The medical device industry consists of any kind of implants, instruments and equipment intended for therapeutics, monitoring, diagnostics and healthcare. These also include reconstructive devices such as hip and knee replacements and implantable sensors for cardiac and diabetic care.
The Indian Medical Device market contributes to 4% of the Indian healthcare market with diagnostic imaging being the largest segment. India is one of the top 20 global medical device markets and the 4th largest medical device market in Asia. The evolving medical devices industry in India consists of large multinationals and small and medium enterprises (SMEs). The current market size of the medical devices industry in India is estimated to be nearly $10 bn.
Medical Equipment can be classified into the following categories:
- Orthopedics- includes reconstructive devices, spinal implants, arthroscopy, orthobiologics, hip implants and knee replacement.
- Surgical Instruments & Technologies- this includes dilators, sutures and surgical robotics.
- Diagnostic Apparatus- Endoscopic devices, ultrasound and magnetic resonance instruments.
- Cardiovascular Devices- This highly competitive sector includes pacemakers, defibrillators and drug stents.
- Diabetes Devices- Continuous glucose monitoring (CGM), insulin pumps, insulin pens, glucometers are leading examples of this sector.
- Dental Instruments & Technologies- Imaging equipment, implants, drills etc.
- Other segments- Spinal devices, catheters, syringes and hypodermic needles, blood transfusion and IV equipment, internal fixation devices, neuromodulation devices and urology devices.
Processes involved in manufacturing medical instruments are
- 3D Imaging- Three-dimensional data capture includes the tools and processes involved in understanding 3D digital data from physical objects. This process combines hardware and software. The use is growing in medical manufacturing as the ability to manufacture custom, additive manufactured devices increases.
- Quality Systems- Quality systems like FMEA (Failure Modes and Effects Analysis) are key to medical device manufacturing. The main function of the FMEA is to examine known causes and unknown effects. There are different types of FMEA, for medical devices the so-called Design (looks at construction errors) and Process (looks at the individual steps of manufacture) FMEA are often applied.
- Measurement & Inspection- Maintaining quality requires consistent, reliable and verifiable measurement and inspection. Down to micron and submicron levels, medical device manufacturing can face unique technology and process challenges.
- Additive Manufacturing/3D Printing- Combined with 3D imaging technologies, additive manufacturing allows for customized design with reduced development time. Used for surgical guides , surgical instruments, organs and prosthetics are some common areas in which this technology is used.
- Assembly- Appropriate joining methods must be selected to meet biocompatibility requirements and enable efficient handling of micron-sized components. Medical device manufacturing assembly which must be conducted within clean room environments.
- Lasers– Highly accurate and flexible, a narrow laser beam can cut, machine, mark or weld intricate details with accuracies to one micron.
- Coatings and Surface treatments- Coatings help out in various ways such as increased wear resistance, increased bone in-growth, reduced friction and enhanced abrasion. Biocompatible coatings are used for passive and drug-eluting applications on cardiovascular stents and other implantable medical devices. The ultra-thin coating formulation on implantable devices is designed to protect surrounding tissue from potential harmful interactions with bare metallic stents.
- Machining- Machining is done to cut a material to a desired final shape and size by removing unwanted material from a large chunk of material. From components of medical devices to joint implants, many require machining of medical grade materials.
- Materials- Biocompatible materials that do not react with tissues in the body are to be used for making devices. Alumina, Bioglass, Titanium, Zirconium etc. are some of the commonly used biocompatible materials.
- Micromanufacturing- As products and devices continue to get smaller and smaller, micromanufacturing processes are extremely essential. Micromanufacturing is done to create extremely fine substrate surfaces and produce micron sized products. Micromanufacturing also includes processes like micromachining and micro molding.
- Nanotechnology- The use of nanotechnology in medical devices involves incorporating new materials and coatings to drug delivery and imaging systems.
- Power Sources- With the advancement of implantable devices for monitoring and treatment, the selection and development of power sources has become a critical part of medical manufacturing.
Technologies and Devices in Healthcare continue to evolve according to the needs of the population, to improve the medical infrastructure and provide better quality of life. The demands for devices to manage chronic and lifestyle disorders have increased and the pandemic has also spurred the development of newer monitoring technologies. Thus, the medical devices market has the potential to increase by 37% and reach $50 billion by 2025.