SPMT Consulting, LLC

Steven K. Pollack, Ph.D., Principal Consultant

Over 40 years of industry, academia and government experience in polymer chemistry, polymer characterization and of the use of polymers in medical devices. Internationally recognized expert in the use of 3D printed polymers in medical device manufacture

Services:

  • Provide technical and regulatory expertise in support of device manufacture, process troubleshooting and device feasibility.
  • Provide a resource for companies contemplating additive manufacturing (AM) as a process.
  • Provide intellectual properties assessment for AM-based processes and their use in medical devices.

 

Core Expertise:

Extensive experience in failure analysis for devices and device manufacturing processes.  Skilled in the use of physical and chemical analytical procedures to determine the underlying cause of failure modes in a variety medical device:

  • led team which identified improper sharpening of non-coring Huber syringe needles as source of failure
  • diagnosed peristaltic infusion pumps failure due to diffusion of the therapeutic through tubing
  • discovered and compensated for undisclosed raw materials changes that shut down intraocular lens manufacture
  • identified root cause of “glistenings” in elastomeric intraocular lenses as due to hyperosmotic inclusions
  • identified progressive loss of power of an ophthalmic laser as being due to pyrolysis of adhesive volatiles
  • identified solvent welding as the cause of Leuer lock failure on catheter hubs
  • identified use of a remote silicone oil heating bath as root cause for adhesion failures in multiple manufacturing processes

Former Senior Executive at the FDA, Center for Devices and Radiological Health, directing the Office of Science and Engineering Laboratories. 

  • versed in FDA regulatory policy for medical devices, especially as regards the role of additive manufacture
  • used background in computer science in helping Center to assess software as a medical device designation
  • led a team of 120 regulatory scientists and engineers in developing technical support for product review including the FDA’s Technical Guidance for Additive Manufacturer of Medical Devices.
  • managed 80,000 sq foot laboratory infrastructure including small animal facility

Science Fellow, Carbon, Inc.

  • versed in all modern methods of additive manufacture
  • helps startups and legacy medical device firms to assess the use of additive manufacturing to speed design iteration and move to early low to medium volume manufacture.
  • works with internal business development team to assess viability of new medical products, their predicates and potential for long term success.
  • worked with several startup to utilize Carbon technology in their first products, which are now under FDA review
  • instrumental in the rapid deployment (3 weeks from conception to shipping) of 3D printed nasopharyngeal swabs during the COVID-19 pandemic.

Some recent articles onAdditive Manufacturing and Medical Devices