There are costs involved in designing and developing the idea you have for a medical device. Those costs can vary, however, depending on a range of factors. This includes the complexity of the device and the intended use.
Understanding the costs of designing and developing your idea for a medical device is an important part of the business planning process. For example, it will help you understand the level of funding that you require, it can influence the timeline for the project, and it will start to build a picture of the commercial viability of the product.
The Stages Involved in the Process
At Arrotek, our engineers have developed a tool that will give you an instant estimate of how much it will cost to design and develop your medical device idea. The estimate covers the six steps of our medical device design process:
- Requirement specification – defining the critical user requirements of the device, creating a specification document, etc.
- Concept generation – the ideation part of the process where our design engineers generate potential concepts and solutions.
- Concept development – further development and filtration of the concepts agreed as having the best potential, including creating 3D CAD models and exploring potential manufacturing methods.
- Stage 1 prototype – production of physical rapid prototypes of the concepts for review, testing, and assessment.
- Concept refinement – selecting a single design to progress further and refining the product, particularly in relation to Design for Manufacture (DfM) and Design for Assembly (DfA).
- Stage 2 prototype – the final step involves creating high quality prototypes based on the, refined, and improved design. The prototypes produced in this stage are fabricated so they are suitable for further bench testing and in vivo studies.
Step-By-Step Guide to Estimating Medical Device Design Costs
The Arrotek Medical Device Design & Development Estimate tool is the best approach for getting a quick and accurate estimate of the cost of taking the idea you have for a new medical device product through the various design stages to a point where you have a working prototype.
Step 1 – Getting Started with the Calculator
- Visit the calculator page on the Arrotek website and click Start
Step 2 – Enter Your Details
- Click the checkbox if you wish to receive the Arrotek monthly newsletter, then click to approve our use of your data to provide you with the estimate.
- Click Next
Step 3 – Stage of Development
You can decide to work with experienced medical device design engineers at any stage of the development process. This includes:
- Concept generation – where there is a kernel of an idea, but it needs further work before moving onto the development of product concepts.
- Concept development – where the main user requirements and functional specifications are known, allowing for the development of potential concepts.
- Prototyping – where you have advanced product concepts and, potentially, 3D CAD models, and now need to develop a physical prototype for further analysis and testing.
- Concept refinement – where you have a prototype and need to go through the next stages of the iterative design process, as well as to look at and make decisions on DfM and DfA considerations.
- Clinical trials – where you are ready to produce a final working prototype that can be used in clinical trials.
In our estimate tool, click the option that is most applicable to your project, and click Next.
Step 4 – Target Markets
All medical devices must go through regulatory approval processes in the markets you intend to target. In other words, your medical device product will need a CE mark issued by a regulatory body in the EU if you want to target countries in Europe, and it will need FDA approval if you want to target the US.
Over recent years, the regulatory landscapes in the US, the EU, and other countries have become more and more aligned. This reduces the complexity of the design process when considering regulatory requirements. However, differences between regulators in different jurisdictions remain, so they must still be taken into account.
So, the next step in the process involves selecting the markets you intend to target. You can select more than one. Click Next to continue.
Step 5 – Device Complexity
The complexity of the device you want to develop will have a significant impact on the costs involved. While there are multiple factors to consider, the general rule is that the more complex the device, the more expensive it will be to design and develop.
At Arrotek, we have grouped the complexity of medical device products into four categories:
- Simple medical devices such as syringes, sutures, etc.
- Moderately simple medical devices such as urinary or drainage catheters
- Semi complex medical devices such as diagnostic and therapeutic catheters
- Very complex medical devices such as devices used for structural heart repair procedures
Select the option that applies to your medical device and click Next.
We have a bonus tip here before moving on with the next steps in the process. At each stage of our cost estimate tool, you have the option of requesting a call back from one of our engineers.
So, if you need help with one of the questions in the tool, or you would prefer to discuss the factors involved in developing your idea with an expert, simply click the Ask an engineer button below the form.
Step 6 – Funding
Funding methods for your medical device product idea can impact the process in various ways, including the timeline involved, the requirements of funding milestones, and who is involved in the iterative and approval aspects of the design and development process.
In the estimating tool, select the option that best describes the funding plans for your project. The options are personal funding, grant funding, investor funding, or venture capital funding. You can also select other if your plans for funding are not covered by these options, or the no funding option if you have not yet progressed to this stage in your project. Click Next once you’ve made your selection.
Step 7 – Organisational Progress
You will need to take steps in your organisation to ensure there is a proper framework in place for the design and development process to begin. You might already have this framework in place if you represent a company. On the other hand, you might need to go through the steps required, whether that is the formation of a company or another route you choose to take.
It’s important to have these elements in place to ensure the process goes as smoothly as possible. Examples include the feedback and approval processes, both of which can impact the project development timeline if there are delays.
Another example is having the right people in place at the beginning of the project, particularly as new people can bring new ideas and perspectives that can alter the direction of a project.
New ideas and perspectives can result in changes. Those changes will have minimal cost implications if they are made at the beginning of a project. However, the cost of change rises considerably the further into the process you go.
To complete the next step in our cost estimate tool, indicate when you think you will have the necessary resources in place to begin the work. Click Next when done.
Step 8 – Review Your Estimate
You will now receive an estimate for the cost of designing and developing the idea you have for a medical device.
As you can see from the step-by-step guide, our tool doesn’t go into specifics about your idea, not least because of intellectual property and patent considerations. Therefore, the estimate is a guide.
It does, however, provide a useful additional piece of information to help you decide on the next steps.
For further information and advice on designing and developing a new medical device product, please get in touch with us to speak to one of our engineers.