The Importance of Design for Inspection (DFI) in Medical Device Design

August 4, 2022

The Importance of Design for Inspection (DFI) in Medical Device Design

August 4, 2022

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Making sure medical device products can be inspected as they come off the production line is an essential part of the product development process. Any changes in the design of a product for inspection reasons can increase costs, with those costs rising exponentially as the development project progresses. Design for Inspection (DFI) aims to minimise and often eliminate these added costs. It also helps to optimise inspection processes, streamlining the global distribution of your medical device products when you get to the scale-up manufacturing stage. What is DFI, though, and what are the benefits?

You have probably heard of the design concepts DFM (design for manufacture) and DFA (design for assembly). They are both concerned with designing medical device products to make them as easy and cost-effective as possible to manufacture/assemble.

DFI follows the same principles, except that it’s about making sure measurement and inspection processes for new products are:

  • Possible,
  • Practical, and,
  • Optimised.

First, a Recap on DFM and DFA

Without DFM and DFA, a new medical device product might work in the virtual space and even as a prototype. It might even be suitable for small-batch manufacturing, such as for clinical trials and other testing purposes.

However, problems can start to arise when the product moves into the production engineering phase, i.e., where production engineers and manufacturing teams start looking at methods, processes, tools, and moulds to manufacture the product at scale.

Problems at this stage can often mean a redesign of elements of the product. When this occurs, delays are inevitable, and costs can skyrocket.

As a result, DFM and DFA are often crucial to the commercial success of a product, particularly during its initial market launch phase.

What about DFI, though?

How DFI Cuts Medical Device Product Development Costs and Risks

The importance of DFM and DFA means they are now commonly adopted concepts in medical device product development projects. DFI, however, is often overlooked.

This overlooking of DFI means metrology and inspection considerations sometimes don’t come up until the product moves into the manufacturing engineering phase of a project. This can create considerable problems.

To design and then commercialise a medical device product, it must be certified through inspection, with further measurement to ensure ongoing conformity.

As design best practice should involve considering the steps required to commercialise the product, not just to design it. Those considerations should include regulatory compliance, manufacturability, and, of course, metrology.

As with DFM and DFA, when measurement and inspection issues are only identified in the production engineering stage (or later), costs can soar.

For example, it might be discovered that specialist equipment is required to inspect a particular component, or that the required tolerance range cannot be achieved using existing machines and workflows. Engineering your way out of challenges like these can be expensive and time-consuming. This is one of the reasons why DFI is so important.

Optimising Inspection and Measurement Through DFI

While the above points are highly relevant, the concept of DFI isn’t just about avoiding unnecessary costs and delays. Adopting DFI principles (see below) in the development of a new medical device product can also improve and optimise inspection processes.

For example, automation could be introduced into the inspection process or inspection rates could be maximised. These things might not be possible if metrology is only considered in the latter project stages.

DFI Best Practices

  • Consider inspection early – the starting point when adopting DFI is to consider metrology and inspection as early in the design process as possible, just as manufacturing expertise is often called upon in design stages.
  • Maintain a focus on metrology – it is then beneficial to refer to metrology experts as the project moves through the design phases, up to and including the point where the design is approved and passed to the manufacturing team.
  • Final decisions and advice – metrology experts should then provide final advice to manufacturing teams – advice that is enhanced because of ongoing involvement in the project. This can help the manufacturing team get a deeper understanding of drawing specifications, particularly in relation to geometric dimensioning and tolerancing.
  • Optimise workflows and inspection processes – the final element is to pull everything together to create and optimise the metrology and inspection workflows and processes for the new product.

There is one final point to consider here. Even in situations where DFI is not implemented during the design phase, many measurement and inspection challenges can be overcome by engaging metrology experts to conduct drawing reviews with manufacturing teams.

However, the best results are achieved through the adoption of DFI principles.

Benefits of DFI

  • Faster and more accurate inspection processes during full-scale production
  • Improved compliance
  • Less re-work during product development, especially in the costly latter stages
  • Optimised use of metrology and inspection equipment
  • Eliminates unnecessary capital expenditure (by identifying elements that will need new instruments to be inspected so those elements can be altered)
  • Faster return on investment

Conclusion: Eliminating Avoidable Costs, Reducing Risks, and Optimising Processes

To maximise the success of a medical device product development project, you need the following four elements:

  1. Product design excellence
  2. Smooth regulatory compliance
  3. Optimised manufacturability
  4. Fast, accurate, and effective inspection

DFI is only one part of achieving the above four-part objective, but it should not be overlooked. By adopting DFI best practices, you can eliminate risks and costs associated with design changes for inspection reasons. You can also make sure your inspection processes are fully optimised, i.e., where inspection processes help to improve production line productivity, throughput, OEE, and the streamlining of product distribution to all global markets. To find out more about implementing DFI in your medical device product development project, please contact us at Verus Metrology 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.