Manufacturing Metrology and Standards for the Health Care Enterprise Progam

Program Goal -- To apply proven MEL manufacturing technology and expertise to healthcare systems, biomedical devices and equipment, and biomedical data management

Program Manager -- Dr. Ram D. Sriram

Technical Approach -- There are two dimensions to the program: (1) Healthcare informatics; and (2) Medical devices. Healthcare informatics deals with all the processes or “software” of the healthcare enterprise: modeling and simulation, design and production, biosurveillance, manufacturing and its associated supply chains, and information and data management both in clinical practice and biological research. Medical devices deal with all the products or “hardware” of the enterprise: the characterization, design, manufacture, testing, and metrology of medical devices at scales ranging from large equipment to nano-scale drug delivery mechanisms.

This program has several projects within each of the two dimensions:

1. Healthcare informatics
   1. Enterprise modeling and simulation
   2. Design and production of pharmaceuticals
   3. Biosurveillance
   4. Manufacturing and value chain management
   5. Clinical informatics
   6. Bioinformatics
2. Medical devices
   1. Mobility devices
   2. Hearing devices
   3. Intelligent assistive surgical devices (medical robots)
   4. Surface characterization of biomedical devices
   5. Meso-micro-biodevices
   6. Nano-biodevices

Customer Need -- The healthcare industry is facing major challenges: increasing costs, unacceptable error rates, and dissatisfied patients and providers. Healthcare costs in the United States were about 14.9% of the GDP - $1.6 trillion - in 2002 , estimated to be 1.9 trillion in 2005  and projected to rise to 3.6 trillion by 2014.¹ These costs are also a major concern for U.S. industry, as escalating healthcare costs are impeding our ability to globally compete.  According to a February 11, 2005 issue  of the Washington Post, General Motors spent $5.2 billion on healthcare in 2004 for its employees, retirees and their families. These healthcare expenses added $1,500 to the price of each GM car. Other U.S. automobile manufacturers face similar costs.

In addition, medical errors are of great concern.  In a much debated Institute of Medicine (IOM) report entitled “To Err is Human: Building a Safer Health System,” it is claimed that  “at least 44,000, and perhaps as many as 98,000, Americans die in hospitals each year as a result of medical errors.”  The numbers may not be exact, but the key point is that there is considerable loss of life due to medical errors that can be avoided if appropriate safety mechanisms are put in place.

Healthcare and manufacturing share many similar organizational, technological and informational issues. Thus, the healthcare industry as a whole is a customer  for the metrology, standard-setting support and technology approaches and solutions that MEL has developed for the manufacturing sector that are transferable or adaptable to the healthcare sector.

Why NIST? 

Given the size and importance of the health care industry, there are obviously many organizations devoted to research and development leading to practical applications of organizational, technological and informational knowledge to health care and the transmission of its benefits to patients. Foremost among such organizations are the National Institutes of Health (NIH), engaged in research on a broad range of medical problems. NIH is akin in many respects to the National Science Foundation (NSF). However, unlike NSF, it does not have a Directorate of Engineering. Thus, there is no separate organization responsible for research and development of the technological (both hardware and software) support of the healthcare enterprise, and efforts are dispersed among many separate governmental, professional and trade organizations.

Part of the mission of the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) is ensuring the safety and effectiveness of thousands of types of medical devices ranging from heart pacemakers to contact lenses. Veterans Administration (VA), Department of Homeland Security (DHS), Defense Advanced Research  Program Agency (DARPA), Department of Energy (DOE), Agency for Healthcare Research and Quality (AHRQ) are some of the other government agencies with programs in the healthcare field. NIST/MEL is in an excellent position to collaborate with NIH, FDA’s CDRH , VA , DHS, DOE, AHRQ, DARPA, NSF, and other governmental agencies, serving as a central source of support technology that can be transplanted or adapted from the manufacturing sector.

The knowledge-base of the healthcare enterprise is increasing rapidly, and exceeds our ability to transmit it for use by researchers, pharmaceutical companies, and healthcare workers.  The problem affects the entire range of knowledge transfer, from coordination of basic research, development of cures, performance of clinical trials, to application in clinical and homeland security settings. This is due to lack of standards and technology for reliable recording, exchanging, and distilling biological and medical information.  NIST's work on information interoperability contributes to its overall mission of providing critical standards and measurements for efficient industrial production.  NIST can apply this experience directly to similar problems in biology, medicine, and clinical practice.

NIST should play a leading role in standards, performance metrics and advanced technology for areas such as healthcare assistive devices.  No other organization is studying advanced areas toward standards and performance metrics of these devices.  Some organizations are studying advanced technologies in powered wheelchairs and other similar assistive devices, but not advanced robotic technologies or blind driver capabilities.

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