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Technology Challenges & Opportunities in the Biotechnology, Pharmaceutical & Medical Device Industries
Abstract
Realization of the projected benefits of biotechnology involves a variety of challenges and portends many opportunities.ï¾ ï¾ This article focuses on technology challenges as seen by executives in the biotechnology, pharmaceutical, and medical device industries.ï¾ ï¾ The results of an interview study of the nature of these challenges and opportunities are presented.ï¾ ï¾ Extensive telephone interviews were conducted with executives as well as academic experts and senior managers of research institutes.ï¾ ï¾ These interviews focused on identifying key cross-cutting technology challenges and opportunities, as well as sources of expertise for pursuing these ends.ï¾ ï¾ Results suggest that the nature of the challenges differ for technology applications in disease control vs. applications for enabling the pursuit of science, although many of the technologies and competencies cut across these two areas.ï¾ ï¾ With regard to sources of expertise, external collaboration was found to be the norm with various business-related and expertise-related factors governing choices of collaborators.
... In spite of this initial vagueness, these organizations must rapidly establish trustworthy relationships with prospective users and purchasers, as well as with capital investors who may not always be fully cognizant of the commercialization challenges of non-drug health technologies (Ackerly et al., 2008). As a result, very early on in their existence, academic spin-offs stand at the confluence of significant but often ill-defined challenges that affect both their business and the development of their innovation (Farley and Rouse, 2000;Niosi, 2006). ...
... Moreover, the mismatch we observed in the third case is, we believe, a salient example of the necessity to take seriously and articulate what successful alternative innovative business models could be. Overall, strategic decisions that may prove entirely rational at the level of the spin-off could explain why, at the industry-level, the creation and spread of new business models remain limited even in highly technology-intensive sectors like the medical device industry (Farley and Rouse, 2000). ...
... S cholars acknowledge that the design of medical innovations is a complex and multifaceted process that involves a diversity of participants (Blume, 1992;Dixon, Brown, Meenan, & Eatock, 2006;Farley & Rouse, 2000;Faulkner, 2008). While engineers and industrial designers play a key role in the problem-solving process, other participants with backgrounds in medicine, health sciences, business and healthcare management, and computer sciences may also make important contributions to the design process. ...
... Bucciarelli (2002: 220) uses the term "design collective" to refer to the large set of individuals and groups who may have a legitimate say in the design process, either directly or indirectly. In the case of medical devices, a design collective would include potential users (clinicians, patients and their relatives) and a variety of stakeholders who may provide policy and/or financial support (R&D policymakers, capital investors, shareholders) or set specific constraints (regulators, health policymakers, third-party payers) (Boenink, 2010;Farley & Rouse, 2000;Vicente, 2004). This is why we use "worlds" (not "object worlds") to refer to the universe in which design participants locate their own contribution and to the universes they encounter when dealing with the concerns of the broader design collective (for instance, clinical safety and effectiveness, intellectual protection, or medical liability issues). ...
Individuals with different backgrounds such as engineering, medicine, industrial design, business, healthcare management and computer science often contribute to the design of a medical innovation. But how do such heterogeneous design participants actually combine their expertise to develop a medical device? Adapting Bucciarelli’s concept of “object worlds”, which recognises that those who contribute to a design process inhabit different worlds and see the object of design differently, this paper examines the perspectives of 8 design participants who contributed to the design process of three Canadian medical devices. In-depth analyses of semi-structured interviews clarified what design participants saw through their particular “lens”, how their responsibilities, knowledge and motivations combined and how they engaged into the design process.
... Similar research methods with specific questionnaires and in-depth interviews were developed and tested by previous investigations in the field of product innovation and R&D management (Karlsson and Ahlstrom, 1992;Denison et al., 1996;Farley and Rouse, 2000;Barczak and Wilemon, 2003;Thamhain, 2003;Lee and Kelley, 2008;Enkel and Gassmann, 2010). ...
... The second limitation is the sample size. Even though sample size is consistent with many studies in NPD and innovation team studies (Buckler and Zien, 1996;Farley and Rouse, 2000;Cooper, 2005), it certainly has its limits for generalization. The results presented are just a beginning, which need both refinement and further testing in a larger sample and more additional methodologically and statistically rigorous data assessment. ...
New sensor and actuator concepts based on microelectromechanical systems (MEMS) and nanoelectromechanical systems (NEMS) are increasingly being developed from lab status toward commercialization. The associated technology development for the provision of improved functionalities and cost reduction often requires highly interdisciplinary development teams where scientists and engineers from different disciplines closely work together. Managing these teams is a key challenge for MEMS/NEMS organizations. This research examined eight technology developments in MEMS/NEMS in international companies. Based on in‐depth interviews with innovators, we explored the managerial aspects of development teams. We identified and discuss (1) leadership, (2) market, (3) team structure and culture, (4) innovation motivation, (5) innovation driver, (6) experience and know‐how, and (7) product vision and innovation strategy as key influences on teams in the early development phases of MEMS/NEMS. Our study reveals that integrative and manufacturing know‐how and capabilities are the most critical capacities to be developed by the team from the idea to the concept phase. The team's lived experience during long development times from 5 to 10 years or more may allow a fast response to changes from market and technology (e.g. materials and nanotechnology). The results indicate that the process of how know‐how and capabilities are created by the team is more important than the mere existence of specific expertise.
... Given the above context, rehabilitation practice may encounter a multifaceted problem: First, it might not properly define a particular problem of a rehabilitation situation due to a lack of both understanding and the development of domain-specific expertise; second, because of an absence of interdisciplinary expertise in healthcare design, design practice might not ensure the design of healthcare innovations. Traditional healthcare design projects incur limitations in tackling problems around the rehabilitation of elderly patients because the problems are complex and multifaceted, involving a diverse range of domain-specific expertise [31][32][33]. Using an empirical study integrated with the co-design research practice, this study aims to investigate elderly patients suffering from LBP in the current context of rehabilitation and introduce and test an exercise intervention program to support the rehabilitation practice. ...
The rehabilitation practices encounter multifaceted problems inherent in the current context of the elderly with chronic low back pain (LBP). We addressed a particular multifaceted problem in the current context using an interdisciplinary co-design research practice that consists of three phases: context exploration, patient-expert interaction, and patient-centered rehabilitation. Using an empirical study integrated with this practice, we investigated 30 Korean elderly patients suffering from LBP and introduced an exercise program design. In the context exploration phase, we found that the elderly patients neglected proper posture during work causing spine instability and resultantly developing chronic LBP. The patient–expert interaction phase explored latissimus dorsi (LD) and lumbar erector spinae (LES) muscles as the back trunk muscles that had caused LBP in most of these elderly patients. In the patient-centered rehabilitation phase, we designed an exercise program with exercise protocols and an exercise object for flexion and extension of trunk muscle relaxation and stabilization. Using electromyography (EMG), we found that the exercise program significantly increased the muscle activation levels of the muscles and reduced LBP. Our practice defines and addresses a multifaceted problem with several challenges both in healthcare design and the problem itself. This integrated approach can easily be expanded and adapted to other domain-related research projects that possess characteristics of complex problems.
... The traditional methods in healthcare design present limitations on tackling problems around healthcare because they are multifaceted, involving a diversity of other domain-specific expertise [1][2][3]. These methods aim at the exploration of experiences by social processes of identifying patient requirements. ...
This study presents three forms of interdisciplinary expertise in the healthcare design context to approach a particular multifaceted problem around the current healthcare for older adult patients with chronic low-back pain (LBP). Using an interdisciplinary co-design framework, first, our design approach performs the role of an initiator to define the problem by exploring the current context of healthcare. Second, it facilitates the experiences of experts and patients to reach the roots of the problem by functioning as a mediator. Third, our approach fulfills the primary role of healthcare design in producing new meanings considering the principles of patient-centeredness. These roles significantly contributed to the design of healthcare innovations. Our framework transformed the distributed disciplinary knowledge developed while tackling the multifaceted problem into new forms of expertise for collaboration in healthcare innovation.
... The act of designing requires engineers to transform initial abstract ideas into the final usable product following a number of actions involving individuals and the system (Hales and Gooch 2004). Therefore, the design process of medical devices is often a complex and multifaceted involving a diversity of participants with the ability to solve problems (Blume 1992;Dixon et al. 2006;Farley and Rouse 2000;Faulkner Downloaded by [179.61.162.121] at 04:32 21 November 2017 2008; Lehoux et al. 2011). The medical device industry is characterised by high levels of problem-solving demands: Designers of medical technologies have to produce novel solutions to complex engineering problems, and are subject to compliance with regulators to ensure the safety of a product. ...
We investigated accounts of how individuals in public and private organisations operating in the medical device industry use different forms of capital (social e.g. networks and cultural e.g. knowledge) to solve design based problems. We define capital as resources embedded in social networks, knowledge or economic wealth (Bourdieu, 1986). Data were collected from interviews and written diaries from individuals involved in the design process of medical devices using interpretative analysis. Inferences made from our analyses suggested that individuals working in organisations who successfully solve problems may do so by using both social and cultural capital and so may be more likely to engage in innovative activity than others. These exploratory findings suggest workers in large organisations may have the capability to use a greater level of in-house social and cultural capital, whereas those in smaller organisations may be more reliant on high levels of social capital in order to ‘tap into’ cultural capital beyond organisational boundaries.
... Second, the sample size is limited. The sample size is consistent with many exploratory studies in new product development and innovation team studies [318,319,320], but it certainly has its limits for generalization. The third and fourth limitations are the company size and geographical aspects, respectively. ...
What influences microsystems (MEMS) and nanosystems (NEMS) innovation teams apart from technology complexity? Based on in-depth interviews with innovators, this research explores the key influences on innovation teams in the early phases of MEMS/NEMS. Projects are rare and may last from 5 to 10 years or more from idea to concept. As fundamental technology development in MEMS/NEMS is highly complex and interdisciplinary by involving expertise from different basic and engineering disciplines, R&D is rather a 'testing of ideas' with many uncertainties than a clearly structured process. The purpose of this study is to explore the innovation teams' environment and give specific insights for future management practices. The findings are grouped into three major areas: people, know-how and experience, and market. The results highlight the importance and differences of innovation teams' composition, transdisciplinary knowledge, project evaluation and management compared to the counterparts from new product development teams.
This book is about people who operate, maintain, design, research, and manage complex systems, ranging from air traffic control systems, process control plants and manufacturing facilities to industrial enterprises, government agencies and universities. The focus is on the nature of the work these types of people perform, as well as the human abilities and limitations that usually enable and sometimes hinder their work. In particular, this book addresses how to best enhance abilities and overcome limitations, as well as foster acceptance of the means to these ends.
The role of medical innovation in fuelling the growth in private and public spending in healthcare is a contentious issue. It is often being cast in two different lights - as a major cost driver that needs to be more stringently regulated and as a solution to reducing costs. While both of these positions may be valid, one key element is missing from the debate: how incentives and dynamics have driven the design of medical innovations in the past decades and led to the present debate. This essay argues that although most industrialized countries are now looking at cost-effectiveness analyses as the best way to make rational choices between various medical technologies, such tools do not address the problem at its root. Solving healthcare financial problems requires creating innovations that embody a more thoughtful set of values. Three examples of medical advances (management of low-birth weight babies, stem cell research and in-vitro fertilization) are used to illustrate how their design may reinforce certain values and not others. The discussion provides new insights about how alternative design strategies and business models could lead to the development of more sustainable innovations in healthcare.
Innovations in information technology have revolutionized business
A generation ago academia was pure and profitless. Now look what's up at stanford. Depending in your perspective, it's either selling out or keeping up with the times.
If you think the Internet has changed the shape of business,just imagine what genetic engineering is going to do. In this groundbreaking article, Juan Enriquez and Ray Goldberg explain how advances in genetics will not only have dramatic implications for people and society, they will reshape vast sectors of the world economy. The boundaries between many once-distinct businesses, from agribusiness and chemicals to pharmaceuticals and health care to energy and computing, will blur, and out of that convergence will emerge what promises to be the largest industry in the world: life science. And as scientific advances continue to accelerate, more and more businesses will be drawn, by choice or by necessity, into the life-science industry. Companies have realized that unlocking life's code opens up virtually unlimited commercial possibilities, but operating within this new industry presents a raft of wrenchingly difficult challenges as well. Companies must rethink their business, financial, and M&A strategies. They must make vast R&D investments with distant and uncertain payoffs. They must enter into complex partnerships and affiliations, sometimes with direct competitors. And perhaps most difficult, they must contend with a public that is uncomfortable with even the thought of genetic engineering. The optimal structure of the life-science industry-and of the companies that compose it-is as yet unknown. But the actions that executives take now will go a long way toward determining the ultimate role their companies play in the world's largest and most important industry.
Biotechnology is a diverse enterprise that captured the imagination of the general public in the last quarter of the 20th century.ï¾ ï¾ The announcement of the rough draft of the human genome at the beginning of the 21st century may prove to be one of the greatest steps in the development of mankind.ï¾ ï¾ For this potential to be fully realized, many technical barriers must be overcome.ï¾ ï¾ This perspective identifies and briefly discusses the major scientific areas that contributed to the foundations of biotechnology.ï¾ ï¾ This is not a complete historical account of the scientific advancements that were hallmarks of progress in the field.ï¾ ï¾ But, key contributions are noted to give the reader some feeling for the rapidity with which biotechnology is evolving.ï¾ ï¾ Now is an exciting time to be involved in biological research.ï¾ ï¾ Hopefully, this perspective will convey some of that excitement felt by the scientific community over the future of biotechnology.
Trends in computer and communications technologies are enabling increased globalization and integration of enterprises, and corresponding increases of enterprise complexity.ï¾ ï¾ This article addresses management of this complexity using a complex adaptive systems framework.ï¾ ï¾ The nature of complex adaptive systems is first reviewed, drawing upon a range of examples to illustrate key concepts.ï¾ ï¾ The domain of disease control is then introduced in terms of prevention, detection, and treatment of disease, as well as major stakeholders in these processes.ï¾ ï¾ Overall approaches to managing complex systems are discussed in the context of disease control.ï¾ ï¾ Finally, strategic implications for stakeholders in disease control are considered.
Presents a ranking of the top United States universities in their quest for intellectual property, commercial partners, and profits. Bases rankings on a consideration of patent numbers, patent quality, and licensing revenues. (WRM)
By cataloging the entire protein content of a cell, proteomics should not
only provide insight into the molecular basis of life, but also accelerate
the identification of molecular targets for use in diagnostics and therapeutics.
Questions remain, however, as to the capacity of current technology to fulfill
these audacious aims.
Another boom in biotechnology stocks
- L M Fisher
Maturing biotech sector heats up
- M Krantz
- T Friend
MIT seeds inventions but wants a nice cut of profits they yield
- A D Marcus