BP MedTech Resources and Support Services

BP MedTech will support grantees by providing commercialization, verification, and validation resources. Resources anticipated to be provided by BP MedTech-funded incubator hubs are indicated by the “Hubs” label. All other resources will be provided through BP MedTech contracts.

Available resources are anticipated to include:

Design, Prototyping, and Risk Analysis

  • Electronics Manufacturing (Hubs)
  • Prototype Manufacturing (Hubs)
  • Design Optimization and Risk (Hubs)
  • Computational Modeling (Hubs)

Bench and Safety Testing

  • Electrical Safety (Hubs)
  • Electromagnetic Compatibility (Hubs)
  • MR Testing (Hubs)
  • Software (Hubs)
  • Cybersecurity (Hubs)
  • Shelf-life Testing (Hubs)

Biocompatibility and Animal Studies

Blueprint MedTech (BPMT) Biocompatibility, Sterilization, and Animal Studies RFP

BPMT plans to award a contract to a contract research organization(s) 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 and marketing approval by the US FDA.

  • Biocompatibility and Animal Studies Advising

  • Biocompatibility Testing
  • Materials characterization and analytical chemistry
  • Sterilization testing/validation
  • Preclinical Studies – Animal Testing (GLP)
  • Preclinical Studies – Animal Testing (non-GLP) (Hubs)
  • Cadaver Testing (Hubs)

Clinical Support

Research and Development for Clinical Studies in the Blueprint MedTech (BPMT) Initiative RFP

BPMT plans to award a contract to a contract research organization(s) 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. The contractor will be responsible for developing the study design and obtaining approval before starting the study. The contractor 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.

  • Clinical trials
  • Biostatistics
  • Data Management
  • Neuroethics (Hubs)

Business Development

  • External Oversight Committee
  • Public-Private Partnerships – CRA, MTA
  • Entrepreneurship (Hubs)
  • Business Development (Hubs)
  • Market / User Research (Hubs)
  • Commercialization (Hubs)

Regulatory, Compliance, and Quality System

CRO Support for Blueprint MedTech (BPMT) Regulatory Affairs Support/Related Services RFP

BPMT 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 US FDA, 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.

  • Regulatory Advising – Contract (75N95022D00020) with PPD

  • QMS – Quality Management System – setup and audits 
  • GMP – Good Manufacturing Practice – setup and audits
  • Compliance
  • Legal - Intellectual Property (Hubs)