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California Medical Innovations Institute (CalMI2): Center for BioMed Device Innovation Education

Vision & Mission

To be the global leader in education of advanced health technologies innovation through didactic and hands-on training. This educational program intends to train the next generation of innovators in medical devices. It is especially oriented towards international communities to take advantages of the latest innovation processes implemented in U.S. health technologies industries. The major premise of this course is that innovation can be learned through proper training and education.

Overview

California Medical Innovations Institute (CALMI2, www.calmi2.org) is a non-profit multidisciplinary and dynamic place, bringing together scientists and engineers to create innovations with the power to improve health care. Our location is in San Diego, center of many bio-engineering companies as well as University of California in San Diego (UCSD) and health science research centers like Scripps Research Institute and Salk’s Institute, world well known health care research centers.

The CALMI2 Center for BioMed Device Innovation Education program is a four-week project-based course for graduate and post-doctoral students, academic faculty and industry engineers with an interest in entrepreneurship and a commitment to improving health-care around the world through health technology innovation.

The primary goal of the course is to teach the participants the process of innovation from concept to implantation. Our proven process for health technology innovation is taught in a hand-on fashion with the help of our experienced faculties, research staff, and engineers.

The students will be given a certificate in recognition of successful completion of the requirements of the certificate program in “Health Technologies Innovation process”.

To our knowledge, we are not aware of mini-course in the world that takes the student from medical question identification to idea generation, to conceptual design techniques, to building a proof of concept prototype, to pre-clinical testing.

Program Director

The program director is Dr. Ghassan Kassab who has 25 years of teaching and research experiences. He trained with Prof. YC Fung who is world renowned in biomechanics and bioengineering (https://drive.google.com/open?id=0BzIH55ycbvsIQ2Jsak03RTFLRHM).

Dr. Kassab developed the undergraduate curriculum at University of California, Irvine in Biomedical Engineering and Premedical majors. He is also a very experienced researcher who was the recipient of the NIH Young Investigator Award, the AHA Established Investigator Award, Farriborz Maseeh Best Research Award, Abraham M. Max Distinguished Professor Award, Eminent Engineer Award of Tau Beta Pi Engineering Honor Society, Indiana’s President Circle Award, and Glenn Irwin, MD Chancellor Best Research Scholar Award. He is a Fellow of the American Institute for Medical and Biological Engineering, the American Physiological Society Cardiovascular Section and the American Venous Forum. He has served as a regular reviewer on two NIH study sections (Systems Biology; and Hypertension and Microcirculation) and as ad hoc on multiple other study sections; the Editorial Board of American Journal of Physiology-Heart and Circulatory Physiology, Journal of Biomechanics, and has previously served as an Associate Editor of Mechanics and Chemistry of Biosystems. He has published over 600 proceedings, abstracts and full length publications and his current scientific interests encompass the biomechanics of cardiovascular and gastroenterology systems in health and disease. He also has over 200 issued or pending patents in the areas of diagnosis and treatment of heart failure (including electrical, valvular and coronary artery disease), aneurysm, and obesity.

Program Faculty

Ali Dabiri, PhD,     Xiao Lu, PhD,    Xiaomei Guo, MD ,     Susy Choy, MD ,         Gregory Dick, PhD ,     Hyowon Choi, PhD,     Carlos Labarrere, MD,    Huan Chen, PhD,     Ravi Namani, PhD,    Lijuan Fu, PhD,     Henry Chen, PhD,     Tong Luo, PhDAashish Ahuja, PhD,     Bhavesh Patel, PhD

Process

During this short course, you will learn how to identify unmet health care needs, generate ideas (invention), design, and execution.

In the first phase, the instructors will review the topic areas that have the highest impact on the overall improvement of the health care of the patients such as cardiovascular disease, digestive tract disease, nerve injury, obesity, and venous system disease, and others suggested by participants. The participants will learn how to identify the important unmet health care needs in each topic area. They will categorize the needs and associated medical cost to society. They will choose the highest opportunity that needs to be addressed.

In the idea generation phase, the participants will be divided into separate groups to discuss the potential solutions to the problems identified in the first phase. Instructors will guide the participants on how to find the most promising solutions in various subject areas.

In the design phase, participants will become familiar with the latest design tools in the field. Participants will be divided into separate groups with one idea assignment to take through conceptual design of the medical device using the techniques they have learned. The participants will learn bio-medical compatibility and safety issues of the potential device as well as anticipate potential efficacy.

In the execution phase, instructors will teach participants how to build a typical device prototype of a conceptual design in the laboratory, assess implantation in patients, ease of use and eventual cost of the device. The proof of concept prototypes will be validated on the bench and pre-clinically to assess potential shortcomings. The feedback will inform improvements in the second prototype.

Course Description

Week 1 (Problem identification)

The participants will be separated into four groups of four and asked to identify medical areas of unmet needs. Each group will nominate a group leader. Instructors will provide one topic each day as illustratory examples for a total of five topics for the week. The topic areas that will be selected for the course are the ones that innovations will have the highest impact on the overall improvement of health care of the patients. The lectures will be held in the morning and in the afternoon to guide the process. The instructors will overview the most recent advancement of the subject areas and discuss the major challenging issues that will need to be addressed. At the end of this week, the participants are expected to understand the challenges involved in each topic areas that require solutions and provide a brief report that summarizes their recommendations along with a presentation to convince a committee of fellow participants and instructors on their choice of topic.

Week 2 (Solution generation)

The participants in each of the four groups will discuss potential solutions to the problem they identified in the first week. Each group will nominate a group leader different than that of previous week. Several solutions are expected to each problem identified which will be ranked in terms of novelty, feasibility, cost, path to market, regulatory approval, etc. The participants will deliberate to select the highest-ranking solution of the several candidates. At the end of this week, the participants are expected to provide a brief written report and an oral presentation that summarizes their recommendations.

Week 3 (Conceptual design)

The instructors will provide an overview of potential design tools that may be used to design a device. This will include various numerical modeling techniques to calculate the surface interaction of the device with the organ of interest. Biomaterial selections will be discussed. The participants will learn bio-medical compatibility and cytotoxicity issues of the potential device as well as the potential efficacy of the device. The participants will be divided into the same groups to conceptually design the devices they selected in the previous week. This includes the use of the numerical codes available in the center. The instructors will guide the participants through the design process. The conceptual design will be completed in this week and brief report and presentation will be made by a group leader different than that of first two weeks.

Week 4 (Implementation)

In this final week, the participants will spend time in the laboratory and surgical suite. The feasibility to build a proof of concept (POC) prototype from the conceptual design selected in the previous week will be discussed. The participants will be divided into the same groups and a group leader other than that selected earlier will lead the team. Each group will be assigned to build a feasible POC prototype of a medical device, using all the tools available in the laboratory. If the selected prototype is not feasible within the allotted time, the participants will build POC prototype from an illustrator design devices selected by the instructors. The participants will be supervised by the instructors to build a draft prototype for testing. The participants will perform bench and pre-clinical testing of the device to obtain some POC findings for possible refinement. In this final week, a written report and oral presentation will conclude the course.

Summary of topics to be covered

Physiology/ Pathology

Simulations for design and optimization of biomedical devices

Design, fabrication and testing of biomedical devices

In vivo testing and imaging of medical devices

Biomaterials for regenerative medicine

Clinical applications of medical devices

Accommodations

This is a four-week short course and it is very important that the students have time to take full advantage of the opportunity provided by the Institute. To accomplish this goal, the Institute will provide lodging, meal, and daily transportation. The housing location will be very close to the Institute, so there will be no time wasted in commute. The breakfast and lunch will be served at the Institute and there will be a coffee break in the mornings and in the afternoons. The Institute will provide dinners from Monday through Thursday in the lodging facility.

City tours will be scheduled for the students during one day of the weekend. Special accommodations will be provided for those who would like to be with the spouse during the program. Most of the cost associated with the accommodations will be part of the registration fee.

The program starts on 17th of July. The students are encouraged to arrive in San Diego on Saturday, July 15th, to have some time for time adjustment. Lodging information and other arrangements will be provided to each student after the registration.

Visa

You will receive an invitation letter once you register in the course. You will need to take the invitation letter and your passport to the U.S. Embassy/Consulate to receive the visa (most probably it will be B-1 visa) to attend the course in the U.S. The letter will indicate that you have fully paid the tuition.

Application

Thank you for your interest in California Medical Innovations Institute (CALMI2) Center for BioMed Device Innovation Education

The program starts on July 17, 2017 for four weeks. The program will accept only 16 participants. The registration fee is $20,000 for the 4-week course. The accommodations cost except for the dinners from Friday through Sunday and lunch for the weekends will be part of the registration fee. The fee should be fully paid during registration and it is non-refundable. Early registration is highly recommended as positions are reserved quickly. Once the participants register, an invitation letter will be provided to facilitate a visiting visa. The registration deadline is March 15th, 2017. Spouses of the students are welcome with additional cost of $1,000.

Please provide the following information to apply.

Last name:
First name:
Email:

Education: Please indicate degree type, field of study and year of graduation.

Relevant research and/or work experience.

Why are you interested in health technology innovation? Why are you interested in this course?

A Short Bio-Sketch (no more than 200 words), including your present occupation.

Please e-mail your application to Dr. Ali Dabiri (adabiri@calmi2.org )