Ger O'Carroll

An Introduction to Standard Operating Procedures

by Ger O'Carroll

When you design and develop a new medical device product, you must establish, manage, and enforce standard operating procedures, otherwise known as SOPs. What are SOPs, though, why do you need them, when do you need them, and what do you need to do?

Before getting into those questions, let’s look first at why SOPs are important even when you are at the early stages of developing your concept for a new medical device.

Having SOPs in place and enforcing them is a requirement of regulators around the world, including in Europe and the US. More specifically, SOPs are part of your quality management system, another key requirement of regulators.

What Are SOPs?

SOPs are written, step-by-step instructions on the procedures that must be followed to perform specific tasks.

Crucially, you must have separate SOPs in place for all tasks carried out in relation to your medical device product. This includes tasks that would be similar to all medical devices, such as document controls, as well as tasks that will be unique to your product, such as manufacturing and risk management.

SOPs aren’t just documents that go into a file to be checked by regulators, though. Instead, they should be living documents in your organisation, followed by members of your team when completing tasks. They should also be kept up to date.

Why Do You Need SOPs?

The primary purpose of SOPs is to ensure the proper completion of tasks in relation to your medical device. They also ensure consistency in the completion of tasks. In theory, it shouldn’t matter who is completing the task. As long as the individuals involved follow the relevant SOP, the task should be completed correctly.

The ultimate goal is to ensure safety and maintain quality.

What is Included in a SOP?

Each SOP you create should feature several essential sections. This includes:

  • Purpose of the SOP
  • Scope of the SOP
  • Roles and responsibilities in relation to the task covered by the SOP
  • Procedure to be used to complete the task

Other information is required as well, but the medical device company you are working with to develop your new product will help you through this process. They will have templates that will form the basis of your SOPs, plus your medical device product designer will provide much of the required information.

One thing that is important to point out, though, is that you not only have to keep SOPs up to date, you also need to document the revisions you make. So, you need to keep a revision history of each SOP.

What Do You Need to Do and When?

You will have ongoing requirements in relation to SOPs for your medical device, but it’s important to get started with the creation of SOPs during the design stage. In other words, as early as possible.

Documentation isn’t one of the most exciting parts of developing a new medical device, but it is an essential part. The medical device design company you work with will help you through the process. At Arrotek, for example, we have a lot of experience creating quality management systems that include SOPs and all other necessary documentation.

Finally, when creating each individual SOP, make sure you do so from the perspective of the people who will be using them, i.e. the members of your team completing the tasks covered in the SOPs. This means writing procedures clearly and making sure you cover each required step. The goal is to avoid confusion as much as possible.

This will not only help meet your regulatory requirements, but it will reduce risks, maximise productivity, ensure safety, and maintain quality standards.

Estimating the Probability of Occurrence and Severity of Harm When Assessing Medical Device Risks

by Ger O'Carroll

There are a number of steps that need to be taken in relation to risk management when designing a new medical device. This includes identifying hazards and hazardous situations.

You then need to evaluate the hazards and hazardous situations you identify before, potentially, putting control/mitigation measures in place and then monitoring those controls.

The second stage of the above process, evaluating hazards and hazardous situations, involves estimating two essential factors:

  1. The probability of occurrence
  2. The severity of harm

By combining these two estimations together you will be able to define the risk as being either acceptable or unacceptable. This definition of acceptability will determine what you do next.

Risk Acceptability = Severity of Harm X Probability of Occurrence

This is all outlined in ISO 14971 which is a common framework used by regulators when deciding on whether or not to approve your medical device.

Medical Device Risk Acceptability Table

It can be helpful to create a risk acceptability table to determine the acceptability of each hazard and hazardous situation you identify. The table will need to be customised for your medical device, but an example of such a table is below.

Medical Device Risk Acceptability Table

In this example of a risk acceptability table, hazards or hazardous situations that are green are low risks while orange indicates a medium risk and red highlights high risks. Without further steps, only those that are green can be deemed to be acceptable.

In other words, hazards and hazardous situations that have a negligible severity of harm are likely to be classified as acceptable regardless of the probability of occurrence. Therefore, for these hazards and hazardous situations, no further action is needed apart from documenting why you reached this conclusion.

However, hazards or hazardous situations that could cause the patient or user a minor injury or worse would require further steps if you deem the probability of occurrence to be probable or frequent.

Those further steps would involve putting mitigation or control measures in place. Once you do this, you then need to estimate the probability of occurrence and severity of risk again to determine if the risk is now acceptable.

As you move further across the severity of harm axis, there is an increased requirement for the taking of additional mitigation and control steps, i.e. as the potential harm that can be caused becomes more severe and the probability of occurrence increases.

Readily Predictable Human Behaviour

When going through the above, you can’t simply assume that people will use your medical device the way you have designed it when you are identifying and evaluating hazards and hazardous situations. There is also a requirement for you to anticipate misuse or user error and to then:

  • Evaluate how user error impacts your existing acceptability evaluations; and,
  • Identify additional hazards and/or hazardous situations the user error/misuse creates.

To determine device misuse and user error under ISO 14971, you must take into account “readily predictable human behaviour”.

Benefit-Risk Analysis

In an ideal world, you would be able to determine that all the hazards and hazardous situations you identify are acceptable, particularly after applying control measures to those that needed them. In reality, however, this is not possible.

Even after applying all the control measures you can, you may still have risks that remain categorised as unacceptable. What do you do in these situations?

For risks that remain categorised as unacceptable even after all possible control measures are taken you will need to conduct a Benefit-Risk Analysis. Put simply, this means assessing whether the benefit outweighs the risk.

It’s important to note the phrasing of this in ISO 14971 as Benefit-Risk Analysis rather than Risk-Benefit Analysis. In the 2019 update to ISO 14971, more emphasis is placed on benefits, with a benefit being anything that has a desirable outcome or positive impact.

Data to Back-Up Your Evaluations

Finally, you need to document the above process in detail to get regulatory approval for your medical device product. To make sure this documentation is watertight when you submit it to regulators, make sure you gather data from everywhere.

This includes data from:

  • Published standards
  • Clinical data
  • Investigation results
  • Technical data
  • Results from your own tests
  • Information from user/patient complaints
  • Expert opinion
  • And more

The above data should clearly show how and why you reached your risk acceptability and benefit-risk analysis conclusions.

Medical Device Risk Management Plan – What You Need to Know

by Ger O'Carroll

As we have covered in a previous blog, risk management is essential when designing and developing a new medical device product. An important part of this process involves creating and maintaining a risk management plan.

Before going any further, it’s helpful to define risk management. What is risk management?

Risk management is not the act of carrying out a risk analysis at various points during the design of your medical device. This is an action that is part of risk management.

Instead, risk management is a process and, for that process to be effective, documented, and transparent, you need a plan – a risk management plan.

An Introduction to Medical Device Risk Management Plans

A medical device risk management plan should be put together in the very early stages of the product development and design process.

You then must review and update the plan regularly as the development progresses. In other words, a risk management plan is a document that evolves along with the product.

Key Questions Answered

What Is a Medical Device Risk Management Plan?

A medical device risk management plan identifies and documents all the activities you plan to take to manage risks associated with your new medical device. Medical device risk management plans are product-level documents.

How Does a Medical Device Risk Management Plan Fit into the Risk Management Process?

Your risk management plan is a planning document and should be part of your medical device risk management file.

What Does a Risk Management File Include?

  • Risk management plan
  • Individual risk analyses
  • Risk evaluations
  • Risk control measures
  • Evaluation of risk acceptability
  • Risk management reports

What Does a Risk Management Plan Include?

A medical device risk management plan should contain six important sections:

1. Scope of the Risk Management Plan

In this section, you should define the scope of the risk management plan. This definition should include a detailed description of your medical device including who will use it, who benefits from it, its lifecycle, etc.

You should also include the more formal intended use definition of the product.

Other information that should be in this section includes details of the quality management system.

2. Roles and Responsibilities

This section should include details of the risk management team. These are the people who are responsible for all aspects of risk management in relation to your medical device.

This team needs to be qualified and experienced medical device product designers. They also must know everything about the device from how it’s made to what it does to how it is used.

3. Risk Management Activities

This section is for outlining the risk management activities you will take over the entire lifecycle of the product. This includes details of the risk evaluation and mitigation process as well as information about your quality management system.

4. Criteria You Will Use to Determine the Product’s Risk Acceptability

Outlining acceptable risks for your medical device product is an important step that you should document in your risk management plan. Specifically, you need to define quality standards, margins of deviation that are acceptable, and the requirements for approval whenever deviations occur.

5. Measures to Verify Risk Control

In this section of your medical device risk management plan, you should include the quality assurance activities you will use to ensure the proper implementation of risk control measures. Examples of those activities include:

  • Design verification and validation testing
  • Shelf-life testing
  • Packaging testing
  • Shipping testing
  • Process validation

6. Measures to Capture and Use Post-Production Information

As already mentioned, a medical device risk management plan is a living document that remains relevant after the product has gone into production. Therefore, you need to outline the post-production risk management activities you plan to take.

This includes how post-production information will be fed into the risk management process to further manage, control, and mitigate risks as well as to ensure continued improvements in product quality.

Creating a Medical Device Risk Management Plan

The team you appoint to design your new medical device product should lead the process to create a risk management plan and establish effective processes. You will still be a part of these activities, however, so it’s important you have a clear overview.

An Overview of Risk Management in Medical Device Product Design

by Ger O'Carroll

Risk management is an essential part of the medical device product design process. It ensures the safety of patients, users, and operators so it’s no surprise that risk management is a regulatory requirement.

Risk management is also essential to the medical and commercial success of the new product you plan to develop.

In terms of the processes and steps required to ensure the proper management of risk, this is part of the Quality System that you need to have in place when designing a medical device product.

In addition to risk management, a Quality System includes management controls, document control, and more.

Risk Management and Getting Regulatory Approval for a New Medical Device

Risk management is a complex part of the regulatory approval process. There are several reasons for this, not least the fact there are many different variables that can impact risk type and severity.

In addition, the analysis of risk is often subjective which means there can be many different interpretations of the same risk.

On the positive side, regulators around the world all use the international standard ISO 14971. This provides a common framework for risk management when designing a new medical device.

How Do You Define a Risk in Medical Device Product Design?

A risk is a combination of two things:

  1. The probability of a particular event, situation, or outcome occurring
  2. The severity of the consequences if the above happens

What is Risk Management in Medical Device Product Design?

Risk management in medical device product design involves taking a structured and documented approach to analysing, evaluating, controlling, and monitoring risks.

Why Is Risk Management Important?

We’ve already touched on the essential role risk management plays in the regulatory approval process. However, its importance goes much further than this.

When you are designing and developing a new medical device, you have an obligation to ensure patient safety. You also need to ensure the safety of the operator or user of the medical device product if that person is different from the patient or person getting the benefit.

From a regulatory, moral, and commercial standpoint, this safety must be proven beyond doubt.

The Risk Management Process in Medical Device Product Design

Risk management in medical device product design requires a plan at the beginning which eventually leads to a report at the end. The process in the middle is the most important.

There are four main steps in this process:

The Risk Management Process in Medical Device Product Design

 

  1. Identify risks
  2. Evaluate risks
  3. Control risks
  4. Monitor the controls

Let’s look at each in more detail.

1. Identify Risks

The types of risks you can identify include:

  • Risks in the design of the medical device
  • Risks in how the device is manufactured

Both are important. To start with, does the design of the product itself create risks? Hazards the design might present include biological, chemical, or mechanical energy hazards, with vibration being an example of the latter.

What about the manufacturing process? What if parts are assembled incorrectly? What if there is a lack of consistency in a particular manufacturing process? What is the risk of these things occurring and what impact will they have on safety let alone the quality and reputation of the product?

2. Evaluate Risks

Once you identify risks you need to score them. For example, you could assess risk as being high, medium, or low. This will be based on the probability of the risk occurring and how severe the consequences will be.

3. Control Risks

This stage involves putting in place controls to eliminate the risks deemed to be unacceptable. In the classification example of risk above, this could mean developing and implementing controls for risks classed as high and medium.

The control measures you put in place usually fall into one of the following three categories:

  1. Changing the design of the product
  2. Changing a manufacturing process
  3. Implementing protective measures on the product or in the manufacturing process. Examples of this type of control include providing instructions for use or warnings on the label.

4. Monitor the Controls

Monitoring risk management controls starts by verifying the control measures have been implemented. You then need to analyse the effectiveness of the controls. This often means re-evaluating the risk to determine if it is now within an acceptable range (i.e. low risk) or if further mitigation measures are required.

Documentation

Finally, it’s crucially important that all the above steps are properly documented. This means recording all the actions taken in each of the steps as well as the results and decisions.

These records are usually included in the design history file and ensure you not only properly carry out risk management, but that you have documented proof.

Medical Device Design Verification and Design Validation – What They Are and Why They Are Important

by Ger O'Carroll

Design verification and design validation are essential parts of the medical device product development process. Sometimes referred to as V&V, it’s important to understand what both terms mean and how they differ if you are about to embark on a medical device product development project.

This is because V&V can take more time than necessary if proper design controls are not put in place in the early stages of the design process.

In other words, both design verification and design validation are made easier if you have well-documented user needs, design inputs, design outputs, and outcomes from design reviews.

What Do the Terms Design Verification and Design Validation Mean?

Design verification and design validation are terms that are often used together, but they mean very different things.

You then need to add to this mix the fact there are many different types of verification and validation, some of which apply to medical device product design and some don’t.

Design validation is only one type of validation. Another, by way of example, is process validation, a topic we have covered in a previous blog.

In this blog, we are going to focus specifically on design verification and design validation as they apply to Design Controls.

These definitions will help you understand the difference:

  • Design verification confirms the device was designed correctly
  • Design validation confirms you designed the right device

Let’s look at both in more detail.

The Design Verification Process

The objective of design verification is to demonstrate your design outputs (i.e. the medical device product you have designed) meet the design inputs (which you derive from the process of defining user needs).

It is good at this point to reference an image from the FDA we have published previously. It is the design control waterflow diagram and it outlines the design control process:

Design control waterfall diagram

So, in summary:

  • You start by defining user needs
  • You then use the user needs definition to create design inputs, i.e. you define what you want to design
  • Then, you go through the design process
  • The result of the design process is the latest iteration of your medical device product – this is your design output
  • Verification should happen at this stage to ensure the design output matches the design input

How do you verify the design? Testing is often a big part, but design verification often also involves visual inspections and analysis.

As stated previously, having good documentation helps ensure the design verification process is as efficient as possible.

Another good strategy to ensure efficient design verification is to consider how you will verify design inputs before moving forward to the design process. In other words, you should think about and plan for design verification at the earliest possible stage.

The Design Validation Process

Design validation confirms you have designed the correct product. So, design validation must refer all the way back to user needs.

Defining user needs is one of the first things you must do in the medical device product design process. The things this definition will contain includes:

  • The medical device product’s purpose
  • What the medical device does
  • The diseases, conditions, circumstances, or situations where the product will be used
  • Whether the medical device treats, prevents, cures, diagnoses, or mitigates
  • The type of patient who will benefit from the product

Design validation ensures the medical device design meets your user needs definition.

Design validation usually occurs when you are in the final iterations of the design process and it usually involves using a small batch production run of the product.

Importantly, the product must be fully produced including all packaging, labelling, usage instructions, and anything else that will be with the product when it is launched on the market. Everything must be validated.

The process itself usually involves clinical evaluation which often includes either clinical trials or simulated trials using, for example, mathematical modelling.

Another common approach is to compare the medical device product with a similar product already on the market that is used for a similar purpose.

Inspections and analysis are part of the process too, but testing is the most important method of design validation.

The Importance of Design Verification and Design Validation

Both design verification and design validation are essential processes to go through and document to ensure your new medical device product gets regulatory approval. The processes also improve the design of your product to give it the best possible chance of success.

Documenting User Needs – Key Questions You Need to Answer

by Ger O'Carroll

In a previous article, we outlined the importance of identifying and documenting user needs when designing a new medical device product. In that article, we looked at the two objectives you must achieve when documenting user needs:

  1. Defining the intended use of your new medical device product
  2. Defining the indication for use of your medical device product

This sounds straightforward enough but when you go through it in practice, the process can be quite tricky, not least because documenting it is a regulatory requirement.

So, how do you create the above definitions to complete the process of documenting user needs? An effective approach is to ask and answer a series of questions about your product including how and when it will be used, and who will use it.

Questions to Ask When Documenting User Needs

Here are some examples of the questions you should ask. This is not an exhaustive list, and some may not apply to your product, but they will give you an indication of the process you must go through.

  • What does the product do?
  • What conditions, symptoms, and diseases is the product designed for?
  • Is the product designed to diagnose, prevent, mitigate, treat, or cure?
  • Who will benefit from the product? When considering this question, think about the condition, disease, or symptoms the beneficiary suffers from, even if those conditions, diseases, or symptoms are not directly related to the product. Also think about things like age and gender as well as other defining characteristics.
  • Who will use your product?
  • Is the user of the product different to the person benefiting, i.e. is the user a medical professional or other third-party, or does the patient use the product on themselves? If the user is different from the beneficiary, who will be using your product?
  • When will the product be used?
  • In what circumstances will the product be used? For example, will it be used under clinical supervision, in a sterile environment, in an emergency situation, etc? Think of the environment, the people who will be involved, other people who might be nearby, etc.
  • Will the user use all the product’s features?
  • What are the stages the user will go through in order to use the product, i.e. remove packaging, remove safety features, prime the device, etc?
  • How will the user interact with the product?
  • If the user and the patient are different people, how will the patient interact with the product?
  • How long will these interactions last?
  • Does the product interact with other devices? What are the implications of that interaction?
  • How often will the patient need to use the product?
  • Will the patient use the product multiple times, or will they require a new product for each use?
  • If the product can be used multiple times, is there a maximum, or recommended maximum, number of uses?
  • How will used versions of the product be safely disposed of?

Documenting User Needs

Remember, you shouldn’t just think about the answers to these questions. Instead, you should also document your answers, so you have a record.

Don’t worry about the wording you use or the thoroughness of your answers. The key is to demonstrate and provide proof of the thought process that went into defining the user needs that your new medical device product addresses.

If you have an idea for a new medical device product and would like to speak to one of the product design and development experts on our team, contact us at Arrotek today.

How Design Changes Impact Medical Device Product Development Costs and Time to Market

by Ger O'Carroll

You have an idea for a new medical device – this is the starting point for all new product development projects. Where the project goes from there, however, the costs involved, and the timeline depends on a range of factors.

Examples include the complexity of the product, availability of funding, regulatory issues, medical trials, and more. Unfortunately, you have limited control over many of these factors.

That said, there is another factor that can have a substantial impact on the cost of product design as well as the time it takes to bring your new medical device to market. As an innovator, inventor, or entrepreneur with an idea for a new medical device, you do have significant influence over this factor.

Design Changes – a Necessary Part of New Medical Device Product Design

The factor we are talking about is design changes. This can be anything from superficial visual tweaks to major changes in how the product works or is used.

Making design changes is not only a part of the product design process – it is an essential part.

After all, an iterative design process is crucial to improving your product and ensuring it performs according to its intended use.

In other words, design changes to improve your product are important to making the product a success.

Crucially, however, the impact of design changes on development costs and timescales differs substantially depending on when those design changes take place.

The Earlier the Better

There is a well-known cost of design changes graph in the product design industry. It shows the potential cost difference of making design changes at various stages of a product’s lifecycle. Here is a representation of the image:

Cost of design changes graph

In summary, the later you make a change in the design of your product, the greater the cost.

We’re not talking small increases in cost here, either, as changes after the design is frozen and production tooling has been created can be thousands of times more expensive than making a change in the concept stage of the product’s development.

Impact on Time to Market of Late-Stage Design Changes

In addition to the cost implications, the later a design change occurs, the more work has to be redone. The change request could impact other aspects of the medical device too, meaning those aspects will also have to be reworked.

For example, a component might have to be redesigned to facilitate the design change but redesigning this component might also necessitate the redesigning of other components. This adds time to the development process.

In addition, design changes often mean new 3D models or CAD drawings have to be created. New prototypes of the product will have to be produced too if the design change request comes in after the prototyping stage.

It’s also likely the product will need to go through the verification process again and may even need re-validated. This causes further delays.

It’s easy in these situations for a product development timescale to drift by weeks or even months.

The Solution – and the Influence You Have

The straightforward solution to preventing these problems from occurring is to make decisions as early in the design process as possible.

At Arrotek, we have a six-step product design process to facilitate this decision-making. The aim is to establish an iterative design process, provide you with expertise from our design engineers, and encourage your feedback.

The process also involves getting sign-off at each step before moving forward to the next one, eliminating the unnecessary reworking of elements and the time delays that result.

Our experienced product design project managers lead the six-step process as we turn your idea into a working product. You play a critical role, however, particularly in relation to ensuring decisions are made early and are then adhered to.

By following this approach, you will keep a cap on design and development costs, and you will keep to your schedule for bringing the product to market.

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.