The early days of a project are critical, as this is the time where the project definition is shaped and solidified.

An important role of a project manager is to ensure that there is a strong rudder to guide the project.  It requires discipline to avoid sprinting into the design work at lightning speed, but in the long run this discipline is rewarded in terms of producing a high quality product, while minimizing costly design changes.  Moving quickly is of little benefit if it is in the wrong direction.

Following are five key areas within the medical device field to hone your focus, and help ensure that early requirements definition are well formed to solve the right problem.

Know Your End User

Who are they?  What is most important to them?  What are their challenges, and where are the areas that can be helped the most?  What is the work environment like, and what are the routine operations that the device cannot impede?  Interviews with KOLs (Key Opinion Leaders) or experts in their field can be very beneficial at this point to better understand activities of the end user.  Market surveys can be useful tools for consumer devices.  Options available include detailed analysis through specialized market research firms, as well as light weight web based surveys.  This is the time to dig in and deeply understand the problem.

Once the problem is clear, try to take a step back.  Resist the urge to solve the problem until you fully understand the whole picture.

Think Big – Understand the System

As technology advances, the medical device field is becoming increasingly complex.  Historically, many devices had one specific task or purpose.  More and more, devices are becoming part of integrated systems.  In a 2013 report, the West Health Institute (WHI) estimated that improving interoperability between medical devices and across health records could save more than 30 billion dollars a year:

Increased integration of data is extending both inside and outside of the hospital facility.  As demographics shift, and the Baby Boomers get older, providing health care in a smart economic way becomes increasingly important.  One way that technology is working to drive cost down is through telemedicine and various health monitoring devices:

Where does this device fit into the big picture?  Where could it fit in the big picture?  Defining the system and the implications of where a solution can help maximize the device’s potential and its success.

Make a Model

If a picture is 1000 words, then a model can provide a novel of information.  Models can take many forms including low fidelity cardboard, 3D printing, conceptual sketches, or a GUI wireframes.  This process can quickly and clearly expose requirements that may be nearly impossible to uncover with a pen and paper exercise.  It also helps align the design team with the user needs.

Understand the Regulatory Pathway

What standards or regulatory bodies apply to the device?  Does the device fall under the Food and Drug Administration (FDA)?  If the answer is yes, then are there potential predicates available?  The characteristics of these potential predicates can help shape the device requirements.  If no predicates are available, and the device is instead 513(g) or De Novo, this is beneficial to know upfront in order to plan the potential release timeline.

As a guideline, a Boston Medtech Advisor 2010 Report cited a De Novo average total review time of 482 days, while the Emergo Group reports a 510(k) submission can typically fall between 3-6 months:

An additional item to keep in mind is whether the device could be applicable for the FDA Expedited Access Pathway (EAP).  To find out more information, here is a link to the informative blog Virginia Anastassova wrote earlier this year:

Keep an Open Mind

During refinement of the requirements, as the problem is viewed from different angles, the product definition can shift and change as new discoveries are made.  This is an important part of the process.  Keeping an open mind during this initial phase provides the design freedom to create a solution that will lead to the product’s success.

With a solid requirements in place, and clear direction, your medical device project can charge full steam ahead with confidence.