Medical Device Product Development Case Study

October 3, 2014

Medical Device product development is a very challenging endeavor.

Even the simplest product development project can have all sorts of twists and turns before being market-ready.

Few would contend that developing a medical device is anything close too fast.In fact, the simplest product can easily take a year or longer to launch.

Why is medical device product development so challenging?

The quick, easy response is regulations.

More specifically, in the U.S., the FDA. Those three letters can strike fear and often becomes the easy scapegoat for medical device companies.

I'm not here to argue whether or not FDA makes medical device product development slower and more challenging than it needs to be.

Instead, I'd like you to think for a moment about a medical device product development project you're either working on or worked on in the past.

What went well? What parts of the process were smooth and efficient? What parts of the project did not go well? What parts of the product development efforts were bumpy and time-wasters?

Go ahead, make a short list... 

I speculate that you could easily lose hundreds of hours and tens of thousands of dollars in delayed revenue for every medical device product development project you have.

Let me suggest a few things that were bumpy and time-wasters from some of the medical device product development projects I've been part of:

  • There are limited tools and solutions available to help medical device product development project teams with effective communication and collaboration.
  • Important documents get buried in emails, local hard drives, network folders, battleship document management systems, etc.
  • Meetings . . . I could stop there but will expand. There are so many meetings called during product development in an attempt to communicate and get the team on the same page.
  • Team members change throughout the project. Getting new team members up to speed takes time and effort.
  • Ensuring Design Controls are kept up to date usually takes a back seat.
  • Putting together a regulatory submission (such as a 510(k)) takes more time than anticipated.

I could go on.

But you get the point.

I also suspect you have (or are about to) faced similar challenges with your medical device product development efforts.

I'm guessing, too, you have no clue just how many hours you lose during product development projects.

I didn't either. And then I decided on one project to actually keep track. Let me share what I discovered.


Medical Device Product Development Case Study

First, let me give you a little background on the medical device product development project.

The project was a FDA class II device, requiring 510(k) market clearance.

The company is a startup, and relied on third party resources for mechanical design, electronics design, software design, manufacturing, and project management.

The project lasted roughly 18 months.


In the beginning

At least 38 hours were lost during the first few months of the project.

Where was the time lost?

Sending, receiving, retrieving, and updating documents via email accounted for 20 hours. The team had to rely heavily on email to communicate and collaborate.

Another 18 hours were lost driving to and from multiple face to face meetings.


Project Team Changes

Getting the initial team up to speed and going took time. More time was required when the team members changed.

Getting the right documents to the new team members easily took 10 hours.


The Middle

The "meat" of the medical device product development happened in the middle stage of the project.

The team realized email was poor at best for collaborating. Lots and lots of meetings became the alternative.

Again so much time was lost just driving to and from meetings: 80 hours.

All the meetings meant more documentation. And coordinating feedback and updates from the project team.

Another 30 hours were spent on dealing with document updates.


Deep Dive Into Development

More and more documentation. Email! Ugh.

No good way to communicate or collaborate. Emails flying back and forth. Documents being saved on each team member's hard drive.

And the need to start extracting information contained within the documents to support a 510(k) submission was critical. 40 hours lost.


Continuing Towards Launch

Moving closer and closer to production and launch meant the addition of new team members and resources. Each new addition required preparation of a documentation packet.

Another 20 hours lost. But at least the end was in sight with 510(k) being in review at FDA. Right?


Production Readiness

With FDA clearance near, it seemed as though the hours and hours lost during this project would slow down.

But as contract manufacturing got more and more involved, there were numerous requests for drawings, specifications, and other project documents. And more meetings, driving to and from.

Manufacturing had questions--questions that had been asked and answered several times throughout the project. 44 more hours lost.


Getting FDA Clearance

Optimistically, we hoped to get FDA clearance without any questions. Wrong.

The questions were not simple and easy to address. They required collaboration and communication and meetings with the team.

Did I mention we relied heavily on email to collaborate? Chalk up 40 hours lost.



Did you keep track of all the hours lost during this medical device product development project?

I'll help you out: 312 hours.

I don't know what you pay per hour. You can do that quick math.

More importantly, imagine if you could have SAVED these 312 hours during the project? That's almost 8 work weeks.

How much does each product sell for? How many do you sell in a month? Could you imagine generating revenue 8 weeks earlier?

Would that matter?

Quality Management Software

Jon Speer is a medical device expert with over 20 years of industry experience. Jon knows the best medical device companies in the world use quality as an accelerator. That's why he created Greenlight Guru to help companies move beyond compliance to True Quality.

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