Bas Oosterman

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Nir Shafir

University of California, San Diego

David Seamon

Kansas State University

Armando Marques-Guedes

UNL - New University of Lisbon

Martijn Koster

Wageningen University

Areti Pentedeka

Hellenic Ministry of Culture & Sports

Sunil Bhougal

University of Jammu, Jammu, Jammu and Kashmir, India

Çağlar Kıvanç KAYMAZ

Ataturk University

Yucel Kadioglu

Ataturk University

Mohamad Ivan Fanany

University of Indonesia

Daniel Jeske

University of California, Riverside

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Papers by Bas Oosterman

Development of a bupivacaine sustained release formulation for non-opioid analgesia following instrumented spinal surgery

Lack of concentration-dependent local toxicity of highly concentrated (5%) versus conventional 0.5% bupivacaine following musculoskeletal surgery in a rat model

Journal of Experimental Orthopaedics

Purpose Various sustained-release formulations incorporate high bupivacaine concentrations but da... more Purpose Various sustained-release formulations incorporate high bupivacaine concentrations but data on local toxicity is lacking. This study explores local toxic effects of highly concentrated (5%) bupivacaine compared to clinically used concentrations in vivo following skeletal surgery, to assess the safety of sustained-release formulations with high bupivacaine concentrations. Methods Sixteen rats underwent surgery, in which screws with catheters affixed were implanted in the spine or femur in a factorial experimental design, allowing single-shot or continuous 72 h local administration of 0.5%, 2.5% or 5.0% bupivacaine hydrochloride. During the 30-day follow-up, animal weight was recorded and blood samples were obtained. Implantation sites underwent histopathological scoring for muscle damage, inflammation, necrosis, periosteal reaction/thickening and osteoblast activity. Effects of bupivacaine concentration, administration mode and implantation site on local toxicity scores were ...

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Product architecture from a coordination point of view

Refereed proceedings EIASM 7th international product development conference

Visualizing Interdependencies in Technical Design

Design for Configuration, 2001

The control and understanding of complex design processes is an important issue in practice and t... more The control and understanding of complex design processes is an important issue in practice and theory. Recent research shows that documentation and analysis of technical interactions between design tasks (using Design Structure Matrices) gives a thorough understanding of the underlying complex structure of design processes. Generally, these studies are based on an existing set of design tasks and interactions and claim that understanding a design structure is particularly helpful to improve (future) design processes. However, we argue that this claim can not be demonstrated because current studies do not document technical cause and nature of interactions. This hampers an objective understanding of design structures of future design processes. In this paper we propose a taxonomy of technical interactions based on product architecture in order to obtain descriptive clarity and better understanding of cause and nature of technical interactions. This will help to better focus on coordination where it is most needed. Further it gives structural insight how to make significant changes in product architecture in order to improve future management and organization of technical product development.

Robust gelatin hydrogels for local sustained release of bupivacaine following spinal surgery

Acta Biomaterialia

Original Research Efficient Source Data Verification Using Statistical Acceptance Sampling: A Simulation Study

Improving product development projects by matching product architecture and organization

Je afzonderlijke delen zijn niet zo bijzonder, maar als geheel ben je een wonder'. Broadly speaki... more Je afzonderlijke delen zijn niet zo bijzonder, maar als geheel ben je een wonder'. Broadly speaking this means: 'The whole is more than the sum of the parts alone'. This not only relates to the topic of this dissertation, but also refers to the PhD. project itself. One might have the opinion that this book is the main result of my project. For me though it is only a part of it. I consider the experience of exploring the scientific field as being equally important. Especially the sum of the final book and all trial and error during the process make the last 5 years complete and a valuable and unique happening for me. Unfortunately for the reader, the best memories and stories of the scientific journey cannot be found in this book. In order to provide the reader a glimpse of it, I will take the opportunity to mention some of the many people who played an important role. Without them the dissertation would not have been completed. I like to express my enormous gratitude to them. First of all I would like to thank Wim Klein Haneveld and Martin Land who were my supervisors during my master thesis in econometrics and inspired me to further explore the world of science. Table of Contents 1 Introduction to the research problem 1 1.1 Research area and scope 1 Design literature in general 1 Concurrent Engineering 1 The 'underlying design structure' 2 Product architecture 2 Organization of design projects 2 Linking product architecture and Organization: the gap 5 1.2 Research questions and objectives 5 1.3 Research method 7 1.4 Outline of the thesis 8 2 Product Architecture: Key Concepts and Implications 11 2.1 Problem solving in general 11 2.1.1 Problem-solving basics 12 2.1.2 Hierarchies 13 2.1.3 Link with product development 15 2.2 Design methods 16 2.2.1 Introduction to engineering design models 16 2.2.2 Prescriptive design models 17 2.2.3 Axiomatic design 22 2.2.4 Discussion 26 2.3 Product architecture 29 2.3.1 Definition of product architecture and modularity 30 2.3.2 Representing architecture 34 2.3.3 Comparison 36 2.4 The implications of architecture 37 2.5 Summary 38 3 Organization of design processes: principles and applications 41 3.1 Classic organizational theory 41 3.1.1 Introduction: tasks and coordination 42 3.1.2 Structuring organizations according to Galbraith 43 3.1.3 Structuring organizations according to Thompson 45 3.1.4 Alternative structures of organization 47 3.1.5 Discussion 47 3.1.6 Lessons 49 3.2 Organization of design project 50 3.2.1 Types of innovation: scope 50 3.2.2 Design project teams 51 IX 3.2.3 Design Structure Matrix studies 53 3.2.4 Discussion of the DSM approach: strengths and weaknesses 56 3.2.5 Summary 58 4 Coupling Product Architecture and Organization 59 4.1 Organizing tasks around building blocks 59 4.2 The consequences of architecture for coordination 61 4.3 Detailed analysis of architecture and system-level coordination 62 4.3.1 Sosa and Eppinger: main idea 62 4.3.2 Discussion 63 4.4 The consequences of organization for architecture 65 4.5 Formulation of the problem 66 5 Proposed taxonomy 70 5.1 Introduction to the taxonomy's main concept 70 5.2 The three types of interactions proposed 71 5.2.1 The functional type of interaction between building blocks 71 5.2.2 The mapping type of interaction between building blocks 72 5.2.3 Physical interactions 72 5.2.4 The relationship between the types: discussion 73 5.3 Impact on coordination per interaction type 74 5.3.1 Functional interaction and coordination 75 5.3.2 Mapping interaction and coordination 76 5.3.3 Physical interactions and coordination 77 5.4 Discussion of the taxonomy: its role, comparison, and restrictions 78 5.4.1 The role of the taxonomy 78 5.4.2 Comparison with Pimmler and Eppinger 79 5.4.3 The taxonomy's limitations 80 5.5 Summing up and field of application 82 6 The results of the case study 83 6.1 The research setting 84 6.1.1 Case study setting: theory 84 6.1.2 Case study setting: the characteristics of the case 85 6.1.3 Data collection: tactics and protocol 89 6.1.4 Summing up 93 6.2 The interactions between the building blocks 95 6.2.1 The functional interactions 95 6.2.2 Mapping interactions 96 6.2.3 The physical interactions 96 6.2.4 Final remarks 97 6.3 System-level coordination 97 6.3.1 System-level coordination for functional type interactions 97 6.3.2 System-level coordination for mapping type interactions 98 6.3.3 System-level coordination for the physical type of interactions 100 6.3.4 Summing up and overall remarks 101 X 6.4 Towards options for improvement 101 6.4.1 Introduction 101 6.4.2 Improvement in general awareness of system-level interactions 102 6.4.3 Improvement per interaction 104 6.4.4 The contingencies behind the interactions 108 6.5 The implications of the analysis 109 6.5.1 The effects within the design teams 109 6.5.2 The architecture team 110 6.5.3 Measuring performance 111 6.5.4 Summing up 113 6.6 Discussion of the results 113 6.6.1 The validity of the interaction constructs: discussion 114 6.6.2 Discussion of the relationship between the interaction types and required coordination 114 6.6.3 The generation of options for improvement: discussion 118 6.6.4 Methodological considerations 120 6.6.5 Measuring of the effect on improvement: discussion 122 7 Conclusions and suggestions for further research 125 7.1 Conclusions 125 7.1.1 Theoretical conclusions 126 7.1.2 Conclusions of the application 128 7.2 Directions for further research 132 7.2.1 External validation 132 7.2.2 Refinement or extension of the taxonomy 133 7.2.3 Alternative interpretations 134 7.2.4 A guide to design new architectures 135 7.2.5 Broadening the scope of the taxonomy 135 References 137

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Sensory Innervation of Human Bone: An Immunohistochemical Study to Further Understand Bone Pain

The Journal of Pain

Predicting enrollment performance of investigational centers in phase III multi-center clinical trials

Contemporary Clinical Trials Communications

Failure to meet subject recruitment targets in clinical trials continues to be a widespread probl... more Failure to meet subject recruitment targets in clinical trials continues to be a widespread problem with potentially serious scientific, logistical, financial and ethical consequences. On the operational level, enrollment-related issues may be mitigated by careful site selection and by allocating monitoring or training resources proportionally to the anticipated risk of poor enrollment. Such procedures require estimates of the expected recruitment performance that are sufficiently reliable to allow centers to be sensibly categorized. In this study, we investigate whether information obtained from feasibility questionnaires can potentially be used to predict which centers will and which centers will not meet their enrollment targets by means of multivariable logistic regression analysis. From a large set of 59 candidate predictors, we determined the subset that is optimal for predictive purposes using Least Absolute Shrinkage and Selection Operator (LASSO) regularization. Although the extent to which the results are generalizable remains to be determined, they indicate that the prediction accuracy of the optimal model is only a marginal improvement over the intercept-only model, illustrating the difficulty of prediction in this setting.

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A Computationally Simply Central Monitoring Procedure was Proposed and Effectively Applied to Empirical Trial data with Known Fraud

Journal of clinical epidemiology, Jan 12, 2017

Central monitoring of multi-center clinical trials becomes an ever more feasible quality assuranc... more Central monitoring of multi-center clinical trials becomes an ever more feasible quality assurance tool, in particular for the detection of data fabrication. More widespread application, across both industry-sponsored as well as academic clinical trials, requires central monitoring methodologies that are both effective and relatively simple in implementation. We describe a computationally simple fraud detection procedure intended to be applied repeatedly and (semi-)automatically to accumulating baseline data, to detect data fabrication in multi-center trials as early as possible. The procedure is based on anticipated characteristics of fabricated data. It consists of seven analyses, each of which flags approximately 10% of the centers. Centers that are flagged three or more times are considered 'potentially fraudulent' and require additional investigation. The procedure is illustrated using empirical trial data with known fraud. In the illustration data, the fraudulent cente...

Steam ironing device having heating means, pump, and control circuit to control ratio of fluid flow rate of pump to power of heating means

Steam Generator Having at Least One Spiral-Shaped Steam Channel and at Least One Flat Resistive Heating Element

Ion Exchange Cartridge

Steam Ironing Device

Efficient Source Data Verification Using Statistical Acceptance Sampling: A Simulation Study

Therapeutic Innovation & Regulatory Science, 2015

Background: One approach to increase the efficiency of clinical trial monitoring is to replace 10... more Background: One approach to increase the efficiency of clinical trial monitoring is to replace 100% source data verification (SDV) by verification of samples of source data. An intuitive strategy for determining appropriate sampling plans (ie, sample sizes and the maximum tolerable number of transcription errors in the samples) is to use acceptance sampling methodology. Expanding upon earlier work in which the use of acceptance sampling strategies for sampling-based SDV was proposed, we describe an alternative acceptance sampling strategy that, instead of relying on sampling standards, evaluates all possible sampling plans algorithmically, thereby ensuring that selected sampling plans conform to prespecified criteria. Methods: Empirical trial data guided the design of the proposed strategy. In addition, extensive simulations, also based on the empirical data, were performed to assess the performance in terms of workload reductions and the post-SDV error proportion of applying the proposed strategy. Results: 13 different scenarios were simulated, but results of the default scenario show that the average pre-SDV error proportion per trial of .056 was reduced to .023 by inspecting only 40.5% of the case report form entries. Of the inspected data entries, almost half (18.0/40.5) was, on average, SDV-ed as part of the sampling process; remaining entries were inspected during full inspections after too many errors were observed in the samples. Conclusion: Our results suggest that major reductions in workload can be achieved, while maintaining acceptable data quality levels. However, the results also indicate that the proposed strategy is conservative and further improvement is possible.

Improving product development projects by matching product architecture and organization

... door Bas Jeroen Oosterman geboren op 5 augustus 1972 te Meppel Page 4. ... Cees Wesdorp and M... more

Effects of recruitment strategies and demographic factors on inclusion in a large scale vaccination trial in adults 65 years and older

Vaccine, 2014

Large-scale randomized studies generate the highest level evidence for medical interventions. Yet... more Large-scale randomized studies generate the highest level evidence for medical interventions. Yet, successful recruitment frequently is challenging, especially when targeting elderly populations. Although several studies investigated specific recruitment barriers, there is little quantitative understanding of such barriers. We therefore determined associations between patient related and study-related factors and study inclusion in healthy elderly (>65 years) invited to participate in a double-blind placebocontrolled randomized study to determine effectiveness and safety of a 13-valent pneumococcal vaccine for community-acquired pneumonia in the Netherlands. Inclusions for this study took place between September 2008 and January 2010. The analysis was performed on replies to invitations sent between February 2009 and October 2009. In our analyses 260,700 replies from this period resulted in 48,982 candidates included in the study (18.8%). Study inclusion was associated with travel time to the vaccination site (decline of 0.6% per 4 min travel time, adjusted odds ratio (OR) 0.972, 95% CI 0.964-0.980), number of published advertorials in local newspapers (increase of 0.4% per consecutively placed advertorial, adjusted OR 1.030, 95% CI 1.026-1.035), age (decline of 0.7% per year, adjusted OR 0.953, 95% CI 0.951-0.955) and male gender (adjusted OR 0.588 versus female, 95% CI 0.576-0.599). Introduction letters sent on behalf of general practitioners prior to the actual invitation letter were not associated with study inclusion. Careful consideration of these parameters in study preparation may facilitate more successful patient recruitment in clinical trials in healthy elderly.

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Polysaccharide Conjugate Vaccine against Pneumococcal Pneumonia in Adults

New England Journal of Medicine, 2015

Pneumococcal polysaccharide conjugate vaccines prevent pneumococcal disease in infants, but their... more

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Development of a bupivacaine sustained release formulation for non-opioid analgesia following instrumented spinal surgery

Lack of concentration-dependent local toxicity of highly concentrated (5%) versus conventional 0.5% bupivacaine following musculoskeletal surgery in a rat model

Journal of Experimental Orthopaedics

Download

Product architecture from a coordination point of view

Refereed proceedings EIASM 7th international product development conference

Visualizing Interdependencies in Technical Design

Design for Configuration, 2001

Robust gelatin hydrogels for local sustained release of bupivacaine following spinal surgery

Acta Biomaterialia

Original Research Efficient Source Data Verification Using Statistical Acceptance Sampling: A Simulation Study

Improving product development projects by matching product architecture and organization

Download

Sensory Innervation of Human Bone: An Immunohistochemical Study to Further Understand Bone Pain

The Journal of Pain

Predicting enrollment performance of investigational centers in phase III multi-center clinical trials

Contemporary Clinical Trials Communications

Download

A Computationally Simply Central Monitoring Procedure was Proposed and Effectively Applied to Empirical Trial data with Known Fraud

Journal of clinical epidemiology, Jan 12, 2017

Steam ironing device having heating means, pump, and control circuit to control ratio of fluid flow rate of pump to power of heating means

Steam Generator Having at Least One Spiral-Shaped Steam Channel and at Least One Flat Resistive Heating Element

Ion Exchange Cartridge

Steam Ironing Device

Efficient Source Data Verification Using Statistical Acceptance Sampling: A Simulation Study

Therapeutic Innovation & Regulatory Science, 2015

Improving product development projects by matching product architecture and organization

... door Bas Jeroen Oosterman geboren op 5 augustus 1972 te Meppel Page 4. ... Cees Wesdorp and M... more

Effects of recruitment strategies and demographic factors on inclusion in a large scale vaccination trial in adults 65 years and older

Vaccine, 2014

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Polysaccharide Conjugate Vaccine against Pneumococcal Pneumonia in Adults

New England Journal of Medicine, 2015

Pneumococcal polysaccharide conjugate vaccines prevent pneumococcal disease in infants, but their... more

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