The Requirements and Benefits of Metrology in Medical Device Production

March 22, 2022

The Requirements and Benefits of Metrology in Medical Device Production

March 22, 2022

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The Requirements and Benefits of Metrology in Medical Device Production

Metrology is a crucial part of the medical device production process. It is also a key component in the development of new and innovative medical device products while helping medical device manufacturers refine processes, improve efficiencies, and reduce costs.

As an overview, quality, safety, and compliance are the crucial areas where high-quality metrology solutions benefit medical device manufacturers.

In all manufacturing industries, quality, safety, and compliance are important. However, these factors are critical in the production of medical devices. After all, many medical device products are used in a patient’s body, so quality and safety are paramount considerations.

There are also strict regulations that control the full lifecycle of a medical device product. Manufacturers must adhere to these regulations, and metrology helps them do so. Brand reputation is another consideration, as is avoiding the legal problems that can arise because of a defective batch of medical device products. Metrology mitigates these risks.

Then there are the considerations that apply to all manufacturers, such as minimizing costs, enhancing efficiencies, and improving process accuracy, speed, repeatability. Metrology plays an important role in all these areas.


Medical Device Manufacturing – A Unique Industry

Medical device products, particularly those with higher risk classifications, must be manufactured to a very high degree of accuracy within very tight tolerances.

The main objective of the medical device manufacturing process is to produce products that exactly match their intended purpose. As the products will be used in healthcare settings, there is no room for error. So, validating the production process is crucially important. There are two main reasons for this:

  • Ensures medical device products meet their intended purpose and are safe to use
  • Ensures the previous point is documented so it can be proven when checked by regulators

Metrology equipment, applications, and processes properly measure, validate, and analyze dimensions, hole diameters, concentricity, surface characterization, particulates, and more. This helps manufacturers ensure the medical device products they produce meet their intended purpose.

This helps manufacturers ensure the medical device products they produce meet their intended purpose.

Overcoming Challenges

There are also challenges that apply specifically to the medical device industry that advanced metrology solutions help to overcome.

Materials

Part of the metrology process is to consider the materials used to manufacture the product. Flexible plastic is one of the most common materials in the medical device industry, as plastics are especially effective at delivering the required performance capabilities.

Medical Device Manufacturing

However, flexible plastic presents a range of challenges in ensuring production repeatability. Modern, automated metrology solutions help to overcome these challenges, even for the most advanced medical devices.

Making Use of Data

Modern, 21 CFR Part 11 compliant metrology solutions can automate data collection during medical device production. This can improve traceability, identify changes or deviations from the norm, and optimize processes.

Difficult to Measure Devices and Components

Non-contact measurement is another increasingly required feature of medical device metrology solutions. Non-contact measurement can be beneficial when validating fragile medical devices, for example, or highly intricate devices that have areas that are difficult to reach using traditional measuring methods.

Prototype Production

Metrology doesn’t just play an important role in full-scale manufacturing, either. It is also used in the development of new and innovative medical device products. This particularly applies during the prototype design and production stages.

The Benefits of Metrology in Medical Device Production

The-Importance-of-Metrology-in-Medical-Device-Production
  • Streamlines the inspection and validation processes
  • Improves quality across the entire product lifecycle
  • Enhances product safety
  • Ensures compliance and optimizes the compliance process
  • Ensures a more efficient and traceable manufacturing process
  • Improves productivity
  • Helps with reverse engineering of medical device products and components

Metrology: Facilitating Transformation in the Medical Device Industry

Moreover, metrology can also help medical device manufacturers transform their operations to remain competitive, address current challenges, and take advantage of new and evolving opportunities.

Metrology at All Stages

For example, the traditional approach in medical device production was to use metrology towards the end of the manufacturing process. In other words, metrology was used to validate the complete or near-complete parts of the product.

Medical device manufacturers are now increasingly using metrology during all manufacturing stages, improving the overall manufacturing and quality control process.

Evolving Regulations

It is also important to consider the changing requirements of regulators and how those changes force medical device manufacturers to adapt and transform.

For example, there is now more emphasis than ever on quality management systems and ensuring quality across all stages of the product’s lifecycle. Metrology can help with this enhanced regulatory requirement from concept development in the early design stages to full-scale production to disposal of the product at the end of its life.

Reduced Costs and Improved Processes

Modern metrology solutions can also lower the cost of the necessary inspections that must take place, as well as improve validation processes. Furthermore, high-quality metrology solutions reduce time to market for new, upgraded, or updated medical device products.

Metrology solutions are also becoming more nuanced, making them even more suitable for modern medical device production and allowing manufacturers to move away from the traditional go/no-go approach.

With advanced metrology solutions, medical device manufacturers can identify issues earlier, as well as identify solutions. Metrology is also helping to reduce operator error and provide insights that can lead to process improvements.

The Benefits of Metrology - Reduced Operator Interaction

The Future of Metrology in Medical Device Production, Today

One of the most exciting trends in the MedTech sector is the development of medical devices that are becoming increasingly smaller and more intricate. Many new medical device products are also becoming multi-faceted. Hence, they are able to perform more than one function when in use inside the body. The production of personalized medical devices is also on the increase, where production batch sizes can be as low as one.

These smaller and more advanced medical devices offer significant benefits to patients, as they are less invasive, as well as being capable of carrying out new and innovative procedures.

Metrology is rising to the challenge of these exciting new innovations in the medical device industry with the development of solutions that can effectively and accurately measure smaller and smaller components within ever-reducing tolerances.

Advances in metrology are also facilitating the measurement and validation of increasingly intricate devices and components, as well as optimizing processes to meet the changing demands of patients and healthcare professionals.

Quality, safety, and compliance remain the core of metrology in medical device production. However, metrology is also helping the industry modernize its manufacturing processes, enhance competitiveness, and develop new diagnostic and treatment innovations.


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Have a query? Speak to a Verus expert today

Introduction 

As 2024 unfolds, the field of metrology is witnessing transformative changes. At Verus Metrology, we recognize the importance of keeping pace with technological advancements and new trends in the science of measurement. In this rapidly evolving landscape, innovations in metrology are not just about achieving precision; they are about meeting the evolving challenges of industries like medical devices, where accuracy is critical for ensuring safety and quality. This article explores the emerging trends and technological breakthroughs shaping metrology’s future. 

As 2024 unfolds, the field of metrology is witnessing transformative changes. At Verus Metrology, we recognize the importance of keeping pace with technological advancements and new trends in the science of measurement. In this rapidly evolving landscape, innovations in metrology are not just about achieving precision; they are about meeting the evolving challenges of industries like medical devices, where accuracy is critical for ensuring safety and quality. This article explores the emerging trends and technological breakthroughs shaping metrology’s future. 

Metrology Fixture Types – What’s Available, and Which is Best?

9 February 2023

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Fixture type and use cases

Metrology fixturing technologies continue to develop at a rapid pace, offering manufacturers in the medical device industry new and innovative solutions. Those solutions don’t just meet inspection and quality process requirements, but they also deliver efficiency savings and productivity gains. How do you know what metrology fixture types are available and which is best for your application? In this blog, we’ll outline the main options, their underlying technologies, and the use cases they are best suited for. 

However, it is also important to point out that the fixture types described in this blog represent broad categories. Within those categories, there is an infinite number of ways that a fixturing solution can be developed to meet your specific needs, reduce risk, and take advantage of opportunity

While there are metrology fixture types that we can explore, every fixture solution that we develop here at Verus Metrology is completely unique. In other words, fully customised for the product or component being measured, as well as the inspection machine, quality department workflows, production processes, and any other influencing factor. 

Metrology Fixture Types 

There are six main metrology fixture types: 

  • Auto rotational 
  • Manual rotator 
  • Multi-station
  • Proof of Principle (POP) 
  • Vision system 
  • Docking station 

 

Auto-Rotational Fixtures

Isometric view of an auto rotational metrology checking fixture, the automatic part of the fixture is the turning of the rail by a motor. The fixture has white plastic components held in place using brown clips

 

At a fundamental level, the job of a metrology fixture is to hold a product or component securely in place so it can be effectively inspected and measured. However, there are situations where the inspection process requires the part to be presented at different orientations to enable all the relevant measurements to be taken. This requirement for measurement in multiple orientations is increasing as medical device products become more complex and intricate. 

Auto-rotational fixtures enable the inspection of products and components in multiple orientations with minimal operator intervention. An auto-rotational fixture can be a single-station set-up, but they more commonly come in multi-station designs to minimise the time it takes to achieve your required sample rate. 

The most important feature of an auto-rotational fixture is that you can measure multiple components in multiple orientations in a single setup. 

Manual Rotator Fixtures

Manual Rotator Metrology Fixtures by Verus Metrology

Manual rotator fixtures offer similar benefits to auto-rotational fixtures. The obvious main difference is that operators manually rotate components once they are loaded into the fixture. 

Manual rotator fixtures can be multi-station. They are also designed so that all measurements in all orientations can be taken in one set-up. So, while the operator will need to manually control the rotation mechanism, there is no requirement to touch or adjust the components as the fixture holds them securely in place during rotation. 

The benefits of manual rotator fixtures include: 

  • Significantly reduced operator intervention 
  • Improved measurement accuracy 
  • Elimination of errors 
  • Faster and more efficient metrology processes 

Furthermore, we can design your manual rotator fixture so it can be loaded with components away from your CMM. This improves CMM availability as the machine doesn’t have to sit idle while components are being loaded onto the fixture. 

Multi-Station Fixtures 

multi station rotator

According to FDA regulations and ISO 13485, it is essential that you can statistically justify sampling rates in your quality procedures using a risk-based approach. The operational part of this requirement isn’t covered in the guidelines, but it is an important business consideration. How do you efficiently, accurately, and cost-effectively inspect the number of products or components that are required to hit your sampling rate target? 

Multi-station fixtures are a common solution. We can design multi-station fixtures in any configuration. This could be a large cavity multi-station fixture, a fixture to inspect very small and complex medical devices, or solutions for products or components of any size, geometry, or characteristic. 

The benefits of multi-station fixtures include: 

  • Operator intervention is greatly reduced 
  • Fixtures only need to be loaded once before full inspection routines can take place on multiple products at the same time 
  • Reduce human error 
  • Speed up inspection processes while achieving your sampling rate target 
  • Reducing the cost of inspections 

 

Proof of Principle Multi-station Prototype Fixtures 

proof of principle

 

In many product development and process change situations, it is beneficial to have a POP fixture that can be used for verification and validation purposes. The approach we typically take at Verus Metrology is to design a multi-station fixture to deliver on your requirements. 

However, before this multi-station fixture design goes into manufacturing, we design and produce a single-station POP prototype fixture. This POP prototype can be manufactured quickly in our advanced manufacturing facility. We’ll then put it through a gage R&R study to give you confidence in its repeatability and reproducibility, before sending it to you for evaluation and testing. 

POP prototype fixtures offer a range of benefits: 

  • Facilitates design for inspection during the product development process 
  • Minimises delays in process verification 
  • Enhances and speeds up the design transfer process 
  • Reduces time to market in line with regulatory requirements 

 

Vision System Solutions

We also design and manufacture fixturing solutions for vision systems in addition to the fixtures we design for use on CMMs. Fixturing solutions that are optimised for vision systems have a number of specific and differentiating features, including ensuring there is a clean and clear view of the part. 

Vision system solutions can also allow for backlighting where necessary. Furthermore, a single set-up is all that is required for the full inspection routine to take place, with parts securely held with as little force as possible. 

 

Docking Systems 

Docking System Verus Metrolody

Docking systems enhance the efficiency of quality departments that use multiple fixtures and/or have high sampling rates. Docking systems are securely fixed to CMMs to make it quick and easy for technicians to load fixtures that are fully set up with components ready for inspection. Once the inspection routine for a fixture is complete, it can be quickly and easily removed from the docking system ready for the next fixture to be loaded. 

With a custom-designed docking system, you can have confidence that each changeover results in precisely secured fixtures for repeatable and reproduceable inspections. 

Choosing the Right Fixture for Your Requirements

There are many factors to consider when choosing the best type of metrology fixture for your requirements. Your budget is an important consideration, as are your ROI goals, quality processes, quality resources, and future requirements. 

The best approach is to speak to a fixture design expert to explore the options and get an understanding of what is possible. Contact us today to find out more. 

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About Verus Metrology Partners

Verus is committed to the enhancement of our client’s metrology laboratories, machine efficiencies, and inspection processes. Since our beginning, our expert metrology engineering team has partnered with some of the world’s largest MedTech multinationals.

 

We specialize in high quantity, difficult to measure, yet critically important, medical device parts. As well as working in the MedTech, Pharmaceutical and Personal Care industry, we also work with metrology departments in the FMCG and Aerospace industry.