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.
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.
|Medical devices are designed by a diverse team. Users are often asked for input on design concepts, however medical professionals often speak a different language than the design engineers creating the products. 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.|
Alan Lipschultz, President of HCTC
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"Mr. Lipschultz has an impressive body of knowledge and experience in hospital administration and the medical device industry, as well as the regulations each must abide. He tops this off with a background in electrical engineering, making him extraordinarily versatile. He is also not afraid to tell you when you need different expertise; and was even willing to locate another expert to supplement his own opinions. His professionalism, availability, and timely turnaround is also impressive. If you need special knowledge to help you evaluate the conduct of a hospital or medical device company, I fully recommend him."
"Alan Lipschultz is one of the most dedicated healthcare technology professionals I know. Over the last 15 years, I’ve come to admire Alan for his critical thinking skills and his keen insights, his excellent writing skills, his incredible work ethic, and his ability to be at the forefront of trends and challenges facing the profession. As the COO of AAMI, I know I can always count on Alan’s analytical mind and problem-solving abilities to help resolve issues and move projects along. He’s dependable, curious, and deeply knowledgeable about clinical care environments and technology challenges. His many years of front lines management of healthcare technology make him ideally suited for consulting in this field. He has a winning combination of skills and experience that make him an invaluable expert."
"My firm retained Alan on a complex medical device case. He did an excellent job sifting through a significant amount of information and finding some key points for our case. He is very knowledgeable, was thorough and well prepared. He did a great job for us."
"Alan provided an external assessment of many aspects of our Clinical Engineering program. His findings were detailed and accurate, and his subsequent recommendations were intelligent and realistic. Sometimes consultants only leverage their personal prior experiences when making recommendations. I feel that Alan operates with a broad industry perspective, thinking (excuse the cliche) outside the box. He facilitated discussions that drove introspection and innovation, including at the "C" level within our organization."
"One thing about Alan is he didn't worry about titles when it came to getting a project completed. In his mind it was a team effort in order to accomplish project goals. I recall one instance when we had to move equipment from one location to another and Alan did not hesitate in assisting picking up and moving the equipment. There are not too many Directors I know who would roll up their sleeves and help in that fashion. I work in Information Technology and have also noticed over the years that Alan understood technology. With more and more devices today there is that fine line between IT and Clinical Engineering and having a person like Alan eased the need for an IT resource attending various vendor meetings or conference calls because Alan could understand detail discussed and relay information back to IT. Alan has passion in what he does and any organization will benefit from having him as an employee."
Alan assisted us with a complex medical device safety assurance case development, he was very diligent, hard-working and thoughtful in his reviews, willing to share his extensive experiences as a clinical engineer and medical device expert witness in acute care medical devices, as well as relevant published literature. Alan was a great independent voice and asset to our team, I recommend him to those in need of his services.