Three of the following four statements are true.

• The medical device industry is poised for accelerated growth.  Aging baby-boomers in the U.S. and burgeoning new middle-classes abroad will drive demand for lifesaving and life-enhancing medical devices.

• Silicone elastomers, adhesives, gels, and fluids are crucial biomaterials and are found on devices used in a range of therapies including cardiology, neurology, urology, ophthalmology, bariatrics, orthopedics, and plastic surgery. 

• Medical device manufacturers, from small start-ups to Fortune 500 firms, employ talented and often brilliant specialists in disciplines such as material science, toxicology, statistics, metallurgy and chemical engineering to name a few.

• Medical device companies have sufficient in-house silicone expertise to manage and even anticipate processing and performance challenges inherent to this family of biomaterials.

The last statement is false.  My name is Mark Paulsen. I know firsthand that with few exceptions, medical device companies in fact do not have adequate in-house understanding of silicone materials and processes.   This shouldn’t be surprising.  As silicone manufacturers are not device experts, device manufacturers are not silicone experts.    That said, as the Healthcare Product Director at NuSil Technology from 1992 to 2007, I worked with hundreds of device manufacturers, solving problems that could have been avoided.

I founded Silicone Consulting, LLC to do four things well, and in fact to do these things better than anyone else. 

• First, provide medical device companies with the most current and complete database of silicone materials.  Only this type of survey can insure that the most appropriate material is identified for each application.  Material selection is simply too important not to get it right the first time.

• Second, evaluate, develop and implement manufacturing processes that insure maximum efficiency and lowest costs.

• Third, assist device companies in understanding and managing the inherent variability of silicone raw materials.  This variability can have significant effects on both processability and the performance of silicone components. 

• Fourth, promote and develop combination products which benefit from silicone’s unique drug eluting properties.  These combination products, bioactive agents encapsulated in a silicone matrix, represent an exciting new class of therapy delivery.  Silicone elastomers and gels will play an increasingly important role in the research and commercialization of combination products.

I’ve enjoyed a rewarding career.  Working closely with a leader in the field of cardiac rhythm management, I developed an elastomer used as insulation on implantable electrical leads.  This material improved both the performance and durability of the device.   In 1999 I was awarded 3 U.S. patents for this work.  In 2004 I was named by a leading publication as one the “100 Notable People in the Medical Device Industry”. 

If you are one of the many device engineers I’ve had the pleasure of working with, you know that I’m passionate about silicones and their vital role in the medical device industry.  If we haven’t met, I hope that this website provides some helpful insight into this exciting biomaterial.

Mark J. Paulsen
President, Silicone Consulting, LLC