How Metrology Improves Profitability for Medical Device Manufacturers 2024

January 8, 2024

How Metrology Improves Profitability for Medical Device Manufacturers 2024

January 8, 2024

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The perception of metrology as a mere business expense remains prevalent in the medical device industry, but in 2024, it’s crucial to reevaluate this perspective. While metrology is undeniably essential, dismissing it solely as a cost center neglects its potential to drive business value. This blog aims to shift the narrative by examining the intersection of metrology and profitability within the context of the medical device sector, emphasizing how it can contribute to innovation, risk management, and overall competitiveness.

There are two main areas where metrology creates profit-enhancing opportunities:

  • Optimising productivity in your production and quality functions, i.e., doing more and doing it better with less
  • Supporting strategic business initiatives that are crucial to achieving your objectives

In both these areas, taking a forward-thinking approach to metrology processes is essential. This includes being forward-thinking in how new and innovative solutions can deliver benefits that don’t compromise priorities like patient safety, product quality, and regulatory compliance.

To demonstrate this need for taking a forward-thinking approach, we’re going back to the 1800s.

Lessons From the Early 19th Century

Today, interchangeable parts are the norm in manufacturing. In other words, manufacturing identical parts so they can be easily swapped when required. In the 19th century, however, the use of interchangeable parts was cutting edge, as manufacturing lines were staffed by highly skilled workers who made each individual product by hand. The parts made by a single operator were not identical, let alone the parts made across the production line.

During the Napoleonic War in the early 18th century, this method of manufacturing wasn’t delivering on one unique but essential requirement of the British Royal Navy. It needed 100,000 pulley blocks a year for the rigging systems on its ships. This was a requirement that traditional manufacturing simply couldn’t deliver without a massive workforce of skilled labour.

So, the navy brought in Marc Isambard Brunel, father of one of the greatest engineers of all time – Isambard Kingdom Brunel.

Marc Brunel developed machines that could manufacture the pulley blocks. Once fully up and running, the machines could manufacture 130,000 pulley blocks a year. This not only exceeded the original requirement, but it did so with over 90 percent fewer workers than would be needed to produce the same amount of pulley blocks by hand.

How was this achievement possible? It was possible through a forward-thinking approach to mass manufacturing and a reliance on precise measurement.

The science of measurement is now known as metrology, and it continues to have positive impacts on productivity and, by extension, profitability in manufacturing operations. This includes in the medical device industry, where high-speed, high-volume, and highly regulated lines are the norm.

Enhancing Profitability Through Improvements in Productivity

When managed properly, improved productivity leads to higher profits. By optimising, modernising, and automating the metrology processes in your facility, and by working with an expert partner, you can improve productivity in the following areas:

  • Quality
  • Metrology equipment costs
  • Production
  • Compliance

Optimising the Performance of Your Quality Function

Driving productivity improvements is a key priority for medical device manufacturers. However, when looking at productivity improvements, the focus is typically on areas like production, packaging, and supply chain management. While all these areas are important, there are also productivity gains that can be made in the quality function of your facility and, more specifically, in relation to metrology.

One of the ways you can improve productivity in your quality function (and, by extension, enhance overall profitability) is by implementing the right metrology strategies, processes, and equipment.


There are five main ways that an optimised approach to metrology enhances quality function productivity:

  • Reduced human error – human error is a reality when metrology processes are manual. These errors are a drain on productivity as they lead to other issues and often require additional resources to correct.
  • Faster inspection processes – this one is a simple and easy-to-measure productivity gain in your quality function. By improving metrology workflows and automating or semi-automating processes, you will be able to inspect medical device products or components faster than is currently possible.
  • Real-time, in-process inspection – modern technologies make it possible to implement real-time inspection processes on medical device production lines. Crucially, these real-time inspection solutions also deliver on compliance requirements. An essential component of real-time inspection is the fact they are in-process, i.e., taking place on the production line rather than in a separate location. The productivity gains that are possible from this metrology enhancement are substantial.
  • Increased volume of inspected components – best-in-class metrology solutions enable the inspection of more products or components than is currently possible through standard processes. By inspecting more parts, you will have better batch quality data, thereby improving your overall quality control function.
  • Minimised operator requirement – automated and semi-automated metrology solutions minimise the requirement for operator intervention. This means you need fewer operators to complete metrology processes, including dimensional inspection, allowing you to reallocate those resources to more productive tasks.

Reduced Metrology Equipment Costs

Metrology equipment is expensive to purchase and maintain. However, in many medical device manufacturing facilities, the equipment that is used is not fit-for-purpose. Usually, the equipment has been over-specified. The result of this is higher capital investment costs than what was needed, as well as ongoing maintenance costs that are also higher than necessary.

In a competitive market where every investment decision is important, optimising your expenditure on metrology equipment is essential, not least because it leaves more profits at the end of your accounting period.

Improved Production Line Productivity

Optimised metrology processes and systems can also help drive productivity improvements on production lines.

For example, by implementing optimised inspection routines that are semi-automated, you will have dimensional inspection data that can highlight product quality deviations. With this information, you can investigate the cause of the deviation and correct it before tolerance ranges are breached and batches of product have to be scrapped.

Reduces the Regulatory Burden

Regulatory compliance in the medical device industry is a necessary cost, but a cost, nonetheless. Therefore, making compliance as efficient, effective, and productive as possible should be a priority. Optimised metrology processes are not the only solution for reducing the regulatory burden, but they can make a significant contribution.

Supporting Strategic Business Initiatives

Metrology can also have a positive impact on business profits by supporting business initiatives. Here’s how:

  • Risk mitigation
  • Market reputation
  • Competitiveness
  • Decision-making
  • Innovation

Reduced Risks

Inspection processes are all about minimising risk. In fact, your quality function is largely about risk mitigation. The risks that metrology aims to mitigate include:

  • Risk of releasing sub-standard products into the distribution chain and the problems this can create
  • Patient safety risks created by defective or sub-standard products
  • Financial, regulatory, and reputational risks that are the result of product recalls
  • Risk of product complaints because of quality issues
  • Risk of manufacturing bad products, as bad products increase material waste in your facility and result in double work
  • Risk of litigation due to product quality issues
  • General reputational risks around your brand and the perception the market has of the quality of your products

All medical device companies aim to minimise risks, as not doing so can have a devastating impact on profitability. Metrology has an important role to play.

Enhanced Market Reputation

One of the points mentioned in the previous section deserves further exploration – the reputation you have for quality in the marketplace. In general, the better your reputation for quality, the more successful your products will be.

Metrology can help maximise product quality in your operations, enhancing profitability.

Improved Competitiveness

You will also be in a better position to compete when you have high-quality products and an excellent reputation in the market.

Effective metrology processes can also enhance competitiveness in other areas. Here are three examples:

Improves Decision-Making

Even small medical device production lines capture thousands of dimensional measurements every day. These measurements are used to make a range of decisions. The accuracy of the data you are working from is essential, as bad dimensional data will lead to bad decisions and, ultimately, lower profits.

Accurate dimensional data – data you can rely on – does the opposite, by improving decision-making.

There are several advantages that improved decision-making capabilities will bring:

  • Help you optimise inspection processes
  • Improve manufacturing processes
  • Identify tolerance deviations before they breach limits
  • Improve product quality

Supports Innovation

Effective metrology processes also support innovation by, for example, enhancing the R&D process. High-quality metrology support can also help you get to scale-up production faster and with fewer costly missteps along the way.

Conclusion: Metrology is About More Than Quality

One of the key takeaways from this blog on metrology and profitability is that your metrology processes can and should be about a lot more than quality control. That is not to undermine the importance of quality control and the role that good metrology processes play in driving productivity improvements.

Metrology, when viewed strategically, can deliver so much more, including improving profitability and moving you closer to Quality 4.0. Quality 4.0 is a whole other topic, however, that you can find out more about here.

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.