• Clinical Engineering
  • Expert Witness
  • Patient Safety & Risk
  • Forensic Engineering
  • Device Improvement
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.

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. Medical Device
EKG Flat Line Alert Dialysis Machine

References for
Alan Lipschultz, President of HCTC

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Peter Mullenix web link

"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."​

Steve Campbell web link

"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."

John Gagliardi web link

"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."

Scott Skinner web link

"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."

William "Butch" Crouse web link

"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."

Jim Martucci web link

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.