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Tips & Tricks

Tips & Tricks: Regulatory Path

Create an outline of the regulatory plan that will enable marketing approval of your technology/product. Determine which FDA division is likely to have oversight for development and approval by visiting www.fda.gov as direct consultation with the appropriate FDA Division is an essential step to ensure the smoothest possible design and conduct of a development plan…

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Tips and Tricks: Defining Your Market

A “top-down” analysis is based on current technologies or products that address the medical need your technology/product is intended to address, and the market defined by their sales figures. The bottom-up analysis starts with identification and enumeration of the specific target patient population your technology/product will address.  What is the patient population and what are…

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TIPS AND TRICKS: Defining Your Competitive Landscape

The first step in defining your competitive landscape is to identify and define the technology’s current competition and how they fit into or define current standard of care (SoC). An important step in the process is to forecast how is the SoC landscape may shift during your technology/product development. Identify other technologies/products in development that…

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Tips & Tricks: Explaining Your Proposed Solution

Understand the population you are targeting and why.  It may be preferable to define a narrower niche for your entry to the market. Consider where your device/drug will be administered and by what means.  This choice will greatly influence the preclinical and clinical development needs and strategies. Most investors will want to see proof-of-concept (POC)…

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Tips & Tricks: Defining Your Need Statement

Contributed by Josh Tolkoff An unmet need is more than an incremental improvement and once it exists in the market – it makes a substantial change for the better. Talk with many stakeholders (patients, clinicians, hospital administrators, hospital purchasing agents, insurance providers, etc.) to better understand the need, and determine what kind of solutions would…

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Tips & Tricks:  Writing your B-BIC Proposal or Business Plan Overview

The best way to begin an overview is by presenting a clear picture of the problem that needs to be solved.  Aim to tell a narrative story about the specific problem that patients or clinicians are currently experiencing. Address a specific disease or healthcare management issue, and include key facts to show the potential market size. Define…

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FAQ: B-BIC APPLICATION PROCESS

  Who can apply for B-BIC grants? Anyone holding a faculty appointment at a B-BIC member institution may apply for a B-BIC grant. May I submit more than one application? Applicants may submit more than one proposal to both the Pilot and DRIVE programs.  However, each application must have a distinct set of aims and…

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Tips & Tricks: Customer Research Basics

The “build it and they will come” approach may have worked for Steven Jobs at Apple but does not work for most new products.  For us mere mortals, it is important to conduct customer research before proceeding too far with a new idea.  You want to know if there is a market for your product…

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Tips & Tricks: When Searching for Market Information

It is always important to know your competitors and how your product compares to theirs, but did you know competitors’ websites can also provide information on reimbursement and market size.  Companies often provide a reimbursement guide for their customers and a company’s annual report frequent has market size and market share data. When searching for…

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FAST PITCH FOR FUNDING: Quick Tips for a successful pitch

Keep pitch short and focused on the technology and its commercial application. Limit the discussion of preliminary results, and focus on the most relevant results with conclusions – not data. Present the science within the context of the business strategy. Keep details to a minimum and use visuals without words when possible. FAST PITCH FOR FUNDING is April 27th at 10:00am.…

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