2019-11-15T11:59:28-06:00 2018-12-31 410746749 CLIFTONLARSONALLEN LLP 220 SOUTH SIXTH STREET SUITE 300 MINNEAPOLIS MN 55402 990 2018-01-01 461465348 MEDICAL DEVICE INNOVATION CONSORTIUM MEDI 2028681600 1501 WILSON BOULEVARD NO 910 ARLINGTON VA 22209 PAMELA W GOLDBERG PRESIDENT AND CEO 2028681600 2019-11-14 1 JOHN TAUER P00294068 6123764500 67.137.57.251 2019-11-14 11:27:16 CS P E168BB59A4AC1B98DF6FDFCBC72C1446FCA85D8B 14B4624D99AA7844762AEF943CCCB1636A2EBA62 2018 2020-03-31 21:24:44Z PAMELA W GOLDBERG 1501 WILSON BOULEVARD NO 910 ARLINGTON VA 22209 6896963 0 X WWW.MDIC.ORG X 2012 MN A PUBLIC-PRIVATE PARTNERSHIP WITH THE OBJECTIVE OF ADVANCING MEDICAL DEVICE REGULATORY SCIENCE. 25 22 21 25 0 2201 4713194 6835051 22238 14696 355 1256 70355 45960 4806142 6896963 0 0 0 0 1642753 2003679 0 0 0 2902151 3250887 4544904 5254566 261238 1642397 2747853 3743346 1228660 581756 1519193 3161590 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 2393233 0 11445 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. 794298 0 152 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. 713024 0 2643 CLINICAL SCIENCE: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. 186616 0 456 DATA SCIENCE AND TECHNOLOGY:MDIC'S DATA SCIENCE AND TECHNOLOGY EFFORTS INCLUDE THE ORGANIZATION'S ABILITY TO DEVELOP AND LEVERAGE NEW METHODS TO ENHANCE THE QUALITY IN WHICH DEVICES ARE CREATED AND MEASUREMENTS BY WHICH DEVICES ARE EVALUATED. THIS INCLUDES REMOVING BARRIERS TO INCREASING USE OF REGULATORY-GRADE DATA METHODS, TOOLS, AND ANALYTICS TO ADVANCE MEDICAL DEVICE DEVELOPMENT. MDIC'S DEVELOPMENT OF A FRAMEWORK FOR SURROGATE SAMPLE USE IN THE REGULATORY PROCESS FOR CLINICAL DIAGNOSTICS ADDS TO THE ORGANIZATION'S SUCCESS IN SUPPORTING MORE PREDICTABLE PATHS. TAKING INTO ACCOUNT BOTH THE VALUE AND THE CHALLENGES THAT TECHNOLOGY BRINGS, MDIC IS COLLABORATING WITH STAKEHOLDERS TO COMBAT CYBERSECURITY THROUGH THE DEVELOPMENT OF METHODS THAT WILL SUPPORT SAFETY AND EFFECTIVENESS OF THE COMPLETE MEDICAL DEVICE LIFECYCLE. 186616 0 456 4087171 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 29 0 21 1 1 1 0 0 0 0 0 0 0 0 0 0 0 X 25 22 0 0 0 0 1 0 0 1 1 0 0 1 1 1 1 1 1 1 1 0 MN VA X CLIFTON LARSONALLEN 6123764800 220 SOUTH SIXTH STREET SUITE 300 MINNEAPOLIS MN 55402 PAMELA GOLDBERG PRESIDENT AND CEO 40.00 X X 252004 0 20003 WILLIAM V MURRAY PRESIDENT AND CEO 40.00 X X 120487 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 PETER ARDUINI DIRECTOR 1.00 X 0 0 0 MARK CARLSON 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 BILL HAWKINS III DIRECTOR 1.00 X 0 0 0 ROSS JAFFE 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 KRISHNA KANDARPA DIRECTOR 1.00 X 0 0 0 RICHARD KUNTZ DIRECTOR 1.00 X 0 0 0 CAROLL NEUBAUER DIRECTOR 1.00 X 0 0 0 BRYAN OLIN DIRECTOR 2.00 X 0 0 0 LINDA PETERS DIRECTOR 1.00 X 0 0 0 PETER SALTONSTALL DIRECTOR 1.00 X 0 0 0 JOE SELBY DIRECTOR 1.00 X 0 0 0 RANDALL SHIESTL DIRECTOR 1.00 X 0 0 0 JEFFREY SHUREN DIRECTOR 1.00 X 0 0 0 BETH STAUB DIRECTOR 1.00 X 0 0 0 NADIM YARED DIRECTOR 1.00 X 0 0 0 TANISHA CARINO DIRECTOR 1.00 X 0 0 0 DANA MCMAHON DIRECTOR 1.00 X 0 0 0 SHACEY PETROVIC DIRECTOR 1.00 X 0 0 0 RACHAEL FLEURENCE NESTCC EXECUTIVE DIRECTOR 40.00 X 316284 0 13150 DANIELLE DUFFY PROGRAM DIRECTOR 40.00 X 132854 0 10799 RACHEL RATH CHIEF OF STAFF 40.00 X 109043 0 9615 CAROLYN HILLER PROGRAM DIRECTOR 40.00 X 107800 0 26467 1038472 0 80034 6 0 1 0 HOGAN LOVELLS US LLP 1000 INTERNATIONAL DRIVE SUITE 2000 BALTIMORE MD 21202 LEGAL SERVICES 359860 LISA GRIFFIN VINCENT 730 STINSON BLVD UNIT 108 MINNEAPOLIS MN 55413 CONSULTING SERVICES 301562 DELOITTE CONSULTING LLP 1919 N LYNN ST ARLINGTON VA 22209 CONSULTING SERVICES 293489 BESTBIO CONSULTING INC 11010 HARBOR HILL DRIVE NW STE B5 GIG HARBOR WA 98332 CONSULTING SERVICES 241912 DAN SCHWARTZ 5901 WOODDALE AVENUE EDINA MN 55424 CONSULTING SERVICES 187500 7 3010597 3097454 727000 6835051 PROGRAM REVENUE 541900 14696 14696 14696 1256 1256 43140 0 43140 43140 43140 MISCELLANEOUS REVENUE 900099 2820 2820 2820 6896963 14696 0 47216 X 721927 637687 84240 1052932 714805 338127 40693 40328 365 70204 56028 14176 117923 96128 21795 501706 413353 88353 137756 42490 95266 1735948 1493872 242076 26855 13380 13475 51185 27797 23388 88104 16121 71983 237895 186448 51447 232731 173335 59396 158129 138992 19137 38208 38208 PROJECT EXPENSES 36374 36374 5996 33 5963 5254566 4087171 1167395 0 2016550 2109788 555580 1331389 74856 56151 251014 46524 59339 204490 41528 41528 2747853 3743346 432646 465658 796014 116098 1228660 581756 X 1469193 2583664 50000 577926 1519193 3161590 2747853 3743346 1642397 0 X 0 1 X 1 1 1 X 1072186 1289806 2332677 4713194 6835051 16242914 420538 694116 303956 22238 14696 1455544 1492724 1983922 2636633 4735432 6849747 17698458 300000 358333 575000 775000 1654167 3662500 0 300000 358333 575000 775000 1654167 3662500 14035958 21813 44396 66209 21813 44396 66209 31 183 48897 2820 51931 1492755 1983922 2636816 4806142 6896963 17816598 0.78780 0.56720 0.00370 0.00190 X SCHEDULE A, PART III, LINE 12, EXPLANATION OF OTHER INCOME: MISCELLANEOUS REVENUE RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED 149213 9670 139543 101801 36854 64947 204490 X 6896963 0 6896963 0 6896963 5254566 0 5254566 0 5254566 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 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 DURING THE YEAR ENDED DECEMBER 31, 2018, THE ACCOMPANYING FINANCIAL STATEMENTS DO NOT INCLUDE ANY PROVISION FOR FEDERAL OR STATE 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. X X 0 0 0 0 0 0 0 0 0 PAMELA GOLDBERG PRESIDENT AND CEO 252004 0 0 0 0 0 9500 0 10503 0 272007 0 0 0 RACHAEL FLEURENCE NESTCC EXECUTIVE DIRECTOR 316284 0 0 0 0 0 11800 0 1350 0 329434 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 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 2018. 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 2018. 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 1,493,872. MANAGEMENT AND GENERAL EXPENSES 242,076. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 1,735,948.