2021-11-04T14:00:25-05:00 2020-12-31 410746749 CLIFTONLARSONALLEN LLP 220 S 6TH STREET SUITE 300 MINNEAPOLIS MN 55402 990 2020-01-01 461465348 THE MEDICAL DEVICE INNOVATION CONSORTIUM MEDI 2028681600 1501 WILSON BOULEVARD NO 910 ARLINGTON VA 22209 PAMELA W GOLDBERG PRESIDENT AND CEO 2028681600 2021-11-02 1 PAMELA GOLDBERG 999009999 JOHN TAUER P00294068 6123764500 2021-11-02 2 AAL1 IAL1 2020 2022-09-23 18:48:47Z PAMELA W GOLDBERG 1501 WILSON BOULEVARD NO 910 ARLINGTON VA 22209 21447770 0 X WWW.MDIC.ORG X 2012 MN A PUBLIC-PRIVATE PARTNERSHIP WITH THE OBJECTIVE OF ADVANCING MEDICAL DEVICE REGULATORY SCIENCE. 22 22 42 25 0 0 7482503 21429766 4071 1741 1418 6339 78868 9924 7566860 21447770 0 0 0 0 3815185 4956541 0 0 0 3868708 14644332 7683893 19600873 -117033 1846897 4143598 6445785 1099041 1554331 3044557 4891454 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 15291160 0 0 NATIONAL EVALUATION SYSTEM FOR HEALTH TECHNOLOGY COORDINATING CENTER:THE NATIONAL EVALUATION SYSTEM FOR HEALTH TECHNOLOGY (NEST) IS AN INITIATIVE OF MDIC WHICH SERVES AS A CATALYST IN ESTABLISHING FUNCTIONAL AND EFFICIENT PATHWAYS FOR KEY STAKEHOLDERS TO GENERATE LOWER-COST, NEARER REAL-TIME REAL-WORLD EVIDENCE (RWE) OF SUFFICIENT QUALITY FOR REGULATORY, COVERAGE, PATIENT, AND CLINICAL DECISION-MAKING. BY SOLVING THE CHALLENGES THAT HAVE SLOWED MEDICAL DEVICE INNOVATION, DELAYED THE DETECTION OF SAFETY SIGNALS, AND CREATED INEFFICIENCIES, NESTCC COULD IMPROVE PATIENTS' TIMELY ACCESS TO SAFE MEDICAL DEVICES AND THEIR QUALITY OF LIFE. 2123075 0 1741 CLINICAL SCIENCE TECHNOLOGY:MDIC'S FOCUS ON CLINICAL SCIENCE IS THE DEVELOPMENT OF TOOLS AND METHODS TO DRIVE EFFICIENCIES (TIME AND RESOURCES), QUALITY, AND A PREDICTABLE PATH IN DATA COLLECTION AND EVIDENCE DEVELOPMENT. THE ORGANIZATION'S CLINICAL SCIENCE PROGRAM AIM TO IMPROVE DIAGNOSTIC TESTING AND PRODUCT DEVELOPMENT BY SUPPORTING MANUFACTURES IN OBTAINING CREDIBLE CLINICAL EVIDENCE, AND THE FACILITATION OF FIRST-IN-WORLD PATIENT ACCESS TO SAFE AND EFFECTIVE NEW TECHNOLOGIES OF SIGNIFICANT HEALTH IMPORTANCE. 289579 0 0 HEALTH ECONOMICS & PATIENT ACCESS:MDIC'S VALUE-BASED HEALTHCARE PROJECTS ARE DEVELOPED TO IMPROVE THE INDUSTRY'S ABILITY TO INCLUDE PATIENT PERSPECTIVES IN THE DEVELOPMENT, PRE-MARKET APPROVAL, AND POST-MARKET EVALUATION OF MEDICAL DEVICES AND SUPPORT A MORE PREDICTABLE PATHWAY IN REIMBURSEMENT DECISIONS UNDER FEDERAL HEALTH CARE PROGRAMS. 17703814 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 26 0 42 1 0 0 0 0 0 0 0 0 0 0 0 0 X 22 22 0 0 0 0 1 0 0 1 1 0 0 1 1 1 1 1 1 1 1 0 MN X CLIFTONLARSONALLEN 6123764800 220 SOUTH SIXTH STREET SUITE 300 MINNEAPOLIS MN 55402 PAMELA GOLDBERG PRESIDENT AND CEO 40.00 X X 424577 0 35361 JON HUNT VP, CLINICAL SCIENCE & TECHNOLOGY 40.00 X 304846 0 42116 LENWOOD FAULCON GENERAL COUNSEL 40.00 X 206673 0 36019 FLORA SIAMI SENIOR VICE PRESIDENT, NESTCC 40.00 X 173808 0 18153 JITHESH VELICHAMTHOTU VEETIL DIRECTOR, DATA SCIENCE & TECHNOLOGY 40.00 X 170162 0 14591 ALAN BAUMEL PROGRAM DIRECTOR, CASE FOR QUALITY 40.00 X 158589 0 28137 ROBBERT ZUSTERZEEL DIRECTOR DATA NETWORK NEST 40.00 X 149047 0 0 CAROL ALLIS COUNSEL, NESTCC 40.00 X 147076 0 14616 LILIANA RINCON-GONZALEZ PROGRAM DIRECTOR, CLINICAL SCIENCE 40.00 X 137881 0 15884 LEAH DERGACHEV ASSISTANT VP, MEMBERSHIP & MARKETING 40.00 X 128202 0 22769 SEAN MCNABB DIRECTOR OF MARKETING 40.00 X 126260 0 9158 NADIM YARED BOARD CHAIR 2.00 X X 0 0 0 PETER ARDUINI DIRECTOR 1.00 X 0 0 0 WES CETNAROWSKI DIRECTOR 1.00 X 0 0 0 ANDREW CLEELAND DIRECTOR 1.00 X 0 0 0 STEVE FERGUSON 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 JIJO JAMES DIRECTOR 1.00 X 0 0 0 TAMARA SYREK JENSEN DIRECTOR 1.00 X 0 0 0 GARY JOHNSON DIRECTOR 1.00 X 0 0 0 KRIS KANDARPA DIRECTOR 1.00 X 0 0 0 SAM KHICHI DIRECTOR 1.00 X 0 0 0 ESTHER KROFAH DIRECTOR 1.00 X 0 0 0 RICHARD KUNTZ DIRECTOR 1.00 X 0 0 0 DANA MCMAHON DIRECTOR 1.00 X 0 0 0 MIKE MINOGUE DIRECTOR 1.00 X 0 0 0 CAROL NEUBAUER DIRECTOR 1.00 X 0 0 0 BRYAN OLIN DIRECTOR 1.00 X 0 0 0 SHACEY PETROVIC DIRECTOR 1.00 X 0 0 0 JODY POWELL DIRECTOR 1.00 X 0 0 0 PETER SALTONSTALL DIRECTOR 1.00 X 0 0 0 RANDALL SCHIESTL DIRECTOR 1.00 X 0 0 0 JEFFREY SHUREN DIRECTOR 1.00 X 0 0 0 JEAN SLUTSKY DIRECTOR 1.00 X 0 0 0 2127121 0 236804 14 0 1 0 VERRILL ONE PORTLAND SQUARE PORTLAND ME 04101 LEGAL SERVICES 127641 CLIFTONLARSONALLEN LLP 220 S 6TH ST SUITE 300 MINNEAPOLIS MN 55402 ACCOUNTING SERVICES 124173 WS COLLABORATIVE LLC 934 BELLVIEW ROAD MCLEAN VA 22102 CONSULTING SERVICES 120000 3 3244166 18085600 100000 21429766 CFQ FORUM 541900 1741 1741 1741 6339 6339 3203 0 3203 3203 3203 MISCELLANEOUS REVENUE 900099 6721 6721 6721 21447770 1741 0 16263 X 646665 531680 114985 3572262 2661100 911162 126259 157444 -31185 320919 166602 154317 290436 231511 58925 143644 137449 6195 33265 16633 16632 5652309 5495690 156619 43817 14192 29625 77045 24460 52585 216324 112727 103597 502427 342237 160190 36999 26721 10278 97467 47790 49677 PROJECT EXPENSES 7712236 7712236 FACILITIES AND EQUIPMEN 104949 20963 83986 MISCELLANEOUS EXPENSES 23850 4379 19471 19600873 17703814 1897059 0 2280992 4564523 1508202 1599190 152360 128794 308988 197238 160516 111750 41528 41528 4143598 6445785 984490 1196152 114551 77432 0 280747 1099041 1554331 X 2726516 4511454 318041 380000 3044557 4891454 4143598 6445785 1846897 0 X 0 1 X 1 1 1 X 2332677 4713194 6835051 7482503 21429766 42793191 303956 22238 14696 4071 1741 346702 2636633 4735432 6849747 7486574 21431507 43139893 575000 775000 1654167 500000 895833 4400000 0 575000 775000 1654167 500000 895833 4400000 38739893 21813 44396 48746 9542 124497 21813 44396 48746 9542 124497 183 48897 2820 31540 6721 90161 2636816 4806142 6896963 7566860 21447770 43354551 0.89360 0.83000 0.00290 0.00480 X SCHEDULE A, PART III, LINE 12, EXPLANATION OF OTHER INCOME: MISCELLANEOUS REVENUE RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED 149213 91354 57859 159775 105884 53891 111750 X 21447770 0 21447770 0 21447770 19600873 0 19600873 0 19600873 PART X, LINE 2: THE ORGANIZATION IS GENERALLY EXEMPT FROM FEDERAL INCOME TAXES UNDER THE PROVISIONS OF SECTION 501(C)(3) OF THE INTERNAL REVENUE CODE AND IS ONLY SUBJECT TO INCOME TAXES ON NET UNRELATED BUSINESS INCOME. SINCE THE ORGANIZATION HAD NO UNRELATED BUSINESS TAXABLE INCOME DURING THE YEARS ENDED DECEMBER 31, 2020 AND 2019, THE ACCOMPANYING FINANCIAL STATEMENTS DO NOT INCLUDE ANY PROVISION FOR INCOME TAXES. IN ADDITION, THE ORGANIZATION HAS BEEN CLASSIFIED AS AN ORGANIZATION THAT IS NOT A PRIVATE FOUNDATION. MANAGEMENT EVALUATED THE ORGANIZATION'S TAX POSITIONS AND CONCLUDED THAT THE ORGANIZATION HAD TAKEN NO UNCERTAIN TAX POSITIONS THAT REQUIRE ADJUSTMENT TO THE FINANCIAL STATEMENTS. 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PART I, LINE 1B THERE IS NO WRITTEN POLICY FOLLOWED BUT THERE IS BOARD APPROVAL OF THE HOUSING ALLOWANCE. 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 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 IS PREPARED BY AN INDEPENDENT PUBLIC ACCOUNTING FIRM USING INFORMATION PROVIDED BY THE ORGANIZATION. ONCE A DRAFT IS READY, 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 EXECUTIVE COMMITTEE AND REPORTED TO THE BOARD OF DIRECTORS WHICH IS RECORDED IN THE BOARD MEETING MINUTES. THE MOST RECENT REVIEW INCLUDING COMPARABILITY DATA OCCURRED 2020. COMPENSATION OF KEY EMPLOYEES IS REVIEWED AND APPROVED BY THE EXECUTIVE COMMITTEE AND RECORDED IN THE EXECUTIVE COMMITTEE MINUTES OR OTHER COMMITTEE DOCUMENTS. A REVIEW INCLUDING COMPENSATIONS REPORTS AND OPINIONS FROM RECRUITING CONSULTANTS OCCURED IN 2020. 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 OTHER CONSULTANTS AND CONTRACT LABOR: PROGRAM SERVICE EXPENSES 5,495,690. MANAGEMENT AND GENERAL EXPENSES 156,619. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 5,652,309.