Microscope Solutions for Medical Device Manufacturing

The medical device manufacturing industry continues to grow rapidly due to increased global demand. Reasons for this growth include an aging population, a rise in lifestyle-related diseases, the implementation of medical insurance systems in developing countries, and globalization. Medical devices must be easy to use, reliable, and durable to protect the lives of patients and ensure their safety.

Medical device manufacturers build and maintain effective quality management systems that comply with strict international laws and regulations. At some medical equipment manufacturing sites, employees perform complicated manual work using a microscope for each item in high-mix, low-volume production. Maintaining the health and safety of these employees during long working hours is a major concern. Other top challenges include reducing human error in operations and improving the efficiency of technical training for workers.

Our solutions contribute to the development of medical device manufacturing sites with improved work efficiency, training, and quality, as well as safer and more comfortable operation of optical microscopes.

Solutions for Quality Management and Regulation

Medical devices can impact human health and safety, so safe and effective products and services are mandatory and strictly regulated. Medical device manufacturers build reliable quality management systems to consistently meet customer and regulatory requirements.

Solutions used in the implementation of a manufacturers’ quality management system should be based on the international standard ISO13485:2016, which is specialized for medical devices, and should comply with the regulatory requirements of each country, including Title 21 CFR Part820 QSR in the United States.

Our Solutions

We provide the following product and service solutions for maintenance during and after installation, enabling compliance with ISO13485:2016 as well as your country’s specific laws and regulations.

After installation, our service technicians can perform OQ, provide OQ documents, and return to calibrate the system at regular intervals.

Ergonomic Solutions for Efficiency and Occupational Health and Safety

In the assembly process of precision parts in medical equipment manufacturing, the operator may use a microscope for long durations, making ergonomics critical for user comfort. If forced to continue to work for long periods with non-ergonomic equipment, operators may experience health problems and injuries.

Our SZX™ series (SZX7, SZX10, SZX16) stereo microscopes are ergonomically designed to help users work comfortably and stay safer and healthier. To enable each operator to work in a comfortable position, the microscope’s parts and functions can be personalized and adjusted, for example, to the height of each new user.

Solutions for a Faster, More Efficient Assembly Process

Due to unique and complex product characteristics, medical devices are often assembled and inspected manually using microscopes. The products produced include a wide variety of devices in small quantities, so operators often need to switch work procedures each time a new item is placed under the microscope. The frequent switching of procedures can lead to errors during assembly, as operators must repeatedly look away from the eyepieces to check the instructions.

Our SZX-AR1 augmented reality microscope system overcomes these challenges by projecting work procedures as digital information into the eyepieces of your stereo microscope. The digital projection of text, digital images, and videos helps improve the speed and quality of medical device assembly and inspection. The system can also be used with third-party collaboration software to streamline training and problem-solving with remote guidance.

Measurement and Inspection Case Studies for Medical Device Manufacturing

Medical Injection Needles

Case Study 1: Medical Injection Needles

Medical syringes are used for injecting fluids into the human body and for collecting and transfusing blood and bodily fluids.

Purpose and Challenges

• The length, outer diameter, needle tip angle, etc. are stipulated in the standard, and highly reliable measurement is required.
• Since the needle is pierced directly into the human body, the surface condition of the needle and the minimum load when pulling out are specified for each outer diameter so that the needle does not come off during injection. Since the area to measure is very small, it may be extremely difficult if not impossible to take the measurement using a conventional contact roughness meter.

Catheters and Stents

Case Study 2: Catheters and Stents

A catheter is a soft tube used for medical purposes. It is inserted into a part of the body, such as the digestive tract, ureter, or blood vessels, and is used for draining bodily fluids and injecting drug solutions.

Purpose and Challenges

• Standards require measurement of the length, outer diameter, and inner diameter of catheters and guide wires, as well as the wall thickness uniformity.
• The surface roughness of the inner wall of the tube is also controlled to avoid accumulation of deposits and to ensure the tube‘s transparency.

Implants

Case Study 3: Implants

Implants are medical devices manufactured to replace lost biological structures, support damaged biological structures, or enhance existing biological structures.

Purpose and Challenges

• Dental implants have an appropriate roughness by some processing on the surface, which facilitates adhesion to the living body and is more firmly fixed.
• Requirements for breast implant safety, intended performance, materials, evaluation, etc. are specified in ISO 14607: 2018.
• In artificial joints, surface roughness measurement is used to evaluate the surface texture of the worn part of the sliding surface.

Micro Flow Path

Case Study 4: Micro Flow Path

A microchannel chip is a device that utilizes the characteristics of hydrodynamics with microscale channels. It is used for DNA inspection, etc.

Purpose and Challenges

Since the width and height of a microchannel can be submicron, it is necessary to control the shape of the channel and the roughness inside the channel using powerful microscopes

Artificial Bone Replacement

Case Study 5: Evaluating Pore Size of Artificial Bone Replacement Material

Artificial bone replacement materials are surgically implanted into the body to fill in defects or gaps and stabilize the tissue to compensate for bone loss. The material used is a porous ceramic such as calcium phosphate.

Purpose and Challenges

• Controlling the pore size and its ratio is important because the dispersion of pore size and strength greatly influence the performance of the bone replacement material.
• In the past, observation of pores was performed using scanning electron microscopy (SEM) on small pieces of resin-embedded filler material. However, the sample preparation involved (e.g., sample fragmentation, resin embedding, and sputtering) added two to three days to the inspection time.

Our Solutions

The LEXT™ OLS5100 3D laser scanning microscope provides a faster method to evaluate pore size and expands the range of observation and measurement.

• Place the sample on the stage to immediately begin a nondestructive observation. No sample preparation is required, significantly shortening the inspection time.
• Can acquire height data in a plane for a wide range of measurements and observations, such as pore diameter and area ratio by particle analysis, pore depth measurement by profiles, and 3D display.

Application Notes:
Evaluating Pore Size of Artificial Bone Replacement Material Using a 3D Laser Scanning Microscope