2024-10-03T14:05:52-05:00 2023-12-31 410746749 CLIFTONLARSONALLEN LLP 220 S 6TH STREET SUITE 300 MINNEAPOLIS MN 55402 990 2023-01-01 461465348 THE MEDICAL DEVICE INNOVATION CONSORTIUM MEDI 2028681600 1655 FORT MYER DRIVE 12TH FLOOR ARLINGTON VA 22209 ANDREW FISH PRESIDENT AND CEO 2028681600 2024-10-01 1 0 ANN NEIL P01817922 6123764500 2024-10-01 2023 2024-10-15 13:58:12Z ANDREW FISH 1655 FORT MYER DRIVE 12TH FLOOR ARLINGTON VA 22209 14899712 0 X WWW.MDIC.ORG X 2012 MN BREAK DOWN BARRIERS IN THE MEDICAL TECHNOLOGY LIFE CYCLE TO ACCELERATE INNOVATION AND ADOPTION OF SAFE, EFFECTIVE AND HIGH-QUALITY MEDICAL TECHNOLOGIES. 22 22 53 23 0 0 10002314 9899161 1688525 4974275 -979930 26276 0 0 10710909 14899712 0 0 0 0 8138887 8422774 0 0 0 6108550 7217162 14247437 15639936 -3536528 -740224 11514040 11871420 8681418 9779022 2832622 2092398 BREAK DOWN BARRIERS IN THE MEDICAL TECHNOLOGY LIFE CYCLE TO ACCELERATE INNOVATION AND ADOPTION OF SAFE, EFFECTIVE AND HIGH-QUALITY MEDICAL TECHNOLOGIES. 0 0 5425684 0 457026 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. 4657661 0 4432918 SCIENCE AND TECHNOLOGY:SCIENCE AND TECHNOLOGY'S FOCUS INVOLVES DEVELOPING TOOLS AND METHODS TO ENHANCE EFFICIENCY (IN TERMS OF TIME AND RESOURCES), QUALITY, DESIGN, MANUFACTURING, AND A PREDICTABLE PATHWAY IN DATA COLLECTION AND EVIDENCE DEVELOPMENT. THE ORGANIZATION'S CLINICAL SCIENCE PROGRAM AIMS TO IMPROVE DIAGNOSTIC TESTING AND PRODUCT DEVELOPMENT BY SUPPORTING MANUFACTURERS IN OBTAINING CREDIBLE CLINICAL EVIDENCE PATIENT PREFERENCES AND FACILITATING FIRST-IN-WORLD PATIENT ACCESS TO SAFE AND EFFECTIVE NEW TECHNOLOGIES OF SIGNIFICANT HEALTH IMPORTANCE. 410223 0 0 HEALTH ECONOMICS AND PATIENT VALUE:MDIC'S VALUE-BASED HEALTHCARE PROJECTS ARE DEVELOPED TO IMPROVE THE INDUSTRY'S ABILITY TO REAL WORLD EVIDENCE AND 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 HEALTHCARE PROGRAMS. 537789 0 84331 537789 84331 11031357 1 1 0 0 0 0 0 0 0 0 1 0 0 1 1 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 28 0 1 53 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 KARA ONORATO 2028281600 1655 FORT MYER DR FL 12 ARLINGTON VA 22209 ANDREW FISH PRESIDENT & CEO 40.00 X 736875 0 75623 SIMON MASON PRESIDENT, NESTCC 40.00 X 337863 0 40406 JOSEPH SAPIENTE SVP, SCIENCE & TECH 40.00 X 281520 0 49989 RICHARD SMITH SVP, NESTCC 40.00 X 267000 0 48518 LENWOOD FAULCON GENERAL COUNSEL 40.00 X 270374 0 47195 KARA ONORATO CFO 40.00 X 264891 0 46525 TODD WEST VP DEV & MEMBERSHIP 40.00 X 252000 0 46530 HARRY KOTLARZ VP HEPV 40.00 X 228063 0 26075 JITHESH VELICHAMTHOTU VEETIL SR PROG DIR DIGITAL HEALTH & TECH 40.00 X 212259 0 25843 PAUL SUMNER PROG DIR FOR CASE FOR QUALITY 40.00 X 209000 0 35097 LATARA HENRY VP HUMAN RESOURCES 40.00 X 211164 0 37117 MARYELLEN CULOTTA PROG DIR CLINICAL DIAGNOSTICS 40.00 X 187082 0 14480 KEERTHI GUNASEKARAN PROG DIR SCIENCE OF PATIENT INPUT 40.00 X 187000 0 16676 EILEEN MIHAS PROG DIR EFS 40.00 X 187000 0 42992 AMI SIMUNOVICH DIRECTOR 1.00 X 0 0 0 ANDREW CLEELAND DIRECTOR 1.00 X 0 0 0 CHIP HANCE DIRECTOR 2.00 X 0 0 0 ESTHER KROFAH DIRECTOR 1.00 X 0 0 0 GARY JOHNSON DIRECTOR 1.00 X 0 0 0 JEFFREY SHUREN DIRECTOR 1.00 X 0 0 0 JIJO JAMES DIRECTOR 1.00 X 0 0 0 JIM HOLLINGSHEAD DIRECTOR 1.00 X 0 0 0 JODY POWELL DIRECTOR 1.00 X 0 0 0 KENNETH STEIN DIRECTOR 1.00 X 0 0 0 KEVIN SAYER DIRECTOR 1.00 X 0 0 0 KRIS KANDARPA DIRECTOR 1.00 X 0 0 0 LAURA MAURI DIRECTOR 1.00 X 0 0 0 LUCILE BLAISE DIRECTOR 1.00 X 0 0 0 NADIM YARED 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 RANDY RUTTA DIRECTOR 1.00 X 0 0 0 RICK GEOFFRION DIRECTOR 1.00 X 0 0 0 STEVE FERGUSON DIRECTOR 1.00 X 0 0 0 TAMARA SYREK JENSEN DIRECTOR 1.00 X 0 0 0 WES CETNAROWSKI DIRECTOR 1.00 X 0 0 0 3832091 0 553066 14 0 1 0 KLEIN HERSCH 220 GIBRALTAR RD SUITE 150 HORSHAM PA 19044 RECRUITMENT SERVICES 259555 MINTZ LEVIN COHN FERRIS ONE FINANCIAL CENTER BOSTON MA 02111 PROFESSIONAL & LEGAL CONSULTING 177234 2 2988750 5741411 1169000 9899161 PERFORMANCE CONTRACT 541900 4763616 4763616 MDIC MEETINGS 541900 109633 109633 PRODUCT DEVELOPMENT 541900 101026 101026 4974275 26276 26276 14899712 4974275 0 26276 3267729 2219238 1048491 3931126 2284175 1646951 259538 140345 119193 498387 304938 193449 465994 311248 154746 185258 185258 42181 42181 1308032 1119936 188096 97751 47491 50260 101574 26219 75355 415452 182135 233317 619342 455051 164291 194182 129831 64351 581492 200165 381327 PROJECT EXPENSES 3149548 3149548 RECRUITMENT COST 280601 275779 4822 FACILITIES AND EQUIPMEN 211165 211165 30584 30584 15639936 11031357 4608579 0 300127 300127 2012421 3316745 1753356 1333651 20019 0 167832 262036 1914953 271331 1839002 1643622 5421283 5015239 11514040 11871420 1342562 2422481 5000 7338856 7351541 8681418 9779022 X -276592 -829611 3109214 2922009 2832622 2092398 11514040 11871420 -740224 0 X X 0 1 X 1 1 1 X 7482503 21429766 16657002 10002314 9899161 65470746 4071 1741 235825 1688525 4974275 6904437 7486574 21431507 16892827 11690839 14873436 72375183 500000 895833 534750 1700000 700000 4330583 132418 132418 500000 895833 534750 1832418 700000 4463001 67912182 48746 9542 14543 12404 26276 111511 48746 9542 14543 12404 26276 111511 31540 6721 786 39047 7566860 21447770 16908156 11703243 14899712 72525741 0.93640 0.91540 0.00150 0.00200 X SCHEDULE A, PART III, LINE 12, EXPLANATION OF OTHER INCOME: MISCELLANEOUS REVENUE RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED 1730192 229539 1500653 184761 41792 142969 1643622 ROU ASSET 5015239 5015239 ROU ASSET LEASE LIABILITY 7332455 CC-FVC BANK 19086 7351541 X 14899712 0 14899712 0 14899712 15639936 0 15639936 0 15639936 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, 2023 AND 2022, 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 ORGANIZATION. 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. 1 X 0 0 0 0 0 0 0 0 0 ANDREW FISH PRESIDENT & CEO 650000 0 86875 0 0 0 44694 0 30929 0 812498 0 0 0 SIMON MASON PRESIDENT, NESTCC 337500 0 0 0 363 0 22875 0 17531 0 378269 0 0 0 JOSEPH SAPIENTE SVP, SCIENCE & TECH 246330 0 35190 0 0 0 19706 0 30283 0 331509 0 0 0 RICHARD SMITH SVP, NESTCC 240000 0 27000 0 0 0 17355 0 31163 0 315518 0 0 0 LENWOOD FAULCON GENERAL COUNSEL 240000 0 30374 0 0 0 16222 0 30973 0 317569 0 0 0 KARA ONORATO CFO 234281 0 30600 0 10 0 15893 0 30632 0 311416 0 0 0 TODD WEST VP DEV & MEMBERSHIP 220500 0 31500 0 0 0 17640 0 28890 0 298530 0 0 0 HARRY KOTLARZ VP HEPV 208563 0 19500 0 0 0 15131 0 10944 0 254138 0 0 0 JITHESH VELICHAMTHOTU VEETIL SR PROG DIR DIGITAL HEALTH & TECH 202134 0 10125 0 0 0 14453 0 11390 0 238102 0 0 0 PAUL SUMNER PROG DIR FOR CASE FOR QUALITY 199500 0 9500 0 0 0 14630 0 20467 0 244097 0 0 0 LATARA HENRY VP HUMAN RESOURCES 196000 0 15129 0 35 0 14779 0 22338 0 248281 0 0 0 MARYELLEN CULOTTA PROG DIR CLINICAL DIAGNOSTICS 178500 0 8500 0 82 0 12750 0 1730 0 201562 0 0 0 KEERTHI GUNASEKARAN PROG DIR SCIENCE OF PATIENT INPUT 178500 0 8500 0 0 0 5610 0 11066 0 203676 0 0 0 EILEEN MIHAS PROG DIR EFS 178500 0 8500 0 0 0 12619 0 30373 0 229992 0 0 0 FORM 990, PART VI, SECTION A, LINE 1A 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. THE EXECUTIVE COMMITTEE MAY ELECT AND REMOVE MEMBERS OF ANY OF THE COMMITTEES, EXCEPT THAT THE EXECUTIVE COMMITTEE SHALL NOT SELECT AND REMOVE MEMBERS OF THE EXECUTIVE COMMITTEE. 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 MEMBER ORGANIZATIONS WITH NO VOTING RIGHTS. FORM 990, PART VI, SECTION B, LINE 11B FINANCE DEPARTMENT INITIATES THE PROCESS OF THE 990, WITH THE LEGAL DEPARTMENT AND THE FINANCE COMMITTEE PROVIDING REVIEW BEFORE REPORTING TO THE FULL BOARD. 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 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 COMPENSATION REPORTS AND OPINIONS FROM RECRUITING CONSULTANTS, OCCURRED IN 2023. 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 IV LINE 2C THIS PROCESS HAS NOT CHANGED