News from Arrotek

Quality Systems and Design Controls in the New Medical Device Development Process

by Ger O'Carroll

Design controls are essential to ensuring your medical device idea achieves regulatory approval. Without design controls, you won’t be able to launch your product, while the poor implementation of design controls, particularly in the early stages of a project, will delay the launch of your product.

What are design controls?

Design controls are part of the Quality System that you must have in place before regulators will allow your product to enter the market. So, let’s start there.

An Introduction to Quality Systems

All new medical device products need a Quality System to comply with regulations. In the US, this means complying with FDA 21 CFR Part 820. In Europe, it means complying with EU medical device regulations. Most MedTech companies achieve this by meeting the standards set out in ISO 13485:2016.

Both FDA 21 CFR Part 820 and ISO 13485:2016 are similar as there has been a drive by regulators in recent years to harmonise the requirements in different countries and regions. Therefore, it’s possible to take an overall look at what you need in terms of a Quality System.

Importantly, neither the FDA nor EU regulators specify what your Quality System should look like or the procedures you should follow. This is up to you, but there are best practice standards you should follow.

A specialist medical device design company, like Arrotek, can guide you through the process and ensure you meet the requirements of regulators.

Design Controls and Quality Systems

The Quality System you put in place for your medical device product will have a range of different components. This includes management controls, document control, supplier management, and risk management.

This blog, however, focuses on another crucial component of a new medical device Quality System – design controls.

The purpose of design controls in a Quality System is to prove a medical device product is safe, effective, and fit for purpose.

There are three central questions to the above:

  1. Does the product meet user needs – i.e. does it do what you claim it does?
  2. Is the product suitable for its intended uses – i.e. does it diagnose, prevent, treat, cure, or mitigate the disease or condition you specify?
  3. Can you prove it – do you have documentation to prove the above?

Design Control Requirements for the Quality System of a New Medical Device Product

The central component of design controls for a new medical device product is to have a plan or process that describes all the design and development activities that take place to bring your product from the idea stage to the stage of seeking regulatory approval.

This process will produce a document that contains a full history of the product’s design iterations. This document is often called the design history file.

The design history file also includes:

  • Design inputs, i.e. the performance criteria and requirements of the product based on the needs of users
  • Design outputs i.e. all the components the design produces from testing protocols to materials to parts
  • Verification, i.e. verifying the design outputs meet the design inputs
  • Validation, i.e. validating the design
  • Details of design changes and how they were controlled
  • Reviews of design results (or design reviews)
  • How the design was transferred to production documents – drawings, specifications, etc

Beyond Compliance

Design controls offer more benefits than smoothing the path to regulatory compliance. By having design controls in place, you will be more confident your new medical device product will be safe to use in addition to potentially shortening the product design and development timeline.

When you add a DFM (Design for Manufacture) approach to the process, design controls can also help ensure your medical device product can be effectively manufactured for an acceptable cost.

Importance of Implementing Design Controls Early

By meeting the above requirements at the start of the design process, you will save considerable amounts of time compared to doing it retrospectively, i.e. once the product is ready for submission to regulators for approval.

Adopting an approach to product design that is both fluid and flexible helps too.

What is DFM – Design for Manufacture?

by Mark Pugh

Design for Manufacture, or DFM, involves designing medical device products so they can be easily manufactured within a target manufacturing cost. It takes into account other aspects of designing a medical device product too, such as ensuring regulatory compliance and performance, however it doesn’t ignore the manufacturing element.

DFM typically involves simplifying and refining the product at all stages in the design process with the aim of optimising it for manufacturability.

An example is the number of parts used to manufacture a medical device product. By going through a DFM process, design engineers will seek to eliminate or combine parts to ensure there are as few as possible. This saves time in production and assembly, while the reduced number of steps to assemble the product (because there are fewer parts to assemble) reduces the risk of errors.

In addition to parts reduction, parts standardisation is one of the main goals of DFM.

When Should DFM Begin?

By following a DFM process, problems that arise when designing and developing a new medical device product can be fixed during the design phase rather than later.

Therefore, it’s important to consider DFM principles during the earliest stages of the design process and then through each stage including concept development, CAD modelling, prototyping, and all design iterations.

It’s crucial to use DFM from the start of the design stage as the further into the process you go, the more costly it is to make changes.

For example, it is massively more expensive to make a change to the design of a product when you are at the mould designing and building stage compared to during the initial concept development, CAD modelling, and prototyping stages.

In other words, it’s important to ensure the product development specialist designing your new medical device product follows DFM principles.

What Does DFM Entail?

A DFM approach to designing a new medical device product involves questioning all aspects of the product and the design.

Doing this requires experience with similar products and designs. Knowledge of what others have done in the industry is also helpful, while a creative and innovative approach to MedTech product design is essential.

Factors Considered During a DFM Process

  • Process – the method used to manufacture the product, i.e. machining, vacuum moulding, 3D printing, etc. Consideration will be given here to tolerances to ensure they are not too tight for the chosen manufacturing process.
  • Design – the design of the new medical device product must adhere to Good Manufacturing Principles (GMP). For example, the design needs to consider the practicalities of manufacturing the components and then handling them for assembly. Does the design involve unnecessary steps that could be eliminated? The designer could also design the part so its production can be largely automated.
  • Materials – the materials that will be used to make the product
  • Performance – the product should perform in real-world situations as expected
  • Regulations – the design of the product should also comply with all relevant regulations

Benefits of DFM

  • Reduces the time it takes to bring a product to market
  • Reduces overall costs to design and develop the product
  • Ensures the product can be made profitably
  • Get a higher quality product

Introducing DFMA

Another abbreviation you might hear in relation to the medical device design process is DFMA. DFMA is an extension of DFM that is common in many industries, including MedTech. It stands for Design for Manufacture and Assembly.

As you can tell by the name, it involves ensuring the whole manufacturing process, including parts manufacture and all stages of assembly, is both efficient and cost-effective. Given that most medical device products require an element of assembly, DFMA and DFM can be used interchangeably.

The objective always remains the same, i.e. ensuring you get a product that performs as expected, complies with regulations, and can be manufactured cost-effectively.

Moving premises

by Arrotek Medical Ltd

We would like to remind everyone that Arrotek will be moving premises next week! Our new purpose-built facility in Finisklin is looking great and we can’t wait to get moving.

Please note that due to the move, our phone and internet lines may be down between Wednesday the 26th June to Wednesday 3rd July.

As of now our phone number will remain +353 (0)71 91 15111 and our new address is:

Arrotek Medical Ltd

Finisklin Business Park

Finisklin

Co. Sligo

Ireland

F91 RR99

The Importance of Prototyping When Developing a New Medical Device Product

by Mark Pugh

It is not enough when designing a new medical device product to just create a design based on an initial ideal before moving straight to testing and real-world evaluation. In fact, most medical device products go through several iterations during the design and development process to get to the final design.

Often, this final design can be significantly different from the original sketched-out idea.

The prototyping process is crucial to achieving this final design.

What is Prototyping?

Prototyping usually starts after the concept development stage, i.e. once detailed drawings are produced. It’s about turning the digital design of the product into something you can hold in your hand to test, inspect, and analyse.

Why Is Prototyping Important in the Medical Device Product Design Process

The medical device design process has three main priorities:

  • The product must be functional, i.e. it must be able to perform the task that it was created for to a high standard
  • The product must be practical and cost-effective to manufacture, i.e. ensuring the device can be effectively and efficiently manufactured at a reasonable cost
  • The product must adhere to regulations including regulations in the US, Europe, and anywhere else the product will be marketed

Prototyping is essential to ensuring your product delivers on all the above priorities.

Manufacturing Methods Used in the Production of a Medical Device Product Prototype

There are several manufacturing methods used to develop medical device products. Those that we use at Arrotek include:

  • Balloon blowing
  • Tipping
  • Laser welding
  • Injection moulding
  • Bonding
  • 3D printing
  • Film welding

It is not unusual for a prototype to be produced using a variety of the above methods before the product is assembled.

Benefits of Prototyping

  • Helps you and the engineers working on the product get a better understanding of what makes it unique
  • Helps engineers better understand how the device will work
  • Also helps engineers better understand where improvements to the device can be made
  • Helps engineers understand the manufacturability of the product

All the above are crucial to the overall design process as they identify potential issues as well as potential opportunities. Prototyping also helps to save time in the overall process as well as getting more accurate costs estimates for commercial manufacturing.

How Prototyping Works

There are often two main stages in the prototyping process:

  1. Creation of the first prototype based on initial detailed design drawings. This prototype is a crucial part of the iterative design process and is mainly used to improve and enhance the design.
  2. Creation of the final prototype at the end of the design process. This usually involves manufacturing a small batch of the prototype so you can use it for testing and evaluation purposes. This prototype will be validated and compliant with regulations.

Creating a Prototype for Your Medical Device Idea

As prototyping is such an important part of the medical device design and development process, it’s essential you work with a development team with prototype production capabilities. This includes having in-house manufacturing and toolmaking capabilities to ensure consistent quality and efficiency as well as to protect your intellectual property.

An Overview of the Medical Device Design and Product Development Process

by Mark Pugh

While each new medical device product design and development project is different, the process followed is typically well-structured. There are many reasons for this, not least the importance of ensuring the product is safe to use as well as ensuring both the product itself and the design process adheres to medical device regulations.

At Arrotek, we have a well-established medical device design and product development process. It is outlined below.

Before going through it, however, it may also be helpful to read our blog on the Considerations that Inform and Guide the Medical Device Product Design Process. Both blogs together will give you a holistic view of medical device development from all main perspectives.

Before the Design and Product Development Process Begins

There are two steps you should go through before you get into the full-blown design and development process. You can go through these steps yourself, or you can get the help of an experienced medical device product developer – like us at Arrotek.

The two steps are:

  1. Identify a need in the market
  2. Check any existing intellectual property

Identify a Need in the Market

Designing a new medical device product is only part of the journey of making the product a success. It also needs buyers/users in the market, and you need to be able to reach those buyers. This involves identifying the need in the market that your new idea for a medical device will meet.

Remember, developing a new medical device product isn’t just about creating something completely new that nobody has seen or tried before. In fact, many of the most successful medical devices are improvements on existing ideas.

Therefore, it’s crucial to focus on ensuring your idea meets the real needs (rather than perceived needs) of the market.

Check Any Existing Intellectual Property

Any existing intellectual property on the idea you have, or something similar to your idea, could prevent you from bringing your idea to market. The earlier you know about this, the better.

The Process for Designing and Developing New Medical Devices

1. Specification

This includes creating two lists:

  1. A list of critical requirements
  2. A list of aspirational requirements

This step also involves developing a design brief for the product. It’s also important to classify the device to ensure the correct regulations are followed during the next steps.

The classification will depend on where you plan to market the device. In the US, for example, the following FDA classifications apply:

  • Class I – for simple designs and products that carry very little or no risk
  • Class II – for products with a more complicated design and that pose some risk to users
  • Class III – for intricate designs and products that carry the greatest amount of risk

2. Concept Development

Using the design brief, your designer will generate concepts for the new product you want to develop. This involves creating a series of sketches to form a storyboard.

In other words, this step is about visualisation of the idea and exploring what is possible as well as the best way to achieve the desired outcome.

3. Develop 3D CAD Models

After you and the designer reach agreement on which concept to pursue, 3D CAD models and detailed drawings of the product are developed.

4. Prototype Production

This step involves the production of a first prototype. This prototype can be manufactured using a range of techniques depending on the product being produced. This includes:

  • Balloon blowing
  • Tipping
  • Laser welding
  • Injection moulding
  • Bonding
  • 3D printing
  • Film welding

The final product is then assembled so it can be analysed and assessed.

5. Design Iterations to Refine the Product

This step is about learning from the first prototype to refine the design and improve the product. It involves concept enhancement to create a new and improved version utilising an iterative design process.

6. Prototype Production

In this step, a final prototype is produced. It is typically manufactured in a small batch to allow for the product to be tested and evaluated.

Going Through the Product Design and Development Process

As you can see, the process for developing a new medical device product is quite involved with many different elements and factors to consider. It’s critically important, therefore, that you work with a design team with experience and a proven track record. This will give you the best chance of success.

GALT ACQUIRES ARROTEK MEDICAL

by Arrotek Medical Ltd

GALT ACQUIRES ARROTEK MEDICAL

Combination of Arrotek’s Product Development with Galt’s Manufacturing Capabilities will Benefit Customers and Provide Access to New Segments of the Interventional Market

GARLAND, TX – May 20, 2019 – Galt Medical, a subsidiary of Theragenics Corporation® and a global supplier of access and procedure products for a range of interventional and endovascular procedures, today announced it has acquired Arrotek Medical Limited. Arrotek, located in Sligo, Ireland, develops and designs minimally invasive medical devices supporting a range of catheter-based, interventional applications. Arrotek’s capabilities include concept, design, product development, regulatory approval, and certain manufacturing services. Mark Pugh and Ger O’Carroll, co-founders of Arrotek, will remain with Arrotek in Sligo as co-Managing Directors.

Frank Attardo, President of Galt Medical commented, “The capabilities of Arrotek and Galt are highly complementary to each other. Arrotek’s product development capabilities, combined with Galt’s manufacturing and processing capabilities, will allow the combined company to better serve existing customers and address and serve a wider segment of the interventional market.”

Mark Pugh and Ger O’Carroll commented, “Galt provides Arrotek with access to markets, capabilities and expertise previously unavailable to us. The combination with Galt will benefit existing customers of both companies, as well as provide Arrotek with opportunities to serve new segments of the market in Europe, North America and other global markets. Becoming part of the larger Theragenics organization also provides the resources to accelerate our growth and continue to expand.”

Considerations that Inform and Guide the Medical Device Product Design Process

by Mark Pugh

Turning an idea for a new medical device into a product that is ready for testing and evaluation is a complex process, particularly if you have never been through it before.

This overview of the medical device design and development process will outline the things you and your design/development team will consider.

In the next blog, we’ll look at the steps and stages you will go through.

Considerations During the Design and Development Process for New Medical Devices

There are many concepts, principles, and requirements that will determine the course of the design process. This includes:

  • Regulations
  • DFM – Design for Manufacture
  • Quality systems
  • Testing, verification, and validation

Let’s look at each in more detail.

Regulations

It’s essential in the design and development process to ensure your device meets the regulatory requirements and product standards for all markets it is intended to be sold in.

It’s also important that the design and development process itself adheres to Good Manufacturing Practice (GMP) as this is a regulatory requirement for medical device products.

One thing that is important to note when considering regulations is that while there are many similarities between regulations in different jurisdictions, there are important differences too. Understanding these differences and working through them at the design and product development stage avoids delays in getting the product approved.

Remember, even though there are ongoing efforts to harmonise medical device regulations and standards through organisations like the International Medical Device Regulators Forum, regulations are still enforced, determined, and governed on a national basis.

DFM

Designing a product is very different from designing a product that can be effectively manufactured. Therefore, DFM is the design philosophy that should be used in the development of your product.

In practice, this means giving consideration at the design stage to the practicalities of manufacturing the product. The benefits of doing this include:

  • Ensures the product meets your target manufacturing cost
  • Creates a higher quality product
  • Ensures the manufacturing process is reliable
  • Ensures the assembly process is as simple as possible
  • Makes sure the device meets all regulatory requirements

Quality Systems

Regulators require new medical device products to follow a quality system through the design and development process. The FDA, for example, requires a quality system to be in place before a product can enter the US market.

For most medical device products, a quality system should have the following components:

  • Design controls, i.e. controls in the design stage to ensure the product is safe, is suitable for the use it is intended, and to make sure it meets the needs of the end user as well as your requirements
  • Risk management
  • Document control
  • Supplier management

Testing, Verification, and Validation

Testing, verification, and validation of your new medical device product is a requirement from a regulatory perspective, but it’s also essential from a user/patient safety perspective too.

Other benefits include controlling the cost of development, controlling the cost of manufacturing the product, reducing delays in getting the device to market, anticipating the impact of future changes, and analysing issues when exporting the device.

Therefore, testing, verification, and validation should be considerations throughout the process.

The Process for Designing and Developing Medical Devices

The above outlines the factors a professional and experienced medical device product design and development team will consider when making your idea for a new product a reality. What about the design and development process, though?

We cover this in our next blog: An Overview of the Medical Device Design and Product Development Process. Check it out today.