Innovation and Invention in Medical Devices Workshop Summary (2001) / Chapter Skim
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4 Sources and Support of Medical Devices Innovation
4 Sources and Support of Medical Devices Innovation
Pages 47-60
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From page 47... ...
AN OVERVIEW OF PUBLIC AND PRIVATE FACTORS AFFECTING MEDICAL DEVICE INNOVATION Clifford Goodman`, Ph.D. Senior Scientist The Lewin Group Sources and timing of support for medical device innovation can be viewed in the context of the medical device life cycle, which can be described in five main streams or pathways of activity: (1)
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From page 48... ...
One of the challenges in the medical technology industry in the more developed nations is that most new technologies do not result in obvious gains in mortality or morbidity, so that it is important to demonstrate improvements in quality of life and economic advantages. Further, more health care providers and payers want to see evidence of effectiveness in community settings rather than just efficacy in the carefully controlled settings that characterize data gathering for purposes of regulatory approval.
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From page 49... ...
These are exemplified by various "conditional coverage" arrangements for investigational technology, such as the 1995 Health Care Financing Administration/l? DA interagency agreement on reimbursement of investigational medical devices, and greater collaboration of research agencies and health care payers to support clinical trials and other studies of investigational technologies.
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From page 50... ...
Support for basic Bioengineering research, contrasted to applied and developmental research, was reported as 30% of the total, compared to an NIH average of 60% for all other fields. These reports also addressed the need for an evaluation of the NIH peer-review process for bioengineering research, membership on advisory committees, the movement of new device introduction overseas, the biomaterials availability problem, uncertainties in the innovation process, and using patent information to trace back to related federal research support.
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From page 51... ...
Center for Integration of Medicine and Innovative Technology Massachusetts General Hospital Academia has much to offer the field of medical device innovation, including "problem-rich" and "solution-rich" environments, "molecular" understanding of pathophysiology and mechanisms of therapy, expertise and skills, access to patients, and a culture of scientific methodology. There are multiple barriers intrinsic to most academic institutions that limit the development of diagnostic and therapeutic devices.
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From page 52... ...
CMIT is led by senior academicians whose full-time commitment is to integrate technology into health care by systematic, non-random purposeful mixing and matching of appropriate clinical champions and engineering experts. The process is intended to: identify difficult health care problems amenable to technological solutions, encourage teams of clinicians and engineers to generate new solutions, provide resources to develop solutions for safer and more efficacious treatments, and facilitate the application, transfer and commercialization of CIMIT technology.
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From page 53... ...
Researchers have to shore up their fiscal resources. Despite this, academic health centers retain great advantages for clinical trials.
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In most areas of the United States, in venture capital there are only two things that are important, feasibility and market acceptance. The regulatory and health care payment environments introduce additional levels of uncertainty.
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From page 55... ...
This is a very complex time in history, and a large medical company has the internal resources to help deal with this complexity. For example, in the not too distant future researchers might expect to run a diagnostic test that identifies a gene protein or cell profile that enables a physician to prescribe a course of treatment.
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From page 56... ...
In addition, limited liquidity from the public sector limits venture capital's ability to guess predictably when it will turn a profit on an investment in the medical device industry. One area where initial public offerings have been on the rise in recent years is in genomics, in large part leveraged by the enormous investment made by the federal government in basic research in this field.
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From page 57... ...
GENERAL DISCUSSION OF SOURCES AND SUPPORT OF MEDICAL DEVICE INNOVATION Tom Fogarty from Stanford began the discussion with a question contained in a story about a clinical trial involving carotid pathology. He was approached about participating in this multisite trial, he said, which upon close inspection turned out to be a brilliant effort to do something real stupid.
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From page 58... ...
Dr. Alpert pointed out that the PMA process and the clinical trials process are for unproven technologies, for real innovation where no answers are available, while 510(k~s are for incremental changes to proven technology.
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From page 59... ...
Jim Benson pointed out that there are indeed such tools, humanitarian exemptions, treatment with investigational new drugs (INDs) , IDEs, and postmarket coverage as opposed to premarket data, but what is often missing is knowledge on the part of a company that has an issue like this that they can, in fact, have those discussions Robert Califf of Duke University promised to address academic overhead and costs of clinical trials in his afternoon talk because, as he put it, there is no shortage of innovative ideas.
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From page 60... ...
Obviously, communication is very important, but there is opportunity for products to evolve during clinical trials and not be absolutely frozen. There are formulation issues in dealing with drugs, and there are changes in device design that can, in fact, render the data non-poolable.
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