Risk Management & My First Clinical Experience

I had my first real experience with medical device risk management 15 years ago, yet I didn’t realize it at the time.

I was a product development engineer, designing airway devices, central venous catheters, and other critical care devices.

I inherited a project that had been passed from one new engineer to the next. I was thrilled to receive it. I was young. Hungry.

The purpose of the project was to redesign a double-lumen catheter introducer, used to monitor pressure while offering a working channel to place a Swan-Ganz catheter.

The advantage of the introducer would provide an extra lumen, or channel for fluid infusion and pressure monitoring.

Journey into Design Controls

As I mentioned, the company already had an existing double-lumen introducer on the market. However, the product had a few issues and was not used very often.

I was a sponge. I dove right in to learn as much as I possibly could about introducers, Swan-Ganz catheters, the clinical procedure, and so on.

Swan-Ganz placement (courtesy of http://www.nlm.nih.gov/medlineplus/ency/article/003870.htm)

Swan-Ganz placement (courtesy of http://www.nlm.nih.gov/medlineplus/ency/article/003870.htm)

By this time in my young career, I had a chance to go through the Design Controls process a time or two. Granted, the previous times were for product modifications and line extensions, which was great “practice”.

And this project may also sound like a product modification. However, this was not my approach.

I was searching for a wow.

While the existing product was good for my feasibility and research, I planned to design a brand new double-lumen introducer. It would be a brand new product.

In addition to all my product research, I also spoke to several physicians to gather User Needs.

Without taking you step by step, I led the design, development, regulatory submission, and launch.

double-lumen introducer (image courtesy of Cook Medical)

double-lumen introducer (image courtesy of Cook Medical)

The first clinical experience

Taking the product idea through the design and development process was fun and exciting.

One day, my boss asked me to get a few kits ready for actual clinical use. This, too, sounded very exciting.

We had solid performance testing. All biocompatibility, sterilization validation, packaging, and other safety testing was completed and satisfactory.

The benchtop simulated use testing demonstrated the product worked.

The product was ready for clinical use.

Gut check time

I traveled to Detroit, with a few double-lumen introducer kits in hand, to meet with an anesthesiologist about using the product–my product.

Upon arrival, I did a short product demonstration / walk-through with the physician.

He then showed me where to change into scrubs.

My heart was racing.

I was very excited.


How often does a medical device product developer have this opportunity?

Donned in scrubs, I was directed to a rack with face masks, bonnets, and shoe covers. Once applied, I was then directed to the correct operating room. I was invited to enter.

I could feel sweat collecting, matting against the fiberous material of the bonnet on my head. I could feel my breath bounce off the mask and hit me in my face. My heart felt like it would escape my chest.

I was nervous. And the reasons why were not obvious to me at that moment and time.

As I entered the OR, I internally freaked. Should I call the whole thing off? Is my product truly ready for clinical use?

I fought through those knee-jerk reactions and found my place next to the anesthesiologist. Within a few minutes, he opened one of the double-lumen introducer kits, grabbing a needle and syringe.

With grace, the anesthesiologist located the left subclavian vein and inserted the needle at an acute angle. A small amount of blood began to exit.

Almost without looking, he next grabbed the guidewire and navigated it through the needle. Once in place, needle out and discarded.

And then the moment of truth.

He grabbed the introducer near the tapered tip end. He meticulously directed the guidewire into the opening and smoothly directed the introducer into the patient’s subclavian vein. While doing so, the anesthesiologist rotating and advanced the device with one hand while holding onto the guidewire now exiting out the distal end with the other.

Within a few seconds, the procedure was completed and a double-lumen introducer was in place.

It felt like hours.

It was intense.

The purpose of good Design Controls

When I designed the double-lumen introducer, I had a decent understanding of Design Controls. I didn’t fully appreciate their purpose, however, until much later.

At that time, I did not have a good understanding of Risk Management. Sure, I completed a design FMEA. But doing so was really a check box activity. I had no real grasp of the purpose of Risk Management.

Design Controls & Risk Management are like twins

Design Controls are intended to demonstrate that a medical device has been:

  • Designed to address the needs of users and patients.
  • Designed to meet inputs and requirements.
  • Prove the product meets applicable standards.
  • Meets performance criteria.

Ultimately, Design Controls demonstrates your medical device is SAFE for use.

Inherently, Design Controls is part of Risk Management.

Think about it.

Your reasons for implementing Risk Management practices are to identify, evaluate, analysis, assess, and mitigate potential product issues.

Design Controls and Risk Management are like twins.

But not identical twins.

Design Controls is also a way to identify, evaluate, analysis, assess, and mitigate potential product issues. Yet, Design Controls comes at this from a different perspective versus Risk Management.

Good Design Controls reduces risks

During my double-lumen introducer product development, I know my Design Control practices were decent.

I was pretty thorough when defining user needs and design inputs. I documented design outputs. I followed several industry standards and conducted numerous design verification activities.

Prior to clinical use, I knew without a doubt that the product was safe.

Embrace this in your own medical device product development efforts.

Realize Design Controls and Risk Management are related. Realize that your overall goal is to prove and demonstrate that your product meets clinical needs and is safe and effective.

Design Controls is NOT a substitute for Risk Management

When I developed the double-lumen introducer, I had very little appreciation of the importance of Risk Management. I treated this like a check box activity–something I had to do because the company procedure said so.

And as I stated just above, Design Controls are a way to address product risks during the product development process.

But don’t make the mistake that I did and treat Risk Management as a check box.

Realize that Risk Management is just as important (maybe more so) than Design Controls.

Realize that Risk Management is a way to evaluate your product from a different perspective.

Realize that good Risk Management involves a series of tools, when used properly, will drastically improve the quality, safety, and effectiveness of your medical device.





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 handle Design Controls. Because of this greenlight.guru was born. You can find him on Google+Twitter, and LinkedIn.  


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