Kenneth A Collins

With degrees in Biochemistry, Medicine, and Biomedical Engineering and many years experience in the medical device industry, I find great fulfillment working in the boundary between medicine and the technology that it uses to heal.

The lesson I have learned through successfully steering companies through regulatory and quality issues is that product development is not simply the execution of an initially successful design. A device must be sufficiently stable in its design and documentation to allow iterative improvements and to maintain a competitive edge in quality and performance.  It is this and the unwavering focus on patient safety that will ensure a long term stable profit stream and the confidence of customers and their patients.

I have direct and successful experience in each of the phases of the life cycle of medical devices, ranging from external equipment (thermal regulation systems, external T-wave alternans stress machines and T-cell culture systems) to Class II and Class III implantable medical devices (pacemakers, AICD, stents, cardiac catheters, auditory implants, AAA and peripheral covered stents). I have successfully conducted and led Applied Research, Research and Development, Clinical Investigation and Post-market Studies.

Putting all this together under the banner of product development requires a flexible understanding of regulations and quality systems. With stable Quality Systems that are flexible, R&D cycle times shorten and costs are reduced.

By putting in place well maintained Design History Files I have delivered quicker iteration and, just as importantly, a base upon which planning assumptions for delivery times and costs can be accurately predicted. In developing human models for design validation activities I have reduced validation cycle times for complex software controlled external equipment by 75%.

In our regulated industry, there is no mens rea. What you intended to do is not that important. If an inspection results in findings, responding to and clearing them effectively to the satisfaction of the regulatory body will prevent escalation and will minimize the disruption to business, while maintaining the trust of your customers.

I have successfully lead two remediation programs for products and facilities under FDA Consent Decree, both of which involved multi-site activities and the use of external contractors.  I have taken an FDA "for cause" design control inspection to a "no 483" result based upon the quality of the Design History File and Complaint systems I developed and instigated.

In the case of product recall, focusing on managing risk to patients is paramount in ensuring the maintenance of customer trust. I have successfully managed multiple Class I and Class II recalls. One recall that had triggered a 3.5 billion dollar class action saw success under my direction in having the Class dismissed based upon the Company's effective and open handling of the recall and the focus on patient care. ln many less extreme examples, success lay in taking customers through a correction (notice to the field) without removal of the product.

The experience I can bring to your challenge includes:

  • P&L responsibility for an operating division.
  • Direct control over operations for Product Development and/or Production. 
  • Direction of international Clinical Studies, IDE & Postmarket Studies.
  • Multiple successful submissions of numerous original PMA & clearances of 510k.
  • Presentations at FDA, EU, and Japanese Panels. 
  • Design and development of implantable medical product. 
  • Design of prototype external devices.
  • Transfer and clean up of production facilities failing compliance audits.
  • Complete overhaul of documentation systems such that access by all departments maintains a unified approach to design and regulatory. requirements.
  • Assessment of prospective company purchase for potential profit or liability.