Strategic group mapping and strategy canvas analysis of the environmental consulting sector : a project-based dissertation on the German Market : a public archival data web-content analysis

Nesta dissertação na modalidade de projeto tive a oportunidade de entrar em contacto com uma Pequena Média empresa no setor de consultoria ambiental, onde me foi pedido para realizar uma análise à competição no mercado alemão, focando-me em mercados específicos em que a empresa se planeia especializar (Nanomateriais, Biocidas e Instrumentos Médicos). É possível observar que as leis ambientais mais restritivas, desenvolvimentos dentro da química e consciência ambiental estão a criar um grande potencial para crescimento e relevância deste setor. Gestão estratégica e categorização estratégica desenvolveram muitas correntes de pesquisa e no entanto, ferramentas estratégicas ainda não foram utilizadas para analisar o setor da Consultoria ambiental, que tem sido negligenciado na literatura. Através de uma análise de dados de arquivamento públicos (websites, páginas de LinkedIn, e relatórios anuais), foi possível aplicar ferramentas estratégicas (Mapeamento de grupos estratégicos e o Canvas estratégico) a uma amostra de 57 empresas de consultoria ambiental no mercado alemão assim como recolher sinais de competitividade e tamanho das empresas. Nesta análise pode-se comprovar que a revolução digital, sustentabilidade e responsabilidade corporativa já se encontram presentes nesta indústria, que várias empresas oferecem tanto apoio ambiental com foco regulatório e de gestão como um apoio ambiental com foco cientifico, procurando eficiência ambiental e redução de desperdício, e que nanomateriais parecem ser o mercado menos presente em websites, comparativamente com o mercado dos biocidas e dos instrumentos médicos. Este trabalho permitiu demonstrar o valor que ferramentas estratégicas podem ter, mesmo quando aplicado a informação publica, neste caso de websites, e também demonstrar as respetivas limitações, permitindo-nos ter uma melhor visão das nuances estratégicas e estrutura de um setor negligenciado. Para além disso, o contexto da análise estratégica também demonstra que o Brexit pode agir como um catalisador de expansão geográfica, o que é um impacto estratégico que ainda não tinha sido estudado previamente em empresas nesta indústria.In this project-based dissertation I had the chance to work with an environment consulting SME, where I was asked to do a competitor analysis of the German Market in particular sectors in which they will focus on (Nanomaterials, Biocides and Medical Devices). It is possible to observe that the increasingly stringent environmental policies, chemistry developments and environmental consciousness are creating a great potential for the growth in size and relevance of this sector. Strategic management and strategic categorization have developed into many streams of research, and however, strategic tools still haven’t been used to describe the environmental consulting sector, which has been overlooked in the literature. Through an analysis of public archival data (Company website, LinkedIn and annual reports), it was possible apply the Strategic group mapping and Strategy canvas frameworks to a sample of 57 environmental consulting companies in the German market, as well as to collect other signs of competitiveness and size. In this analysis it was found that the digital revolution, sustainability and corporate responsibility are already present in this industry, it was found that many companies are providing not only environmental regulatory and managerial support but at the same time providing scientific support, focusing on environmental efficiency and waste management, and that nanomaterials seem to be the least featured market in companies websites comparatively to biocides and medical devices. This paper allowed to demonstrate the value that strategic tools can have, even when applied to public website-content, as well as to demonstrate their limitations, allowing us to give a better overview of the strategic nuances and structure of an overlooked sector. Moreover, the context of this company’s strategic analysis also showcases that Brexit can act as a catalyst of geographical expansion, which is a strategical impact in this industry that hasn’t been studied before for companies in this industry

Possibilities of utilizing lean management tools in the high-level structure (HLS) concept

PURPOSE: This article attempts to identify Lean Management tools that have the potential to support the implementation of management requirements outlined in the International Organization for Standardization (ISO) standards, including ISO 9001:2015, ISO 14001:2015, and ISO 45001:2018.DESIGN/METHODOLOGY/APPROACH: The research aimed to identify Lean Management tools that could support the requirements of businesses operating based on the High-Level Structure (HLS) framework. The theoretical and cognitive objective was to conduct a comprehensive review of the subject literature and scientific works related to management systems. The analysis of the problem revealed the previously unidentified potential of utilizing selected Lean Management tools to support the requirements outlined in ISO 9001:2015, ISO 14001:2015, and ISO 45001:2018.FINDINGS: The generated conclusions will allow companies operating based on the HLS framework to increase the likelihood of effectively implementing quality, environmental, and health and safety management processes.PRACTICAL IMPLICATIONS: Lean Management tools have been presented in a practical format that enables their application in companies operating based on the HLS framework. The generated conclusions will allow companies with multiple management systems and those operating based on the HLS framework to use the presented Lean Management tools, which may contribute to developing more cost-effective solutions for these companies.ORIGINALITY/VALUE: The authors present the possibilities of using individual Lean Management tools in companies operating based on the HLS framework. The article pays particular attention to the HLS concept, which operates based on unifying the structure of all management system standards (consistent text, identical terminology). The analysis of the problem revealed the previously unidentified potential of utilizing Lean Management tools to improve processes related to quality, environmental, and health and safety management.peer-reviewe

Impact of EU Medical Device Directive on Medical Device Software

Directive 2007/47/EC of the European Parliament amending Medical Device Directive (MDD) provides medical device manufacturers with a compliance framework. However, the effects of the amendments to the MDD on competition in the U.S. medical device software industry are unknown. This study examined the impact of this directive on the competitiveness of U.S. medical device software companies, the safety and efficacy of medical device software, employee training, and recruitment. The conceptual framework for this study included 3 dimensions of medical device regulations: safety, performance, and reliability. The overall research design was a concurrent mixed method study using both quantitative and qualitative techniques. The qualitative techniques involved case studies of 5 purposively selected companies. Data collection involved both surveys and interviews. The sample consisted of 56 employees within medical device firms with markets around the European regions. Qualitative data analysis consisted of descriptive thematic analysis along the study questions and hypotheses and summative evaluation. Quantitative data analysis included descriptive statistics and correlation to test the 4 hypotheses. The results suggested that the MDD has realigned medical device software manufacturing practices, and US medical device companies have gained global competitiveness in improving product safety and increasing sales revenue. Key recommendations to medical device manufacturers include adopting MDD 93/42/EEC, using model-based approaches, and being comprehensive in model use. Adopting the MDD will provide positive social change to patients, as human safety improves with better product quality while companies experience fewer product recalls

Implementing innovation more effectively within the highly regulated non-invasive medical device field: a case of pragmatic entrepreneurship

My public works are a combination of a number of varied examples that when combined demonstrate that during my 26 year career I have not only contributed to but have significantly affected daily practice by implementing innovation more effectively within the non-invasive medical devices field. In the following sections I will reflect on these public works and in context outline how through both institutional and work based learning I gained and imparted new knowledge to my field of expertise. I will explore the barriers to successful implementation of innovation and will elaborate on the specific challenges faced as I transitioned within, and between organizations and up the leadership ladder. I will explore how I overcame these varied challenges and created new opportunities along the way implementing a number of innovative products into the global marketplace. I will demonstrate how I established and managed innovative organizations with virtual structured teams of uniquely competent professionals across dispersed geographic locations, encompassing the required expertise in all the highly technical and clinical areas needed to allow for more effective implementation of complex medical products. I will then expand this discussion further to evidence my more effective implementation of a number of innovations. Furthermore, I will illustrate my progression and provide examples of my journey to becoming a pragmatic entrepreneur. I will conclude by detailing and critiquing my unique contribution to the field, supporting my claim that I have; ‘Implemented innovation more effectively within the highly regulated non-invasive medical device field’

Packaging solutions for biodegradable tissue engineering products

Tissue engineering is a multidisciplinary field that develops biological substitutes to restore, maintain, or improve damaged tissues. Biodegradable tissue engineering applications are often complex composite structures that combine a biodegradable medical device with biological factors. Materials used in tissue engineering applications are sensitive and cannot withstand high temperatures, humidity, irradiation, and/or chemicals. These qualities pose special challenges to sterilization process and packaging design. The heavy regulations that apply to tissue engineering products affect the packaging solution from choosing the sterilization method to the design and testing of the final package. This thesis is a literature review. The scope of this thesis was to examine suitable packaging solutions for biodegradable tissue engineering products. For background, the current relevant legislation and regulations in the European Union and in the United States were reviewed, and different aspects of packaging of medical devices were discussed. Also several sterilization methods, as well as aseptic processing were reviewed, and multiple packaging solutions that are or could be suitable for sterile biodegradable implantable medical devices were presented. Due to the diverse nature of biodegradable tissue engineering products, it is impossible to suggest one universal packaging solution. Some general guidelines, however, can be suggested based on the common features of biodegradable tissue engineering products, usability studies, and sustainability considerations. An ideal packaging would be a double sterile barrier system consisting of a rigid tray in a flexible, clear pouch that would also serve as a moisture barrier. All the packaging components should be easy to open quickly in an operating room environment. The outer carton should be as small as possible, while still providing sufficient protection and information. The final materials for the packaging should be chosen based on whether the product will be sterilized in the final package or whether it will be aseptically processed

Solving the Continual Improvement and Innovation Challenge for the Benefit of Patients: How an Effective Pharmaceutical Quality System (PQS) and Risk-Based Approach Could Transform Post-Approval Change (PAC) Management

Patients deserve their medicines on time every time. Regulators safeguard public health by ensuring availability of safe, effective, high-quality medicines. Pharmaceutical companies must continually improve and innovate to deliver such medicines. In spite of these patient-centric objectives, drug shortages have continued to grow as a global public health concern. The drug shortage problem has existed for decades though there has been no shortage of effort, recommendations, papers, and expectations to resolve it. During the ongoing COVID-19 pandemic even exceptional measures were rapidly implemented to prevent shortages, yet no long-term solutions have been found. This research hypothesis was that due to the high global regulatory complexity of making post-approval changes (PACs), pharmaceutical companies are slow in implementing new knowledge to continually improve and innovate their products and processes – even when this reduces risk to patients or improves the state-of-control. This results in sub-optimal operations, and eventually drug shortages. To date, most efforts and solutions to tackle drug shortages by the industry or regulatory authorities have been from their individual respective perspectives. This research concluded that no one stakeholder can solve this ‘wicked problem’, and that its resolution lies in practical standard solutions collaboratively developed and globally implemented across the pharmaceutical industry and its regulatory authorities. This research explored how an enhanced science and risk basis which considers current product and process knowledge within the framework of an effective Pharmaceutical Quality System (PQS) – could provide a clear pathway to overcome the global regulatory complexity, accelerate continual improvement and innovation, and help reduce drug shortages. It proposed that any PAC which can be demonstrated to not increase risk to product quality or patient safety should be implemented immediately within the construct of an effective PQS, without requiring prior regulatory approval; such changes would still remain under regulatory oversight through routine inspections that assess effectiveness of a company’s PQS. The research resulted in the development of standard practical solutions for the pharmaceutical sector - to enable regulatory flexibility, faster decision-making and implementation of PACs by allowing more changes to be managed in the PQS without requiring prior-approval. The research also defined what constitutes an effective PQS for PAC management, and how companies could demonstrate this during inspections, thereby shifting the regulatory oversight from review of individual PACs by assessors, to evaluation of the PQS effectiveness for PAC management by inspectors. A portion of this research occurred during the COVID-19 pandemic. Given the pandemic is still ongoing, it did not assess implications or consequences of the “new normal” state that will emerge post-pandemic. However, the thesis touches on anticipatory considerations and poses relevant questions on how faster risk-based decision-making and collaborative models that emerged during the pandemic could and should continue as part of the “new normal”

A study assessing the viability of using Fused Filament Fabrication (FFF) Additive Manufacturing (AM) technology to manufacture customised Class I medical devices

Additive manufacturing (AM) is becoming an increasingly common manufacturing method for medical devices due to the benefits of advanced customisation, improved fit and opportunities for innovation. However, many AM medical devices remain inaccessible due to high costs of hardware and consumables, and the large infrastructural requirements required for operation. Fused filament fabrication (FFF) is a highly accessible AM technique due to its open-source nature, which has led to an extensive market of affordable desktop 3D printers. In this work FFF has been demonstrated as a potentially viable technique to fabricate low-risk medical devices in two case studies presented in this thesis: a customised daily living aid and a range of medical devices in response to the COVID-19 pandemic. Although the potential of the technology has been demonstrated, research around the practical suitability of FFF for medical applications remained limited, with much of the research in the field focussing on proof-of-concept applications, which did not explore the necessary requirements for the integration of the technology into daily clinical practices. This thesis investigates the fundamental requirements of the FFF AM technique for it to be used for Class I medical device applications in three identified use cases: non-specialist, research and industrial use. In keeping with the ambition for FFF to provide accessible solutions, mid-range hardware aimed at professional printing applications was selected to carry out this work, which encompasses the activities present in each of the three identified use cases. A methodology was presented to determine the repeatability and reproducibility of FFF across three potential use cases, which revealed varying process capability between the X-, Y- and Z- printing directions for individual machines, and significant variation between multiple machines of the same make and model. The repeatability and reproducibility of the FFF technique was identified as a key limitation for the widespread adoption of FFF technology for specialist and industrial use. The smallest tolerance achieved from a professional desktop FFF printer was 0.3mm in both the X- and Y- directions, and 0.4mm in the Z-direction. Additional variable factors were studied, including the condition of filament with respect to its storage environment and duration of storage, the influence of different colours and pigments present in filament and the use of an air management add-on unit intended to enhance the hardware. The glass transition temperature of Tough PLA remained largely unaffected from variable storage conditions, which when submerged in water decreased by around 1.4ºC from that of ambiently stored filament. The mechanical properties of printed parts were influenced by filament colour, with white filament producing parts with increased elongation and tensile strength than other colours studied. Dimensional accuracy in the Z-printing direction was affected by air management, where samples produced with air management were measured higher than the nominal value, and without air management lower than the nominal value. This thesis is the first known work to explore the suitability of FFF technology for Class I medical devices, from the perspective of both specialist and non-specialist users. The key barriers to widespread adoption were identified as the repeatability and reproducibility of the technique, and the influence of variable factors on the process and part performance. The exploration of these continually referenced medical device regulations, whilst consideration was given to how the experimental work can be applied to real-world Class I medical device manufacturing applications

Business plan for an innovative feminine medical device

The gynecological area related to vaginal infections is not very explored from the practical point of view of the patient. The range of options of self-testing kits is limited and little publicized, so women tend to go to the doctor whenever they feel any discomfort, or they simply buy medicine without a prescription. Therefore, a market opportunity arises to fill the lack of public information about this often neglected area of their personal health, without having to consult a doctor. This thesis explores the Femtech and Medtech market in Portugal and Europe. The business plan is about the launching of an innovative medical device to self-test vaginal infections and which connects to a mobile app to create records and analyticaly analyse the test results. This product’s aim is therefore to promote women’s well-being and health, allying with technology to inform them and subsequently help them to make decisions regarding their gynecological health.A área ginecológica relacionada com as infeções vaginais apresenta-se pouco explorada do ponto de vista prático do paciente. O leque de opções de testes de auto-diagnóstico é limitado e pouco divulgado, o que leva a que as mulheres tenham o hábito de consultar o médico quando sentem algum desconforto ou comprar um medicamento sem receita médica. Assim, surge uma oportunidade no mercado de colmatar a falta de informação do público sobre esta área da sua saúde pessoal, muitas vezes negligenciada, sem ter de recorrer a uma consulta médica. Esta tese explora os mercados das Femtech e Medtech, em Portugal e no resto da Europa. O plano de negócios desenvolvido diz respeito ao lançamento de um dispositivo médico inovador para auto-diagnosticar infeções vaginais. Este tem conexão com uma app móvel, de forma a criar um histórico e analisar analiticamente os resultados dos testes. O objetivo deste produto é, assim, promover o bem-estar e a saúde da mulher, aliando-se à tecnologia para a informar e, consequentemente, a ajudar a tomar decisões no que diz respeito à sua saúde ginecológica

Regulatory Data Science for Medical Devices

Regulations that cover the legal obligations that manufacturers are bound to are essential for keeping the general public safe. Companies need to follow the regulations in order to bring their products to market. A good understanding of the regulations and the regulatory pathway defines how fast and at what cost the manufacturer can introduce innovations to the market. Regulatory technology and data science can lead to new regulatory processes and evidence in the medical field. It can equip stakeholders with unique tools that can make regulatory decisions more objective, efficient, and accurate. This book describes the latest research within the broader domain of Medical Regulatory Technology (MedRegTech). It covers concepts such as the complexity and user-friendliness of medical device regulations, novel algorithms for regulatory navigation, descriptive datasets from a health service provider, regulatory data science techniques, and considerations of the environmental impacts within a national health service. This book brings all these aspects together to offer an introduction into MedRegTech research. In the long term, these technologies and methods will help optimize the regulatory strategy for individual healthcare innovations and revolutionize the way we engage with regulatory services