Medical devices have become important of the Health & Science Industry. The technology has witnessed a rapid form of advancement that has reached all sectors; from schools to medical or health services, technology has reached all corners. The medical or health sector is not limited to specific tests or diagnosis.
The computer technology has made a diagnosis, treatment, and research easier. From medical coding that helps in research as well as a diagnosis to other applications, the medical sector has taken an amazing turn. The medical device manufacturing industry has contributed a lot to the health sector.
Medical devices manufacturing is not limited to a specific field, there are many types of devices and other equipment that are manufactured on a daily basis. Medical device manufacturing comprises of five broad segments. These devices include patient aids like pacemakers and hearing devices; dental products like braces and dentures; MRI and other diagnostic machines; prosthetics like knee implants and artificial joints; disposal & consumables like needles and syringes.
Pandemic- 2020 has increased the demand for many types of equipment, devices, implants, and instruments. The COVID-19 has forced many Medical Research Institutions to take up various research projects and medical studies along with the support of respective governments. The medical industry is in dire need of instruments, equipment, and devices to complete their studies, perform accurate diagnoses, or even to treat their patients.
Some of the widely popular sectors in the medical the device manufacturing industry is:
1) Orthopedics:
Orthopedics is considered to be one of the rapidly growing sectors in medical device manufacturing. The orthopedic devices include- reconstructive devices, spinal implants, arthroscopy, orthobiologicals, hip implants and knee replacement.
2) Surgical Instruments & Technologies:
There is no doubt that the surgical instruments have become one of the most growing sectors of medical device manufacturing. This sector includes the following devices- dilators, sutures and surgical robotics.
3) Diagnostic Apparatus:
Diagnostic apparatus and devices have only witnessed a rapid increase in their demand with each year. Some of the important diagnostic apparatus or devices in this sector are- Endoscopic devices, ultrasound and few other magnetic resonance instruments.
4) Cardiovascular Devices:
This is also an incredible sector in the medical device manufacturing industry. Also, it is considered to be a highly competitive sector that includes- pacemakers, defibrillators, and drug stents.
Apart from these, the other sectors or important technologies in the medical device industry are:
· Dental Instruments & Technologies – Imaging equipment, implants, drills and instruments.
· Diabetes Devices- glucose monitoring (CGM)
· Spinal devices
· Catheters, syringes and hypodermic needles.
· Blood transfusion and IV equipment
· Internal fixation devices, neuromodulation devices, and urology devices.
Other key technology and process in Medical device manufacturing:
· Micromachining, surface treatments and other materials.
· Nanotechnology, sensors/assembly.
· Machining, additive manufacturing and 3D imaging.
· Additive Manufacturing/3D Printing
· Power Sources
(Courtesy-sme.org)
There are several benefits of using computerized system validation. Some of them are:
- It has the ability to provide all required documents readily by the FDA, other regulatory agencies to your customers.
- CSV helps in maximizing the value of the computer system.
- Computerized system validation will help in reducing labor costs by enhancing employee efficiency.
- The computerized system validation also helps in effective project management that is scheduled on time and a specific budget.
- It will save you loads of money and time as it can detect defects at an early stage.
- Apart from this, CSV will help in reducing the risk of legal liability, and not regulatory makes it one of the most important reasons to perform validation.
In simple words, Computer system validation (often called as computerized validation or CSV) is the simple process of documenting that a computer system meets a set of defined system requirements as well as other specific needs.