Medical Device Development in 5 Steps

The medical device development process is usually divided into five different steps. Each of these phases requires intensive planning, complete documentation and controlled collaboration between teams in order to be successful.

By understanding how the five steps of medical device development are related to one another and how their results can be stored, shared and controlled using the right quality management tools, companies can determine the feasibility of projects much more quickly and their product with greater success.

The Difference of Medical Device Development

Technical Safety and Clinical Effectiveness

Every medical device company must prove this. And in contrast to other industries, there is the following triad: patients, users and third parties. They all need to be considered for safe use during and after development, this must be evaluated again and again by means of strict risk management and, if necessary, countermeasures must be initiated.

Companies who want to bring a medical product onto the market should also make it clear beforehand which markets they want to go to, whether they want to develop and produce the product completely themselves or outsource individual steps. This sets the course for the scope of the procedure before it is launched on the market.

For the EU, the following applies in a very simplified way:

Establish a suitable quality project management system ,
Pass the audit,
Obtain an ISO 13485 certificate,
Document compliance with the so-called basic requirements
Set up technical documentation and, last but not least,
Submit it to the notified authority for inspection.

Only when all of these requirements are fulfilled, will you have a reason to celebrate.

What are the 5 Steps to Medical Device Development ?

Step 1 - Brainstorming & Risk Analysis

This first step of medical device development involves brainstorming, followed by an opportunity and risk analysis that decides whether you can and should proceed to the next step.

Activities in this phase include:

Define what the product should do and what its unique selling point will be. This is about defining if the product and the market fits together.

Ask yourself:

Is there enough demand and uniqueness to the product that it is worth developing?
Decide for which markets you want to develop your product. Do you intend to sell your product in the EU and the US?
What category the product is likely to fall into?

This is important as it depends on how much time and money you have to spend to get the product onto the right market.

Step 2 - Conceptualization and Feasibility

At this stage, a more formal risk assessment takes place. Regulatory and consumer requirements are captured, with an initial prototype serving as a Proof of Concept for further testing before the project moves forward.

You will now document detailed client needs, gather feedback through surveys and research with patients and clinicians. All this is complemented by competitive analysis and market research to underpin your planning and designs.

These customer needs form the basis of the initial design and development work that supports conceptualization and proof of concept through the creation of prototypes of all or part of the intended product.

At the end of this step you will know if the concept is viable, if it can be translated into a product that can be manufactured for practical use in the marketplace while also meeting customer needs in a way that enhances or replaces existing solutions.

Step 3 Verification and Validation

This phase is all about controlling the design and development of a medical device to ensure that you:

Effectively capture user requirements
Transforming user requirements into effective technical specifications
Design and build your product according to these user requirements and specifications

The user requirements are further captured and converted into a User Requirements Specification (URS) document.

Step 4 – Final Validation, Product Testing & Authority Approval

All data and documents must be compiled in such a way that they can be submitted to the authorities for product approval, including the results of the clinical trials.

This part of the process includes verification and auditing by the Notified Bodies in the UK or the FDA in the US. You need to validate your process and product through an inspection of your premises and a detailed analysis of specific technical documentation, including:

The Device Master Record (DMR) – The definitive “instructions for use” for safety and proper manufacture of your medical device.
The Design History File (DHF) – The complete record of how this manual was originally designed and compiled.
The Device History Record (DHR) – The verifiable proof that you have used this manual in the manufacture of your product.

Step 5 – Product Launch and Post-Launch Evaluation

Once you have received go-to-market approval, you must submit your plans to your chosen manufacturer for production.