Modern medical devices designers have the difficult task of trying to take on the role of both engineer and medical expert at the same time, meaning a new product development company has to spend extensive resources and design time submitting and resubmitting models for review by the appropriate authorities.
An ideal way around these obstacles is by involving medical professionals into the design process from the earliest stages of conceptualization. How? By using functional decomposition to identify key processes, create clear goals for needed inventions and make sure solutions work on paper before blindly forging onto mechanical design and prototyping.
How To Apply Functional Decomposition to Medical Device Design
The premise of functional decomposition is simple: to break down key functions into their most essential sub functions in an easy-to-understand diagram. Engineers first state a device’s proposed purpose in simple terms. Then they conceptualizing each step required for the development process:
- General functions
- Sub functions
- Basic functions
- Object of actions
- Causes of actions
Can this method be applied to medical device design? Absolutely. Product development companies just need to assign new tags to familiar functions:
- Performed_On: The patient – or patient organ – becomes the recipient of an action.
- Performed_By: Doctors or components that cause an action.
- Has_Environment: Environmental considerations such as sterility are stated.
- input_flow: Indicates the need for mechanical energy in the procedure or device.
- output_flow: Refers to the action of removing unneeded material from the patient’s body during a procedure.
These brief tagging examples show how even complex medical procedures or required medical actions on the part of a device can be broken down in a functional decomposition diagram, before ever starting to design a physical model.
An Example of Functional Decomposition in Practice
Consider the gastric compression band. What is the overall function of this simple device? To reduce the size of the patient’s stomach. This requires creating a diagram of the object – the stomach – and the action of applying compression from the medical device – the band. A simple flow chart indicates the steps required, including the presence of a new physical device.
Advantages of Using Functional Decomposition for Medical Device Creation
Here’s why taking the time to convert medical knowledge into digital data is valuable for medical device designers in many situations:
- A searchable database reduces time needed to find effective subcomponents.
- Past designs can be easily extrapolated from and expanded upon.
- Larger teams offering engineering design services can work simultaneously.
- Time-to-production is reduced for many complex devices.
By creating detailed functional diagrams prior to embarking on the medical device design services they were contracted for, the new product development company would have to start from scratch every time. In a way, functional decomposition becomes a pathway to new medical procedures. By employing functional decomposition, perhaps other product development companies in Philadelphia can be a translator that helps doctors and engineers understand each other clearly when talking about patient needs.