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What is medical manufacturing?

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The medical device industry covers implants, instruments and equipment intended for therapeutics, monitoring and diagnostics. These include reconstructive devices such as hip and knee replacements as well as implantable monitors for cardiac and diabetic care.
Industry Sectors

Orthopedics — This has been one of the fastest growing sectors in medical device manufacturing. It includes reconstructive devices, spinal implants, arthroscopy, orthobiologicals, hip implants and knee replacement. This sector utilizes manufacturing processes such as machining, casting, grinding, polishing, metal injection molding and rapid manufacturing.

 

MedicalMfg1
Hip replacement parts.

 

Surgical Instruments & Technologies — One of the largest segments, this includes dilators, sutures and surgical robotics. Key technologies include micromachining, surface treatments and materials.

Diagnostic Apparatus — Endoscopic devices, ultrasound and magnetic resonance instruments are examples of this sector. Key technologies include imaging, IT and micromanufacturing.

Cardiovascular Devices — This highly competitive sector includes pacemakers, defibrillators and drug stents. Key technologies include power sources, micromolding and assembly.

Diabetes Devices — Continuous glucose monitoring (CGM) is a leading example of this sector. Key technologies include nanotechnology, sensors and assembly.

Dental Instruments & Technologies — Imaging equipment, implants, drills and instruments. Key technologies include machining, additive manufacturing and 3-D imaging.

Other segments — Spinal devices, catheters, syringes and hypodermic needles, blood transfusion and IV equipment, internal fixation devices, neuromodulation devices and urology devices.

Technologies & Processes

3-D Imaging — Three-dimensional data capture refers to both the tools and the process for the collection of 3-D digital data from physical objects. It is a process that combines hardware and software. The use is growing in medical manufacturing as the ability to manufacture custom, additive manufactured devices increases.

Quality Systems — In a highly regulated environment and a critical need for consistent quality, quality systems like FMEA are key to medical device manufacturing. 

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/Rapid Prototyping Combined with 3-D imaging technologies, additive manufacturing allows for custom with reduced design and development time. Used for surgical guides (conjoined twins separation) and prosthetics are two of the most common areas this technology is used.

 

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Acetabular cup (hip joint) produced by EOS.

 

 

 
Assembly — From selecting appropriate joining methods to meet biocompatabilty requirements to handling what can be micron-sized components, medical device manufacturing assembly must be conducted often within clean room environments.  

 

LasersHighly 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 serve numerous functions, 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 a broad range of 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 — From components to other devices to joint implants, many require machining of medical grade materials. This includes the unique challenges of machining to extreme accuracies of titanium.

Materials — In addition to all the usual material requirements for materials, biocompatibility presents a unique challenge for material choice for medical device manufacturing.

Micromanufacturing — For many reasons, devices continue to get smaller and smaller. Features and components of just a few microns require the specialty processes of micromanufacturing including micromachining and micromolding.

 

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Deborah McGee of CardioMEMS examines an EndoSure sensor in the company's clean
room facility in the ATDC Biosciences Center located at Georgia Tech's Environmental
Science and Technology Building. The sensor is implanted to measure pressure in an
aneurism being treated by a stent graft. Photo courtesy Georgia Tech

Nanotechnology — From new materials and coatings to drug delivery systems, the use of nanotechnology in medical devices and medicine is expected to grow.  

 

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.