Medical Technology and Evaluation

Innovations in medical technologies are one of the leading areas of economic growth in the world. Whether new technologies take the form of pharmaceutical, medical device, biotechnology, information technology of some combination of these innovations, the opportunities for both private enterprise and social welfare are substantial. However, these innovations are not without cost, and require reimbursement from either a privately or publicly financed health care delivery system to enter the marketplace.

This course aims to provide knowledge of the concepts, data, and methodology required to critically evaluate new medical technologies in order to secure financial investment, reimbursement, and regulatory compliance objectives, such as FDA approval. The course is designed to provide understanding of the analytic tools needed to evaluate medical technologies. After completing this course, students will have the skills needed to:

- Understand the reimbursement systems financing medical technology use.

- Understand the role of government and regulatory agencies in the development and use of new medical technologies.

- Identify a population to be served by a medical technology.

- Use health care data to evaluate a medical technology.

- Perform cost/benefit and cost/effectiveness analysis of a new technology.

What's inside

Syllabus

Medical Technology Assessment in the Current Health Care Financing and Regulatory Environment

This module includes an overview of the healthcare industry, focusing on the U.S., and provides context for why medical technology evaluations are important sources of information within the industry. The module begins by discussing the aspects of health care industry that make it unique from other industries and the many stakeholders who have interests in the results of medical technology evaluations. The remainder of the module covers the various regulation and payment systems that exist within the industry and where and how medical technology evaluations are necessary elements of those systems.

Traffic lights

Read about what's good

what should give you pause

and possible dealbreakers

Explores the interplay between medical technology, healthcare financing, and regulatory compliance

Covers essential data and methodologies for evaluating medical technologies

Prepares learners to analyze and assess the financial viability and regulatory compliance of new medical technologies

Provides insights into the role of government and regulatory agencies in the development and use of medical technologies

Suitable for healthcare professionals, researchers, and policymakers involved in the evaluation and implementation of medical technologies

Taught by Eric Barrette, an expert in medical technology assessment

Reviews summary

Evaluating medical technologies overview

Based on the course description and structure, learners could expect a comprehensive overview of the medical technology evaluation landscape, particularly within the U.S. healthcare system. Students may find the course provides a solid foundation in understanding reimbursement systems, regulatory pathways like FDA approval, and different stakeholder perspectives. The inclusion of clinical trials and insurance claims data analysis is a practical strength, along with learning cost/benefit and cost/effectiveness analysis. Some learners might find the quantitative methodologies in Module 4 to be challenging if they lack prior background, potentially requiring supplementary study.

Primarily focused on the U.S.

"As someone outside the U.S., the strong focus on the American system was less applicable."

"The information on FDA and U.S. reimbursement is highly relevant for that market."

"I understand why it focuses on the U.S., but a broader perspective would be nice."

Provides overview of healthcare industry.

"I gained a better understanding of the U.S. healthcare industry's unique aspects."

"The module on stakeholders and regulations was very informative."

"Learning why these evaluations are important in the current system was helpful."

Explores clinical trials and claims data.

"The comparison between clinical trial data and claims data was a highlight for me."

"Understanding the types of information in claims data is really useful."

"I appreciated learning about potential data sources and validity considerations."

Details types of assessments and analysis.

"The discussion on cost/benefit and cost/effectiveness analysis is exactly what I needed."

"I now understand the pros and cons of different evaluation approaches."

"Learning how to measure costs and benefits provides practical skills."

May require prior quantitative background.

"Some of the quantitative methods in Module 4 were difficult to grasp without a stronger stats background."

"I felt I needed to do extra reading to fully understand the models discussed."

"More detailed examples for the advanced methodologies would have been beneficial."

Activities

Be better prepared before your course. Deepen your understanding during and after it. Supplement your coursework and achieve mastery of the topics covered in Medical Technology and Evaluation with these activities:

Review the basics of healthcare financing

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Refresh your understanding of the different types of health insurance, payment models, and reimbursement mechanisms

Browse courses on Healthcare Financing

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Review course materials from previous courses
Read articles and blog posts
Attend a workshop or webinar

Develop a health technology business plan

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Develop a comprehensive business plan that outlines the market opportunity, competitive landscape, financial projections, and regulatory considerations for a new health technology

Browse courses on Business Development

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Identify a healthcare problem
Research the market
Develop a unique solution
Build a business model
Secure funding and resources

Attend webinars on medical technology trends

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Participate in live or recorded webinars to stay up-to-date with the latest advancements and developments in medical technology

Browse courses on Continuing Education

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Identify relevant webinars
Register for the webinars
Attend the webinars
Take notes and ask questions

Four other activities

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Perform cost-benefit and cost-effectiveness analysis

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Practice using quantitative methods to evaluate the financial impact and value of new medical technologies

Browse courses on Cost-Benefit Analysis

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Identify the costs and benefits
Calculate the cost-benefit ratio
Interpret the results

Join a study group for medical technology evaluation

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Engage with classmates to discuss course concepts, share insights, and prepare for assessments

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Find a study group
Meet regularly
Discuss course materials
Prepare for assessments

Write a white paper on a specific medical technology

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Compose a detailed report that summarizes the scientific evidence, clinical data, and regulatory considerations for a particular medical technology

Browse courses on Technical Writing

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Research the topic
Develop an outline
Write the first draft
Revise and edit
Submit the white paper

Contribute to an open-source project related to medical technology

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Participate in an open-source project to apply your technical skills and learn from others in the field

Browse courses on Medical Technology

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Identify a relevant project
Join the project community
Contribute to the project
Review and test changes
Merge your contributions

Career center

Learners who complete Medical Technology and Evaluation will develop knowledge and skills that may be useful to these careers:

Health Economist

As a Health Economist, you might analyze the cost-effectiveness of medical technologies. This could involve assessing the benefits and risks of a technology in relation to its costs and comparing it to other treatment options. By taking a course like Medical Technology and Evaluation, you may gain essential knowledge in assessing medical technologies and performing cost-effectiveness analyses. Completing this course could enhance your credibility and competitiveness in the field.

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Regulatory Affairs Specialist

A Regulatory Affairs Specialist might ensure that medical devices and technologies comply with government regulations. This course might provide you with a solid foundation in the regulatory environment surrounding medical technologies. By understanding the approval process and the role of regulatory agencies like the FDA, you may be better equipped to navigate the complex regulatory landscape of the healthcare industry.

See salaries and explore the career path for Regulatory Affairs Specialist

Clinical Research Associate

A Clinical Research Associate might assist in the design and implementation of clinical trials for medical devices or technologies. Taking a course such as Medical Technology and Evaluation may enhance your comprehension of clinical trial design, data collection, and analysis. This knowledge could be beneficial in ensuring the validity and reliability of clinical research.

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Health Policy Analyst

As a Health Policy Analyst, you might assess the impact of healthcare policies on the adoption and use of medical technologies. A course like Medical Technology and Evaluation may provide you with a deeper understanding of the reimbursement systems and regulatory factors that influence the use of medical technologies. This knowledge could be valuable in developing policies that promote access to innovative technologies and improve patient outcomes.

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Healthcare Consultant

Healthcare Consultants might advise healthcare providers on the adoption and implementation of medical technologies. Understanding the evaluation process and the factors that influence technology adoption could be valuable for providing informed recommendations. A course like Medical Technology and Evaluation may equip you with the knowledge and skills to analyze medical technologies and make evidence-based recommendations.

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Medical Science Liaison

As a Medical Science Liaison, you may provide scientific and technical information about medical technologies to healthcare professionals. Taking Medical Technology and Evaluation may help you gain a comprehensive understanding of the development, evaluation, and clinical applications of medical technologies. This knowledge can enhance your ability to effectively communicate the value and benefits of medical technologies to healthcare providers.

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Research Scientist

A Research Scientist might conduct research and development of new medical technologies. Completing a course like Medical Technology and Evaluation may enhance your understanding of the evaluation process and the factors that influence the success of new technologies. This knowledge can aid in the design and development of innovative and effective medical technologies that meet the needs of patients and healthcare providers.

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Product Manager

As a Product Manager for medical devices or technologies, you could be responsible for managing the development, launch, and marketing of new products. An understanding of the evaluation process and the factors that influence market success could be valuable. This course may equip you with the knowledge and skills to assess the potential of new technologies and make informed decisions about product development and marketing strategies.

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Market Research Analyst

As a Market Research Analyst specializing in healthcare or medical technology, you might conduct market research to assess the potential of new products and technologies. Taking a course like Medical Technology and Evaluation may enhance your understanding of the healthcare industry, reimbursement systems, and the factors that influence the adoption of new technologies. This knowledge could enable you to conduct more in-depth market research and provide valuable insights to clients.

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Sales Representative

Sales Representatives for medical devices or technologies might educate healthcare providers about the benefits and uses of new products. A course like Medical Technology and Evaluation could provide you with a deep understanding of the clinical applications, evidence base, and regulatory considerations surrounding medical technologies. This knowledge could enhance your ability to effectively present the value of products to healthcare providers and drive sales.

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Quality Assurance Manager

As a Quality Assurance Manager in the medical device or technology industry, you might ensure that products meet quality and safety standards. A course like Medical Technology and Evaluation may help you develop the skills to evaluate the safety and effectiveness of medical technologies and to implement quality control measures to ensure patient safety.

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Clinical Data Manager

A Clinical Data Manager might be responsible for managing and analyzing clinical data from clinical trials or other research studies involving medical technologies. By taking a course like Medical Technology and Evaluation, you may gain a foundation in the principles of clinical trial design, data collection, and statistical analysis, which could enhance your ability to effectively manage clinical data and ensure the integrity of research results.

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Project Manager

Project Managers in the medical technology industry might oversee the development and implementation of new technologies. Taking a course like Medical Technology and Evaluation may provide you with a broader perspective on the healthcare industry, reimbursement systems, and regulatory requirements. This knowledge could help you effectively manage projects, coordinate with stakeholders, and ensure that new technologies are successfully brought to market.

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Business Development Manager

A Business Development Manager in the medical technology industry might identify and pursue new business opportunities. Understanding the reimbursement systems and regulatory environment for medical technologies can be valuable in this role. A course like Medical Technology and Evaluation may equip you with the knowledge and skills to assess the market potential of new technologies and develop strategies for market entry and growth.

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Medical Writer

As a Medical Writer, you may produce regulatory documents and promotional materials for medical devices, drugs, and other healthcare products. A course like Medical Technology and Evaluation might help you gain a deeper understanding of the development and evaluation of medical technologies, which could be valuable in creating accurate and effective written materials.

See salaries and explore the career path for Medical Writer