Ger O'Carroll

What You Need to Know About User Needs When Designing a New Medical Device

by Ger O'Carroll

When you first came up with your idea for a new medical device, you probably had a fairly clear picture of how it could help improve health outcomes. In the medical device product design process, this is known as User Needs.

What often happens next, however, is new ideas start to come to mind. For example, you might think of other clinical areas or conditions that your new medical device product could help with. Or you might come up with ideas for alterations you could potentially make to the product further down the road that would make it even more beneficial.

This is all before you’ve seen a concept drawing let alone a physical prototype.

The Importance of Documenting User Needs

The above is why identifying, defining, and properly documenting User Needs is so important.

Firstly, it helps focus the medical device product design and development process, ensuring it is as efficient and effective as possible.

Defining User Needs also improves the quality and performance of the product that is ultimately developed, and it aids the regulatory approval process.

Understanding User Needs

In a previous blog, we looked at Quality Systems and design controls. Defining User Needs is an essential part of the design controls you put in place within your Quality System.

The central focus of doing this is that you need to be able to prove your new medical device product does what you claim it does and is suitable for its intended uses.

This brings us to two phrases you are likely to encounter during the medical device product design process: intended use and indications for use. As part of documenting User Needs, you will need to define both.

The Intended Use of Your New Medical Device Product

This involves describing the specific purpose of your new medical device product and what it does.

Importantly, however, you should not include things your new product could be used for. Instead, concentrate solely on the primary use you envisage.

The Indications for Use of Your Medical Device Product

Defining the indications for use of your medical device product involves outlining the situations, circumstances, diseases, and/or conditions where your product can be used to treat, mitigate, diagnose, cure, or prevent.

It’s also important you describe the patient group you are designing the medical device product for.

Why It’s Important to Define User Needs

We’ve already touched on this above, i.e. defining User Needs prevents drift in the design process and it reduces the risk of going off on tangents.

Staying focused on developing a product specifically aimed at addressing the defined User Needs also keeps the development process on track and improves the quality of the finished product.

We also mentioned the regulatory approval process above.

To understand this further, have a look at the image below.

Design control waterfall diagram

This is from the Design Control Guidance for Medical Device Manufacturers document published by the FDA in the US.

It is known in the industry as the design control waterfall diagram.

And at the top of the waterfall is… User Needs.

So, the User Needs definition leads to design inputs, the design process, and the design outputs (concepts, drawings, 3D models, prototypes, etc). Verification then takes place with the design process continuing through as many iterations as required before the final medical device product is finalised.

This final product is then validated based on the defined User Needs.

In other words:

  • Does the product perform according to its intended use definition?
  • Is it suitable for the situations you described when identifying its indications for use?
  • Can you prove both of the above?

As you can see, defining User Needs is a crucial early step in the medical device design process. Your development team will be able to help with this step but in a future blog we’ll look at how to document User Needs.

Understanding Process Validation in Medical Device Product Design

by Ger O'Carroll

If you have looked into the steps involved to design and develop a new medical device product, you are likely to have come across the term process validation.

It’s an essential term and concept to understand as it helps ensure your design, develop, and then manufacture a product that meets the needs of end-users – usually patients or customers. Process validation is also crucial to getting regulatory approval for your product.

What Is Process Validation?

Process validation takes place throughout the product’s entire lifecycle, starting during the design stage. It involves collecting and then evaluating data to prove the product produced is high-quality, repeatable, consistent, and meets the needs of end-users.

The Difference Between Process Validation and Verification

Another term you may have come across is verification. It is also important and is another requirement of regulators. Understanding the basic difference between the two terms – process validation and verification – can help with grasping the concept of process validation.

In basic terms, verification involves assessing whether a manufactured medical device product, or a component of a product, meets the defined specification. So, it involves physically inspecting the product to check the material, tolerance levels, dimensions, etc. This is then compared to confirm everything is within the defined parameters.

This doesn’t tell you if the product meets the needs of end-users, however. All it tells you is the product was manufactured to the intended standard.

Furthermore, verification becomes cumbersome when you have a complex medical device with multiple parts as it can be hard to verify each part.

For example, with verification, you might be able to confirm a tube and a handle are individually manufactured according to specification, but you can’t confirm that the handle and tube won’t detach during use, leaving the tube inside a patient. Process validation, however, can confirm this.

That said, verification is still important. Regulators offer guidance on when it is appropriate to use verification and when you should use process validation instead.

Process Validation in the Design Stage

Process validation happens firstly in the design and development stages of a new medical device product. Continued process validation then takes place once the product is in production and is being sold in the market.

In the design stage, process validation typically happens once the design of the product is locked down.

A crucial part of process validation is to use DFM (Design for Manufacturing) principles. DFM is about ensuring the product can be efficiently and cost-effectively manufactured. In many respects, therefore, the objectives of process validation and DFM are aligned.

At Arrotek, our services include:

  • Designing and developing medical device products
  • Manufacturing medical device products

Sometimes the products we manufacture are designed elsewhere. This has given us detailed insight into how bad design, where DFM is ignored, impacts product quality which, in turn, makes process validation more difficult.

By way of example, one of the things we do at Arrotek during the process validation stage of a design project is to reduce to a minimum the number of components and process steps it takes to manufacture a product.

This is not only good DFM practice, but it also reduces the possibility of things going wrong with the product during use, i.e. it helps ensure the product meets the needs of end-users, which is the goal of process validation.

The Best Approach

From your point of view, the key is to work with a medical device design company that has skills, experience, and knowledge in several crucial areas. This includes:

  • Medical device product design and development
  • Obtaining regulatory approval
  • Quality, including the implementation of quality systems
  • Manufacturing

This will make process validation more straightforward and it will ensure you get a better quality and more fit for purpose product.

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.

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.