2014-11-12T09:40:10-06:00 2013-12-31 410746749 CLIFTONLARSONALLEN LLP 220 SOUTH SIXTH STREET SUITE 300 MINNEAPOLIS MN 55402 990 2013-01-01 461465348 MEDICAL DEVICE INNOVATION CONSORTIUM MEDI 9523141255 1550 UTICA AVENUE NO 740 ST LOUIS PARK MN 55416 WILLIAM MURRAY PRESIDENT AND CEO 9523141255 2014-11-07 1 JOHN TAUER P00294068 6123764500 2013 2015-11-30 17:44:51Z WILLIAM MURRAY 1550 UTICA AVENUE NO 740 ST LOUIS PARK MN 55416 783150 0 X WWW.MDIC.ORG X 2012 MN THE MEDICAL DEVICE INNOVATION CONSORTIUM, THROUGH ITS PUBLIC-PRIVATE PARTNERSHIP, AIMS TO ADVANCE REGULATORY SCIENCE IN THE MEDICAL DEVICE INDUSTRY. MDIC WILL COORDINATE THE DEVELOPMENT OF METHODS, TOOLS, AND RESOURCES USED IN MANAGING THE TOTAL PRODUCT LIFE CYCLE OF A MEDICAL DEVICE TO IMPROVE PATIENT ACCESS TO CUTTING-EDGE MEDICAL TECHNOLOGY. 21 20 3 22 0 0 0 783150 0 0 0 0 0 0 0 783150 0 0 0 0 0 141234 0 0 0 0 292807 0 434041 0 349109 6893 894471 0 538469 6893 356002 X MDIC WILL BENEFIT THE PUBLIC IN THE UNITED STATES BY CONDUCTING RESEARCH THAT WILL ENSURE THAT: 1) SAFE AND EFFECTIVE DEVICES ARE AVAILABLE TO THE PUBLIC AS SOON AS POSSIBLE, AND AS COST-EFFECTIVELY AS POSSIBLE, IN ORDER TO ALLOW PATIENTS IN THE U. S. TO BENEFIT FROM ADVANCES IN SAFE AND EFFECTIVE MEDICAL TECHNOLOGY AT LEAST AS SOON AS PATIENTS IN OTHER PARTS OF THE WORLD, WHERE DEVICES ARE TYPICALLY APPROVED MORE QUICKLY THAN IN THE U. S.; 2) SAFE AND EFFECTIVE DEVICES ARE REIMBURSED BY FEDERAL HEALTH CARE PROGRAMS ON A MORE TIMELY AND SCIENTIFIC BASIS; AND 3) LIMITED FEDERAL RESEARCH FUNDS ARE DEVOTED TO PROMOTE FURTHER IMPROVEMENTS IN MEDICAL TECHNOLOGY THAT HAVE A REASONABLE POTENTIAL TO IMPROVE MEDICAL TECHNOLOGY. 0 0 84786 261000 COMPUTER MODELING & SIMULATION (CM&S):INCREASE THE CONFIDENCE IN SAFETY AND EFFICACY, REDUCE CLINICAL TRIAL SIZE AND ACCELERATE DEVICE REVIEW THROUGH REGULATORY GRADE COMPUTER MODELS AND SIMULATION. 84787 261000 PATIENT-CENTERED BENEFIT RISK (PCBR):ESTABLISH A CREDIBLE FRAMEWORK FOR DEFINING PATIENT PREFERENCE REGARDING PROBABLE BENEFITS AND PROBABLE RISKS OF A PROPOSED MEDICAL DEVICE. 84787 261000 CLINICAL TRIAL INNOVATION & REFORM (CTIR):IMPROVE THE SAFETY AND EFFECTIVENESS OF PRODUCTS BEING INTRODUCED INTO THE MARKET, REDUCE CLINICAL TRIAL CYCLE TIMES AND COSTS, AND YIELD EARLIER ACCESS TO BENEFICIAL INNOVATIVE TECHNOLOGIES FOR U.S. PATIENTS THROUGH INNOVATIVE NEW CLINICAL TRIAL DESIGNS AND METHODS. 254360 1 1 0 0 0 0 0 0 0 0 1 0 0 0 0 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 14 0 3 1 0 0 0 0 0 0 0 0 0 0 X 21 20 0 1 1 0 1 1 0 1 1 0 0 1 1 1 1 0 0 1 0 0 MN X MITZI HAGEN 9527463819 1550 UTICA AVENUE NO 740 ST LOUIS PARK MN 55416 WILLIAM V MURRAY PRESIDENT AND CEO 40.00 0.00 X X 80653 0 16131 WILLIAM A HAWKINS III BOARD CHAIR 2.00 0.00 X X 0 0 0 ALLAN COUKELL BOARD VICE CHAIR 2.00 0.00 X X 0 0 0 VINCENT FORLENZA FINANCE COMMITTEE, VICE CHAIR 2.00 0.00 X X 0 0 0 MICHAEL R MINOGUE BOARD SECRETARY; MBRSHP COMM CHAIR 2.00 0.00 X X 0 0 0 DAVID PEREZ FINANCE COMMITTEE, CHAIR 2.00 0.00 X X 0 0 0 JEFFREY SHUREN MD JD MBRSHP COMM, VICE CHAIR 2.00 0.00 X X 0 0 0 GLENN L CRISER BOARD MEMBER 1.00 0.00 X 0 0 0 KATHY HUDSON PHD BOARD MEMBER 1.00 0.00 X 0 0 0 ROSS JAFFE MD BOARD MEMBER 1.00 0.00 X 0 0 0 TAMARA SYREK JENSEN JD BOARD MEMBER 1.00 0.00 X 0 0 0 RICHARD E KUNTZ MD MSC BOARD MEMBER 1.00 0.00 X 0 0 0 KAREN LICITRA BOARD MEMBER 1.00 0.00 X 0 0 0 DEE MELLOR BOARD MEMBER 1.00 0.00 X 0 0 0 DANIEL J MOORE BOARD MEMBER 1.00 0.00 X 0 0 0 MICHAEL ROUSSEAU BOARD MEMBER 1.00 0.00 X 0 0 0 PETER SALTONSTALL BOARD MEMBER 1.00 0.00 X 0 0 0 RANDALL SCHIESTL BOARD MEMBER 1.00 0.00 X 0 0 0 JOE V SELBY BOARD MEMBER 1.00 0.00 X 0 0 0 NADIM YARED BOARD MEMBER 1.00 0.00 X 0 0 0 DALE WAHLSTROM BOARD MEMBER 1.00 0.00 X 0 0 0 80653 0 16131 0 0 0 0 LIFESCIENCE ALLEY 1550 UTICA AVE SO SUITE 740 ST LOUIS PARK MN 55416 SHARED SERVICES 104422 1 783000 150 783150 783150 0 0 0 X 96784 71620 25164 29405 21760 7645 3904 2889 1015 11141 8244 2897 104422 10442 93980 146819 108646 38173 4836 3579 1257 24324 18000 6324 314 232 82 MISCELLANEOUS EXPENSES 12092 8948 3144 434041 254360 179681 0 6893 566990 0 320000 0 2347 5448 314 0 5134 6893 894471 0 62219 0 476250 0 538469 X 6893 356002 6893 356002 6893 894471 349109 0 X 0 1 X 1 0 X 18750 783150 801900 18750 783150 801900 522325 279575 801900 X RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED 5448 314 5134 5134 X 783150 0 783150 0 783150 434041 0 434041 0 434041 PART X, LINE 2: THE ORGANIZATION IS EXEMPT FROM FEDERAL INCOME TAX UNDER SECTION 501(C)(3) OF THE INTERNAL REVENUE CODE AND APPLICABLE STATE STATUTES. HOWEVER, INCOME FROM CERTAIN ACTIVITIES NOT DIRECTLY RELATED TO THE ORGANIZATION'S TAX-EXEMPT PURPOSE COULD RESULT IN TAXABLE INCOME. THE ORGANIZATION FOLLOWS GUIDANCE IN THE INCOME TAX STANDARD REGARDING THE RECOGNITION OF UNCERTAIN TAX POSITIONS. THE ORGANIZATION HAS IDENTIFIED NO SIGNIFICANT INCOME TAX UNCERTAINTIES AND HAS NO CURRENT OBLIGATION FOR UNRELATED BUSINESS INCOME TAX. FORM 990, PART VI, SECTION A, LINE 1 THE BOARD MAY DESIGNATE AN EXECUTIVE COMMITTEE COMPRISED OF THE PRESIDENT AND SUCH OTHER PERSONS AS MAY BE APPOINTED BY THE BOARD; PROVIDED THAT NO MORE THAN SEVENTY-FIVE PERCENT (75%) OF THE MEMBERS OF THE EXECUTIVE COMMITTEE MAY REPRESENT FOR-PROFIT MEMBERS OF THE MDIC. THE EXECUTIVE COMMITTEE SHALL HAVE AND MAY EXERCISE ALL OF THE AUTHORITY AND POWERS OF THE BOARD IN THE MANAGEMENT OF THE BUSINESS OF THE MDIC IN THE INTERVAL BETWEEN MEETINGS OF THE BOARD, EXCEPT THAT THE EXECUTIVE COMMITTEE SHALL NOT HAVE THE AUTHORITY AND POWER TO CREATE ADDITIONAL DIRECTOR POSITIONS, ELECT OR REMOVE DIRECTORS, CREATE NEW OFFICER POSITIONS, ELECT OR REMOVE OFFICERS, AMEND THE ARTICLES OF INCORPORATION OR BYLAWS, ADOPT A PLAN OF MERGER OR CONSOLIDATION, AUTHORIZE THE SALE OR OTHER DISPOSITION OF ALL OR SUBSTANTIALLY ALL OF THE PROPERTY AND ASSETS OF THE MDIC, AUTHORIZE OR REVOKE A VOLUNTARY DISSOLUTION OF THE MDIC, TAKE ANY ACTION THAT REQUIRES A TWO-THIRDS AFFIRMATIVE VOTE OF THE DIRECTORS VOTING ON A MATTER UNDER THESE BYLAWS OR TAKE ANY OTHER ACTION THAT APPLICABLE LAW REQUIRES BE CONSIDERED BY THE FULL BOARD. DAY-TO-DAY OPERATIONS OF THE MDIC WILL BE MANAGED BY THE PRESIDENT WITH OVERSIGHT AND APPROVAL, AS NECESSARY, BY THE EXECUTIVE COMMITTEE. REPORTS OF EXECUTIVE COMMITTEE ACTIONS SHALL BE PROVIDED REGULARLY TO THE BOARD. THE EXECUTIVE COMMITTEE SHALL AT ALL TIMES BE SUBJECT TO THE CONTROL AND DIRECTION OF THE BOARD. FORM 990, PART VI, SECTION A, LINE 3 THE ORGANIZATION HAS A MANAGEMENT AGREEMENT WITH LIFESCIENCE ALLEY. EFFECTIVE JANUARY 1, 2013, THE ORGANIZATION WAS REQUIRED TO PAY A MONTHLY RETAINER TO LIFESCIENCE ALLEY FOR STAFF TIME SPENT ON THEIR OPERATIONS AS WELL AS OTHER MANAGEMENT SERVICES AND SOME ADDITIONAL REIMBURSEMENTS FOR SERVICES PROVIDED BY LIFESCIENCE ALLEY. FORM 990, PART VI, SECTION A, LINE 4 DURING THE YEAR THE ORGANIZATION AMENDED ITS GOVERNING DOCUMENTS TO ADD THE OFFICE OF PRESIDENT TO THE EXECUTIVE COMMITTEE; CLARIFY BOARD MEMBER VOTING AND THE ROLE OF OBSERVER; CLARIFY ROLE OF EXECUTIVE COMMITTEE; ELIMINATE THE BOARD 2/3 SUPER MAJORITY VOTING REQUIREMENT; AND ADD A NEW ARTICLE ON MEMBERSHIP. FORM 990, PART VI, SECTION A, LINE 6 THE MDIC HAS NON-VOTING MEMBERS IN ACCORDANCE WITH THEIR BYLAWS. MEMBERSHIP IS OPEN TO ORGANIZATIONS THAT ARE SUBSTANTIALLY INVOLVED IN MEDICAL AND/OR MEDICAL DEVICE RESEARCH, DEVELOPMENT, TREATMENT OR EDUCATION; THE PROMOTION OF PUBLIC HEALTH; AND REGULATORY SCIENCE. FORM 990, PART VI, SECTION A, LINE 7A A REPRESENTATIVE DESIGNATED BY THE CENTERS FOR MEDICARE & MEDICAID SERVICES (CMS), AND THE DIRECTOR OF THE CENTER FOR DEVICES AND RADIOLOGICAL HEALTH OF THE FDA (CDRH) WILL SERVE ON THE BOARD AT ALL TIMES. FORM 990, PART VI, SECTION B, LINE 11 FORM 990 WILL BE REVIEWED BY THE CEO, COUNSEL AND FINANCE COMMITTEE, WITH AN ELECRONIC COPY PROVIDED TO THE FULL BOARD OF DIRECTORS PRIOR TO SUBMISSION TO THE IRS. FORM 990, PART VI, SECTION B, LINE 12C EACH BOARD MEETING AGENDA INCLUDES A STANDING ITEM REQUESTING UPDATES ON POTENTIAL CONFLICTS OF INTEREST. OFFICERS, DIRECTORS, AND KEY EMPLOYEES ARE REQUIRED TO DISCLOSE POTENTIAL CONFLICTS OF INTEREST AS THEY ARISE. THE BOARD REVIEWS AND APPROVES ALL TRANSACTIONS THAT HAVE A POTENTIAL CONFLICT OF INTEREST. NO DIRECTOR OF THE MEDICAL DEVICE INNOVATION CONSORTIUM SHALL VOTE ON ANY MATTER IN WHICH HE OR SHE, OR HIS OR HER EMPLOYER, HAS A MATERIAL INTEREST OR FINANCIAL INTEREST THAT WILL BE AFFECTED BY THE OUTCOME OF THE VOTE. ALL PROCEEDINGS RELATED TO CONFLICTS OF INTEREST ARE DOCUMENTED IN THE MEETING MINUTES. FORM 990, PART VI, SECTION B, LINE 15A COMPENSATION OF OFFICERS, BOARD MEMBERS AND MANAGEMENT ARE REVIEWED BY THE CEO AND THE EXECUTIVE COMMITTEE. COMPENSATION OF CEO IS REVIEWED BY THE EXECUTIVE COMMITTEE AND APPROVED BY THE FULL BOARD. FORM 990, PART VI, SECTION C, LINE 19 THE ORGANIZATION MAKES ITS GOVERNING DOCUMENTS, CONFLICT OF INTEREST POLICY, AND FINANCIAL STATEMENTS AVAILABLE TO THE PUBLIC UPON WRITTEN REQUEST. FORM 990, PART IX, LINE 11G PROFESSIONAL FEES AND CONSULTING: PROGRAM SERVICE EXPENSES 108,646. MANAGEMENT AND GENERAL EXPENSES 38,173. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 146,819.