E-mail Erik.Harris@MarketAccessSolved.com to Schedule a Meeting with
Erik Harris and/or Tess Wong
Erik Harris and/or Tess Wong
| Erik Harris' CV |
Erik Harris, MHA
CEO & Founder – Market Access and Reimbursement Strategy and Tactics
erik.harris@marketaccesssolved.com +1 615-779-4174
Over 30 years of expertise in strategic and tactical market access, health economics & reimbursement for the US and International markets to successfully drive the premium pricing opportunity, navigating value analysis committee/technology assessment processes, market adoption and uptake, and differential value messaging & positioning within competitive landscapes.
Specializing in confidential market access due diligence for venture capital, private equity, and corporate development M&A and investments activities, market access strategies and tactics, health economic value positioning, clinical trial evidence generation for commercialization, value dossiers, facility purchaser value analysis committees, health technology assessments, Medicare alternative payment pathways, pricing strategies, and commercial payer coverage landscape assessments.
Medical Device Experience: Moximed, Active Implants, Wright Medical Technology, BioMimetic Therapeutics, Zimmer (now ZimmerBiomet)
Provider Experience: Michigan Health & Hospital Association, Michigan Nurses Association
Payer Experience: Community Health Plan HMO
8400 The Health Network (Israel) - Volunteer CEO Mentor & Symposium Presenter
ZeroTo510 Medical Device Accelerator (U.S.) - Market Access & Reimbursement Presenter & CEO Mentor
CEO & Founder – Market Access and Reimbursement Strategy and Tactics
erik.harris@marketaccesssolved.com +1 615-779-4174
Over 30 years of expertise in strategic and tactical market access, health economics & reimbursement for the US and International markets to successfully drive the premium pricing opportunity, navigating value analysis committee/technology assessment processes, market adoption and uptake, and differential value messaging & positioning within competitive landscapes.
Specializing in confidential market access due diligence for venture capital, private equity, and corporate development M&A and investments activities, market access strategies and tactics, health economic value positioning, clinical trial evidence generation for commercialization, value dossiers, facility purchaser value analysis committees, health technology assessments, Medicare alternative payment pathways, pricing strategies, and commercial payer coverage landscape assessments.
Medical Device Experience: Moximed, Active Implants, Wright Medical Technology, BioMimetic Therapeutics, Zimmer (now ZimmerBiomet)
Provider Experience: Michigan Health & Hospital Association, Michigan Nurses Association
Payer Experience: Community Health Plan HMO
8400 The Health Network (Israel) - Volunteer CEO Mentor & Symposium Presenter
ZeroTo510 Medical Device Accelerator (U.S.) - Market Access & Reimbursement Presenter & CEO Mentor
Tess Wong, MSc
Principal Consultant – Market Access and Reimbursement Strategy and Tactics
Payer Strategy Development and Product Value Positioning
tess.wong@marketaccesssolved.com
Over 30 years of expertise in reimbursement, market access, health economic information, alternative payment programs, payer coverage strategy development, payer engagement, analysis and interpretation of health policy and guidelines, and health technology assessment evaluation. A strategic partner with the ability to identify, assess, and understand the many challenges to commercial adoption and navigating the complex reimbursement environment throughout a product’s lifecycle. Extensive experience in engaging the hospital C-suite, surgical suite leadership, labor and delivery leadership, IDN and GPO, outpatient facility management, physicians, and medical societies to ensure effective and successful communication of clinical and economic value messaging for product adoption.
Medical Device Experience: Medtronic, Zimmer, SI-Bone, Medicem, Barrx Medical, Conceptus, VNUS Medical Technologies, Vertus Neuroscience, Lumicell (biotechnology)
Consulting Experience: ADVI, MCRA
Payer Experience: Humana (denial grievances and appeals), Kemper National Services (worker’s compensation)
Principal Consultant – Market Access and Reimbursement Strategy and Tactics
Payer Strategy Development and Product Value Positioning
tess.wong@marketaccesssolved.com
Over 30 years of expertise in reimbursement, market access, health economic information, alternative payment programs, payer coverage strategy development, payer engagement, analysis and interpretation of health policy and guidelines, and health technology assessment evaluation. A strategic partner with the ability to identify, assess, and understand the many challenges to commercial adoption and navigating the complex reimbursement environment throughout a product’s lifecycle. Extensive experience in engaging the hospital C-suite, surgical suite leadership, labor and delivery leadership, IDN and GPO, outpatient facility management, physicians, and medical societies to ensure effective and successful communication of clinical and economic value messaging for product adoption.
Medical Device Experience: Medtronic, Zimmer, SI-Bone, Medicem, Barrx Medical, Conceptus, VNUS Medical Technologies, Vertus Neuroscience, Lumicell (biotechnology)
Consulting Experience: ADVI, MCRA
Payer Experience: Humana (denial grievances and appeals), Kemper National Services (worker’s compensation)
Ryan Belaney, M.S.
Consultant – Clinical, Regulatory, Quality
ryan.belaney@marketaccesssolved.com
Over 20 years of medical device leadership and expertise in regulatory, clinical, and quality in the US and OUS markets. Successful track record with clinical trial/study/registry design and implementation, US FDA regulatory pathways for medical device PMA approval, 510(k) and De Novo 510(k) clearance, FDA Breakthrough Designation, Software as a Medical Device (SaMD), OUS regulatory/registration/quality criteria, and corporate development. A biomedical engineering foundation brings a keen understanding and unique approach to successful clinical and regulatory strategies and tactics, and in due diligence for M&A and investments by venture capital, private equity and corporate development.
Medical Device Experience: Active Implants, RTI Surgical, AgNovos Healthcare, Wright Medical Technology, Osteotech
Orthopaedic Surgical Manufacturers Association (OSMA) - VP Board of Directors
ORTHOWORLD, Inc. - Advisory Board Member
ZeroTo510 Medical Device Accelerator (U.S.) - Regulatory & Clinical Presenter & CEO Mentor
Consultant – Clinical, Regulatory, Quality
ryan.belaney@marketaccesssolved.com
Over 20 years of medical device leadership and expertise in regulatory, clinical, and quality in the US and OUS markets. Successful track record with clinical trial/study/registry design and implementation, US FDA regulatory pathways for medical device PMA approval, 510(k) and De Novo 510(k) clearance, FDA Breakthrough Designation, Software as a Medical Device (SaMD), OUS regulatory/registration/quality criteria, and corporate development. A biomedical engineering foundation brings a keen understanding and unique approach to successful clinical and regulatory strategies and tactics, and in due diligence for M&A and investments by venture capital, private equity and corporate development.
Medical Device Experience: Active Implants, RTI Surgical, AgNovos Healthcare, Wright Medical Technology, Osteotech
Orthopaedic Surgical Manufacturers Association (OSMA) - VP Board of Directors
ORTHOWORLD, Inc. - Advisory Board Member
ZeroTo510 Medical Device Accelerator (U.S.) - Regulatory & Clinical Presenter & CEO Mentor
Dr. Lou, MD
Consultant – Payor Medical Director Insights
NOTE: email Erik Harris at erik.harris@marketaccesssolved.com for requests to schedule time with Dr. Lou, MD
“Dr. Lou” is a pseudonym due to his current role as a Medical Director for one of the largest national Payors in the US; all client engagements with Dr. Lou will be conducted under mutual non-disclosure agreement. Dr. Lou, has over 18 years of Payor Medical Director experience encompassing Commercial, Medicare, and Medicaid managed care medical policy, prior authorization/pre-certification, peer-to-peer reviews for medical necessity, and Payer coverage policy. Dr. Lou additionally has 18 years of clinical practice experience in Internal Medicine for one of the largest national health care systems in the US.
Dr. Lou's more than 35 years of Payor and Provider knowledge and expertise helps clients understand and navigate Payor medical necessity criteria, optimize messaging and communication of clinical outcomes, demonstrate and convey health economic value, leverage Peer-to-Peer processes to obtain authorization for patient access to prescribed treatment,
challenge Payor coverage determinations of experimental/investigational/not medically necessary, and processes for
effecting change to Payor coverage policies for novel and/or differentiated technologies and interventions.
Payor Experience: 18 years as a Medical Director for one of the largest national Payors in the US having conducted over 5,000 Peer-to-Peer reviews
Provider Experience: 18 years practicing Internal Medicine for one of the largest national health care systems in the US
Consultant – Payor Medical Director Insights
NOTE: email Erik Harris at erik.harris@marketaccesssolved.com for requests to schedule time with Dr. Lou, MD
“Dr. Lou” is a pseudonym due to his current role as a Medical Director for one of the largest national Payors in the US; all client engagements with Dr. Lou will be conducted under mutual non-disclosure agreement. Dr. Lou, has over 18 years of Payor Medical Director experience encompassing Commercial, Medicare, and Medicaid managed care medical policy, prior authorization/pre-certification, peer-to-peer reviews for medical necessity, and Payer coverage policy. Dr. Lou additionally has 18 years of clinical practice experience in Internal Medicine for one of the largest national health care systems in the US.
Dr. Lou's more than 35 years of Payor and Provider knowledge and expertise helps clients understand and navigate Payor medical necessity criteria, optimize messaging and communication of clinical outcomes, demonstrate and convey health economic value, leverage Peer-to-Peer processes to obtain authorization for patient access to prescribed treatment,
challenge Payor coverage determinations of experimental/investigational/not medically necessary, and processes for
effecting change to Payor coverage policies for novel and/or differentiated technologies and interventions.
Payor Experience: 18 years as a Medical Director for one of the largest national Payors in the US having conducted over 5,000 Peer-to-Peer reviews
Provider Experience: 18 years practicing Internal Medicine for one of the largest national health care systems in the US
Jeff Vandewinckel, BSME, MBA
Consultant – Manufacturing, Supply Chain
Over 30 years of global medical device experience and expertise in product and process development, engineering, manufacturing, supply chain, and operations management spanning optical devices, ear, nose and throat products, and orthopedic/sports medicine implants. Experienced in direct and contract manufacturing of instrument sets, disposable kits, devices, products and implants in compliance with specifications and rigorous quality control. Extensive knowledge in processes for cutting, molding and fastening, with a broad network of operations connections to raw material suppliers, manufacturers and distributors. A passion for operations excellence to ensure best manufacturing practices, by the most appropriate production technologies, and through qualified and certified manufacturers, to bring client products to market.
Medical Device Experience: Active Implants, Bausch & Lomb, Biocompatibles, CooperVision, Gyrus ACMI, Olympus
Consultant – Manufacturing, Supply Chain
Over 30 years of global medical device experience and expertise in product and process development, engineering, manufacturing, supply chain, and operations management spanning optical devices, ear, nose and throat products, and orthopedic/sports medicine implants. Experienced in direct and contract manufacturing of instrument sets, disposable kits, devices, products and implants in compliance with specifications and rigorous quality control. Extensive knowledge in processes for cutting, molding and fastening, with a broad network of operations connections to raw material suppliers, manufacturers and distributors. A passion for operations excellence to ensure best manufacturing practices, by the most appropriate production technologies, and through qualified and certified manufacturers, to bring client products to market.
Medical Device Experience: Active Implants, Bausch & Lomb, Biocompatibles, CooperVision, Gyrus ACMI, Olympus
Jamey Ramsey, MCS
Consultant – Clinical Trial Database Design and Administration, SAS/Oracle Data Analytics
jamey.ramsey@marketaccesssolved.com
Over 30 years of experience in the design, development and integration of clinical trial, clinical study, and registry databases spanning medical devices, pharmaceuticals, and academia. Specialized expertise in clinical data integration across global regions and multi-center trial sites. A skilled leader having global team management experience for clinical data process definition, vertical market applications, custom data plan development, web deployment and data integration using SAS, Oracle, MS SQL Server, and Visual Basic (VB) and Visual Basic for Applications (VBA) across multiple platforms to ensure compliance with Good Clinical Practice (GCP), ICH E6, and ISO 14155. Specialized expertise in statistical analysis and data report creation for Regulatory submissions, consort diagrams, preparation of data tables and graphical outputs for publications, marketing materials and Board/Investor presentations, and preparation of clinical outcomes data for use in
podium presentations by clinical trial physicians.
Medical Device Experience: Medtronic, Smith & Nephew, Active Implants
Academia Experience: St. Jude Children's Research Hospital
Clinical Trial Data Systems: Medrio, Oracle Clinical, DataFax, Amplitude Registry, OpenClinica, Inform
Programming Languages/Packages: SAS (certified), Oracle, VB/VBA, JavaScript
Software Administration: Microsoft Tenant, Clinical Data Management Systems, Adobe Forms/Scripting
Consultant – Clinical Trial Database Design and Administration, SAS/Oracle Data Analytics
jamey.ramsey@marketaccesssolved.com
Over 30 years of experience in the design, development and integration of clinical trial, clinical study, and registry databases spanning medical devices, pharmaceuticals, and academia. Specialized expertise in clinical data integration across global regions and multi-center trial sites. A skilled leader having global team management experience for clinical data process definition, vertical market applications, custom data plan development, web deployment and data integration using SAS, Oracle, MS SQL Server, and Visual Basic (VB) and Visual Basic for Applications (VBA) across multiple platforms to ensure compliance with Good Clinical Practice (GCP), ICH E6, and ISO 14155. Specialized expertise in statistical analysis and data report creation for Regulatory submissions, consort diagrams, preparation of data tables and graphical outputs for publications, marketing materials and Board/Investor presentations, and preparation of clinical outcomes data for use in
podium presentations by clinical trial physicians.
Medical Device Experience: Medtronic, Smith & Nephew, Active Implants
Academia Experience: St. Jude Children's Research Hospital
Clinical Trial Data Systems: Medrio, Oracle Clinical, DataFax, Amplitude Registry, OpenClinica, Inform
Programming Languages/Packages: SAS (certified), Oracle, VB/VBA, JavaScript
Software Administration: Microsoft Tenant, Clinical Data Management Systems, Adobe Forms/Scripting