Technology confidence in early stage development of medical devices

Innovation is a critical factor in ensuring commercial success within the area of medical technology. Biotechnology and Healthcare developments require huge financial and resource investment, in-depth research and clinical trials. Consequently, these developments involve a complex multidisciplinary structure, which is inherently full of risks and uncertainty. In this context, early technology assessment and 'proof of concept' is often sporadic and unstructured. Existing methodologies for managing the feasibility stage of medical device development are predominantly suited to the later phases of development and favour detail in optimisation, validation and regulatory approval. During these early phases, feasibility studies are normally conducted to establish whether technology is potentially viable. However, it is not clear how this technology viability is currently measured. This paper aims to redress this gap through the development of a technology confidence scale, as appropriate explicitly to the feasibility phase of medical device design. These guidelines were developed from analysis of three recent innovation studies within the medical device industry.

Stakeholder engagement in early stage product-service system development for healthcare informatics

This paper presents the findings from four case studies on stakeholder engagement in new health information and communication technology (ICT) product-service system (PSS) development. The degree of connectivity between the new health ICT PSS and its intended operating environment has emerged to be an important contextual factor that may impact the decision of stakeholder engagement in the early stage development process. Along with the proposition of a four-level framework to guide stakeholder identification for new PSS development, three stakeholder engagement propositions that are based on the degree of connectivity are developed. Analysis has shown that there can be two types of connectivity: data and process. Moreover, each connectivity type can be characterized by how much the new PSS is connected with its environment: independent if there is no linkage, linked if it interfaces with, or incorporated if it is embedded into. Furthermore, depending upon whether and to what extent the PSS has data and process connectivity with its intended operating environment, the stakeholder engagement needs in early stage development vary. The propositions presented in this paper provide important directions for future work exploring PSS characterization and stakeholder engagement decision in early stage new PSS development in the healthcare industry. © 2013 PICMET.

The development of turbine exit flow in a swan-necked inter-stage diffuser

This paper describes both the migration and dissipation of flow phenomena downstream of a transonic high-pressure turbine stage. The geometry of the HP stage exit duct considered is a swan-necked diffuser similar to those likely to be used in future engine designs. The paper contains results both from an experimental programme in a turbine test facility and from numerical predictions. Experimental data was acquired using three fast-response aerodynamic probes capable of measuring Mach number, whirl angle, pitch angle, total pressure and static pressure. The probes were used to make time-resolved area traverses at two axial locations downstream of the rotor trailing edge. A 3D time-unsteady viscous Navier-Stokes solver was used for the numerical predictions. The unsteady exit flow from a turbine stage is formed from rotordependent phenomena (such as the rotor wake, the rotor trailing edge recompression shock, the tip-leakage flow and the hub secondary flow) and vane-rotor interaction dependant phenomena. This paper describes the time-resolved behaviour and three-dimensional migration paths of both of these phenomena as they convect downstream. It is shown that the inlet flow to a downstream vane is dominated by two corotating vortices, the first caused by the rotor tip-leakage flow and the second by the rotor hub secondary flow. At the inlet plane of the downstream vane the wake is extremely weak and the radial pressure gradient is shown to have caused the majority of the high loss wake fluid to be located between the mid-height of the passage and the casing wall. The structure of the flow indicates that between a high pressure stage and a downstream vane simple two-dimensional blade row interaction does not occur. The results presented in this paper indicate that the presence of an upstream stage is likely to significantly alter the structure of the secondary flow within a downstream vane. The paper also shows that vane-rotor interaction within the upstream stage causes a 10° circumferential variation in the inlet flow angle of the 2nd stage vane.

Modeling the development of pronunciation in infant speech acquisition.

Pronunciation is an important part of speech acquisition, but little attention has been given to the mechanism or mechanisms by which it develops. Speech sound qualities, for example, have just been assumed to develop by simple imitation. In most accounts this is then assumed to be by acoustic matching, with the infant comparing his output to that of his caregiver. There are theoretical and empirical problems with both of these assumptions, and we present a computational model- Elija-that does not learn to pronounce speech sounds this way. Elija starts by exploring the sound making capabilities of his vocal apparatus. Then he uses the natural responses he gets from a caregiver to learn equivalence relations between his vocal actions and his caregiver's speech. We show that Elija progresses from a babbling stage to learning the names of objects. This demonstrates the viability of a non-imitative mechanism in learning to pronounce.

Investigation of boundary layer development in a multistage LP turbine

This paper describes an investigation of the behavior of suction surface boundary layers in a modern multistage Low Pressure turbine. An array of eighteen surface-mounted hot-film anemometers was mounted on a stator blade of the third stage of a 4-stage machine. Data were obtained at Reynolds numbers between 0.9 × 105 and 1.8 × 105 and 1.8 × 105. At the majority of the test conditions, wakes from upstream rotors periodically initiated transition at about 40% surface length. In between these events, laminar separation occurred at about 75% surface length. It is inferred that the effect of the wakes on the performance of the bladerow is limited and that steady flow design methods should provide an adequate assessment of LP turbine performance during design.

Investigation of boundary layer development in a multistage LP turbine

This paper describes an investigation of the behavior of suction surface boundary layers in a modern multistage Low-Pressure turbine. An array of 18 surface-mounted hot-film anemometers was mounted on a stator blade of the third stage of a four-stage machine. Data were obtained at Reynolds numbers between 0.9 × 105 and 1.8 × 105. At the majority of the test conditions, wakes from upstream rotors periodically initiated transition at about 40 percent surface length. In between these events, laminar separation occurred at about 75 percent surface length. Because the wake-affected part of the flow appeared to be only intermittently turbulent, laminar separation also occurred at about 75 percent surface length while this flow was instantaneously laminar. At all but the lowest Reynolds numbers, the time-mean boundary layer appeared to have re-attached by the trailing edge even though it was not fully turbulent. It is inferred that the effect of the wakes on the performance of the blade row is limited and that steady flow design methods should provide an adequate assessment of LP turbine performance during design.

The development of aerodynamic performance measurements in a transient test facility

Transient test facilities offer the potential for the simultaneous study of turbine aerodynamic performance, unsteady flow phenomena and the heat transfer characteristics of a turbine stage. This paper describes the development of aerodynamic performance measurement techniques in the Oxford Rotor Facility (ORF). The solutions to the technological issues involved with transient testing presented in this paper are expected to achieve levels of precision uncertainty comparable with traditional steady flow test rigs. The theoretical background to the measurement of aerodynamic performance is presented together with a comprehensive pre-test uncertainty analysis. The instrumentation scheme for the measurement of stage mass flow rate is discussed in detail, the measurements of shaft power, total inlet enthalpy, and stage pressure ratio are also outlined. The current working section features a 62% scale, 1-1/2 stage, high-pressure shroudless transonic turbine. The required inlet flow conditions are provided by an Isentropic Light Piston Tunnel (ILPT) with a quasi-steady state run time of approximately 70ms. The testing is conducted at engine representative specific speed, pressure ratio, gas-to-wall temperature ratio, Mach number and Reynolds number.

Value roadmapping: A structured approach for early stage technology investment decisions

Deciding to invest in early stage technologies is one of the most important tasks of technology management and arguably also the most uncertain. It assumes a particular significance in the rise of technology companies in emerging economies, which have to make appropriate investment decisions. Technology managers already have a wide range of methods and tools at their disposal, but these are mostly focussed on quantitative measures such as discounted cash flow and real options techniques. However, in the early stages of technology development there seems to be a lot of dissatisfaction with these techniques as there appears to be a lack of accuracy with respect to the underlying assumptions that these models require. In order to complement these models this paper will discuss an alternative approach that we call value road-mapping. By adapting roadmapping techniques the potential value streams of early stages technologies can be plotted and hence a clearer consensus based picture of the future potential of new technologies emerges. Roadmapping is a workshop-based process bringing together multifunctional perspectives, and supporting communication in particular between technical and commercial groups. The study is work in progress and is based on a growing number of cases. (c) 2006 PICMET.

Environmental priorities in strategic product development

This paper reports some results from a major research project on the integration of environmental issues into design in the electrical and electronic industry. Product development practice and ecodesign methods were examined along with qualitative data from 19 manufacturers, using interviews and an action research methodology. A four-stage framework for ecodesign practice resulted: first, to make an environmental assessment from a life cycle viewpoint; then to communicate the analysis and collect feedback; thirdly to prioritize the environmental issues and finally to complete the design using relevant tools and methods. This 'ARPI' framework (analyse, report, prioritize, improve) applies to both strategic and operational levels. Initial testing of the framework in collaborating companies highlighted difficulties with communication with design teams; the role of 'ecodesign champions' is explained. Other challenges are the development of customized tools and the training of designers. The study concludes that the prioritization step is critical, as it simplifies and clarifies the tasks in design that take place after formulation of the specification. Copyright (C) 2000 John Wiley and Sons, Ltd. and ERP Environment.

Opt-out options in new product co-development partnerships

We study three contractual arrangements—co-development, licensing, and co-development with opt-out options—for the joint development of new products between a small and financially constrained innovator firm and a large technology company, as in the case of a biotech innovator and a major pharma company. We formulate our arguments in the context of a two-stage model, characterized by technical risk and stochastically changing cost and revenue projections. The model captures the main disadvantages of traditional co-development and licensing arrangements: in co-development the small firm runs a risk of running out of capital as future costs rise, while licensing for milestone and royalty (M&R) payments, which eliminates the latter risk, introduces inefficiency, as profitable projects might be abandoned. Counter to intuition we show that the biotech's payoff in a licensing contract is not monotonically increasing in the M&R terms. We also show that an option clause in a co-development contract that gives the small firm the right but not the obligation to opt out of co-development and into a pre-agreed licensing arrangement avoids the problems associated with fully committed co-development or licensing: the probability that the small firm will run out of capital is greatly reduced or completely eliminated and profitable projects are never abandoned.