Search

Surgical replacement of diseased valves with functional substitutes is the dominant therapeutic modality in patients with symptomatic valvular heart disease and generally improves survival and enhances quality of life.1,2 Nevertheless, problems associated with the valve replacement devices remain a major impediment to the long-term success of this procedure. Despite considerable improvement in the technology of heart valve prostheses since their first successful use approximately 45 years ago, both mechanical and tissue heart valve substitutes (illustrated in Fig. 1) remain imperfect, and prosthesis-associated complications have considerable impact on the long-term outlook for those who have had valve replacement surgery. [ABSTRACT FROM AUTHOR]

The term clinical study can mean many things. Premarket clinical studies are necessary to verify the safety and efficacy of a new device, but they may not be able to detect low-level or long-term complications. No matter how much premarket work one does and no matter how sophisticated the protocols, the only valid proof of long-term reliability is performance in the field through postmarketing surveillance. Even studies on the long-term performance of marketed products may be misleading if not done appropriately. Clinically based postmarket surveillance can reveal the true actuarial survival of a device and the clinical mode of failure. Analysis of returned products may be required to understand the details of failure mechanisms per se. [ABSTRACT FROM AUTHOR]

Establishing reimbursement early in product development is essential to the success of a medical device company. Although reimbursement is comprised of coverage, coding, and payment procedures, coverage is the essential first step that drives subsequent coding and payment procedures. After all, if a product is not covered by insurance plans, there can be no reimbursement. Coverage occurs when a product is deemed a "reasonable and necessary" medical treatment. It is widely reported that Medicare takes an average of 2 to 5 years to create coverage for a new product. Given that a new device's product life cycle may be only 10 years, the earlier the process is initiated to obtain coverage, the sooner reimbursement will be established. Perhaps most importantly, this 2- to 5-years anticipated timeframe for coverage can be reduced if a reimbursement plan is implemented early in product development. When developing a reimbursement plan, companies should address the following questions, preferably while their product is still in the development phase: 1.Where will this product fit in the larger health care arena?2.How will this product meet the Food and Drug Administration (FDA) "safe and effective" standards, as well as payors' "reasonable and necessary" requirements?3.How can the reimbursement strategy support the company's overall objectives? [ABSTRACT FROM AUTHOR]

As providers, beneficiaries, device manufacturers, and other stakeholders strive to more fully understand the working parameters of the Medicare local coverage process, there is considerable value in presenting a more global, integrated approach. There are three major defining forces, which provide such a framework, and can be further exemplified by selected recent coverage case studies. These three forces are (1) specific regulatory mandates of the Medicare program, (2) the creation of stakeholder partnerships, and (3) the need to properly use medical evidence. Most coverage policies represent a combination of these forces. In fact, there is only the occasional local coverage scenario, which is characterized by the pure expression of any solitary element. [ABSTRACT FROM AUTHOR]

Missing data are a common problem with data sets in most clinical trials, including those dealing with devices. Imputation, or filling in the missing values, is an intuitive and flexible way to handle the incomplete data sets that arise because of such missing data. Here we present several imputation strategies and their theoretical background, as well as some current examples and advice on computation. Our focus is on multiple imputation, which is a statistically valid strategy for handling missing data. The analysis of a multiply imputed data set is now relatively standard, for example in SAS and in Stata. The creation of multiply imputed data sets is more challenging but still straightforward relative to other valid methods of handling missing data. Singly imputed data sets almost always lead to invalid inferences and should be eschewed. [ABSTRACT FROM AUTHOR]

One of the most important aspects of study design is the selection of outcome measures. The choice of the most appropriate primary and secondary outcome measures can be a complicated decision and represents one of the most complex issues in the design of a clinical trial. Appropriate outcome measures will determine both safety and clinical effectiveness, as well as potential reimbursement, based on the application of the rigorous evidence-based approach taken by the Centers for Medicare and Medicaid Services (CMS) and other payor/providers.1 Therefore, companies should devote considerable time to making certain the outcome measures chosen will be viewed as appropriate by reviewers and clinicians. [ABSTRACT FROM AUTHOR]

The medical device industry is characterized by a high level of innovation and the development of a continuous stream of devices that promise to enhance the life expectancy and quality of life of patients. With changes in US Food and Drug Administration (FDA) regulatory policies and increased demand for more rigorous clinical evidence by payors, physicians, and patients alike, there has been more emphasis on randomized trials to evaluate new devices as they move from bench to bedside. [ABSTRACT FROM AUTHOR]

The passage of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) has generated widespread concern that clinical research may be increasingly difficult to conduct. Certainly, those involved in clinical research may feel frustrated or confused by HIPAA's requirements, particularly when the media report that investigators have been denied access to patient records or that patient enrollment in studies has dramatically decreased. Innovative drugs and devices that improve and save lives would not be possible without the contributions of clinical research and human subject volunteers. [ABSTRACT FROM AUTHOR]

Postoperative adhesions are scar tissues, which develop at the site of tissue injury after surgery.1 Their potential significance is immense because of the frequency with which they form, as well as their consequences of potential morbidity and mortality.2 Yet, many surgeons minimize their significance because of the general inability to identify adhesions without performing a repeat surgery, as there are not good serologic markers or accurate imaging modalities (e.g., ultrasound, computed tomography, or magnetic resonance imaging scans) and the perceived inability to do anything about them. [ABSTRACT FROM AUTHOR]

Corporations create value for their shareholders by earning a return on invested capital that exceeds its cost of capital. A company's ability to do this depends largely on its competitive advantage. In the medical device industry, success is categorically linked to new product flow, transitively marrying innovation and shareholder value creation. The medical device industry follows the punctuated equilibrium interpretation of Darwinism rather than the traditional theory of gradualism. The puncuated equilibrium theory states that evolution tends to happen in fits and starts, sometimes moving fast, sometimes moving slowly or not at all. A particular device market tends to chug along with little change to speak of as companies introduce iterative, "me-too" products; however, every so often, a game-changing new technology emerges that revolutionizes the standard of care. As a result, innovation invariably governs the competitive dynamics in medical devices, with the industry constantly trying to address unmet clinical needs or improve existing treatments to create a sustainable competitive advantage. [ABSTRACT FROM AUTHOR]

A majority of patients with angina related to coronary artery disease respond to medical management, percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG). There is, however, a growing number of patients who have medically refractory angina caused by diffuse coronary artery disease who are not eligible for PCI or CABG owing to diffuse, distal disease.1 Treatment options are limited for this subset of patients. [ABSTRACT FROM AUTHOR]

Intellectual property (IP) broadly encompasses the concepts derived from the intellectual and artistic achievement of innovators. More specifically, IP includes discoveries, inventions, technological advancement or development, literary or artistic works, and unique names for trade or business. A concise summary of the available IP tools appears in Table 1. [ABSTRACT FROM AUTHOR]

The investigational device exemption (IDE) provides an release for medical devices from various sections of the federal Food, Drug, and Cosmetic (FD&C) Act.1 Without the exemption, medical devices would have to comply with performance standard, premarket approval, or notification requirements to be lawfully shipped and used for investigational purposes.2 Furthermore, itwould be exceedingly difficult—if not impossible—to conduct clinical trials for devices to support premarket approval applications (PMAs) or 510(k) premarket notifications without violating the act, if the IDE did not exist. Indeed, according to Congress and the Food and Drug Administration (FDA), the twin objectives of the exemption are "to encourage discovery and development of useful devices for human use"3 and "to protect the public health by requiring safeguards for human subjects of investigations, sound ethical standards, and procedures to assure development of reliable scientific data."4 [ABSTRACT FROM AUTHOR]

The development of combination products (CPs) is a challenging field that faces complex product jurisdiction and development issues. Despite these issues, companies are driven by the potential therapeutic success of combining two components into a single product. The driving force behind this new enthusiasm is the local delivery of drugs or biologics to a specific tissue, thereby minimizing the exposure of the whole body to potential toxic compounds as well as maintaining drug/biologic levels at a specific site within a tissue to obtain a desired therapeutic response. As a recent example, Cordis, a subsidiary of Johnson & Johnson, successfully commercialized the CYPHER™ Sirolimus-Eluting Coronary Stent, bringing cardiologists a promising new therapy for the prevention of restenosis. The CYPHER Sirolimus- Eluting Coronary Stent consists of a device that brings a drug component to the coronary tissue to maintain vessel patency by minimizing the occurrence of restenosis following stent implantation. The device component provides mechanical prevention of restenosis, whereas the drug component delivers a pharmacologic/biologic locally to assist in the vessel's recovery from any injury caused by the stent implantation. Cordis developed this product with both speed and regulatory finesse. The dramatic clinical trial results indicate the CYPHER Sirolimus-Eluting Coronary Stent is a very promising new therapy.1 [ABSTRACT FROM AUTHOR]

The Social Security Act establishes several criteria that must be satisfied in order for an item or service to be eligible for reimbursement under the Medicare program. These threshold Medicare coverage criteria include the requirement that the item or service be reasonable and necessary for the diagnosis or treatment of an illness or injury or to improve the functioning of a malformed body member. Administrators of the Medicare program have generally held that experimental therapies are not reasonable and necessary. This interpretation of the reasonable and necessary criteria traditionally precluded Medicare coverage for services provided to beneficiaries as part of clinical investigations. Denying Medicare reimbursement for investigational interventions and costs related thereto created a barrier to Medicare beneficiaries' participation in clinical trials. This posed a dual problem. First, in the short term, it could deny Medicare beneficiaries access to potentially useful therapies available in the clinical trial context. Second, limited enrollment of Medicare beneficiaries in clinical trials hindered collection of sufficient evidence to demonstrate a new therapy's effectiveness for use in the Medicare population. [ABSTRACT FROM AUTHOR]

The fundamental idea in the Bayesian approach is that one's uncertainty about an unknown quantity of interest is represented by probabilities for possible values of that quantity. For instance, unknown quantities of interest in device trials are the parameters of the clinical safety and effectiveness distribution for the treated and control groups. [ABSTRACT FROM AUTHOR]

The Food and Drug Administration (FDA) has developed multiple interrelated mechanisms for monitoring, evaluating, and taking remedial action (when necessary) against medical devices after they have gone to market. This chapter provides an overview of the various postmarket requirements that can be imposed on manufacturers, importers, distributors, and device-user facilities.1 [ABSTRACT FROM AUTHOR]

More device manufacturers are recognizing the importance of considering Medicare coverage and reimbursement principles during the development of their new technologies. By adopting long- and short-term strategies that incorporate these principles, manufacturers can avoid certain foreseeable delays in bringing devices to market. Although the roadmap for demonstrating to the Food and Drug Administration (FDA) the safety and efficacy of a device has been fairly well established, the steps for obtaining third-party payors' approvals have been less apparent. This chapter highlights Medicare coverage and reimbursement principles and considerations that might be incorporated into a company's business plan during and after the product development stage. [ABSTRACT FROM AUTHOR]

Medical devices are health care products distinguished from drugs for regulatory purposes in most countries based on mechanism of action. Unlike drugs, medical devices operate via physical or mechanical means and are not dependent on metabolism to accomplish their primary intended effect.As defined in the federal Food, Drug, and Cosmetic (FD&C) Act, the term medical device: ...means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article...intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease...or intended to affect the structure or any function of the body...and which does not achieve its primary intended purposes through chemical action within or on the body....1 [ABSTRACT FROM AUTHOR]