Clinical Engineering exists at the intersection of medical technology and clinical practice. Our evaluation of your circumstances filtered by our years of experience in this field can help in making sound economic decisions regarding purchasing, implementation, and management of processes surrounding medical devices.
Clinical Engineering is a specialty within Biomedical Engineering. According to The American College of Clinical Engineering, "A Clinical Engineer is a professional who supports advances to patient care by applying engineering and managerial skills to healthcare technology."
In 2011, Technology Management Council of AAMI (Association for the Advancement of Medical Instrumentation) recommended a new term, Healthcare Technology Management as "the official name of the field responsible for managing the selection, maintenance and safe and effective use of medical equipment and systems." It is largely for this reason that we chose HealthCare Technology Consulting as the name of the firm.
Litigation may result when things go wrong in the clinical environment. We have worked for both plaintiffs and defendants in multiple cases; these cases have involved a wide variety of medical malpractice and/or product liability issues. As professional engineers our scientific and technical observations are admissible in court, and can make a valuable difference.
We can be used by lawyers to evaluate a case and help determine whether a claim has merit. We have the oral and written communication skills to effectively explain technical matters to a lay audience by means of a written report and/or testimony. We can prepare demonstrative evidence to what happened as part of an event.
The president of Healthcare Technology Consulting, Alan Lipschultz, CCE, PE, CSP, CPPS is a member of the Forensic Expert Witness Association.
We have the connections to obtain other, more specialized expert witnesses if warranted. When that happens, we supervise their work.
All of the stakeholders in the medical device chain are committed to patient safety and the reduction of risks. Someone from outside an organization can sometimes help a group see issues that insiders have missed. We have worked with healthcare providers, manufacturers, and independent test labs to mitigate risks before they create hazards. Hospitals are very complex systems within systems. Most of the personnel within hospitals are either clinicians or administrators. We bring enough clinical and hospital administrative experience within hospitals to understand what is going on in those organizations.
We add a broad technical perspective that allows us to add a different dimension during discussions about how to improve patient safety and reduce risk.
The president of Healthcare Technology Consulting, Alan Lipschultz, CCE, PE, CSP, CPPS is a Certified Professional in Patient Safety (CPPS) – by the Certification Board for Professionals in Patient Safety, part of the Institute for Healthcare Improvement (IHI).
In the clinical environment things sometimes go very wrong. Devices may fail in a multitude of ways and for a variety of reasons, users may make errors, and patients may be injured. Forensic engineering is a process whereby the cause(s) of the failures are discovered. The information learned is communicated to the various stakeholders such that improvement may be achieved and the likelihood of recurrence reduced.
We are used to the role of explaining technical subjects to non-technical people. When working for hospitals or other healthcare organizations, we will work collaboratively with clinicians and risk managers to determine root and secondary causes of events. When working for patients or manufacturers, we know how healthcare organizations are supposed to work and therefore what questions should be asked.
If warranted, we have access to several testing laboratories to do physical analysis of devices or accessories involved in an event.
We can prepare written statements as to our findings. If needed, these written statements can be used during legal proceedings.
We are engineers with a lifetime of experience embedded with clinicians - we speak both languages fluently and can bridge the gap for you and your customers. Medical device manufacturers have used us both before devices are on the market and/or reviewing their "Safety Case" for a product.
Our role is to be an outside technical reviewer with real world perspective in order to supplement the internal design team. We are able to assist medical device manufacturers prepare a Safety Assurance Case.