News from Arrotek

How Long Does It Take to Design a New Medical Device Product?

by Ger O'Carroll

A question we are often asked at Arrotek is how long it takes to design a new medical device product. Knowing this helps entrepreneurs and businesses plan future steps, including those that come after the product is designed, including putting the product through clinical trials.

The problem with answering the question of how long medical device design takes is that it is variable.

The simple answer is three to six months.

To understand further, it helps to explain our process, the things that can cause delays, and how we mitigate those delays.

How We Work

At Arrotek, we put a schedule in place when we begin a new medical device design project. This includes the various stages of the process, with each stage requiring sign-off from the client.

A project manager will also be assigned to your project who will keep in regular touch to ensure you are updated. This is usually via a weekly telephone or conference call.

The project manager will also present the design work at the completion of each stage. A PowerPoint presentation is typically used in these meetings. You will be required to make a decision (to select a concept idea to move forward with, for example), give feedback, and/or sign-off the stage so the design team working on your project can move to the next one.

Crucially, if there are any issues that cause schedule slippages from our side, we communicate with you immediately to ensure you know as soon as possible.

Causes for Delay

In the vast majority of projects, however, schedule slippages where we encounter an issue at Arrotek are rare. There are other factors, however, that can, if not properly addressed, cause a project to fall behind schedule. The two most common are:

  • Inefficient approval processes
  • Going off on tangents

Streamlining the Approvals Process

Getting approval from you as the client is essential to ensuring the project stays on track. This is because it eliminates the risk of us having to go back to make changes because of something you are not happy with.

That said, the approvals process itself can introduce delays to a project. This is particularly the case when there are several people involved in the process. It is exacerbated further when some of those people cannot attend a presentation by the engineer managing your project.

As a result, we will discuss with you at the outset ways we can streamline the approvals process and make it as efficient as possible.

Staying Focused

At Arrotek, our clients include creative, innovative, and inspiring entrepreneurs who come up with fantastic ideas. Designing a medical device product, however, requires focus on specific requirements. Therefore, new ideas introduced during the design stage slow the process down.

One of the first things we do, therefore, is to define the project’s requirements. This helps our design and engineering teams to maintain focus and deliver according to the agreed schedule.

Successful Project Delivery

There are variables that impact all medical device design projects. At Arrotek, however, we have tried and tested methods, developed over many years, that ensure the successful delivery of the projects we work on. This includes keeping projects on schedule.

Benefits of an Iterative Design Process

by Ger O'Carroll

The best approach to developing a new medical device product is to use an iterative design process. Iterative design is a methodology used to create products in all industries, from physical products to software. What is iterative design, however, and what are the benefits?

What is Iterative Design?

Iterative design involves the development of a new medical device product using a cyclical process. This involves bringing the design to a certain point and then analysing, evaluating, testing, and getting feedback on that design.

This is all fed back to the design team to inform and shape the next stages of the process before repeating the cycle again.

Those stages include the basic concept stage, 3D modelling, and the creation of prototypes.

Why Use Iterative Design When Developing a New Medical Device Product?

An iterative design process ensures the product you want to develop goes through constant refinement and improvement as it is being designed. It involves multiple members of the design team working on your product.

At Arrotek, for example, we have people who specialise in various fields who contribute at crucial stages of our iterative design process.

An iterative design approach also involves you as the client.

In addition, it’s important the iterative design process starts at the very beginning of the development of a new medical device product. This is because changes are easiest and the least expensive to make when you identify and implement them at the beginning of a project.

The further into the development you go, the more expensive alterations become, even if the change is minor.

Benefits of Using Iterative Design

If you have an idea for a new medical device product, an iterative design approach to its development will deliver a range of benefits. This includes:

  • Highlights and helps to resolve misunderstandings, expectation issues, and requirement inconsistencies as early in the process as possible
  • Helps to ensure the product is fit for purpose and meets its functionality, usability, and reliability objectives
  • Speeds up the design process, particularly of complex medical device products
  • Keeps the design team focused on critical issues, helping them avoid distractions and diversions
  • Improves the safety of the product
  • Identifies previously unpredicted user behaviours which can lead to design changes. These user behaviours are almost impossible to spot without the 3D models and physical prototypes that are part of the iterative design process.
  • Essential in the optimisation of DFM (Design for Manufacturing) which, in turn, ensures your product can be efficiently and cost-effectively manufactured at scale
  • Identifies a range of usability and practical issues that are hard to identify early in the product design process without using an iterative approach.
  • Ensures you are fully aware and up to date with the progress of the design and how your medical device idea is starting to shape up in reality
  • Reduces the amount of reworking required, particularly in relation to clients not being happy with the design. As mentioned above, you as the client should be involved in the iterative design process from the very beginning, giving feedback and signing off on the design as it progresses through the various stages. By using this approach, major reworking of the product is avoided, reducing the overall design time.
  • Helps ensure the product design process adheres to regulations by, for example, improving design control documentation

Get More Information

The specifics of an iterative design process depend on a range of factors including how you want to work, who is involved in the approval process, and the nature of the medical device product you want to develop.

To find out more about how those specifics relate to you, please contact us at Arrotek today.

Press Release: Sligo-Based Medical Device Specialist Arrotek Doubles Its Cleanroom Production Facilities

by Arrotek Medical Ltd

Press Release

1 August 2019

Arrotek, the Sligo-based medical device specialist, has completed its move to a new purpose-built facility that includes significantly expanded cleanroom production capacity.

Arrotek specialises in bridging the gap between an idea or concept for a new medical device and bringing that medical device to market. Its expertise includes designing, developing, and manufacturing medical device products, and its clients include medical professionals, entrepreneurs, and MedTech companies from around the world.

The company was bought by Galt Medical in May 2019. Galt Medical is the US-based medical device company that is part of the Theragenics Corporation.

Arrotek’s new, purpose-built design and production facility is in Finisklin IDA Park in Sligo. This location is known as being the heart of the life sciences industry in the North West of Ireland.

Work on the new 50,000 sq. ft. building began towards the end of 2018, with the Arrotek team moving in ahead of schedule in the middle of July. The move is now complete, and the new building is fully operational.

Arrotek has doubled its cleanroom capacity at its new location, enhancing the level of service it offers to customers. The new cleanroom facilities include a dedicated Class 7 (10,000) room for assembly and packaging activities and a dedicated Class 8 (100,000) room for all moulding.

Sligo-Based Medical Device Specialist Arrotek Doubles Its Cleanroom Production Facilities

Cleanroom facilities at Arrotek

Ger O’Carroll, co-founder and Co-Managing Director of Arrotek, said: “The move to our new location went smoothly and we are delighted to announce that our new production cleanrooms have passed all in-use operational qualifications and are now fully up and running.

“This increased production capacity and dedicated cleanroom facilities are a significant step forward in our development at Arrotek. The new facilities will enable us to further expand and improve the service we offer to our customers and allow us to continue designing, developing, and manufacturing medical devices that improve health outcomes and quality of life for patients all over the world.

“Being in this location in Sligo is important to us too. The medical device industry has expanded considerably in this region since we launched Arrotek back in 2005, and it continues to grow. Ireland’s North West, with Sligo at its heart, is an important part of Ireland’s medical device sector.

“We look forward to welcoming our current and new customers to visit and tour our new facilities to see how we can help them meet their future production needs.”

FDA Medical Device Classifications Explained

by Ger O'Carroll

To sell a medical device product in the US, you need approval from the FDA (the Food and Drug Administration). A key part of getting FDA approval is the classification of your medical device.

Not only will the classification determine much of the design and development process, it will also determine what is required to get approval. This is because the process for getting FDA approval differs depending on the classification of your medical device.

This is very similar to the system in the EU. We covered the EU medical device classification system in a previous blog. In this one, we will concentrate on getting regulatory approval for the US market.

FDA Medical Device Classifications for the US Market

The US has three classifications for medical device products: Class I, Class II, and Class III. As in the EU, the process for determining the classification of a medical device is based on risk, while the classification itself determines what you need to do to bring the product to market.

  • Class I – as with EU regulations, this classification is for the lowest risk medical devices, i.e. surgical caps, toothbrushes, crutches, etc.
  • Class II – this classification is for higher risk medical devices such as catheters, ECG machines, syringes, etc.
  • Class III – Class III is for the highest risk medical device products such as defibrillators, implanted prosthesis, heart valves, etc.

Class I Medical Devices

There is no requirement to notify the FDA when bringing a Class I medical device to the US market. Instead, you must adhere to the FDA’s General Controls. This includes complying with good manufacturing practice, listing requirements, and more.

In fact, all medical device products in the US must comply with the FDA’s General Controls.

Class II Medical Devices

The process of bringing a Class II medical device product to market is more involved and more time-consuming than with Class I medical devices. This is because, in general, Class II medical device products need to go through the FDA’s Premarket Notification application process.

The Premarket Notification process involves showing your medical device is equivalent to another medical device that already has regulatory approval. This equivalence demonstrates the safety and effectiveness of your product.

However, the FDA also produces a list of common Class II medical devices which don’t require Premarket Notification. Instead, they must adhere to the regulator’s other requirements for these types of devices. If your product falls within the scope of this list, getting it to market in the US is much simpler.

Class III Medical Devices

The process for getting FDA approval for a Class III medical device is much more rigorous than with products in the other two categories. This is because Class III medical devices must go through a Premarket Approval process.

The Premarket Approval process is significantly different from the Premarket Notification requirements for Class II medical devices.

In the Premarket Approval process, your medical device will need to go through rigorous study and testing to determine both its effectiveness and its safety. This process can – and often does – include clinical trials.

Getting Approval in Multiple Jurisdictions

Most entrepreneurs, medical professionals, and companies with an idea for a new medical device have the objective that it will be sold and used in multiple countries. High up on the priority list is usually the US and EU markets.

Therefore, it’s important you work with a medical device design and development team that understands both US and EU medical device classifications and regulations, in addition to regulations in other major jurisdictions around the world.

This is what you get with us at Arrotek. Contact us today to find out more.

EU Medical Device Classifications Explained

by Ger O'Carroll

Not all medical devices are the same. Some are non-sterile and pose minimal risk to patients, while others are implanted in the body and carry a high risk. Therefore, regulations for medical devices must distinguish between the different types, setting appropriate requirements for regulatory approval depending on risk. Regulators do this with a classification system.

In other words, understanding the classification that your new medical device falls under is a crucial step in the design and development process. The classification will inform how the development progresses as well as the steps required to obtain regulatory approval.

EU vs US Regulations

In the EU, new EU regulations, known as the new EU Medical Device Regulations, or MDR, are coming into force. One of the main changes in the new regulations involves different rules on the way medical devices are classified.

If you have gone through the process of designing and developing a medical device before, you might find it different with the new EU MDR. For example, the medical device you want to develop might now fall into a higher classification.

If you are going through the process for the first time, however, the changes in EU regulations will have less of an impact. One exception to this is the fact the new EU MDR brings the classification of medical devices in Europe more in line with international regulations. This includes FDA regulations which apply in the US.

There are still some differences, particularly in relation to how you get regulatory approval in the EU compared to the US, but the closer alignment of the two systems has simplified many aspects.

We’ll look at the classification system in the US in more detail in a future blog. The focus here is on medical device classifications in the new EU MDR.

EU MDR Medical Device Classifications

The classification system for medical devices under the new EU MDR is based on risk. The level of risk the medical device presents determines which classification it falls under. This classification then tells you:

  • Whether a conformity assessment is required to ensure it meets MDR requirements; and,
  • If a conformity assessment is required, how that should be done.

If a conformity assessment is required, it must be conducted by a Notified Body, i.e. an independent certification organisation authorised – i.e. notified – by an EU member state.

There are three main classifications for medical devices: Class I, Class II, and Class III. In addition, there are sub-classes such as, for example, Class IIb and Class IIa.

Most medical devices, however, will fall into the following risk classes:

  • Class I – this classification is for the lowest risk medical devices such as wheelchairs, glasses, stethoscopes, etc. Most medical devices in this category do not require a conformity assessment. Instead, they can be self-assessed. The exceptions are Class I medical devices which are reusable surgical instruments, are supplied sterile, or have a measuring function. A notified body is required to certify these types of medical device.
  • Class IIa – this classification is for medium risk medical devices. An example is a surgical clamp. A conformity assessment by a notified body is required for this classification of medical device.
  • Class IIb – this classification is for higher risk medical devices or medical devices classed as a medium-to-high risk. A bone fixation plate is one example. Again, Class IIb medical devices require a conformity assessment.
  • Class III – this classification is for the highest risk medical devices and requires a conformity assessment. Examples include pacemakers and heart valves.

Determining the Classification of Your Medical Device

One of the first things that is required when designing and developing a new medical device for the EU market is to determine its classification. Working with an engineering design and development team with knowledge and experience in this area streamlines the regulatory approval process and ensures the development starts on the right track.

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.