2016-10-24T13:02:48-05:00 2015-12-31 410746749 CLIFTONLARSONALLEN LLP 220 SOUTH SIXTH STREET SUITE 300 MINNEAPOLIS MN 55402 990 2015-01-01 461465348 MEDICAL DEVICE INNOVATION CONSORTIUM MEDI 9523142734 100 NORTH SIXTH STREET NO 989C MINNEAPOLIS MN 55403 WILLIAM V MURRAY PRESIDENT AND CEO 9523142734 2016-10-15 1 JOHN TAUER P00294068 6123764500 2015 2017-02-10 21:41:12Z X WILLIAM V MURRAY 100 NORTH SIXTH STREET NO 989C MINNEAPOLIS MN 55403 1983922 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 7 150 0 0 1072186 1289806 420538 694116 0 0 31 0 1492755 1983922 0 0 0 0 549911 711454 0 0 0 696625 807363 1246536 1518817 246219 465105 1548505 2188308 946284 1120982 602221 1067326 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 429025 0 142333 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. 194065 0 186386 PATIENT-CENTERED BENEFIT RISK (PCBR):ESTABLISH A CREDIBLE FRAMEWORK FOR DEFINING PATIENT PREFERENCE REGARDING PROBABLE BENEFITS AND PROBABLE RISKS OF A PROPOSED MEDICAL DEVICE. 96413 0 3667 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. 80999 0 361730 CASE FOR QUALITY (CFQ) - OFFERS A UNIQUE FORUM FOR MEDICAL DEVICE STAKEHOLDERS TO WORK TOGETHER TO ENHANCE DEVICE QUALITY AND PATIENT SAFETY. PARTICIPANTS IN THE CFQ INCLUDE THE FDA AND A GROWING NUMBER OF MEDICAL DEVICE COMPANIES, HEALTHCARE PROVIDERS AND PAYER ORGANIZATIONS INCLUDING TRADE ASSOCIATIONS AND EDUCATIONAL INSTITUTIONS. 32946 0 0 CLINICAL DIAGNOSTICS (CDX) - IDENTIFY AND PURSUE PROJECTS THAT WILL IMPROVE DIAGNOSTIC TESTING AND PRODUCT DEVELOPMENT USING NOVEL REGULATORY SCIENCE APPROACHES DEVELOPED THROUGH COLLABORATION BETWEEN MDIC STAKEHOLDERS. PROVIDING A PREDICTABLE PATH FOR INNOVATION WILL HELP PATIENTS BENEFIT THROUGH QUICKER ACCESS TO MORE COST-EFFECTIVE ADVANCED DIAGNOSTIC TECHNOLOGIES IN LESS TIME. 113945 0 361730 833448 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 25 0 7 1 0 0 0 0 0 0 0 0 0 0 X 20 19 0 1 0 0 1 0 0 1 1 0 0 1 1 1 1 1 0 1 0 0 MN X CLIFTONLARSONALLEN LLP 6123764800 220 SOUTH SIXTH STREET SUITE 300 MINNEAPOLIS MN 55402 WILLIAM V MURRAY PRESIDENT AND CEO 40.00 X X 298404 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 2.00 X X 0 0 0 DAVID PEREZ TREASURER 2.00 X X 0 0 0 CHIP HANCE BOARD MEMBER 1.00 X 0 0 0 BILL HEETDERKS 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 PETER SALTONSTALL BOARD MEMBER 1.00 X 0 0 0 RANDALL SCHIESTL BOARD MEMBER 1.00 X 0 0 0 JEFFREY SHUREN MD JD BOARD MEMBER 1.00 X 0 0 0 BETH STAUB BOARD MEMBER 1.00 X 0 0 0 TAMARA SYREK JENSEN JD BOARD MEMBER 1.00 X 0 0 0 MICHAEL TARNOFF 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 298404 0 0 1 0 1 0 0 1289806 1289806 BAA-002 CFQ 541900 361730 361730 BAA-001 PCBR 541900 186386 186386 PIL REVENUE 541900 92333 92333 NEURAL STIM REVENUE 541900 50000 50000 REVENUE - MDIC MEETING 900099 3667 3667 694116 1983922 694116 0 0 X 298404 220819 77585 342299 79450 262849 35380 16581 18799 35371 17533 17838 62252 7321 54931 16051 1888 14163 371112 317089 54023 28185 4815 23370 60336 155 60181 139036 103726 35310 61232 57272 3960 3697 3697 3024 3024 SHARED SERVICES 32776 32776 MISCELLANEOUS EXPENSES 29662 6799 22863 1518817 833448 685369 0 819740 1389285 614464 662320 105457 118397 12547 3697 8844 8850 0 9456 1548505 2188308 233220 93724 713064 1027258 946284 1120982 X 502221 992326 100000 75000 602221 1067326 1548505 2188308 465105 0 X 0 1 X 1 0 X 18750 783150 1072186 1289806 3163892 420538 694116 1114654 18750 783150 1492724 1983922 4278546 0 587033 725792 843851 2156676 587033 725792 843851 2156676 2121870 31 31 18750 783150 1492755 1983922 4278577 X SCHEDULE A, PART III, LINE 12, EXPLANATION OF OTHER INCOME: MISCELLANEOUS REVENUE RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED 12547 3697 8850 8850 X 1983922 0 1983922 0 1983922 1518817 0 1518817 0 1518817 PART X, LINE 2: MEDICAL DEVICE INNOVATION CONSORTIUM IS EXEMPT FROM FEDERAL AND MINNESOTA TAXATION PURSUANT TO THE PROVISIONS OF SECTION 501(C)(3) OF THE INTERNAL REVENUE CODE AND SECTION 290.05 OF THE MINNESOTA STATUTES AND IS ONLY SUBJECT TO FEDERAL AND STATE INCOME TAXES ON NET UNRELATED BUSINESS INCOME. SINCE THE ORGANIZATION HAD NO UNRELATED BUSINESS TAXABLE INCOME IN 2015 AND 2014, THE ACCOMPANYING FINANCIAL STATEMENTS DO NOT INCLUDE ANY PROVISION FOR FEDERAL OR STATE INCOME TAXES. THE ORGANIZATION'S FILINGS WITH THE INTERNAL REVENUE SERVICE ARE SUBJECT TO AUDIT. THE INFORMATION RETURNS FOR THE PAST THREE AND ONE-HALF YEARS ARE OPEN TO EXAMINATION. MANAGEMENT HAS EVALUATED ITS TAX POSITIONS AND HAS CONCLUDED THAT THEY DO NOT RESULT IN ANYTHING THAT WOULD REQUIRE EITHER RECORDING OR DISCLOSURE IN THE FINANCIAL STATEMENTS BASED ON THE CRITERIA SET FORTH IN ACCOUNTING STANDARDS CODIFICATION (ASC) SECTION 740. X X X 0 0 0 0 0 0 0 0 0 WILLIAM V MURRAY PRESIDENT AND CEO 248404 0 50000 0 0 0 0 0 0 0 298404 0 0 0 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 HAD A MANAGEMENT AGREEMENT WITH LIFESCIENCE ALLEY. EFFECTIVE JANUARY 1, 2014, 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. THE AMOUNT OF THE SHARED SERVICES WHICH INCLUDED SOME ADDITIONAL REIMBURSEMENTS FOR SERVICES PROVIDED BY LIFESCIENCE ALLEY WAS $32,776 AND $34,985 FOR THE YEARS ENDED DECEMBER 31, 2015 AND 2014, RESPECTIVELY. THIS MANAGEMENT AGREEMENT WAS TERMINATED DURING 2015. 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 THE FORM 990 WILL BE REVIEWED BY THE CEO, COUNSEL AND FINANCE COMMITTEE, WITH AN ELECTRONIC 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 MDIC BOARD MEMBERS ARE NOT COMPENSATED. COMPENSATION OF THE CEO IS REVIEWED AND APPROVED BY THE BOARD AND EXECUTIVE COMMITTEE. THE MOST RECENT REVIEW OCCURRED BETWEEN FEBRUARY 2015 AND SEPTEMBER 2015. CURRENTLY, THERE ARE NO OTHER HIGHLY COMPENSATED EMPLOYEES. 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 317,089. MANAGEMENT AND GENERAL EXPENSES 54,023. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 371,112.