BP MedTech will support grantees by providing commercialization, verification, and validation resources. Resources anticipated to be provided by BP MedTech-funded Incubator Hubs are listed first below. All other resources will be provided through the three awarded BP MedTech resource contracts.
Available Hubs resources are anticipated to include:
Design, Prototyping, and Risk Analysis
- Electronics Manufacturing
- Prototype Development
- Design Optimization and Risk
- Computational Modeling
Bench and Safety Testing
- Electrical Safety
- Electromagnetic Compatibility
- MR Testing
- Software
- Cybersecurity
- Shelf-life Testing
Biocompatibility and Animal Studies
- Preclinical Studies – Animal Testing (non-GLP)
- Cadaver Testing
Clinical Support
- Neuroethics
Business Development
- Entrepreneurship
- Business Development
- Market / User Research
- Commercialization
- External Oversight Committee
- Public-Private Partnerships – CRA, MTA
Regulatory, Compliance, and Quality System
Legal
- Intellectual Property consulting; includes drafting patent applications, patent prosecution (Office Action responses), freedom to operate analyses, patentability reports, and landscape analyses
Note: filing fees to the USPTO and WIPO/PCT are not allowable - Corporate structuring and governance; includes counsel on incorporation and strategic partnerships
- Licensing
Resource Contracts:
Biocompatibility and Animal Studies – Contract (75N95023D00022) with Actuated Medical, Inc.
Blueprint MedTech (BPMT) Biocompatibility, Sterilization, and Animal Studies RFP
BPMT has awarded a contract to Actuated Medical, Inc. to support and provide resources to participating BPMT grantees for completing biocompatibility studies, in vivo animal testing with capabilities for compliance with good laboratory practice (GLP) guidelines, and sterilization and shelf-life testing to support development of therapeutic and diagnostic neurological medical devices. This contractor will provide support for research protocol development, ensure in-house staff training, and conduct all testing necessary to support biocompatibility, sterilization, and animal safety studies, which will be used to inform regulatory filings for Investigational Device Exemptions (IDEs) and marketing approval by the US Food and Drug Administration.
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Biocompatibility and Animal Studies Advising
- Biocompatibility Testing to ISO10993 standards
- Materials characterization and analytical chemistry
- Sterilization testing/validation
- Preclinical Studies – Animal Testing (GLP)
Clinical Support – Contract (75N95023D00011) with PPD Development LP
Research and Development for Clinical Studies in the Blueprint MedTech (BPMT) Initiative RFP
BPMT has awarded a contract to PPD Development, a contract research organization, to support and provide resources to participating BPMT grantees for completing clinical feasibility studies of novel medical devices in the neurotechnology field. The clinical studies may include both feasibility and larger safety and efficacy assessments in patients affected by the condition being studied. BPMT anticipates running 5 to 15 clinical studies per year over the next 5 years. The scope of activities to be performed shall include the provision of a clinical research unit, the conduct of clinical studies, and the provision of a full range of services to support the clinical studies for investigational diagnostic and/or therapeutic neurological medical devices, safety monitoring, and reporting of the results to NIH. PPD will be responsible for developing the study design and obtaining approval before starting the study. PPD will also manage policies and regulations regarding human subjects protections, including, but not limited to, Institutional Review Board (IRB) approvals, informed patient consent, and applicable security and privacy standards in handling study data.
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CLINICAL SUPPORT ADVISING
- Clinical Trials
- Protocol development and study preparation
- Study implementation, including protocol implementation and oversight
- Regulatory and compliance documentation, including audit support
- Biostatistics
- Clinical study analysis, close-out, and final study reporting
- Data Management
- Database support (if applicable)
- Imaging support
- Investigational device management and specimen collection
Regulatory, Compliance, and Quality System – Contract (75N95022D00020) with PPD
CRO Support for Blueprint MedTech (BPMT) Regulatory Affairs Support/Related Services RFP
BPMT has awarded a contract to PPD, a contract research organization (CRO), to provide regulatory affairs services and resources to participating BPMT grantees in support of regulatory documentation and regulatory compliance for supporting medical device development projects from pre-clinical through clinical phases. This contractor will provide support for regulatory consulting advice, preparation and submission of regulatory documents including Q-submissions, Investigational Device Exemption (IDE), 510(k), De Novo, Pre-market Approval (PMA), Humanitarian Device Exemption (HDE), and post-approval studies, interaction with the US Food and Drug Administration, establishment of a Quality System, setup of a regulatory compliance program, and assistance with market/user research and commercialization strategy and with evaluating and obtaining reimbursement/payer coverage.
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Regulatory Advising
- QMS – Quality Management System – setup and audits
- GMP – Good Manufacturing Practice – setup and audits
- Compliance