no standard cleanroom manufacturing process. A cleanroom operation can be very manually intensive, with 20 people or more in the cleanroom assembling products. Other products need a higher level of automation to support reliability and placement precision of components within the products.
Determining the right cleanroom manufacturing process depends on the product, and often it’s a combination of manual labor and automation, coupled with skilled technicians overseeing the entire process.
The process is complex … and needs to be done right.
To take the above point a bit further, let’s return to the example of a complex system for minimally invasive surgery.
The single-use-device component needs to be manufactured within a cleanroom environment. The process involves three six-axis robots for the electronic assembly — picking, placing and inserting electronic components. Once programmed properly, the process can be fully automated and will handle important steps, including laser welding, soldering, adhesive gluing and UV lithography. The robots will also conduct visual inspections during assembly, using different reference points to ensure the proper rotation, placement and insertion of the parts. Next come a variety of tests, including hipot tests, continuity tests, flow tests and other functional tests that follow several protocols and parameters to ensure the reliability of the product. Finally, there is sterile barrier packaging.
Any way you look at it, cleanroom manufacturing is a process that requires technical knowhow and a specialized skill set. Medical device manufacturers need to understand the cleanroom requirements and intricacies specific to each product and plan the process from the beginning to ensure success.
Overcoming the challenges of cleanroom manufacturing.
We’ve seen that as the complexity of devices increases, so do the demands on the production environment. This presents three main challenges in developing the right cleanroom manufacturing process.
Challenge #1: Controlling and continuously monitoring the cleanroom environment.
Medical devices are becoming more sophisticated, sensitive and complex — often having the potential to become damaged or degraded by conventional sterilization processes. The manner in which device manufacturers control and protect their assembly environment, including how they maintain and develop appropriate cleanroom manufacturing processes, is becoming more challenging.
We’ve mentioned the strict regulatory requirements. This includes, for example, the installation of a filtration system and HEPA filters for cleaning the air and filtering compressed air, gowning procedures (e.g., shoe covers, hairnets and hand-washing procedures) and strict rules on how to enter and operate in a cleanroom environment.
Often, the more people involved in the assembly process, the greater the chance of contamination. There can also be microbiological contamination or bioburden risks, so cleaning solutions have to be changed at regular intervals to make it impossible for the microbial to become resistant to certain cleaning procedures.
Challenge #2: Supply chain, tolerances and testing.
Typically, issues arise within the supply chain as product tolerances continue to tighten. It’s critical to have a very robust inspection process to examine incoming components before they become value-added parts of a finished product. It’s an easy rule: If you’re starting off with bad components, naturally, your end product won’t be able to fulfil all the performance and reliability requirements.
The purpose, of course, is to prevent defects, errors or costly quality issues. For example, during critical processes like ultrasonic welding or laser welding, a breach of sterile packaging could mean a recall of the product. On paper, these processes might seem easy, but neglecting them can lead to very serious consequences.
Challenge #3: Hitting cost targets.
The greatest challenge is to achieve a cost target that ensures broad market acceptance. Automation of assembly processes is a start. In the future, AI and machine learning technologies will probably continue to contribute to quality and reliability and, for example, detect malfunctions and contamination at an early stage.
Getting cleanroom manufacturing right = working with an experienced partner.
With so much to consider, the best route for medical device manufacturers is to work with a trustworthy partner with many years of experience in cleanroom manufacturing. Precision and execution are vital to your product’s success. A partner with longstanding expertise — who has already put the necessary processes and controls in place — can guarantee the quality of your product.
Whether you’re supplementing an in-house team or looking to accelerate time to market, there’s efficiency and quality to be gained by working with a single-source partner. A full value stream partner will not only support the integration of the electronic parts, but is also fully involved in the entire value chain. Ideally, the collaboration begins with design and development, includes supply chain solutions and extends through production to aftermarket services.
Consider again our minimally invasive surgical system with three different subsystems. As different as the components might be, relying on three different partners will only add further complexity. Rather, manufacturers can turn to a single partner with all the capabilities necessary to bring the product through development and manufacturing — from the imaging software to the screen, from the housing to cleanroom manufacturing, to the sterile packaging of single-use components. Relying on a single, trusted partner ensures the highest quality product and the greatest transparency for the customer.
Want to learn more about our cleanroom manufacturing capabilities? Contact our team to start a conversation.