2022-11-14T13:33:47-06:00 2021-12-31 410746749 CLIFTONLARSONALLEN LLP 220 S 6TH STREET SUITE 300 MINNEAPOLIS MN 55402 990 2021-01-01 461465348 THE MEDICAL DEVICE INNOVATION CONSORTIUM MEDI 2028681600 1655 N FT MYER DRIVE 12TH FLOOR ARLINGTON VA 22209 ANDREW FISH PRESIDENT AND CEO 2028681600 2022-11-10 1 ANDREW FISH 999009999 JOHN TAUER P00294068 6123764500 2022-11-10 3 AAL1 IAL1 2021 2022-09-23 18:48:47Z X ANDREW FISH 1655 N FT MYER DRIVE 12TH FLOOR ARLINGTON VA 22209 16908156 0 X WWW.MDIC.ORG X 2012 MN A PUBLIC-PRIVATE PARTNERSHIP WITH THE OBJECTIVE OF ADVANCING MEDICAL DEVICE REGULATORY SCIENCE. 25 25 59 27 0 0 21429766 16657002 1741 235825 6339 14543 9924 786 21447770 16908156 0 0 0 0 4956541 6941424 0 0 0 14644332 8489036 19600873 15430460 1846897 1477696 6445785 8765414 1554331 2396264 4891454 6369150 X FASTER, SAFER, AND MORE COST-EFFECTIVE INNOVATION FOR PATIENT BENEFIT. MDIC'S MISSION IS TO LEVERAGE ITS UNIQUE POSITION AS THE ONLY PUBLIC-PRIVATE PARTNERSHIP OF ITS KIND TO TRANSFORM HEALTH CARE INTO HUMAN CARE. COLLABORATING WITH OUR PARTNERS TO ADVANCE SCIENCE, WE ENABLE TRANSFORMATIONAL MEDICAL TECHNOLOGY TO SHAPE THE WORLD WE WANT TO LIVE IN AND MAKE THAT WORLD POSSIBLE BY SHORTENING THE PATH FROM INNOVATION TO SAFETY TO ACCESS. 0 0 9761269 0 223350 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. 2853329 0 12475 CLINICAL SCIENCE AND 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. 577649 0 0 HEALTH ECONOMICS AND PATIENT VALUE: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. 13192247 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 1 59 1 0 0 0 0 0 0 0 0 0 0 0 0 X 25 25 0 0 0 0 1 0 0 1 1 0 0 1 1 1 1 1 1 0 1 0 MN X KARA ONORATO 2028681600 1655 N FT MYER DRIVE 12TH FLOOR ARLINGTON VA 22209 PAMELA GOLDBERG PRESIDENT AND CEO 40.00 X X 477606 0 41770 FLORA SIAMI SENIOR VICE PRESIDENT, NESTCC 40.00 X 348968 0 30861 JON HUNT VP, CLINICAL SCIENCE & TEC 40.00 X 335392 0 35668 JO CAROL HIATT VICE PRESIDENT, HEPV 40.00 X 234578 0 8046 DOUGLAS KURSCHINSKI DIRECTOR OF OPERATIONS, NESTCC 40.00 X 206057 0 34464 LENWOOD FAULCON GENERAL COUNSEL & CORPORATE SECRETARY 40.00 X 202797 0 36538 JOSEPH SAPIENTE VICE PRESIDENT OF CLINICAL SCIENCE AND TECHNOLOGY 40.00 X 181235 0 28934 JITHESH VELICHAMTHOTU VEETIL SENIOR DIRECTOR, DIGITAL HEALTH AND TECHNOLOGY 40.00 X 174174 0 14760 CAROL ALLIS COUNSEL, NESTCC 40.00 X 169089 0 16371 RICHARD SMITH DIRECTOR OF BUSINESS DEVEL. & PARTNERSHIP, NESTCC 40.00 X 160556 0 12658 JIJO JAMES BOARD CHAIR 2.00 X X 0 0 0 NADIM YARED BOARD CHAIR 2.00 X 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 JIM HOLLINGSHEAD 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 KRISHNA KANDARPA DIRECTOR 1.00 X 0 0 0 SAMRAT 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 MICHAEL MINOGUE 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 RANDY RUTTA DIRECTOR 1.00 X 0 0 0 PETER SALTONSTALL DIRECTOR 1.00 X 0 0 0 KEVIN SAYER 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 2490452 0 260070 17 0 1 0 PANDERA SYSTEMS 30 W COLONIAL DRIVE ORLANDO FL 32801 BUILDING CLOUD INFRASTRUCTURE 637312 CLIFTONLARSONALLEN LLP 220 S 6TH ST SUITE 300 MINNEAPOLIS MN 55402 ACCOUNTING SERVICES 229167 2 3105000 11412906 2139096 16657002 PRODUCT DEVELOPMENT 541900 149650 149650 FEASIBILITY STUDY 541900 73700 73700 CFQ FORUM 541900 12475 12475 235825 14543 14543 MISCELLANEOUS REVENUE 900099 786 786 786 16908156 235825 0 15329 X 1698535 1411917 286618 4194615 3347831 846784 234020 203497 30523 407438 301213 106225 406816 322249 84567 101643 52202 49441 31394 15697 15697 4555508 4279414 276094 70708 42776 27932 78693 22949 55744 287194 167735 119459 487666 359866 127800 6917 5506 1411 126221 62749 63472 PROJECT EXPENSES 2493905 2493905 RECRUITMENT COST 117139 82194 34945 FACILITIES AND EQUIPMEN 106453 18954 87499 MISCELLANEOUS EXPENSES 25595 1593 24002 15430460 13192247 2238213 0 4564523 7019694 1545190 457593 54000 104250 128794 813272 607212 278135 111750 329077 41528 41528 6445785 8765414 1196152 1869827 77432 526437 280747 0 1554331 2396264 X 4511454 3967638 380000 2401512 4891454 6369150 6445785 8765414 1477696 0 X 0 1 X 1 1 1 X 4713194 6835051 7482503 21429766 16657002 57117516 22238 14696 4071 1741 235825 278571 4735432 6849747 7486574 21431507 16892827 57396087 775000 1654167 500000 895833 534750 4359750 0 775000 1654167 500000 895833 534750 4359750 53036337 21813 44396 48746 9542 14543 139040 21813 44396 48746 9542 14543 139040 48897 2820 31540 6721 786 90764 4806142 6896963 7566860 21447770 16908156 57625891 0.92040 0.89360 0.00240 0.00290 X SCHEDULE A, PART III, LINE 12, EXPLANATION OF OTHER INCOME: MISCELLANEOUS REVENUE RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED 417756 132196 285560 189456 145939 43517 329077 X 16908156 0 16908156 0 16908156 15430460 0 15430460 0 15430460 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, 2021 AND 2020, 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. X 0 1 X 1 0 0 0 0 0 0 0 0 PAMELA GOLDBERG PRESIDENT AND CEO 392606 0 85000 0 0 0 28416 0 13354 0 519376 0 0 0 FLORA SIAMI SENIOR VICE PRESIDENT, NESTCC 302618 0 46350 0 0 0 10673 0 20188 0 379829 0 0 0 JON HUNT VP, CLINICAL SCIENCE & TEC 302260 0 33132 0 0 0 12828 0 22840 0 371060 0 0 0 JO CAROL HIATT VICE PRESIDENT, HEPV 225578 0 9000 0 0 0 7033 0 1013 0 242624 0 0 0 DOUGLAS KURSCHINSKI DIRECTOR OF OPERATIONS, NESTCC 206057 0 0 0 0 0 13313 0 21151 0 240521 0 0 0 LENWOOD FAULCON GENERAL COUNSEL & CORPORATE SECRETAR 187369 0 15428 0 0 0 14396 0 22142 0 239335 0 0 0 JOSEPH SAPIENTE VICE PRESIDENT OF CLINICAL SCIENCE A 181235 0 0 0 0 0 5550 0 23384 0 210169 0 0 0 JITHESH VELICHAMTHOTU VEETIL SENIOR DIRECTOR, DIGITAL HEALTH AND 165882 0 8292 0 0 0 12202 0 2558 0 188934 0 0 0 CAROL ALLIS COUNSEL, NESTCC 161184 0 7905 0 0 0 5191 0 11180 0 185460 0 0 0 RICHARD SMITH DIRECTOR OF BUSINESS DEVEL. & PARTNE 160556 0 0 0 0 0 10413 0 2245 0 173214 0 0 0 PART I, LINE 1A PAMELA GOLDBERG RECEIVED A TAXABLE HOUSING ALLOWANCE OF $36,000. PART I, LINE 1B THERE IS NO WRITTEN POLICY FOLLOWED BUT THERE IS BOARD APPROVAL OF THE HOUSING ALLOWANCE. PART I, LINE 4A JON HUNT RECEIVED A SEVERANCE PAYMENT OF $138,351. 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 TO 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 15B 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 2021. 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 CONSULTING AND CONTRACT LABOR: PROGRAM SERVICE EXPENSES 4,267,540. MANAGEMENT AND GENERAL EXPENSES 267,582. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 4,535,122. PAYROLL FEES: PROGRAM SERVICE EXPENSES 11,874. MANAGEMENT AND GENERAL EXPENSES 8,512. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 20,386.