2015-11-11T09:09:25-06:00 2014-12-31 410746749 CLIFTONLARSONALLEN LLP 220 SOUTH SIXTH STREET SUITE 300 MINNEAPOLIS MN 55402 990 2014-01-01 461465348 MEDICAL DEVICE INNOVATION CONSORTIUM MEDI 9523141255 1550 UTICA AVENUE NO 740 ST LOUIS PARK MN 55416 WILLIAM V MURRAY PRESIDENT AND CEO 9523141255 2015-10-27 1 JOHN TAUER P00294068 6123764500 2014 2016-02-25 16:41:14Z WILLIAM V MURRAY 1550 UTICA AVENUE NO 740 ST LOUIS PARK MN 55416 1492755 0 X WWW.MDIC.ORG X 2012 MN THE MEDICAL DEVICE INNOVATION CONSORTIUM (MDIC), 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. 20 19 6 150 0 0 783150 1072186 0 420538 0 0 0 31 783150 1492755 0 0 0 0 141234 549911 0 0 0 292807 696625 434041 1246536 349109 246219 894471 1548505 538469 946284 356002 602221 X THE MEDICAL DEVICE INNOVATION CONSORTIUM (MDIC) WILL BRING TOGETHER THE EXPERTISE AND RESOURCES OF MEDICAL DEVICE STAKEHOLDERS TO ADDRESS STRATEGIC AND TECHNICAL ISSUES THAT AFFECT THE MEDICAL DEVICE INDUSTRY AND THE PUBLIC. THE MDIC WILL PROMOTE THE PUBLIC HEALTH BY ADVANCING MEDICAL DEVICE REGULATORY SCIENCE TO REDUCE THE TIME AND COST OF DEVICE DEVELOPMENT, ASSESSMENT, AND REVIEW AND ADVANCE THE SAFETY AND EFFECTIVENESS OF MEDICAL DEVICES THROUGHOUT THEIR TOTAL PRODUCT LIFE CYCLE FOR THE BENEFIT OF PATIENTS. 1 0 388668 0 313635 PATIENT-CENTERED BENEFIT RISK (PCBR):ESTABLISH A CREDIBLE FRAMEWORK FOR DEFINING PATIENT PREFERENCE REGARDING PROBABLE BENEFITS AND PROBABLE RISKS OF A PROPOSED MEDICAL DEVICE.COMPUTER 207778 0 105644 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. 73436 0 0 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. 33475 0 1259 OTHER PROGRAMS 33475 0 1259 703357 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 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 14 0 6 1 0 0 0 0 0 0 0 0 0 0 X 20 19 0 1 1 0 1 0 0 1 1 0 0 1 1 1 1 1 0 1 0 0 MN X MITZI HAGEN 9523141255 1550 UTICA AVENUE NO 740 ST LOUIS PARK MN 55416 WILLIAM V MURRAY PRESIDENT AND CEO 40.00 X X 268025 0 0 WILLIAM A HAWKINS III BOARD CHAIR 2.00 X X 0 0 0 ALLAN COUKELL BOARD VICE CHAIR 2.00 X X 0 0 0 MICHAEL R MINOGUE BOARD SECRETARY; MBRSHP CO 2.00 X X 0 0 0 DAVID PEREZ FINANCE COMMITTEE, CHAIR 2.00 X X 0 0 0 JEFFREY SHUREN MD JD MBRSHP COMM, VICE CHAIR 2.00 X X 0 0 0 BILL HEETDERKS MD PHD BOARD MEMBER 1.00 X 0 0 0 KATHY HUDSON BOARD MEMBER 1.00 X 0 0 0 ROSS JAFFE MD BOARD MEMBER 1.00 X 0 0 0 RICHARD E KUNTZ MD MSC BOARD MEMBER 1.00 X 0 0 0 BRYAN LUCE PHD BOARD MEMBER 1.00 X 0 0 0 ARAN MAREE MD BOARD MEMBER 1.00 X 0 0 0 RICHARD NAPLES BOARD MEMBER 1.00 X 0 0 0 BRYAN OLIN PHD BOARD MEMBER 1.00 X 0 0 0 MICHAEL ROUSSEAU BOARD MEMBER 1.00 X 0 0 0 MICHAEL TARNOFF BOARD MEMBER 1.00 X 0 0 0 PETER SALTONSTALL BOARD MEMBER 1.00 X 0 0 0 RANDALL SCHIESTL BOARD MEMBER 1.00 X 0 0 0 TAMARA SYREK JENSEN JD BOARD MEMBER 1.00 X 0 0 0 DALE WAHLSTROM BOARD MEMBER 1.00 X 0 0 0 NADIM YARED BOARD MEMBER 1.00 X 0 0 0 268025 0 0 1 0 1 0 RTI HEALTH SOLUTIONS 200 PARK OFFICES DRIVE RESEARCH TRIANGLE PARK NC 27709 CONSULTING SERVICES FOR FDA FUNDED PATIE 116548 1 1072186 1072186 BAA-001 PCBR 900099 313604 313604 PROJECT REVENUE 900099 100000 100000 REVENUE - MDIC MEETING 900099 6934 6934 420538 MISCELLANEOUS REVENUE 900099 31 31 31 1492755 420538 0 31 X 252565 186898 65667 230798 49026 181772 31425 15338 16087 35123 17143 17980 93464 93464 7777 7777 358040 340253 17787 51279 25029 26250 69738 37678 32060 42160 28194 13966 2482 2482 2447 2447 SHARED SERVICES 34985 34985 MISCELLANEOUS EXPENSES 34253 3798 30455 1246536 703357 543179 0 566990 819740 320000 614464 2347 105457 11640 2796 5134 8844 894471 1548505 62219 233220 476250 713064 538469 946284 X 356002 502221 0 100000 356002 602221 894471 1548505 246219 0 X 0 1 X 1 0 X 18750 783150 1072186 1874086 18750 783150 1072186 1874086 1217680 656406 31 31 1874117 420538 X SCHEDULE A, PART II, LINE 10, EXPLANATION OF OTHER INCOME: MISCELLANEOUS REVENUE RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED 11640 2796 8844 8844 X 1492755 0 1492755 0 1492755 1246536 0 1246536 0 1246536 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. THE ORGANIZATION'S TAX RETURN FOR THE YEAR 2013 IS OPEN TO REVIEW AND EXAMINATION BY FEDERAL AND STATE AUTHORITIES. 0 0 0 0 0 0 0 0 0 WILLIAM V MURRAY PRESIDENT AND CEO 252565 0 15460 0 0 0 0 0 0 0 268025 0 0 0 FORM 990, PART III, LINE 2 RECEIVED FUNDING FROM THE FDA TO STUDY INTEGRATION OF PATIENT-PREFERENCES INTO THE REGULATORY PROCESS; WORK BEGAN ABOUT JUNE 1, 2014. 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 1 DIRECTORS EMPLOYED BY THE FEDERAL GOVERNMENT WILL NOT PARTICIPATE IN THE STRUCTURING OF MEMBERSHIP DUES OR OTHER FINANCIAL DECISIONS. 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 THE ORGANIZATION AMENDED ITS BYLAWS FOR THE FOLLOWING: TO ADD LANGUAGE TO ITS PRIMARY PURPOSE ARTICLE: "AS A 501(C)(3) CHARITABLE ORGANIZATION, THE MDIC IS FOCUSED ON PROTECTING AND PROMOTING THE PUBLIC HEALTH BY ADVANCING MEDICAL DEVICE REGULATORY SCIENCE TO REDUCE THE TIME AND COST OF DEVICE DEVELOPMENT, ASSESSMENT AND REVIEW AND TO ASSURE THE SAFETY AND EFFECTIVENESS OF MEDICAL DEVICES THROUGHOUT THEIR TOTAL PRODUCT LIFE CYCLES. MDIC WILL NOT PRODUCE ANY MEDICAL DEVICES, AND, AS SUCH, NOTHING THAT THE MDIC PRODUCES WILL BE REGULATED BY THE FOOD AND DRUG ADMINISTRATION (THE "FDA")." TO CLARIFY THAT DIRECTORS EMPLOYED BY THE FEDERAL GOVERNMENT WILL NOT PARTICIPATE IN THE STRUCTURING OF MEMBERSHIP DUES OR OTHER FINANCIAL DECISIONS. TO CLARIFY LANGUAGE FOR THE EXECUTIVE COMMITTEE. TO INCLUDE THE PRESIDENT AND TREASURER OFFICERS OF THE ORGANIZATION AND TO OUTLINE THE RESPONSIBILITIES OF THE POSITIONS. TO CLARIFY THAT THE PRESIDENT'S POSITION ON THE BOARD DOES NOT COUNT TOWARDS THE MAXIMUM NUMBER OF DIRECTORS. TO CLARIFY THE SECRETARY'S RESPONSIBILITIES. TO ALLOW FOR VACANCIES THAT EXIST OR IF THE TOTAL NUMBER OF DIRECTORS IS LESS THAN THE MAXIMUM ALLOWED BY THE BYLAWS, ADDITIONAL DIRECTORS MAY BE ELECTED AT ANY MEETING. TO REMOVE THE PROVISION FOR PROXY VOTING. 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 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,BOARD OF DIRECTORS AND THE EXECUTIVE COMMITTEE. COMPENSATION OF CEO IS REVIEWED BY THE EXECUTIVE COMMITTEE AND APPROVED BY THE FULL BOARD. THIS PROCESS WAS MOST RECENTLY UNDERTAKEN IN 2013. 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 340,253. MANAGEMENT AND GENERAL EXPENSES 17,787. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 358,040.