2017-11-08T15:09:28-06:00 2016-12-31 410746749 CLIFTONLARSONALLEN LLP 220 SOUTH SIXTH STREET SUITE 300 MINNEAPOLIS MN 55402 990 2016-01-01 461465348 MEDICAL DEVICE INNOVATION CONSORTIUM MEDI 9523142734 1501 WILSON BOULEVARD NO 910 ARLINGTON VA 22209 WILLIAM V MURRAY PRESIDENT AND CEO 9523142734 2017-11-03 1 JOHN TAUER P00294068 6123764500 67.137.57.251 2017-11-03 15:57:54 CD P 662AFBF7F2F9883F5E910BA2CC57A7F69F389170 7F0B04ACDB70BCCCF9DAB5CBDF996D6C53679A35 2016 2021-01-29 14:40:06Z X WILLIAM V MURRAY 1501 WILSON BOULEVARD NO 910 ARLINGTON VA 22209 2636816 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. 25 24 6 180 0 0 1289806 2332677 694116 303956 0 0 0 183 1983922 2636816 0 0 0 0 711454 858239 0 0 0 807363 1587948 1518817 2446187 465105 190629 2188308 3341659 1120982 2083704 1067326 1257955 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 516374 0 25000 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. 322631 0 278956 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. 315098 0 0 MDIC NEST COORDINATING CENTER:THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) HAS AWARDED THE MEDICAL DEVICE INNOVATION CONSORTIUM (MDIC) $3 MILLION IN SEED FUNDING TO ESTABLISH THE COORDINATING CENTER FOR THE MEDICAL DEVICE NATIONAL EVALUATION SYSTEM FOR HEALTH TECHNOLOGY (NEST). NEST WILL HELP IMPROVE THE QUALITY OF REAL-WORLD EVIDENCE THAT HEALTH CARE PROVIDERS AND PATIENTS CAN USE TO MAKE BETTER INFORMED TREATMENT DECISIONS AND STRIKE THE RIGHT BALANCE BETWEEN ASSURING SAFETY AND FOSTERING DEVICE INNOVATION AND PATIENT ACCESS. 176300 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. 172745 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. 158466 0 0 PATIENT-CENTERED BENEFIT RISK (PCBR):ESTABLISH A CREDIBLE FRAMEWORK FOR DEFINING PATIENT PREFERENCE REGARDING PROBABLE BENEFITS AND PROBABLE RISKS OF A PROPOSED MEDICAL DEVICE. 69023 0 0 PCOR & CTS PROGRAMS 576534 0 0 1730637 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 27 0 6 1 0 0 0 0 0 0 0 0 0 0 X 25 24 0 0 0 0 1 0 0 1 1 0 0 1 1 1 1 1 1 0 0 0 MN VA X CLIFTONLARSONALLEN LLP 6123764800 220 SOUTH SIXTH STREET SUITE 300 MINNEAPOLIS MN 55402 WILLIAM V MURRAY PRESIDENT AND CEO 40.00 X X 431431 0 0 MICHAEL R MINOGUE BOARD CHAIR 2.00 X X 0 0 0 ALLAN COUKELL VICE-CHAIR 2.00 X X 0 0 0 JOE ALMEIDA DIRECTOR 1.00 X 0 0 0 PETER ARDUINI DIRECTOR 1.00 X 0 0 0 MARK CARLSON DIRECTOR 1.00 X 0 0 0 RACHAEL FLEURENCE DIRECTOR 1.00 X 0 0 0 RICK GEOFFRION DIRECTOR 1.00 X 0 0 0 CHIP HANCE DIRECTOR 1.00 X 0 0 0 WILLIAM HAWKINS DIRECTOR 1.00 X 0 0 0 ROSS JAFFE DIRECTOR 1.00 X 0 0 0 KRIS KANDARPA DIRECTOR 1.00 X 0 0 0 RICK KUNTZ DIRECTOR 1.00 X 0 0 0 ARAN MAREE DIRECTOR 2.00 X 0 0 0 RICK NAPLES DIRECTOR 1.00 X 0 0 0 CAROLL NEUBAUER DIRECTOR 1.00 X 0 0 0 BRYAN OLIN DIRECTOR 1.00 X 0 0 0 PETER SALTONSTALL DIRECTOR 1.00 X 0 0 0 RANDY SCHIESTL DIRECTOR 1.00 X 0 0 0 JEFF SHUREN DIRECTOR 1.00 X 0 0 0 BETH STAUB DIRECTOR 1.00 X 0 0 0 TAMARA SYREK JENSEN DIRECTOR 1.00 X 0 0 0 DALE WAHLSTROM DIRECTOR 1.00 X 0 0 0 JOE WOODY DIRECTOR 1.00 X 0 0 0 NADIM YARED DIRECTOR 1.00 X 0 0 0 DAWN BARDOT VICE PRESIDENT 40.00 X 145914 0 0 577345 0 0 2 0 1 0 DELOITTE & TOUCHE 1919 NORTH LYNN STREET ARLINGTON VA 22209 CONSULTING SERVICES FOR CC GRANT 177457 LIFESCIENCE PARTNER 1230 PEACHTREE STREET NORTHEAST 3 ATLANTA GA 30309 SEARCH FOR EXECUTIVE DIRECTOR, MDIC COOR 161993 DAN SCHWARTZ 5901 WOODDALE AVENUE EDINA MN 55424 CONSULTING SERVICES ON VARIOUS PROJECTS 132358 3 1995394 337283 2332677 BAA-002 CFQ 541900 278956 278956 NEURAL STIM REVENUE 541900 25000 25000 303956 MISCELLANEOUS REVENUE 900099 183 183 183 2636816 303956 0 183 X 431431 319259 112172 349958 112116 237842 41667 23003 18664 35183 19423 15760 85303 11352 73951 44747 5715 39032 1097015 1006332 90683 9366 7161 2205 36238 20556 15682 31958 10006 21952 61092 61092 111526 103751 7775 88260 84554 3706 4602 4602 4193 4193 MISCELLANEOUS 13648 7409 6239 2446187 1730637 715550 0 1389285 2147211 662320 1122691 118397 17311 12547 4219 8850 8328 9456 46118 2188308 3341659 93724 317440 1027258 1766264 1120982 2083704 X 992326 1257955 75000 0 1067326 1257955 2188308 3341659 190629 0 X X 0 1 X 1 0 X 18750 783150 1072186 1289806 2332677 5496569 420538 694116 303956 1418610 18750 783150 1492724 1983922 2636633 6915179 0 587033 725792 843851 1600572 3757248 587033 725792 843851 1600572 3757248 3157931 31 183 214 18750 783150 1492755 1983922 2636816 6915393 X SCHEDULE A, PART III, LINE 12, EXPLANATION OF OTHER INCOME: MISCELLANEOUS REVENUE RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED 12547 4219 8328 8328 X 2636816 0 2636816 0 2636816 2446187 0 2446187 0 2446187 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 2016 AND 2015, 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 299331 0 50000 0 82100 0 0 0 0 0 431431 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 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 11B 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 15 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 CLINICAL DIAGNOSTICS CONSULTING: PROGRAM SERVICE EXPENSES 41,443. MANAGEMENT AND GENERAL EXPENSES 0. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 41,443. CASE FOR QUALITY CONSULTING: PROGRAM SERVICE EXPENSES 271,602. MANAGEMENT AND GENERAL EXPENSES 0. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 271,602. COMPUTER MODELING & SIMULATION CONSULTING: PROGRAM SERVICE EXPENSES 153,799. MANAGEMENT AND GENERAL EXPENSES 0. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 153,799. PATIENT-CENTERED BENEFIT RISK CONSULTING: PROGRAM SERVICE EXPENSES 36,530. MANAGEMENT AND GENERAL EXPENSES 0. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 36,530. OTHER CONSULTANTS AND CONTRACT LABOR: PROGRAM SERVICE EXPENSES 502,958. MANAGEMENT AND GENERAL EXPENSES 90,683. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 593,641. FORM 990, PART XII, LINE 2C: THE PROCESS HAS NOT CHANGED FROM PRIOR YEARS.