Entrepreneurship and Medtech
Master of Science
Sonraí an Chúrsa
Course Code | GA_SEMTG_V09 |
---|---|
Céim | 9 |
Fad ama | 2 years |
Creidmheasanna | 90 |
Modh Seachadta | Blended |
Suímh campais | Galway City – Dublin Road |
Modh Seachadta | Lánaimseartha |
Forbhreathnú Cúrsa
The Master of Science in Entrepreneurship and Medtech is a 90-credit, 2-year full-time programme delivered across four academic semesters. The course has been designed with significant input from industry experts to meet the demands of the medtech sector.
The course offers a wide range of modules covering topics related to Strategic Marketing and Communication, Principles of Finance and Accounting, Managing Innovation, Leadership and Teams, Global Regulatory Strategies for Medical Technologies, Medical Technologies, Pre-clinical Evaluation and Assessment, Design Control and Risk Management, CEO Masterclass, and Research Project.
The program aims to equip learners with interdisciplinary, cutting-edge skills and knowledge essential for the Medtech sector. The research project component of the program provides learners with hands-on experience, while the CEO Masterclass module enhances their understanding of bringing technologies to market.
Sonraí an Chúrsa
Bliain 1
Seimeastar | Sonraí an Mhodúil | Creidmheasanna | Éigeantach / Roghnach |
---|---|---|---|
1 |
Strategic Marketing and CommunicationsThe curriculum aims at providing the students with the latest thinking and practice in strategic marketing and communications, with a particular twist on marketing of innovation, growth and sustainable performance. Torthaí Foghlama 1. Critically appraise the role of strategic marketing andcommunications in growing sustainable organisational success in a variety of global markets and business environments. 2. Analyze the business market environment, market trends, and the concept of consumer behaviourto inform strategic decision-making. 3. Identify and critically evaluate marketing data and marketing information sources and interpret their impacts on strategic marketing and communication issues. 4. Analyze the theory ofmarket segmentation,target marketing, positioning strategies and the concept of value propositions. 5. Select from the toolkit of marketing concepts and analytical frameworks to formulate strategic marketing plans and integrated communication plans. |
05 | Mandatory |
1 |
Principles of Finance and AccountingThis module is designed to introduce learners to the area of accounting and financial management. It looks in detail at what financial management is, its relationship to financial accounting and management accounting, the budgeting process, capital investment appraisal, the importance and management of working capital, and finance and investment decision-making based on accounting statements. The module is designed to take a high level view of the individual topics to facilitate those working in non-financial management positions in industry. Torthaí Foghlama 1. Have knowledge pertinent to financial management and an in-depth understanding of its importance in the business and corporate environment. 5. Analyse and interpret financial statements for the purposes of investment decisions. |
05 | Mandatory |
1 |
Medical TechnologiesMedical technology can be defined as the application of science and engineering to develop solutions to health problems or issues, including the design of smart devices for predictive and diagnostic healthcare. Medical technologies are used to lower the risk of a disease, minimise illness duration, enhance the quality and accuracy of care and widen access to care. Therefore, medical technology plays an important part in our society in improving quality of life and reducing the effect of debilitating illnesses. The most significant trend in healthcare product innovation is to bring together different medical technologies to satisfy the needs of patients and medical professionals. Medical technologies are rapidly converging and having a major influence on the development of new medical devices to deliver more efficient products. Among others, these technologies include artificial intelligence, gene editing and therapy, organ and tissue printing. This module aims to give students a deep understanding of the medical technology field, with a special focus on medical device design and engineering. The topics will be presented through case studies and will include a team project demonstrating the ability to develop a medical device concept incorporating several existing and emerging technologies, including software as medical device (SaMD). Torthaí Foghlama 1. Analyse several current and future medical technologies, including software as medical device, and how they are applied or planned to be applied in healthcare, 2. Discuss how future medical technologies could influence the nature of healthcare provision, as well as predictive and diagnostic healthcare, 3. Examinethe opportunities for the application of future medical technologies, 4. Determinethe development and commercial challenges within the medical device development process, 5. Apply the medical device development process, from clinical need through to regulatory approval and product introduction, 6. Develop a medical device concept usingthe medical device development process, including clinical need, user needs, patient feedbacks and stakeholder needs, using several technologies. |
05 | Mandatory |
1 |
Global Regulatory Strategies for Medical TechnologiesIn supporting the development of skills to deliver state of the art medical technologies, it is imperative that regulatory obligations are understood and applied. The global legal framework to develop and commercialize medical devices is extremely complex and highly regulated. The ability to interpret and implement these expectations in the innovation process is critical to success. Key regulatory principles are a priority for inclusion at design and development stage and when incorporated competently and accurately will ensure the positive delivery of safe and effective technologies for human use. Torthaí Foghlama 1. Compare and contrast the globalregulatory requirements pertinent to commercialising high risk medical technologies. 2. Explainthe technical documentation and post market deliverables to continuously demonstrate safety and efficacy for medical technologies 3. Evaluate the regulatory and business risks at each stage of the innovation and design process. 4. Communicate and proceduralize the systematic regulatory deliverables and associated technical file inputs. 5. Demonstrate the ability tolead aproject toapproval stage by anticipating and engaging withregulatory experts and sourcing regulatory intelligence. |
05 | Mandatory |
1 |
Pre-Clinical Evaluation and AssessmentThis module aims to provide learners with a detailed knowledge of the relevant information required in test protocols and complete test reports for pre-clinical performance evaluation and assessment of technologies in a premarket submission to regulatory bodies. The module will have a particular focus on non-clinical bench performance testing, biocompatibility evaluation, human factors and software verification in validation and will explain the guidance documentation in place by the various regulators for Medical Technologies. Torthaí Foghlama 1. Demonstrate a detailed knowledge and understanding of non-clinical premarket submission, types of tests required, and associated standards for medical technologies. 2. Source and interpret, regulations, standards and guidance to design and execute a relevant test (objectives and methods, pre-defined pass/fail criteria, results summary, discussion and conclusions). 3. Critically evaluate test data to inform design improvement of medical technologies. 4. Interpret key clinical terms and demonstrate an ability to prepare a clinical evaluation report on the perofmace of a medical technology. |
10 | Mandatory |
2 |
Design Control and Risk ManagementThrough this module, the student will understand and apply Design Control and Risk Management principles to the design of Medical Devices. The module content includes the full Design and Development process including the full product life cycle from product concept to product launch, encompassing the phases of Design and Development and the elements of Design Control as required to ensure regulatory compliance. This module will also give the students an understanding of Risk Management as it applies to the design and development process and to medical device design. The content will be delivered such that it addresses the practical needs of industry, and all company sizes within the sector from Start-up through to SME's and multi-national corporations. Torthaí Foghlama 1. Critically evaluate product design to ensure compliance with essential safety and performance requirements. 2. Explain the technical documentation required to demonstrate compliance to relevant regulatory requirements and quality standards. 3. Communicate and proceduralizethe relationship between Design Control and Risk Management principles. 4. Demonstrate the ability to identify,critically assess, and manage risk throughout the medical device life cycle. |
05 | Mandatory |
2 |
CEO MasterclassThe CEO Masterclass module will focus on the key processes and building blocks to support the innovation journey of medical technologies from concept phase to marketplace. Industry speakers will introduce students to a range of commercialisation strategies based on customer value proposition, key business processes and profit realisation. This will be enhanced through a number of workshops focussed on intellectual property, commercialisation, healthcare reimbursement models and RDI funding. Torthaí Foghlama 1. Devise a commercialisation strategy for medical technologies. 2. Demonstrate knowledge and understanding to manage intellectual property and its transfer into or out of an organisation. 3. Critically interpret the theories and concepts of various healthcare and reimbursement systems and how to demonstrate value for money of a medical technology. 4. Evaluate and assess the research and innovation funding landscape to support the development of medical technologies based on technology readiness levels. |
05 | Mandatory |
2 |
Research ProjectThe project should take the form of a proposal for the development of a medical technology (biopharmaceutical or medical device product) to prevent, treat or diagnose a specific medical condition. The student will undertake a literature review to source information on the target condition and current therapies for the treatment of the disease. Based on this information and the student's knowledge gained through the programme, the student should propose an alternative product/technology, for prevention, treatment or diagnosis of said medical condition. Thereafter, students should include a detailed overview of the design, function, clinical trials, manufacturing, marketing and financial strategy of their proposed product. Torthaí Foghlama 1. Lead the development of a proposal for the development of a novel medical technology product. 2. Critically evaluate and reviewliterature (and other relevant, reliable sources) using appropriate keywords and databases. 3. Synthesize and collate relevant information from the programme modules to apply their knowledge to a current medical concern and the proposed design, manufacture, marketing and financial strategy of medical technology. 4. Communicate results of the reviewin written and oral forms, demonstrating critical analysis, synthesis and organisation of knowledge. |
10 | Mandatory |
2 |
Managing InnovationInnovation is a key element in successfully growing business and competing in an ever-changing global environment. This module provides learners with an understanding of innovation at individual and firm level. An appreciation of the ever-changing macro and micro environments and stakeholder interest for contemporary organisations will be integral to the module. Learners will appraise different approaches to innovation. A key focus will be the drive for business growth in today's rapidly changing business landscape. The development of effective organisation-wide strategies in the successful management of innovation in any industry. Torthaí Foghlama 1. Demonstrate the economics of innovation and implications of the macro environment and stakeholder interests in successfully driving business growth. 2. Appraise effective approaches to innovation. 3. Establish and implement organisation wide strategies in the management of innovation. 4. Explore approaches for enhancing organisational creativity. 5. Assess the importance of people, culture and organisation in the effective management of innovation. |
05 | Mandatory |
2 |
Leadership and TeamsEffective leadership is needed to understand, predict, plan and communicate the nature of organisational change and manage the response. This module explores various opportunities and challenges associated with leading and managing organisational change. Through the learning outcomes mentioned below, learners will be equipped with the knowledge, skills and attitudes necessary to effectively lead and collaborate with teams in a variety of organisational settings. It fosters collaborative engagement through the understanding of cross-functional teams within an organisation. Torthaí Foghlama 1. Demonstrate an understanding of leadership theories and concepts. 2. Develop essential and ethical leadership skills/practices, while enhancing personal leadership development 3. Apply leadership strategies to diverse/challenging situations 4. Foster effective team dynamics, by identifying and leveraging the strengths of team members to achieve collective goals. 5. Apply effective strategies for team building and employee engagement. |
05 | Mandatory |
Bliain 2
Seimeastar | Sonraí an Mhodúil | Creidmheasanna | Éigeantach / Roghnach |
---|---|---|---|
1 |
Design and Analysis of ExperimentsThis module provides the student with the design of experiments concepts, tools and techniques for optimising products and processes. The student will learn to build empirical models of a process and assess their validity. The R statistical software or equivalent will be used extensively for data analysis and interpretation. Torthaí Foghlama 1. Demonstrate principles of statistical design, hypothesis testing and model diagnostics 2. Plan, conduct and analyse experiments using completely randomised design (CRD) and randomised block design 3. Design,analyse and interpret the results of the factorial, fractional factorial and repeated measures design 4. Analyse and interpret data from experiments involving latin square design, split plots and response surface design 5. Review concepts of statistical power and sample size and theirimplications for design and analysis of experiments |
05 | Mandatory |
1 |
Research MethodsResearch methodology is an integral part of any Masters course. The aim of this module is to ensure that students will be fully competent to devise, run and present research in a professional manner. Torthaí Foghlama 1. Systematically review and evaluate current literature, using appropriate tools and techniques. 2. Identify, analyse and evaluate appropriate research methods for research project proposal development. 3. Demonstrate the synthesis and integration of knowledge. 4. Draft a research proposal appropriate to their career stage and aligned with their research interests. 5. Create an appropriate data management structure. 6. Communicate research in various formats including written and oral presentation methods. |
05 | Mandatory |
Year |
Comercialisation ProjectStudents will undertake an approved research project under the direction of an internal supervisor and, if appropriate, a supervisor from a relevant external organisation. Design of the project should be produced by the learner with the advice of the supervisors and may also be of relevance to an organisation such as an employer. Learners enroled are expected to develop the knowledge, know-how and skills, and competencies required to successfully research, develop, scope the project and present and project implementation plan. Learners are expected to either individually or as part of a team develop research, problem analysis, project planning and communication skills at masters level. Projects may be drawn from any discipline within the course or from an area of expertise of the supervisors. Torthaí Foghlama 1. Identify and choose a research project topic and plan the delivery of that research project. 2. Demonstrate critical engagement with existing literature or commercial practice relevant to their topic. 3. Develop creative ways of solving new research problems. 4. Collect and analyse data qualitatively and quantitatively, including an assessment of the statistical validity of the research results. 5. Communicate research results in written and oral forms, demonstrating critical analysis, synthesis and organisation of knowledge, and |
20 | Mandatory |
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Riachtanais Iontrála
A H2.2 Bachelor degree at level 8 in any cognate discipline or equivalent in science, technology or engineering, is the minimum entry requirement for this programme
Gairmeacha
Learners can potentially find jobs in both the medtech and business sectors, with potential fields and departments including regulatory affairs, product design and development, quality assurance and compliance, business and commercialization strategies, quality management systems, product management systems, and validation and verification.
Potential job titles include Principal Scientist/Engineer and Project Manager/Team Lead.
Further Information
Cé Ba Chóir Iarratas a Dhéanamh?
The MSc in Entrepreneurship and Medtech is an ideal program for aspiring entrepreneurs, business professionals, and innovators who are passionate about the intersection of business and medical technology. The program is designed for individuals who want to take on leadership roles, such as healthcare entrepreneurs, innovation managers, and business strategists in the MedTech industry.
Eolas Teagmhála
Programme Co-ordinator
E: Senthilkumar.alagesan@atu.ie
T: 353 91742508
Analytical, Biopharmaceutical & Medical Sciences