Brooks Medtech, LLC is uniquely positioned to help tackle the most critical steps of technology commercialization.
REGULATORY STRATEGY
We will determine the US regulatory pathway, relevant FDA guidances, and similar devices that are currently marketed to provide a roadmap for FDA approval or clearance.
FDA REGULATORY SUBMISSIONS
Brooks Medtech reviews regulatory documents and FDA feedback, drafts FDA submissions, including pre-Submissions, 510(k)s, 510(k) de novo and IDE applications. We facilitate FDA meetings and provide embedded regulatory support.
MARKET ANALYSIS
We perform a full product and market analysis with market sizing, voice of business, voice of customer, and voice of market. Combining primary research with published literature and publicly available utilization data, we provide in-depth analysis on potential use cases and markets.
MARKET ENTRY STRATEGY
Articulation of a product’s value proposition is critical and necessary to consider which possible use cases to pursue. Each has a distinct market size, value, regulatory and evidentiary development requirements. Clinical trials designed to gain adoption and regulatory approval may vary. By understanding evidence thresholds and market size, we assist in developing and implementing the most strategically efficient market entry strategy.
PRODUCT MESSAGING
Identifying the problems and pain points solved by a product or service and articulating this value proposition is critical in gaining market adoption. By demonstrating this value with quantitative data through modeling, clinical trials and health economic studies, we accelerate market adoption.
EVIDENCE DEVELOPMENT
We provide a roadmap of bench, animal and clinical testing required for regulatory approval and market adoption, as well as study designs and testing protocols.
CLINICAL TRIAL DESIGN
Brooks Medtech understands the process of evidence development that speaks to physicians, regulatory bodies, purchasers and payers. Proper clinical trial design streamlines the approval and market adoption process. An integrated approach to design, incorporating scientific and economic endpoints, enables efficient resource utilization to garner the most impact for each stage of product development. Brooks Medtech designs clinical trials for first-in-human, feasibility, pivotal and post-market studies.
REIMBURSEMENT STRATEGY
Understanding how a product will be reimbursed, either directly or by providing a value or efficiency, is critical to product development. We will develop a reimbursement strategy and optimal plans to obtain payment.
MEDICAL DUE DILIGENCE
We provide a 360° evaluation of a technology for the purposes of company evaluation for funding or investment. Assessment includes the scientific and medical merit, industry and market analysis, intellectual property, regulatory and reimbursement potential, as well as projected financials.
CHIEF MEDICAL OFFICER SERVICES
Brooks Medtech provides the duties of a Chief Medical Officer, including all of the above listed services, as well as medical and clinical decision making and guidance. The arrangement can be ad hoc, or embedded as a partial or full-time employee.
LITERATURE REVIEW & MEDICAL WRITING
We perform scientific and medical research, incorporating data for internal use or medical publishing as a white paper or published article.