ThinkMedTek

I started in medical device development in October of 2021. Previously I had some interaction with the medical industry, but it was always from the standpoint of providing parts to them and making adjustments to their requests. Yes I had some interactions with regulations, but it was minimal. When I got my job at a medical device company, needless to say I was a bit overwhelmed. On top of the many steps and design stages you had to go through in industries such as automotive and consumer products, you have the added steps of human factors engineering and medical device regulation. While there are a lot of moving pieces to tackle, you can tackle it in the same way you would eat an elephant; one piece at a time. Start with a plan and know where you are going and go from there. While you develop your plan, here are 5 phases I would include in your medical device development.

1. Identify User Needs, Inputs, and Outputs

To start off the development of your medical device you first need to know what your aim is and what you are designing for. To start off, identify the user’s needs. You can get this information by getting feedback and by looking at the market. This allows you to see what exactly the customer is looking for. Next identify the design inputs that will be a part of your device design. These inputs will be derived from user needs and is an iterative process that converts requirements into “device design starts.” After you have your inputs you will need to identify what you design outputs need to be. This process will confirm whether your specifications are meeting the requirements you established. (2)

2. Develop a prototype

Once you develop the requirements and specifications needed for your medical device, it is time to build a prototype. Developing a prototype can do a lot for your design process. First it identifies whether you are meeting your user needs and the specifications you established. It also provides proof of concept for your design and whether your idea will work or not. Finally it provides a basis to begin looking at the regulatory process.

3. Validation and Verification

To prove your design you will want to take your device through validation and verification. When going through this process be sure to answer the following questions:

• How are your user needs fulfilled?
• What type of testing is needed to verify and validate your device?
• What processes are needed in designing, developing, validating, and verifying your device?
• What kind of test equipment do you need?
• How is your device being manufactured?
• How is quality being controlled?

While this is not a comprehensive list of questions regarding the verification and validation process it will help you get started in thinking through it. (3)

4. Regulatory Approval

This is perhaps the most stressful step of developing a medical device and the most crucial. Regulatory approval is important in allowing your product to go to market. Without it your product will not be able to go past the development stage. When you are getting regulatory approval you will be audited and will want a few key documents ready to go. One document you want to include is the Device Master Record (DMR). This document details how your device is being made in a safe and compliant manner. The next document to have is the Design History File (DHF). The DHF is a record of how the instruction manual of DMR was created and compiled. Another document to include is the Device History Record (DHR). This document is proof that the DMR has been used in manufacturing. (1) These documents are important to have. There are many other documents you will want to have ready as well so be sure to prepare well when submitting for regulatory approval.

5. Launch your Product and Assess

This is the most exciting phase of any project. All the hard work you did has finally paid off and now you can launch your device. As part of your product launch be sure to have all your technical documentation completed and up to date. In addition to this, create a system that allows feedback and complaints to be captured. This will allow you to see how your device is doing in the market and is an opportunity for improvement. (3)

While this is not a complete overview of the medical device design process, it does give you a good start of what to include. As you work through your project ensure that you have the right expertise for each stage of the design whether that is mechanical, electrical, regulatory, manufacturing, etc.

Sources:

1. Byrne, Joe. “How to Develop a Medical Device; the 5 Phases of Med-Tech Development.” Lean Document Management for Medical Device and High-Tech Product Development, Cognidox Ltd, 7 Sept. 2022, https://www.cognidox.com/blog/develop-medical-device. 
2. Borad, Anand. Medical Device Design and Development: A Definitive Guide, 12 Aug. 2021, https://www.einfochips.com/blog/medical-device-design-guide-for-medtech/. 
3. “Understanding the 5 Phases of Medical Device Development.” Greenlight Guru, https://www.greenlight.guru/blog/5-phases-of-medical-device-development.

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