Business Ethics of Abandoning Medical Products, a Case Study

 

If a manufacturer decides to take a product off the market and does not license another company to produce it, what can users do?

 
Date: Thursday, June 3, 2021
Time: 7:00pm-8:00pm PDT
Registration is FREE: Click here
Co-sponsors: Santa Clara Valley Chapter of the Engineering in Medicine and Biology Society (EMBS-SCV), Silicon Valley Chapter of the Society on Social Implications of Technology (SSIT-SCV)

Abstract:
If a manufacturer decides to take a legacy product off the market, and furthermore does not license another company to produce it, what can current and future users do? Does the manufacturer have any continuing obligation to a small but dedicated user community? Does an abandoned product qualify as an “orphan device”?

Stereotactic neurosurgery is the practice of locating a target in the brain based on known anatomical coordinates, using specialized hardware to safely place electrodes, needles or cannulas at the exact target. This talk will briefly review the history and hardware options currently available to the neurosurgeon. In August, 2020, neurosurgeons were selectively informed by the manufacturer of one of the most widely used stereotactic systems (known by its originators’ initials, “CRW”) that it would cease production and sale of new systems in December. At the same time, another manufacturer announced that it is discontinuing one of its two models of stereotactic hardware. The user community, as represented by the American Society of Stereotactic and Functional Neurosurgery (ASSFN), is understandably disturbed by these business decisions.

Based on statements by ASSFN and 15 years personal experience with the CRW system, this device is far from obsolete. Despite some weaknesses and the advent of disposable devices, the CRW system remains the “gold standard” for accuracy and durability, being specified by name in clinical trials of (for example) brain regeneration by stem cells and serving as a platform for development of new hardware and software.

Speaker: Eric E. Sabelman, PhD

Eric Sabelman concluded his education at Stanford University with a PhD in Bioengineering (1976). He had a post-MS position with NASA-JPL in spacecraft hardware R&D (1969-71) and a post-doc at NASA-Ames in space life sciences (1976-79). Subsequently, he worked in biotech at Collagen Corporation and as a consultant under the name “Pro-Zooics Research”. While at the Palo Alto VA Rehabilitation R&D Center and as adjunct faculty at Stanford Medical School (1986-2005), he was principal investigator on projects in regeneration of human peripheral nerve, acute spinal injury patient care and wearable sensors for human motion analysis. He recently retired (July 2020) from the Neurosurgery Department of Kaiser Permanente Hospital in Redwood City, CA, where he provided technical support and innovation in clinical treatment of movement disorders with Deep Brain Stimulation. He currently teaches a course on medical device design at Santa Clara University in the Department of Mechanical Engineering, and continues consulting in this field.