Medical Devices in Academic Research

University of Michigan – MICHR presents

RAPS Training: Monday, October 14 & Tuesday, October 15

U-M Symposium (optional): Wednesday, October 16

Join regulatory experts for a three-day event to learn about and discuss issues specific to academic medical device research

Join regulatory experts for an event specific to academic research

Join regulatory experts for a

Attendance is free to members of CTSA hubs.

If you are unable to attend this workshop, please cancel your registration to release a seat for those on the wait list. If your cancellation is not received at least two weeks prior to the workshop, your department will be billed a $50.00 cancellation fee.

Medical devices drive clinical care, whether in the form of a surgeon’s scalpel, a simple blood test, or a complex imaging machine. With the technological innovation and advances made in precision medicine, 3-D printing, and mobile medical applications, these devices are now a large part of the research landscape.

As the rapid advances in technology outpace changes in regulation, FDA oversight and the regulatory requirements have become more challenging. Join us for this three-day event to get the information you need to advance your regulatory expertise.

Why attend?

Medical devices drive clinical care, whether in the form of a surgeon’s scalpel, a simple blood test, or a complex imaging machine. With the technological innovation and advances made in precision medicine, 3-D printing, and mobile medical applications, these devices are now a large part of the research landscape.

As the rapid advances in technology outpace changes in regulation, FDA oversight and the regulatory requirements have become more challenging. Join us for this three-day event to get the information you need to advance your regulatory expertise.

Medical devices drive clinical care, whether in the form of a surgeon’s scalpel, a simple blood test, or a complex imaging machine. With the technological innovation and advances made in precision medicine, 3-D printing, and mobile medical applications, these devices are now a large part of the research landscape.

As the rapid advances in technology outpace changes in regulation, FDA oversight and the regulatory requirements have become more complex and confusing. Join us for this three-day event to get the information you need to advance your research.

DAYs 1 & 2

RAPS Training

Trainer: Tony Blank

RAPS (Regulatory Affairs Professional Society) will provide a 2-day, Investigational Device Exemption (IDE) Submission Workshop specific to academic research. Sessions will include developing an IDE strategy, preparing for and conducting Pre-Submission meetings, and preparing and submitting an IDE application.

DAY 1 AGENDA >

DAY 2 AGENDA >

Day 3 (optional)

U-M Symposium

All participants are also invited to attend the U-M Medical Devices in Academic Research symposium on Wednesday, October 16. Topics include:

• Regulatory Challenges in Precision Medicine

• Design Controls

• Medicare Reimbursement

• Digital Health and the use of Artificial Intelligence

Full agenda coming soon

Attendance is free to members of CTSA hubs. Registration is limited to 30 participants on a first-come first-served basis.

If you are unable to attend this workshop, please cancel your registration to release a seat for those on the wait list. If your cancellation is not received at least two weeks prior to the workshop, your department will be billed a $50.00 cancellation fee.

Sign Me Up

RAPS TRAINING AGENDA

DAY 1

8:00 – 8:30

Registration and Continental Breakfast

8:30 – 8:35

Welcome

8:35 – 9:50

Regulatory Framework?

The purpose of an IDE exemption
Different types of IDEs
What an IDE does (and does not) permit
When should manufacturers or physicians seek an IDE
Roles of IRBs, investigators, and sponsors
How devices are classified in the U.S. and determining classification
Predicate Devices

9:50 – 10:30

Developing an IDE Strategy

What to consider and when
Preclinical testing before human studies
Making the best use of Pre-Submissions
Using foreign data in a US submission
What makes an IDE submission successful

10:30 – 10:45

BREAK

10:45 – 12:00

Using the Pre-Submission Program to Reduce Risk

What type(s) of interactions are appropriate and/or necessary
Determining the right sequence of interactions
When in the development cycle is optimum to have the interactions
Defining relevant and meaningful objectives for Pre-Sub interactions
Examples for Discussion

12:00 – 1:00

LUNCH

1:00 – 1:45

Planning for Pre-Sub Interactions

Integrating into product development schedule
Identifying critical questions to reduce development time and/or

submission risks
How much background information is appropriate
Identifying objections

1:45 – 3:00

Preparing for Pre-Submission Meetings – The Submission

Required Elements
Defining the Questions
Providing context and background
Examples for Discussion

3:00 – 3:15

BREAK

3:15 – 5:00

Preparing for and Conducting Pre-Submission Meetings

Identifying the audience
Identifying the Team with Roles and Responsibilities
Determining quantity of material to present (linkage to Submission)
Internal communications

RAPS TRAINING AGENDA

DAY 1

8:00 – 8:30

REGISTRATION AND CONTINENTAL BREAKFAST

8:30 – 8:35

Welcome

8:35 – 9:50

Regulatory Framework?

• The purpose of an IDE exemption
• Different types of IDEs
• What an IDE does (and does not) permit
• When should manufacturers or physicians seek an IDE
• Roles of IRBs, investigators, and sponsors
• How devices are classified in the US and determining classification
• Predicate devices

9:50 – 10:30

Developing an IDE Strategy

• What to consider and when
• Preclinical testing before human studies
• Making the best use of pre-submissions
• Using foreign data in a US submission
• What makes an IDE submission successful

10:30 – 10:45

BREAK

10:45 – 12:00

Using the Pre-Submission Program to Reduce Risk

• What type(s) of interactions are appropriate and/or necessary
• Determining the right sequence of interactions
• When in the development cycle is optimum to have the interactions
• Defining relevant and meaningful objectives for pre-sub interactions
• Examples for discussion

12:00 – 1:00

LUNCH

1:00 – 1:45

Planning for Pre-Sub Interactions

• Integrating into product development schedule
• Identifying critical questions to reduce development time and/or

submission risks
• How much background information is appropriate
• Identifying objections

1:45 – 3:00

Preparing for Pre-Submission Meetings – The Submission

• Required elements
• Defining the questions
• Providing context and background
• Examples for discussion

3:00 – 3:15

BREAK

3:15 – 5:00

Preparing for and Conducting Pre-Submission Meetings

• Identifying the audience
• Identifying the team with roles and responsibilities
• Determining quantity of material to present (linkage to submission)
• Internal communication

RAPS TRAINING AGENDA

DAY 2

8:00 – 8:30

CONTINENTAL BREAKFAST

8:30 – 10:30

Mechanics of an IDE Application

• The elements of an IDE
• Use of standards (e.g., ISO, ANSI, AAMI, etc.)
• Protocols, records, reports
• Avoiding common errors and deficiencies
• Key elements to the study protocol
• The role of risk analysis in the IDE
• Managing planned or unplanned device or study changes
• Reimbursement for clinical studies

10:30 – 10:45

BREAK

10:45 – 12:00

Submission Review

• Defining team
• Ensuring timely and accurate responsiveness
• Responding to questions
• Understanding the question
• Defining the response strategy (when necessary)

• Ensuring completeness of response

• Review of timelines and expectations

10:45 – 12:00

Using the Pre-Submission Program to Reduce Risk

• Defining team
• Ensuring timely and accurate responsiveness
• Responding to questions

• Review of timelines and expectations

12:00 – 1:00

LUNCH

1:00 – 2:00

BIMO Audits

• The purpose of a BIMO inspection
• When and how a BIMO inspection occurs
• Preventing findings and responses to findings
• Typical and atypical observations – cautionary tales from the field

2:00 – 3:00

Regulatory Requirements

• Monitoring
• Consenting of patients
• Enrollment requirements
• Adverse Event Reporting
• Sponsor records and reports
• Investigator records and reports
• Protocol deviations

3:00 – 3:30

BREAK

3:30 – 4:30

Reporting Results

• Clinical study reports (interim and final)
• Dissemination to the medical community and regulators
• Incorporation into pre-market submissions
• Assessment of impact to product labeling

4:30 – 5:00

Questions/Adjourn

DAY 2

8:00 – 8:30

CONTINENTAL BREAKFAST

8:30 – 10:30

Mechanics of an IDE Application

The elements of an IDE (Bench Testing, Animal Testing, Biocompatibility, Sterility,

GLP vs. non-GLP)
Use of Standards (e.g., ISO, ANSI, AAMI, etc.)
Protocols, Records, Reports
Avoiding common errors and deficiencies
Key elements to the study protocol
The role of risk analysis in the IDE
Managing planned or unplanned device or study changes
Reimbursement for clinical studies

10:30 – 10:45

BREAK

10:45 – 12:00

Submission Review

Defining team
Ensuring timely and accurate responsiveness
Responding to Questions

Review of timelines and expectations

12:00 – 1:00

LUNCH

1:00 – 2:00

BIMO Audits

The purpose of a BIMO Inspection
When and how a BIMO inspection occurs
Preventing findings and responses to findings
Typical and atypical observations – cautionary tales from the field

2:00 – 3:00

Regulatory Requirements

Monitoring
Consenting of patients
Enrollment requirements
Adverse Event Reporting
Sponsor records and reports
Investigator records and reports
Protocol deviations

3:00 – 3:30

BREAK

3:30 – 4:30

Reporting Results

Clinical study reports (interim and final)
Dissemination to the medical community and regulators
Incorporation into pre-market submissions
Assessment of impact to product labeling

4:30 – 5:00

Questions/Adjourn

LOCATION

Michigan Institute for Clinical & Health Research (MICHR)

LOCATION

Michigan Institute for Clinical & Health Research (MICHR)

1600 Huron Parkway, Building 300, Room 376
Ann Arbor, Michigan 48109

Attendance is free to members of CTSA hubs.

However, due to the limited spaces available, you may be billed a $50 charge if you register and fail to attend.

Sign Me Up

Location

Michigan Institute for Clinical & Health Research (MICHR)

1600 Huron Parkway, Building 300, Room 376
Ann Arbor, Michigan 48109

LOCATION

Michigan Institute for Clinical & Health Research (MICHR)
1600 Huron Parkway, Building 300, Room 376
Ann Arbor, Michigan 48109

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R. Harrison

CEO, Art Director, Creative Director, co-Founder

Medical Devices in Academic Research

Training & Symposium

A first-of-its kind session tailored to academic research, academic investigators, and regulatory support staff

Monday, October 14 - Wednesday, October 16

RSVP

Medical Devices in Academic Research

Training & Symposium

Monday

,

October

14

-

Wednesday

,

October

16

Register here

Free of charge

If you are unable to attend, please cancel your registration to release a seat for someone else who may be waiting to sign up. If you don't cancel by two weeks prior to the training and symposium, you will be charged a 50.00 cancellation fee.

RSVP

Medical devices drive clinical care, whether in the form of a surgeon’s scalpel, a simple blood test, or a complex imaging machine. With the technological innovation and advances made in precision medicine, 3-D printing, and mobile medical applications, these devices are now a large part of the research landscape here at Michigan Medicine. As the rapid advances in technology outpace changes in regulation, FDA oversight and the regulatory requirements have become more complex and confusing.

Join other investigators, regulatory experts, and study teams at the Medical Device in Academic Research Symposium to learn about the new developments in the medical device regulatory landscape and discuss the benefits and challenges that this technology has brought to investigator initiated research. Topics will include:

· Next Gen Sequencing for Precision Medicine Trials

· 3-D Printed Devices

· Design Controls

· Medicare Reimbursement

· Digital Health and the use of Artificial Intelligence

RSVP

Schedule

DAY 1-2: RAPS Training

The first two days will feature a speaker from RAPS to train us about xyz. This is a session with limited seats, open only to members of CTSAs.

DAY 3 (Optional): Symposium

The third day features a symposium open to CTSA members as well as the entire UM community

Attendance is free to members of CTSA hubs. Registration is limited to 30 participants on a first-come first-served basis.

If you are unable to attend this workshop, please cancel your registration to release a seat for those on the wait list. If your cancellation is not received at least two weeks prior to the workshop, your department will be billed a $50.00 cancellation fee.

Sign Me Up

THIS EVENT IS BROUGHT TO YOU BY

The Michigan Institute for Clinical & Health Research (MICHR) is here to enable & enhance clinical & translational research at U-M. We do this by being a catalytic partner that educates, funds, connects & supports research teams here and beyond.