Insight Into How Medical Device Companies Work
Medical device manufacturing is growing faster and steadily, bearing signs of a promising future. To understand medical device manufacturing, it is essential to know what a medical device is.
What are Medical Devices?
In general, a medical device is any device or instrument intended for medical purposes by healthcare providers to diagnose and treat potential health hazards. Specifically, the term refers to a product licensed and approved by the FDA for diagnosis, treatment, or prevention of health problems.
These devices can be any instrument, apparatus, appliance, machine, or other similar material that ranges in size from small handheld implements to large-size machines and come in all shapes and sizes solely used for medical purposes.
What is Medical Device Manufacturing? Why Does It Matter?
Medical device manufacturing involves the process of designing, prototyping, checking for errors, and then ultimately, manufacturing the finished product. These medical devices or products can be as simple as bandages or syringes or as complex as life-saving machines or MRI Scanners.
Throughout the manufacturing process, the manufacturing company strives to meet strict quality standards before the devices can be used in the healthcare industry. After finalizing the design, engineers create prototypes and test them multiple times to ensure they meet all safety and performance requirements. Production begins soon after the prototype is approved.
In parallel to the recent advancements to lifesaving ultra-advanced technology, medical device production demand is increasing rapidly. Though fast and cost-saving manufacturing is vital to meet the increasing demand, the standard quality of devices cannot be overlooked.
As the demand for medical device manufacturing increases with each passing day, manufacturers in California have shown remarkable advancement in producing these devices. Keeping patient safety and effective medical devices as the top priority, the government is currently importing an estimated 80% of the medical devices.
Medical Device Manufacturers in California
Medical Device Manufacturer California is rapidly growing in the Golden State of California, which has the largest population and the most significant GDP of any state in the US due to its almost 40 million inhabitants and three-trillion dollar economy.
Approximately 300,000 Medtech jobs are located in California, and the number of patents and venture capital investments here is far higher than in other states. California is ranked top in the medical device industry and has shown remarkable growth since 2015.
Even though the state has higher operating costs than other states, California leads the country in medical device manufacturing.
Just under $1.25 billion in venture capital investments were received by medical device companies during the same year, which contributed to the industry’s expansion.
The latest technologies of 3D printing, artificial intelligence, robotic surgery, and digital healthcare tools have brought advancements in medical device companies beyond expectations. Since medical device companies have a promising future in California, a lot of future progress in the medical device industry is expected to occur in Orange City, San Juan, Capistrano, and surrounding areas throughout California.
An estimated three-quarters of Orange County’s exports were medical devices and diagnostic equipment in 2015. Many other cities such as San Diego, Santa Barbara, San Carlos, San Mateo, San Pablo, San Clemente, and San Rafael in California are paying high contributions to the medical device industry.
Santa Rosa is the central place for two Medtronic business units: Aortic and Peripheral Disease Management and Coronary and Structural Heart Disease Management.
Many other renowned medical device companies such as Align Technology, Arthrex, Biomatrica, BioPioneer, Bruin Biometrics, Lic, The Cooper Companies, and Easy Breathe Ins are located in San Jose, San Diego CA, Los Angeles, San Roman, Aliso Viejo, Santa Monica, Redondo Beach, San Leandro, San Francisco, and Santa Clara as well as other regions in California. They align technology with the industry’s needs.
General Manufacturing Process in Medical Devices Industry, San Diego
Medical device manufacturing is a process-driven industry that has a crucial contribution to the healthcare field. Manufacturers must strictly adhere to standard processes and procedures to manufacture high-quality, safe, and effective medical products.
Stage 1: Identify your target user’s needs
Manufacturing medical devices is a challenging and highly complex process. To successfully create an effective medical device, it is essential to know the user’s needs.
Generally, to achieve the best outcomes, medical device manufacturers initiate the process after determining the impact of the medical products’ use.
They also choose the most significant features of the medical products, the clinical aspects of the development, and, most importantly, the intensity of the product’s benefits after the first use.
For instance, for a device for glucose monitoring, continuous glucose monitoring systems are developed first. After mitigating all the potential risks, the manufacturers head toward laying the groundwork for the medical device design, development, and manufacturing process.
This stage includes setting project timelines, calculating potential revenue, assessing risk, ensuring a clear regulatory path, and creating a budget. For international products, budgeting may be necessary to cover labor costs, materials, consulting, clinical trials, biocompatibility testing, and licensing and fees.
Stage 2: Complying with the International and Regional Regulatory Standards
In the second stage of manufacturing, the reliability, usability, and quality of the biomedical tools, materials, and equipment are assessed by the company using regional and international compliance standards.
To comply with the IEC standard 60601-1 and FDA, the company must adhere to their general requirements. Once the product has been approved by the IEC and International Standards Organization (ISO), it must also comply with FDA guidelines derived from regional and international standards, to which the engineers must also adhere.
Design parameters are also set out by the FDA that are essential to follow so engineers can prove their product is reliable, effective, and able to meet the needs of its target users and market in California.
Stage 3: Prototyping/Product Design Development
In this stage, product samples of the exact design for testing and evaluation are produced before transferring them to the mass volume production stage.
The product design development stage determines the design input and output. The information by the company used to design a device is its physical and performance characteristics.
An excellent design input consists of clear, objective statements that can be independently verified or disproved. Design output is anything associated with a device, such as a drawing, a specification, or manufacturing instructions.
When the device is proven effective in the laboratory and complies with all basic standards and requirements, the device designers begin rapid prototyping and build several forms of the device.
Suppose the device shows the same repeating and expected results. In that case, a functional prototype will be made where the scientific breakthrough will be replicated in a less controlled setting than in a laboratory.
Product engineers consider all aspects of the device as it moves out of the laboratory. Additive manufacturing is preferably followed this way; medical device prototypes are developed quickly and effectively without using tools.
A well-trained and experienced manufacturing engineer can help product designers determine what materials and methodologies are worth following.
Stage 4: Verification & Validation/ Testing
The final stage in medical device manufacturing is testing through verification and validation. An internal verification process ensures that design outputs meet design inputs and that devices fulfill specified requirements.
Validation involves evaluating whether the device delivers on its promises. To ensure the V&V tests are as comprehensive as possible, the development team needs to hire a medical technology expert to assist.
In the testing stage, budgets can rapidly spiral out of control since no device is perfect the first time. Engineers can put their products on the market more quickly with a successful test strategy.
Medical Devices Manufactured in Industry Sectors
One of the fastest growing sectors in the medical devices industry is Orthopedics. It involves reconstructive manufacturing devices, orthobiologicals, spinal implants, hip implants, knee replacement by machining, polishing, grinding, casting, metal injection molding, and several other manufacturing processes.
Endoscopic devices, ultrasound, and magnetic resonance instruments are designed using imaging and IT micro-manufacturing.
Manufacturing Cardiovascular Devices is another highly competitive sector in the medical industry. This involves manufacturing pacemakers, defibrillators, and drugs using the key technologies of power source, assembly, and micro molding.
In this sector dilators, sutures, and surgical robotics are manufactured using the critical technology of micromachining, surface treatments, and materials.
Using technologies like nanotechnology, sensors, and assembly, a device for monitoring blood glucose levels, “Continuous Glucose Monitoring,” is manufactured.
Implants, imaging equipment, drills, and instruments are manufactured using additive manufacturing, machining, and 3D imaging.
Legal Limitations in Medical Device Manufacturing
Medical devices are subject to various laws and regulations in the United States. These laws and regulations are designed to protect patients and ensure the safety and effectiveness of medical devices.
The Food and Drug Administration (FDA) regulates medical devices. The FDA has established rules and standards that all medical devices must meet before being sold in the United States.
In addition to the FDA, state and federal courts also have jurisdiction over medical device litigation. Some of the most common legal issues associated with medical devices include:
● Design defects
● Manufacturing defects
● Failure to warn of risks
● Marketing misrepresentations
If a defective medical device has injured you, you may be entitled to compensation for your injuries. An experienced attorney can help you understand your legal rights and options.
Now that you have in-depth knowledge about how medical device companies in California manufacture these products and offer services, you know what route to take to get devices for your company.