How some medical device companies manage to trip over their own feet? The answer to this lies in the fact that they try to get away with good enough and consequently end up earning a reputation for sloppy work. However, the biggest mistake any company can commit is by putting the risk management, verification and validation at the end of the product development project instead of building it from the start. We have compiled a list of common mistakes that happen in some medical device development companies. You can take a cue from these mistakes so as to shun them in your organization.

• Not focusing on the user

It is essential to validate that the specifications of your medical device conform to the user needs and intended uses. You should not forget the main reason why you are developing a product. The user must be ideally involved in the process of documenting user needs right from the beginning of the product development.

• Not documenting DHF or design controls

Sometimes the developers may get so focused on the end result that they forget the process which has to be followed and fail to document and capture what they should. Design history file and design controls are often missed out thinking they can be documented later. However, the development may move so fast that you won’t be able to recall what should have been documented. The DHF and design controls are amongst four must-haves of a quality management system (QMS).

• Delay in implementing QMS

There should not be a delay in setting up the quality management system. Few basic, core procedures and right process are needed from the beginning of the medical device development. QMS is a basic requirement which is usually inspected by FDA and other relevant regulatory authority.

• Failure to Plan

Planning is essential to identify critical interfaces in your project, resources required, milestones you have to achieve and when you will have design reviews. By planning you can ensure that you are operating in the manner which is designed to get your product to the market as soon as possible. Get acquainted with the road which you need to navigate through while developing medical device so that you can plan accordingly.

• Not able to define regulatory strategies

At times developers may underestimate the regulatory requirements they need to follow for their particular device. You may need to classify your product early on before defining your regulatory strategy. Classification of the medical device is based on the indications for use and so as to classify it properly, you will need to have a clear understanding of classification. The classification will determine how the different regulatory agencies will look at your device.

• Disorganized documentation

You need to keep all your documentation organized to save yourself from the possible regulatory issues that may pop up at a later stage. Electronic systems are recommended over paper-based documents.

The medical device designers must focus on well-defined engineering process and regulatory control of the development process. During all phases of Medical device development lifecycle – risk management, reviews and verification testing should take place. Following a controlled process make both engineering as well as business sense and is simply the best thing to do.