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Book part
Publication date: 2 August 2016

William H. Kitchens

This chapter focuses on the regulatory scheme used by the United States Food and Drug Administration (FDA) to approve medical products for commercial use in this country. After…

Abstract

This chapter focuses on the regulatory scheme used by the United States Food and Drug Administration (FDA) to approve medical products for commercial use in this country. After providing a brief introduction of the role of the FDA and the scope of the products regulated by the agency, the chapter outlines the common characteristics of premarket controls for drugs, medical devices, and biological products, including how clinical trials of these medical products are conducted with humans as part of the premarket approval process. The chapter then provides a detailed examination of the particular regulatory scheme for each product category. The chapter concludes with an analysis of how FDA regulates emerging medical technologies, such as cellular and tissue-engineered products. FDA regulates a variety of products intended to diagnose, cure, mitigate, treat, or prevent diseases or conditions under a legal scheme established in the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act and regulations promulgated by FDA. How a product is classified (drug, device, or biologic) forecasts the regulatory approval pathway that must be followed to bring the product to market. This chapter provides education and direction regarding regulatory requirements that must be met to market medical products in the United States.

Details

Technological Innovation: Generating Economic Results
Type: Book
ISBN: 978-1-78635-238-5

Keywords

Article
Publication date: 6 September 2019

Marta Podemska-Mikluch

The purpose of this paper is to analyze the Parallel Review program that offers simultaneous review of the Food and Drug Administration premarket approval submissions and the…

Abstract

Purpose

The purpose of this paper is to analyze the Parallel Review program that offers simultaneous review of the Food and Drug Administration premarket approval submissions and the Centers for Medicare and Medicaid Services (CMS) national coverage determinations (NCDs) of medical devices.

Design/methodology/approach

The paper analyzes the impact of Parallel Review on medical device innovation, focusing in particular on the causes for low popularity of the program among medical device manufacturers. Program outcomes are evaluated in the light of its intended goals.

Findings

The paper identifies four reasons for the program’s limited impact. First, few devices are eligible to participate. Second, most manufacturers prefer to seek Medicare reimbursement at the local level as less risky than the CMS NCDs. Third, participation in the Parallel Review might actually delay the marketing of the device. Fourth, the program does not address numerous obstacles that device sponsors currently encounter. While giving the appearance of support for the medical device innovation, the policy falls short on its intended goals.

Originality/value

This paper elucidates the challenges to internal reform and serves as a reminder to political economists and health care researchers that to make disruptive innovation possible, we must continue to illuminate the otherwise unseen cost of marketing delays and document the ability of emergent market mechanisms to protect consumer safety.

Article
Publication date: 8 June 2012

January Luczak

The purpose of this paper is to chronicle a small company's path towards establishing a functioning, effective quality system for a medical device technology and to provide some…

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Abstract

Purpose

The purpose of this paper is to chronicle a small company's path towards establishing a functioning, effective quality system for a medical device technology and to provide some “do‐it‐yourself” (DIY) tips learned along the way.

Design/methodology/approach

When a company comes up with an innovation in medical device technology, where can it go from there to transfer its product into the hands of consumers? If the technology is patented, the company has the option to license it. Alternatively, the company may want to move forward with further product development and marketing on its own (whether patented or not). Getting a medical device into any market typically requires regulatory approval, which cannot be obtained without a quality system. This paper focuses on the foundations of establishing a quality system and obtaining certification and regulatory approval in Canada, the EU, and the USA, and is directed towards small medical device manufacturers. It describes the process within four phases that cover the initial start up, implementation of procedures, certification and regulatory approval, and continual improvement.

Findings

Establishing a quality system is a monumental task for any company, but especially so for a small one. However, the benefits of implementing a quality system outweigh the initial setbacks associated with doing so. The descriptions of phases in tandem with the DIY tips presented in this paper are intended to be of help to a small medical device manufacturer wanting to bring their innovative technology to consumers within a major marketplace.

Originality/value

This is an original paper written for the Third Canadian Quality Congress.

Details

The TQM Journal, vol. 24 no. 4
Type: Research Article
ISSN: 1754-2731

Keywords

Article
Publication date: 15 August 2016

Joanne Pransky

The following article is a “Q&A interview” conducted by Joanne Pransky of Industrial Robot journal as a method to impart the combined technological, business and personal…

Abstract

Purpose

The following article is a “Q&A interview” conducted by Joanne Pransky of Industrial Robot journal as a method to impart the combined technological, business and personal experience of a prominent, robotic industry engineer-turned-entrepreneur regarding the evolution, commercialization and challenges of bringing a technological invention to market. The paper aims to discuss these issues.

Design/methodology/approach

The interviewee is Jacob Rosen, a Professor of Medical Robotics at the Department of Mechanical and Aerospace Engineering, University of California, Los Angeles (UCLA), where he directs the Bionics Lab. Professor Rosen is also the Director of Surgical Robotics Engineering at the UCLA School of Medicine’s Center for Advanced Surgical and Interventional Technology and has joint appointments at UCLA’s Department of Surgery and UCLA’s Department of Bioengineering. Professor Rosen is the co-founder of the companies Applied Dexterity, ExoSense and SPI. As a pioneer in medical robotics devices and technologies, Professor Rosen describes his unique approaches and philosophies.

Findings

Dr Rosen received his BSc degree in Mechanical Engineering, MSc and PhD degrees in Biomedical Engineering from Tel-Aviv University in 1987, 1993 and 1997, respectively. From 1987 to 1992, he served as an officer in the Israeli Defense Forces studying human–machine interfaces. From 1993 to 1997, he was a research associate at Tel-Aviv University, as well as held a position at a startup company developing innovative orthopedic spine/pelvis implants. From 2001-2013, he held faculty positions at the University of Washington and at University of California, Santa Cruz.

Originality/value

Dr Rosen developed several key systems in the field of medical robotics, such as the Blue and the Red Dragon, for minimally invasive surgical skill evaluation; RAVEN, a surgical robotic system for telesurgery; and several generations of upper and lower limb exoskeletons including the Exo-UL7 – a dual arm wearable robotic system. He is a co-author of 100 manuscripts in the field of medical robotics and a co-author and co-editor of two books entitled “Surgical Robotics – Systems, Applications, and Visions” and “Redundancy in Robot Manipulators and Multi-robot systems” published by Springer. Professor Rosen has filed eight different patent applications and also works as an expert witness and consultant on design, patent protection & litigation and malpractice regarding surgical robotics.

Details

Industrial Robot: An International Journal, vol. 43 no. 5
Type: Research Article
ISSN: 0143-991X

Keywords

Book part
Publication date: 2 August 2016

Abstract

Details

Technological Innovation: Generating Economic Results
Type: Book
ISBN: 978-1-78635-238-5

Article
Publication date: 1 August 2001

Judith W. Spain, Carolyn F. Siegel and Rosemary P. Ramsey

The online distribution of prescription‐only pharmaceutical products raises serious legal and regulatory issues, including how governments, agencies, or organizations will…

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Abstract

The online distribution of prescription‐only pharmaceutical products raises serious legal and regulatory issues, including how governments, agencies, or organizations will regulate and monitor such activities, particularly when the distributors are offshore Web sites. This paper discusses the current regulatory environment for marketing prescription‐only drugs online and distributing them across national borders, along with product liability issues. Four hypothetical scenarios focus on key legal and regulatory issues.

Details

International Marketing Review, vol. 18 no. 4
Type: Research Article
ISSN: 0265-1335

Keywords

Content available
Article
Publication date: 25 May 2010

131

Abstract

Details

Nutrition & Food Science, vol. 40 no. 3
Type: Research Article
ISSN: 0034-6659

Content available
Article
Publication date: 31 July 2009

290

Abstract

Details

Microelectronics International, vol. 26 no. 3
Type: Research Article
ISSN: 1356-5362

Article
Publication date: 8 February 2023

Poonam Mulchandani, Rajan Pandey and Byomakesh Debata

This paper aims to study the underpricing phenomenon of initial public offerings (IPOs) of 355 Indian companies issued from 2007 to 2019. The research question this paper…

Abstract

Purpose

This paper aims to study the underpricing phenomenon of initial public offerings (IPOs) of 355 Indian companies issued from 2007 to 2019. The research question this paper empirically examines is whether Indian corporate executives deliberately underprice IPOs from its fair value to attract investors, thereby causing an abnormal spike in the prices on the listing day. The findings of this study challenge a commonly held notion of leaving money on the table by IPO issuing companies. Of the overall average listing day returns of 17%, the deliberate premarket underpricing component is found to be mere 5.3%, while the remaining price fluctuation is, inter alia, a result of market momentum along with the unmet demands of impatient investors.

Design/methodology/approach

Following Koop and Li (2001), this study uses Stochastic frontier model (SFM) to study a routine anomaly of disparity between the primary market price (i.e. IPO issue price) and the secondary market price (listing price). The jump in the issue price observed on a listing day is decomposed into deliberate premarket underpricing component that reflects the extent of managerial manipulation and the after-market misvaluation component attributable to information asymmetry and prevailing market volatility.

Findings

This paper uses SFM to bifurcate initial returns into deliberate underpricing by managers and after-market mispricing by noise traders. This study finds that a significant part of the initial return is explained through after-market mispricing. This study finds that average initial returns are 17%, deliberate premarket underpricing is 5.3% and after-market mispricing averages 11.9%.

Research limitations/implications

This study can isolate underpricing done at the premarket by estimating a systematic one-sided error term that measures the maximum predicted issue price deviation from the offered price. Consequentially, the disaggregation of initial returns may be especially informative for retail investors in planning their exit strategy from an IPO by separating the strength of the firm's fundamentals and its causal relationship with the initial returns. Substantial proportion of after-market mispricing implies that future research should focus on factors causing after-market mispricing. As underlying causes are identified, tailor-made policy responses can be formulated to benefit investors.

Practical implications

This paper has empirically validated that initial return is a mix of both components, i.e. deliberate underpricing and aftermarket mispricing. This disaggregation of initial returns can prove helpful for investors in planning their exit strategy. This study can help investors to become more aware of the importance of the fundamentals of the firm and its causal relation with the initial returns. This information in turn can help reduce the information asymmetry amongst investors and help them lessen the costs of adverse selection.

Originality/value

A large number of research studies on IPO pricing find overwhelming evidence of underpricing in public issues. This research attempts to decompose the extent of underpricing into deliberate underpricing and after-market mispricing, thereby supplementing the existing literature on the IPO pricing puzzle. To the best of the authors’ knowledge, this study is the first contribution to the literature on initial return decomposition for the Indian capital markets.

Details

Journal of Indian Business Research, vol. 15 no. 3
Type: Research Article
ISSN: 1755-4195

Keywords

Book part
Publication date: 20 August 2012

Tannista Banerjee

Purpose – The cost of new drug development is increasing every year. Pharmaceutical companies use R&D joint ventures, mergers, and outsource different stages of pharmaceutical R&D…

Abstract

Purpose – The cost of new drug development is increasing every year. Pharmaceutical companies use R&D joint ventures, mergers, and outsource different stages of pharmaceutical R&D activities for a faster and cost minimizing method of innovation. Pharmaceutical companies outsource R&D activities to independent small biotech or pharmaceutical companies that specialize in different stages of pharmaceutical R&D. This chapter examines the determinants of the payment structure of research contracts between large bio/pharmaceutical companies and specialized research firms.

Methods – Determinants of R&D contracts are analyzed using detailed R&D contract data between bio/pharmaceutical companies and independent research firms for 10 years. A multinomial logit model is used in order to understand the determinants of three different types of contracts; royalty contracts, fixed payment contracts, and the mixed contracts.

Findings – Under uncertainty, the likelihood of a royalty contract rises for the early stages of the research and with the patent stock of the research firm. It is more likely to observe both royalty and fixed payment if the pharmaceutical client has past contracts with the same research firm. The results also suggest that if Food and Drug Administration (FDA) is more stringent in any disease area in reviewing the new drug application, then the likelihood of signing pure royalty contract decreases.

Implications – Understanding the nature of R&D contracts and the effects of FDA's behavior on the pharmaceutical R&D contract is important because these contracts not only affect the cost of new drug invention but also the quality and the rate of invention.

Value – Results are useful for both the pharmaceutical companies and the economic/business researchers.

Details

The Economics of Medical Technology
Type: Book
ISBN: 978-1-78190-129-8

Keywords

1 – 10 of 24