Course Preview | Drug and Medical Device Development: A Strategic Approach from MIT xPRO
4:12 min
40
Hello and welcome to Drug and Medical Device Development: A Strategic Approach. I'm Michael Cima. I'm the David H. Koch Professor of Engineering and the Associate Dean of Innovation at the Massachusetts Institute of Technology. I've developed this program to explain medical product development. I want to help managers, leaders, other health care professionals, and those interested in this area, to better anticipate and strategically address the complexities involved in developing medical products. This will help them answer questions such as: How do I quantify the benefits of a potential medical product? What are the steps with highest risks during the development of such a product?
I've collaborated with a diverse group of expert colleagues in my medical product development career many of whom I've interviewed for this program. This group includes corporate executives from our companies such as Arsanis, and T2 Biosystems, physician scientists from Johnson and Johnson, lawyers from Goodwin Proctor, and current or past FDA and CMS directors, influential engineers, and many others. For this program, I've reproduced my extensive conversations with these experts, many of whom you'll meet in the following weeks. I hope that you will find their dedication to the craft of developing medical products as inspiring as I do.
Together we'll explore the foundational areas of drug and medical device development. My basic approach is that it is important to start at the end, to think about what you have to achieve in the entire process. We start with strategy and how to measure outcomes. We hear advice to not begin development unless you understand the proof of concept experiment that has to be performed.
Another major element of this course is an introduction to quality systems. The concept of quality is a required part of any medical product development. While it is required by regulators, we also learned that it's the best way to develop a medical product. It's my position that development of drugs and devices are different in the details but have many important similarities. The same basic principles of development apply to both. After introducing basic development principles, we then take a look at the details of developing devices, diagnostics, and drugs. We take excursions into new areas such as medical software and wearable devices. We even look at the specific needs of biologic drugs which are the largest part of today's pharmaceutical industry.
In addition to the practical knowledge that you will gain from these lectures, you'll also learn from the live webinars with faculty, peer discussions, case studies and interactive hands-on assignments. Throughout the program there will be experienced facilitators to guide you and respond when you need clarification. At the completion of this program, you should be able to understand the fundamental concepts of medical product development and be ready to apply your learning. Whether you're an entrepreneur seeking to launch your own medical device or a representative of a company that is transitioning to develop products for the healthcare industry. This program will provide you the knowledge you need.
If you're a professional in the product development, product management field and want to get a better understanding medical products field on your own, or if you work at a company in need of training employees or new hires in this field, this program will provide you with the knowledge and the know-how, so that you can successfully navigate the complexity of medical product development. We're excited to help you understand the drug and medical device development process. I hope it will benefit you and your organization, and ultimately the patients that will use these products.
I've collaborated with a diverse group of expert colleagues in my medical product development career many of whom I've interviewed for this program. This group includes corporate executives from our companies such as Arsanis, and T2 Biosystems, physician scientists from Johnson and Johnson, lawyers from Goodwin Proctor, and current or past FDA and CMS directors, influential engineers, and many others. For this program, I've reproduced my extensive conversations with these experts, many of whom you'll meet in the following weeks. I hope that you will find their dedication to the craft of developing medical products as inspiring as I do.
Together we'll explore the foundational areas of drug and medical device development. My basic approach is that it is important to start at the end, to think about what you have to achieve in the entire process. We start with strategy and how to measure outcomes. We hear advice to not begin development unless you understand the proof of concept experiment that has to be performed.
Another major element of this course is an introduction to quality systems. The concept of quality is a required part of any medical product development. While it is required by regulators, we also learned that it's the best way to develop a medical product. It's my position that development of drugs and devices are different in the details but have many important similarities. The same basic principles of development apply to both. After introducing basic development principles, we then take a look at the details of developing devices, diagnostics, and drugs. We take excursions into new areas such as medical software and wearable devices. We even look at the specific needs of biologic drugs which are the largest part of today's pharmaceutical industry.
In addition to the practical knowledge that you will gain from these lectures, you'll also learn from the live webinars with faculty, peer discussions, case studies and interactive hands-on assignments. Throughout the program there will be experienced facilitators to guide you and respond when you need clarification. At the completion of this program, you should be able to understand the fundamental concepts of medical product development and be ready to apply your learning. Whether you're an entrepreneur seeking to launch your own medical device or a representative of a company that is transitioning to develop products for the healthcare industry. This program will provide you the knowledge you need.
If you're a professional in the product development, product management field and want to get a better understanding medical products field on your own, or if you work at a company in need of training employees or new hires in this field, this program will provide you with the knowledge and the know-how, so that you can successfully navigate the complexity of medical product development. We're excited to help you understand the drug and medical device development process. I hope it will benefit you and your organization, and ultimately the patients that will use these products.
