Cardiovascular devices operate within a complex, constantly moving biological environment that directly determines long-term performance and durability.

With the launch of our new service, VIBE Solutions, delivered in cooperation with Dr. Christopher Cheng — President of VIBE Solutions, Adjunct Professor of Vascular Surgery at Stanford University, President of CVID, and author of the Handbook of Vascular Motion and more than 100 publications— we bring biomechanical insight earlier into device development.

In this interview, Dr. Cheng explains how bringing biomechanical insight to the earliest stages of development enables the creation of more durable, predictable, and clinically reliable cardiovascular devices.

When you look across cardiovascular device failures, what do they most often have in common beyond the immediate technical cause?

The most common cause of failure is not fully appreciating the dynamic in vivo environment, which affects all downstream device development, including design, testing conditions, and clinical trial inclusion criteria.  When a device is exposed to an unanticipated environment, it is not surprising that it could fail.

What part of the cardiovascular environment is most often underestimated during device design and early development?

Historically, 10-20 years ago, the most often underestimated aspects were related to cardiovascular dynamics from musculoskeletal motion, such as walking and running.  This causes the blood vessels in the pelvis and leg to deform dramatically.  Today, the edge cases of clinical use are often underestimated, for example, the largest treatment sizes, the greatest oversizing, and device overlap.

How do you define biomechanical compatibility in practical terms, and why does it matter so much for long-term device performance?

Biomechanical compatibility is the basic concept that a device must be mechanically harmonious with the in vivo environment for the long term.  This includes being able to durably operate within a dynamic system, as well as not causing any trauma or negative remodeling due to excessive stiffness, sharpness, etc.

What led to the creation of VIBE Solutions?

The original impetus for this type of work began over 20 years ago during my postdoc when stents implanted in the femoropopliteal arteries were fracturing at an alarming rate due to not appreciating the multiaxial deformations of the arteries during hip and knee flexion.  After a decade of academic research and industry device development, I combined them and formed a consulting practice around cardiovascular device biomechanics in 2012, which is now called VIBE Solutions.

How does VIBE Solutions change the traditional design-test-fix approach that many teams still rely on today?

VIBE Solutions decreases the number of development cycles by characterizing the biomechanical environment, which better informs design inputs and improves the fidelity of mechanical testing.  While design-test-fix is still a crucial part of device development, we give you a design head start and makes sure your testing reflects reality, resulting in a more biomechanically harmonious product in less time.

How does biomechanical insight change development decisions not just in testing, but in design and regulatory strategy as well?

Biomechanical insights inform your design space, making design optimization much more efficient.  At the same time, more accurate characterization of boundary conditions reduces regulatory risk due to clarity of performance criteria, and most importantly, reduces risk to patients due to more thoughtful design and realistic testing.

From your perspective, how do clients benefit from the collaboration between VIBE Solutions and Medres?

VIBE Solutions is a perfect pairing with Medres!  Medres is a full-service contract development and manufacturing partner, and VIBE Solutions characterizes the in vivo environment to improve and guide design, testing, regulatory, and marketing strategies for medical device companies.