Mission

The Robert E. Fischell Institute for Biomedical Devices seeks to catalyze the transformation of basic research into clinical practice and commercial success. The Institute will drive innovation by immersing creative and energetic scientists and engineers in a nurturing and rewarding research environment where engineered health systems are conceived of and investigated. The Institute is comprised of staff, resources, facilities, and a “network of experts” who facilitate not only prototyping and manufacturing expertise, but who also facilitate venture creation, intellectual property creation, and product passage through various clinical, regulatory and reimbursement hurdles.

At the Center of Maryland's Biotech Corridor

The state of Maryland is home to the Food and Drug Administration (FDA) the Centers for Medicare and Medicaid Services (CMS), the 
the National Institutes of Health (NIH), the National Institute of Standards and Technology (NIST), the U.S. Army Research Laboratory (ARL), NASA, the U.S. Environmental Protection Agency (EPA), and many other health and medical science-related institutions and agencies—forming a unique hub of health-related activity, one of the largest and most vibrant in the world. The state is also home to one of the nation’s leading industry clusters in biotechnology, and a vast industry focused on system integration, defense, and information technology.
 
The Institute’s home on the fifth floor of the University of Maryland’s new A. James Clark Hall is central to its success as a focal point
for innovating health-related technologies. The new campus Central Animal Facility will reside on the sixth floor of Clark Hall and the
Fischell Department of Bioengineering will reside on the third and fourth floors. Clark Hall will also be home to state-of-the art core facilities on fabrication and 3D printing, confocal microscopy, small animal imaging, and many other analytical technologies.

 

Meet the Director

Distinguished University Professor and founding chair of the Fischell Department of Bioengineering William E. Bentley (affiliate ChBE, IBBR) is the inaugural director of the Robert E. Fischell Institute for Biomedical Devices. His UMD career spans nearly 30 years, throughout which much of his research has focused on the development of molecular tools that facilitate the expression of biologically active proteins. He is a fellow of AAAS, ACS, AIMBE, and the American Academy of Microbiology. He has served on advisory committees for the NIH, NSF, DOD, DOE, FDA, USDA, and several state agencies and has mentored over 40 PhDs and 25 postdocs, many now in leadership roles within industry (24), federal agencies (5) and academia (26). 

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Dr. William E. Bentley

A Prime Location

A. James Clark HallThe Robert E. Fischell Institute’s home on the fifth floor of A. James Clark Hall is central to its success as a focal point for innovating health-related technologies, as the Fischell Department of Bioengineering will reside on the third and fourth floors. Clark Hall will also be home to state-of-the art core facilities on fabrication and 3D printing, confocal microscopy, small animal imaging (including MRI), and many other analytical technologies.
 
The 184,000-square-foot facility is the flagship of the University of Maryland bioengineering and the Institute, and will serve as a hub for new partnerships and collaborations throughout the capital region. The Institute will occupy more than 15,000 square feet of laboratory and research space. Technologies developed here will be translated into clinical environments around the world.
 
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Meet Dr. Fischell

Dr. Robert E. Fischell is known for inventing life-saving medical devices, and pioneering the modern era of space satellites. He holds more than 200 patents, including nearly 30 patents on orbiting spacecraft. In the medical device realm, Fischell has served as a leading contributor to the invention of coronary stents, the implantable heart defibrillator, the implantable insulin pump, a device to prevent migraine headaches, and a device to prevent death from heart attacks. In 2005, he and his family made a transformational gift to establish the Fischell Department of Bioengineering and the Robert E. Fischell Institute for Biomedical Devices at the University of Maryland. 

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The Future of Biomedical Device Development

A convergence of information technology, nanotechnology, and biotechnology is redefining medical care in the United States. Devices will be deployed that interrogate an individual’s genetic background, sense pathogens, and detect maladies. They will wirelessly communicate with other devices and databases. When deployed, they will take action to alter the progression of disease while taking into account the patient’s physiological state and genetic disposition. They will also inform the community—from first responders to city planners and policymakers. Devices will be low cost, biocompatible, and—depending on location—self-powered and networked. The Robert E. Fischell Institute for Biomedical Devices will discover new paradigms for engineering better health. It will catalyze the transformation of basic research into clinical practice and commercial success.

Device creation requires coordination, intellectual capital, resources, facilities, and creative individuals who have an intense desire to learn and succeed. The entrepreneurial environment must be embedded within its fabric. As such, the Institute is a conduit for innovation, and a melting pot of many disciplines and fields. It serves to embrace thought leaders not only in medical science and technology, but also in the practice of health care. The Institute will work with experts in public health, health informatics, regulatory practice, intellectual property, and venture creation, in addition to health care practitioners, scientists and engineers who will be at the core of creating new innovations—carrying out cutting-edge research.

Looking Forward

The individual components of a medical product development plan build on foundational research for commercialization, technology , and clinical studies. Each of these components requires specialized expertise that can be offered in the form of written reports to medical product developers:

The first major component of a medical product Development Plan is the background research supporting the business strategy for commercialization such as an evaluation of the competitive landscape for the putative product, the potential for reimbursement based upon CMS cpt coding, a marketing approach, and the manufacturing and distribution chains. A critical feature of a commercialization plan is identification of realistic milestones and funding mechanisms to keep each project moving forward.

Technology development by small firms is often limited to prototyping or small scale production needed for studies in animal models or human beings. As such, the Institute provides guidance on “Quality by Design." As needed, firms gain advice on the compilation of data needed for regulatory agencies. The Institute will help sponsors utilize industry accepted modeling and simulation tools that inform device design.  It will do this in partnerships with other organizations and institutes, such as the Center for Medical Technology Policy, which focuses on reimbursement strategies for early stage companies.

As devices undergo iteration during development, the Institute and its partners are able to guide sponsors on the assembly of information needed to leverage clinical study data from earliest prototype to final finished form of the commercial product. When industry standards and regulatory guidance documents have been published, the Institute will help sponsors meet safety expectations for patient exposure. As an invention matures toward becoming a commercial product, the Institute will work with sponsors to address engineering issues associated with manufacturing, reliability testing and service management over the entire product life cycle.  Clinical information gathering is embedded with all stages of medical device development. For example, an invention that has been fully developed can still fail to return on initial investments if the final product does not adequately address an unmet clinical need or if use of the product does not reduce cost or substantially improve access to care. 

Another aspect of clinical development is the identification of the appropriate pathway for regulation by FDA, CMS and State licensing of medical practitioners. Forward development of a medical product must be geared to meeting the requirements of the correct regulatory pathway for the medical product to be marketed.

The Institute will offer services in clinical study design. For example, first-in-man studies of therapeutic medical devices identify potential risks and benefits associated with the treatment effect in a low risk population such as healthy volunteers. Next, “feasibility studies” identify a possible primary effectiveness endpoint, the appropriate patient population, the best dose, human factors issues, and broad categories of adverse events. Only after this preliminary work can a scientifically designed clinical study for “pivotal” decision making in a regulatory setting for medical devices be expected to be successful.


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