If you ask me the most important aspect of a medical device product development project, the answer most definitely is Design Inputs.
Design Inputs are the foundation for your project and ultimately the medical device you plan to launch to save and improve lives. And this is the essence and intent behind Design Controls. Establish a framework for medical device product development to ensure products are safe and effective. I read a statement in the FDA Design Controls Guidance that defining Design Inputs should take 30% of a project.
I know from my experience, I always felt like I could have spent just a little more time defining the Design Inputs. And extra time was rarely a luxury. Schedules and due dates were discussed way more often than quality of our documentation. Don’t mishear me, quality was important; it was just expected and maybe somewhat taken for granted.
A Few Tricks for Design Inputs
We all know how important Design Inputs are to your project. And I suspect your project is similar to many of mine from the past: you are under some amount of pressure regarding schedule. But I think the FDA might be right. Design Inputs should take 30% of a project. So we have to figure out a few tricks in order to make this happen.
It Starts With User Needs
Capturing User Needs is one of those things that seem to rarely happen on a medical device product development project. When User Needs are captured, they seem very incomplete. Your Design Inputs are going to depend on the quality of the User Needs. And since an unmet clinical need of some type is why you are pursuing this medical device to begin with, articulating User Needs is important. User Needs feed into your Design Inputs and get Design Controls started.
It may not be your “job” to document the User Needs. You have way too much on your plate to begin with. I know. You might also be asking how do you capture User Needs?
There is really no right or wrong way, as long as you approach it from the point of view of the end-user and the patient. Think of what is important from their perspectives. And it’s okay to be fuzzy, meaning you don’t have to have tons of specifics and details.
I like to think about what happens from the moment the product leaves my facility until it is ready to be discarded after use. Everything that happens between this events will be User Need material. Just do a walk through.
And write it down! Think of User Needs as independent statements.
But this post is about Design Inputs. How do User Needs help you with these? Remember, User Needs feed directly into Design Inputs.
Yes, I know, you’ve had plenty of projects where the User Needs provided just flat out sucked. And you were able to create your Design Inputs just fine then. Why worry about User Needs? Design Inputs describe the functional, performance, and safety requirements of your medical device. Design Inputs define what your product needs to do. Design Inputs are really just an extension of User Needs but stated in a way that can be proven objectively.
Getting User Needs “right” will improve the quality of Design Inputs dramatically.
Get Other Team Members to Help
I just talked a little about User Needs being a trick. Related to this is finding a way to get other team members involved. Usually, engineering owns the Design Controls, and often times drives the medical device product development process.
Most projects also have other team members involved, representing other functions. And there is probably at least one team member who represents “voice of customer” and is involved with end-users. Get this team member to help you with User Needs.
Prototypes Help With Design Inputs
If you spend 30% of your time defining Design Inputs, your boss may become frustrated. The reason is that spending time on documentation is not tangible. You can’t put your hands on Design Inputs. And your boss wants something tangible.
But spending 30% of your time defining Design Inputs is going to make your medical device product better.
Here is a trick to help satisfy your boss with something tangible while also helping you to define better Design Inputs. Make prototypes.
Prototypes can be useful for all sorts of things. You may be thinking that prototypes are useful for testing purposes. And you would be correct.
Prototypes can also be useful to help you define Design Inputs. The prototypes don’t have to be 3D printed components. They can be crude prototypes. Something you can hack together quickly and inexpensively.
Proof of concept prototypes are useful. Plus, they serve as a great way to communicate to your boss and project team and will help you define Design Inputs.
Jon Speer has been in the medical device industry for over 16 years. In 2007, Jon started Creo Quality to help medical device companies with project management, quality systems, and regulatory submissions. As a result of his experience in the medical device industry, Jon had an idea to develop a software solution to improve how companies handles Design Controls. Because of this greenlight.guru was born. You can find him on Google+,Twitter, and LinkedIn.