The medical device industry is one of the fastest-growing sectors in the world. The demand for these devices has been growing exponentially, especially in developing countries where healthcare needs are rising.
The total revenues of the global medical device market are expected to be approximately $360 billion by 2022.
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What Is Contract Assembly?
The process of medical device assembly entails the combination of individually manufactured parts of equipment such as wheelchairs, stethoscopes and various surgical tools, in order to manufacture a functioning device of medical use, ready to be sold or used.
The assembly of medical devices necessitates consideration of the various varieties of such devices.
Suppose a manufacturer of medical device components does not possess the necessary tools and machinery for device assembly. In that case, they should explore the possibility of outsourcing the process to a specialized Medical Device Assembly Companies.
The Need for a Contract Assembly Facility for Medical Device
Many medical device companies are looking to hone in on their strongest suit: designing life-saving medical devices.
The companies differ from others because they have unique manufacturing capabilities, including cutting the tubing to length, drilling and punching catheter holes, tipping shafts, printing, and bonding marker bands.
However, when it comes to putting the pieces together and finalizing the product, they need more time to spend the resources and time setting up and managing a cleanroom to assemble and package the item. So the best practice is to outsource this to a medical device assembly facility.
When you choose to use contract assembly for medical devices, you’re only paying for the time it takes to assemble your device. No need to worry about production efficiencies and production costs.
Also, they follow rigorous product quality standards by manufacturing a product up to customers’ expectations with high performance.
Instead of having someone else assemble your device, if you choose to do it yourself, you’re not only stuck with all the downtimes of the assembly line, but more often than not, the line will be running only for a few hours each day or week.
Services They Provide
For modern medical device assembly technologies to meet product and regulatory standards, advanced production automation, process control, information technology and networking can be used to increase flexibility and scalability. When considering the best way to assemble a product, it is essential to take its purpose into account to achieve maximum efficiency.
These companies specialize in providing optimized Pharmaceutical Packaging Design, Drug Delivery systems, and Combination Products Assembly, alongside Pre-filled Syringes Assembly and Packaging.
They also offer Pharmaceutical Product Assembly and Kitting, Pharmaceutical Primary Packing (Tablets and Capsules), Blistering and Bottling, Pad Printing, as well as Supply Chain Management Pilot, Pharmaceutical Secondary Packing, and Pouching services.
Customized Packaging, Pharmaceutical Kitting, and Boxing, Serialisation, and Aggregation of Medical Devices for Combination are also offered.
How do Medical Device Assembly Companies Work?
For medical device assembly, adhering components requires materials to be selected in compliance with local government regulations.
The selection of materials necessary for the successful completion of a device depends on the components that require assembly. This could include adhesives, screws, welding tools, and other equipment.
If no set requirements have been established, it is necessary to identify the appropriate materials for the medical device in question.
As an example, a wheelchair must be composed of multiple components that are joined together by specific materials in order for it to function correctly and accord with standards.
The Complexity of Medical Device
Depending on the device, putting it together can be a breeze or a real challenge. Some pieces of equipment are super straightforward to put together, while others involve intricate tools, products, and machinery to finish the job.
Companies exist that specialize in assembling medical devices to their specified requirement for commercialization and utilization.
Adhering to rules set by the applicable governing body is necessary during the assembly of products meant to be used in medical operations such as surgery, diagnosis, and therapy.
What Should You Expect?
Product Engineers should be engaged in the assembly process, as they are knowledgeable in the examination of materials and familiar with the most suitable methods for their assembly.
Medical device assembly must be accomplished accurately to ensure the product can successfully perform its intended function during critical medical procedures.
Medical device assembly companies should be equipped with a cleanroom environment to protect the product from possible contaminants and ensure its safety and effectiveness.
Maintenance of Cleanrooms
Cleanroom facilities must be equipped with extensive filtration utilizing HEPA fan filters; gowning rooms with airlocks; feature temperature controls; and sticky mats must be placed at the entrance and exit points to ensure compliance with gowning regulations.
Frequent, rigorous cleaning is imperative for the preservation and security of the device during assembly, as well as during the production period. Protocols must be strictly followed to guarantee the process is efficient and secure.
Monthly testing and annual certification should be conducted on all cleanrooms to guarantee regulatory requirements are met.
It is generally not cost-effective for medical device companies to establish a production line dedicated exclusively to producing a single product, especially if that product is new and uncertain.
But establishing flexible production lines capable of assembling even the most intricate and complex items should already be in place for these companies.
They should have the capacity to proficiently manage large-scale production as well as proficiently assemble on a customized level with their modern equipment.
Experienced engineers must devise the most efficient assembly process to expedite the assembling of your medical device and optimize costs without compromising on quality.
Each product should be monitored by a manufacturing engineer who is experienced in using production time studies to create efficient processes to assemble the finished device, starting from the initial concept.
Moreover, they should adopt successful assembly practices from one line or product and apply them to yours without disruption.
What Does a Medical Device Assembler Do?
Medical Assemblers play a vital role in the medical assembly process. As such, it is their responsibility to undertake a range of duties. To provide an insight into these duties, a Medical Assembler may be called upon to:
Pieces Together Life-Changing Devices
The most important role of a Medical Assembler is to assemble medical devices. Depending on the types of medical devices a Medical Assembler works with and the company they are employed by, they could be involved in assembling items such as hearing aids, pacemakers, defibrillators, and stents.
As a medical assembler, it is essential to keep in mind that rarely will the need to assemble an entire device arise. In reality, only a single component or part of the device will likely be assembled.
Ensures Quality, Cleanliness, and Safety
As a medical assembler, there is a great responsibility in creating medical devices that have real consequences for the patient at the other end. The criticality of the manufactured product to improve the quality of life for the patient is not to be taken lightly.
As you can imagine, medical device manufacturers are under significant pressure to deliver products of the highest standard.
Documents Device History With Accuracy
Adherence to Good Documentation Practices (GDP) is essential for medical device assemblers, as their work is subject to close regulation by the FDA.
Accuracy and precision are mandatory in the documentation of each product they assemble.
It is of utmost importance that medical device assemblers practice proper personal hygiene to avoid any potential contamination or flaws so that the medical devices they create can make an incredible difference in a patient’s life.
The FDA has generated quality standards of pre-eminence through their Good Manufacturing Practices (GMP) to ensure cleanliness is an essential priority.
Medical assemblers are required to adhere to GMPs by removing jewellery, restraining hair, wearing gloves, and otherwise taking precautions to minimize the risk of contamination and facilitate a clean and hygienic workspace.
Medical Device Manufacturing Companies work to create a product that is safe and effective for the patient. There are many different components that make up this product, and each company has its own way of working.
These businesses are responsible for the manufacture, assembly services, and packaging of medical devices. They work with a variety of different types of equipment, such as injection molding machines and laser cutters.