New product development in brazilian technology-based small and medium enterprises

This article examines new product development (NPD) in small and medium-sized Brazilian enterprises (SMEs) in two technology-based industries: medical devices and process control automation devices. A conceptual model that categorizes factors that contribute to the success of a new product was established. The data were collected from a sample of 62 Brazilian SMEs. The conceptual model was tested to examine the relationships between NPD practices and new product success. Data analysis reveals that new product success in medical device companies is related to organizational characteristics such as NPD proficiency and marketing skills; while in process control automation device companies, they deal in a large degree with product differentiation, innovation and capability to analyze the targeted market. Due to the relatively small sample size, caution should be exercised when interpreting the results.

Invention and business performance in the tissue-engineering industry

Tissue engineering is a young and interdisciplinary scientific discipline but it offers exciting opportunities to improve the quality of health care for hundreds of thousands of patients. Lured by its potential, several start-up companies, pharmaceutical corporations, and medical device enterprises alike are investing heavily in this sector. Invention is a key driver of competition in this sector. In this study, we aim to explain the variation in inventive output across the different firms in the sector. Our major premise is that firms that forge alliances will be able to tap into the expertise of their partners and thus improve their chances of inventive output. We further argue that alliances that enable technology acquisition or learning will enhance the inventive output of firms more than other kinds of alliances. We measure the inventive output of a company by the number of patents filed. On the basis of a preliminary analysis of seven companies, we find support for the hypotheses. We also argue that, to achieve commercial success, firms need to manage time to market (through alliances or otherwise), have a global outlook, nurture their financial resources, and attain critical mass through mergers.

Improved polymeric medical devices for active substances delivery

The work presented in this thesis was developed in collaboration with a Portuguese company, BeyonDevices, devoted to pharmaceutical packaging, medical technology and device industry. Specifically, the composition impact and surface modification of two polymeric medical devices from the company were studied: inhalers and vaginal applicators. The polyethylene-based vaginal applicator was modified using supercritical fluid technology to acquire self-cleaning properties and prevent the transport of bacteria and yeasts to vaginal flora. For that, in-situ polymerization of 2-substituted oxazolines was performed within the polyethylene matrix using supercritical carbon dioxide. The cationic ring-opening polymerization process was followed by end-capping with N,N-dimethyldodecylamine. Furthermore, for the same propose, the polyethylene matrix was impregnated with lavender oil in supercritical medium. The obtained materials were characterized physical and morphologically and the antimicrobial activity against bacteria and yeasts was accessed. Materials modified using 2-substituted oxazolines showed an effective killing ability for all the tested microorganisms, while the materials modified with lavender oil did not show antimicrobial activity. Only materials modified with oligo(2-ethyl-2-oxazoline) maintain the activity during the long term stability. Furthermore, the cytotoxicity of the materials was tested, confirming their biocompatibilty. Regarding the inhaler, its surface was modified in order to improve powder flowability and consequently, to reduce powder retention in the inhaler´s nozzle. New dry powder inhalers (DPIs), with different needle’s diameters, were evaluated in terms of internal resistance and uniformity of the emitted dose. It was observed that they present a mean resistance of 0.06 cmH2O0.5/(L/min) and the maximum emitted dose obtained was 68.9% for the inhaler with higher needle´s diameter (2 mm). Thus, this inhaler was used as a test and modified by the coating with a commonly-used force control agent, magnesium stearate, dried with supercritical carbon dioxide (scCO2) and the uniformity of delivered dose tests were repeated. The modified inhaler showed an increase in emitted dose from 68.9% to 71.3% for lactose and from 30.0% to 33.7% for Foradil.

Conflict of Interest Policies at Canadian Universities and Medical Schools: Some Lessons from the AMSA PharmFree Scorecard

Article

Using a design led disruptive innovation approach to develop new services : practising innovation in times of discontinuity

Organisations face increasing competition from new firms in emerging markets and their past superior products may no longer provide competitive advantage in markets based on different cost and value differentials. A shift in design practices from product solutions to health services which are accessible and affordable by all is required. This paper explores a design led approach to innovation to assist medical device companies develop new services and experiences and reshape their notions of the nature, development and deployment of health care services. This approach uses design tools and methodologies that are grounded in the authentic understandings of stakeholder experiences, to assist an organisation create a vision of likely future health care scenarios. Through this process, organisations can explore the complexities in the delivery of future health care services in new and emerging markets allowing them to tailor product and service solutions which focus on being accessible and affordable by all. The industry based case study for the design of health services in carried out in emerging economies. The contribution of this work in advancing research into design innovation and future research directions are also presented.

Improving posture and decreasing pain with novel shoe insoles

A single subject longevity study is presented as a case study for the Medical Device Partnering Program (MDPP). The MDPP supports the development of cutting-edge medical devices and assistive technologies, through unique collaborations between researchers, industry, clinical end-users and government. The study aimed to identify what effect the innersole has on specific muscles that may influence stability and whether the innersole had any influence on gait. Three tests were conducted; a standard gait test, dynamic balance test and a standing balance test. Results from the kinematic analysis showed reduced variability in post testing results when compared to pre testing results. Reductions in muscle activation levels were also found across all tests. Further testing with a larger sample size is required to determine if these effects are due to the innersole.

Nurse-led trials of medical devices: General principles and good practice

Aim To provide an overview of key governance matters relating to medical device trials and practical advice for nurses wishing to initiate or lead them. Background Medical device trials, which are formal research studies that examine the benefits and risks of therapeutic, non-drug treatment medical devices, have traditionally been the purview of physicians and scientists. The role of nurses in medical device trials historically has been as data collectors or co-ordinators rather than as principal investigators. Nurses more recently play an increasing role in initiating and leading medical device trials. Review Methods A review article of nurse-led trials of medical devices. Discussion Central to the quality and safety of all clinical trials is adherence to the International Conference on Harmonization Guidelines for Good Clinical Practice, which is the internationally-agreed standard for the ethically- and scientifically-sound design, conduct and monitoring of a medical device trial, as well as the analysis, reporting and verification of the data derived from that trial. Key considerations include the class of the medical device, type of medical device trial, regulatory status of the device, implementation of standard operating procedures, obligations of the trial sponsor, indemnity of relevant parties, scrutiny of the trial conduct, trial registration, and reporting and publication of the results. Conclusion Nurse-led trials of medical devices are demanding but rewarding research enterprises. As nursing practice and research increasingly embrace technical interventions, it is vital that nurse researchers contemplating such trials understand and implement the principles of Good Clinical Practice to protect both study participants and the research team.

Beyond Wearables : Experiences and Trends in Design of Portable Medical Devices

The use of Portable Medical Devices (PMDs) has become increasingly widespread over the last few years. A combination of factors; including advances in technology, the pressure to reduce public health costs and the desire to make health solutions accessible to a wider patient base are contributing to the growth in the PMD market. Design has a clear role to play in the current and future context of the PMD landscape. In this paper, we identify emerging trends in the design of PMDs; including changes in the form, purpose and mode of use, and explore how these trends are likely to fundamentally impact the nature of healthcare and the patient experience from an experience design perspective. We conclude by identifying a research opportunity for design within the healthcare and PMD context.

IASDR 2015 Interplay Exhibition 2-5 NOV 2015

It has been said that we are living in a golden age of innovation. New products, systems and services aimed to enable a better future, have emerged from novel interconnections between design and design research with science, technology and the arts. These intersections are now, more than ever, catalysts that enrich daily activities for health and safety, education, personal computing, entertainment and sustainability, to name a few. Interactive functions made possible by new materials, technology, and emerging manufacturing solutions demonstrate an ongoing interplay between cross-disciplinary knowledge and research. Such interactive interplay bring up questions concerning: (i) how art and design provide a focus for developing design solutions and research in technology; (ii) how theories emerging from the interactions of cross-disciplinary knowledge inform both the practice and research of design and (iii) how research and design work together in a mutually beneficial way. The IASDR2015 INTERPLAY EXHIBITION provides some examples of these interconnections of design research with science, technology and the arts. This is done through the presentation of objects, artefacts and demonstrations that are contextualised into everyday activities across various areas including health, education, safety, furniture, fashion and wearable design. The exhibits provide a setting to explore the various ways in which design research interacts across discipline knowledge and approaches to stimulate innovation. In education, Designing South African Children’s Health Education as Generative Play (A Bennett, F Cassim, M van der Merwe, K van Zijil, and M Ribbens) presents a set of toolkits that resulted from design research entailing generative play. The toolkits are systems that engender pleasure and responsibility, and are aimed at cultivating South African’s youth awareness of nutrition, hygiene, disease awareness and prevention, and social health. In safety, AVAnav: Avalanche Rescue Helmet (Jason Germany) delivers an interactive system as a tool to contribute to reduce the time to locate buried avalanche victims. Helmet-mounted this system responds to the contextual needs of rescuers and has since led to further design research on the interface design of rescuing devices. In apparel design and manufacturing, Shrinking Violets: Fashion design for disassembly (Alice Payne) proposes a design for disassembly through the use of beautiful reversible mono-material garments that interactively responds to the challenges of garment construction in the fashion industry, capturing the metaphor for the interplay between technology and craft in the fashion manufacturing industry. Harvest: A biotextile future (Dean Brough and Alice Payne), explores the interplay of biotechnology, materiality and textile design in the creation of sustainable, biodegradable vegan textile through the process of a symbiotic culture of bacteria and yeast (SCOBY). SCOBY is a pellicle curd that can be harvested, machine washed, dried and cut into a variety of designs and texture combinations. The exploration of smart materials, wearable design and micro-electronics led to creative and aesthetically coherent stimulus-reactive jewellery; Symbiotic Microcosms: Crafting Digital Interaction (K Vones). This creation aims to bridge the gap between craft practitioner and scientific discovery, proposing a move towards the notion of a post-human body, where wearable design is seen as potential ground for new human-computer interactions, affording the development of visually engaging multifunctional enhancements. In furniture design, Smart Assistive chair for older adults (Chao Zhao) demonstrates how cross-disciplinary knowledge interacting with design strategies provide solution that employed new technological developments in older aged care, and the participation of multiple stakeholders: designers, health care system and community based health systems. In health, Molecular diagnosis system for newborns deafness genetic screening (Chao Zhao) presents an ambitious and complex project that includes a medical device aimed at resolving a number of challenges: technical feasibility for city and rural contexts, compatibility with standard laboratory and hospital systems, access to health system, and support the work of different hospital specialists. The interplay between cross-disciplines is evident in this work, demonstrating how design research moves forward through technology developments. These works exemplify the intersection between domains as a means to innovation. Novel design problems are identified as design intersects with the various areas. Research informs this process, and in different ways. We see the background investigation into the contextualising domain (e.g. on-snow studies, garment recycling, South African health concerns, the post human body) to identify gaps in the area and design criteria; the technologies and materials reviews (e.g. AR, biotextiles) to offer plausible technical means to solve these, as well as design criteria. Theoretical reviews can also inform the design (e.g. play, flow). These work together to equip the design practitioner with a robust set of ‘tools’ for design innovation – tools that are based in research. The process identifies innovative opportunity and criteria for design and this, in turn, provides a means for evaluating the success of the design outcomes. Such an approach has the potential to come full circle between research and design – where the design can function as an exemplar, evidencing how the research-articulated problems can be solved. Core to this, however, is the evaluation of the design outcome itself and identifying knowledge outcomes. In some cases, this is fairly straightforward that is, easily measurable. For example the efficacy of Jason Germany’s helmet can be determined by measuring the reduced response time in the rescuer. Similarly the improved ability to recycle Payne’s panel garments can be clearly determined by comparing it to those recycling processes (and her identified criteria of separating textile elements!); while the sustainability and durability of the Brough & Payne’s biotextile can be assessed by documenting the growth and decay processes, or comparative strength studies. There are however situations where knowledge outcomes and insights are not so easily determined. Many of the works here are open-ended in their nature, as they emphasise the holistic experience of one or more designs, in context: “the end result of the art activity that provides the health benefit or outcome but rather, the value lies in the delivery and experience of the activity” (Bennet et al.) Similarly, reconfiguring layers of laser cut silk in Payne’s Shrinking Violets constitutes a customisable, creative process of clothing oneself since it “could be layered to create multiple visual effects”. Symbiotic Microcosms also has room for facilitating experience, as the work is described to facilitate “serendipitous discovery”. These examples show the diverse emphasis of enquiry as on the experience versus the product. Open-ended experiences are ambiguous, multifaceted and differ from person to person and moment to moment (Eco 1962). Determining the success is not always clear or immediately discernible; it may also not be the most useful question to ask. Rather, research that seeks to understand the nature of the experience afforded by the artefact is most useful in these situations. It can inform the design practitioner by helping them with subsequent re-design as well as potentially being generalizable to other designers and design contexts. Bennett et. al exemplify how this may be approached from a theoretical perspective. This work is concerned with facilitating engaging experiences to educate and, ultimately impact on that community. The research is concerned with the nature of that experience as well, and in order to do so the authors have employed theoretical lenses – here these are of flow, pleasure, play. An alternative or complementary approach to using theory, is using qualitative studies such as interviews with users to ask them about what they experienced? Here the user insights become evidence for generalising across, potentially revealing insight into relevant concerns – such as the range of possible ‘playful’ or experiences that may be afforded, or the situation that preceded a ‘serendipitous discovery’. As shown, IASDR2015 INTERPLAY EXHIBITION provides a platform for exploration, discussion and interrogation around the interplay of design research across diverse domains. We look forward with excitement as IASDR continues to bring research and design together, and as our communities of practitioners continue to push the envelope of what is design and how this can be expanded and better understood with research to foster new work and ultimately, stimulate innovation.

Designing for validation of medical devices and equipment

Validation is important in the design, development and production of medical devices since effective and appropriate validation plays a vital role in defining the success of a product in both technical and economic terms. Regulations and quality standards lay out the requirements for product validation, but it is left to each individual manufacturer to establish and maintain their own validation procedures. More recently, there has also been a change of emphasis in the regulations and standards that encourage the integration of validation into the development process. However, this poses particular challenges to the manufacturer since there is a distinct lack of guidance to assist this integration. This workbook provides the first real guidance on good design practices for medical device development. It has been developed through extensive consultation with device manufacturers and analysis of regulatory requirements. The approach is intended to assist manufacturers in meeting the new regulations.

Stakeholder challenges in purchasing medical devices for patient safety.

OBJECTIVE: This study identifies the stakeholders who have a role in medical device purchasing within the wider system of health-care delivery and reports on their particular challenges to promote patient safety during purchasing decisions. METHODS: Data was collected through observational work, participatory workshops, and semi-structured qualitative interviews, which were analyzed and coded. The study takes a systems-based and engineering design approach to the study. Five hospitals took part in this study, and the participants included maintenance, training, clinical end-users, finance, and risk departments. RESULTS: The main stakeholders for purchasing were identified to be staff from clinical engineering (Maintenance), device users (Clinical), device trainers (Training), and clinical governance for analyzing incidents involving devices (Risk). These stakeholders display varied characteristics in terms of interpretation of their own roles, competencies for selecting devices, awareness and use of resources for purchasing devices, and attitudes toward the purchasing process. The role of "clinical engineering" is seen by these stakeholders to be critical in mediating between training, technical, and financial stakeholders but not always recognized in practice. CONCLUSIONS: The findings show that many device purchasing decisions are tackled in isolation, which is not optimal for decisions requiring knowledge that is currently distributed among different people within different departments. The challenges expressed relate to the wider system of care and equipment management, calling for a more systemic view of purchasing for medical devices.

The use of fault detection and diagnostics to reduce air handling unit energy consumption

The contribution of buildings towards total worldwide energy consumption in developed countries is between 20% and 40%. Heating Ventilation and Air Conditioning (HVAC), and more specifically Air Handling Units (AHUs) energy consumption accounts on average for 40% of a typical medical device manufacturing or pharmaceutical facility’s energy consumption. Studies have indicated that 20 – 30% energy savings are achievable by recommissioning HVAC systems, and more specifically AHU operations, to rectify faulty operation. Automated Fault Detection and Diagnosis (AFDD) is a process concerned with potentially partially or fully automating the commissioning process through the detection of faults. An expert system is a knowledge-based system, which employs Artificial Intelligence (AI) methods to replicate the knowledge of a human subject matter expert, in a particular field, such as engineering, medicine, finance and marketing, to name a few. This thesis details the research and development work undertaken in the development and testing of a new AFDD expert system for AHUs which can be installed in minimal set up time on a large cross section of AHU types in a building management system vendor neutral manner. Both simulated and extensive field testing was undertaken against a widely available and industry known expert set of rules known as the Air Handling Unit Performance Assessment Rules (APAR) (and a later more developed version known as APAR_extended) in order to prove its effectiveness. Specifically, in tests against a dataset of 52 simulated faults, this new AFDD expert system identified all 52 derived issues whereas the APAR ruleset identified just 10. In tests using actual field data from 5 operating AHUs in 4 manufacturing facilities, the newly developed AFDD expert system for AHUs was shown to identify four individual fault case categories that the APAR method did not, as well as showing improvements made in the area of fault diagnosis.

Staphylococcus epidermidis device-related infections: pathogenesis and clinical management

Staphylococcus epidermidis, the most frequently isolated coagulase-negative staphylococcus, is the leading cause of infection related to implanted medical devices (IMDs). This is directly related to its capability to establish multilayered, highly structured biofilms on artificial surfaces. At present, conventional systemic therapies using standard antimicrobial agents represent the main strategy to treat and prevent medical device-associated infections. However, device-related infections are notoriously difficult to treat and bacteria within biofilm communities on the surface of IMDs frequently outlive treatment, and removal of the medical device is often required for successful therapy. Importantly, major advances in this research area have been made, leading to a greater understanding of the complexities of biofilm formation of S. epidermidis and resulting in significant developments in the treatment and prevention of infections related to this member of the coagulase-negative group of staphylococci. This review will examine the pathogenesis of the clinically significant S. epidermidis and provide an overview of the conventional and emerging antibiofilm approaches in the management of medical device-associated infections related to this important nosocomial pathogen.

Innovation in medical tourism service marketing: A case of India

© 2015, IGI Global. The aim of this chapter is to critically examine the latest development of medical tourism as an innovation in India. The existing theories and concepts in medical tourism are reviewed and synthesised in order to lay down a foundation for marketing managers to deploy marketing mix strategies to deliver values to the medical tourists. A secondary research method is adapted to gather relevant literature. This chapter not only provides a background introduction to the growing importance of the medical tourism industry to the Indian economy, but also makes major contributions: firstly, that global healthcare service marketing is quite different from marketing of other services and goods. Secondly, it proposes to examine the application of 8Ps of tourism marketing-mix along with another 6Ps, such as personalisation of healthcare, publication for patient, patient packaging, patient education, patient privacy, and patient medical and cultural sensitivities for effective marketing of the popular Indian wellness and medical tourism destinations, super-speciality hospitals, and complex diagnostic tests and surgeries to the world.

Simplifying medical additive manufacturing: making the surgeon the designer

Additive Manufacturing, a technology which has been in existence since three decades, is now successfully being transitioned from a research setting to finding technologically and financially viable end-user applications. A key sector in which Additive Manufacturing is being used is the medical devices and healthcare sector. Drivers in this sector include the ability to create customized, patient specific devices and implants with quick turnaround time in a cost-effective manner. Doctors and surgeons are important change agents and innovators in the creation of new healthcare devices as well as surgical methods. Often times, they may find it necessary at first to build devices and plan surgeries which are not even being thought of or acted upon by the major healthcare companies. In this sense, they perform the roles of designers, creating new ideas and improving on them until they can be implemented and adopted by others. However, the scope for performing this creative activity is often limited in their workplaces, with resource, time and financial impediments often being present. Additive Manufacturing can be helpful to speed up the iterative process of designing such medical devices or planning surgeries as well as help convince people outside of the surgery room of the feasibility and business case for such innovations. This paper proposes to introduce a framework of design, processes and tools which will enable non-engineers (specifically surgeons) to create custom-built products. It is hoped that this paper will motivate more surgeons and non-engineers to get involved in the process of designing for additive manufacturing.