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Specialist Series

Specialist Series: The Regulatory Path

Contributed by John Randle, Phd B-BIC COACH PRINCIPAL, RANDOM WALK VENTURES, LLC COO, KANTUM BIO   Most new technologies and products will require regulatory scrutiny and approval prior to marketing.  These requirements vary widely depending on the nature of the technology/product and their intended medical use, as well as the regulatory precedent set by existing…

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Specialist Series: Defining Your Market 

Contributed by John Randle, Phd B-BIC COACH PRINCIPAL, RANDOM WALK VENTURES, LLC COO, KANTUM BIO As you prepare to move your technology or product out of the academic setting towards commercial development, a key step is to define the market potential for your technology/product.  Prospective investors will assess the opportunity in terms of the potential…

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Specialist Series: Defining Your Competitive Landscape

Contributed by John Randle, Phd B-BIC COACH PRINCIPAL, RANDOM WALK VENTURES, LLC COO, KANTUM BIO 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).  List the products or substitutes that you would aim to replace…

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Specialist Series: Filling the Unmet Need – Your Proposed Solution

Contributed by Ron Blackman In our previous newsletter, we described how to identify the unmet need that will be served by your device or therapeutic, and here we will help you build the case that you have a solution to meet that need.  A number of points should be addressed and we will go through…

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Specialist Series: Finding and Defining Your Unmet Need

Contributed by Josh Tolkoff The most common reason for the commercial failure of a start-up entity is not having a compelling clinical need.  What exactly is an “unmet need”?  An unmet need is something more than an incremental improvement, and once it exists in the market it will make a substantial change for the better.…

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Specialist Series: How to build an effective overview of your technology.

Contributed by Erin McKenna, B-BIC Deputy Director After the dip in investment in early-stage biotechnology in 2008, the number of funding opportunities for early-stage technologies has been increasing in recent years. Despite this promising trend, finding and securing the funding necessary to move your research out of the lab and towards commercialization is still a…

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Specialist Series: Reimbursement

If reimbursement is so important … why do so many companies address it so half-heartedly and so late? Edward E. Berger, Ph.D. Everyone knows how important reimbursement analysis and planning is to the success of innovative medical technology and life science products.  Ask any venture capitalist, private equity investor, strategic marketing analyst, or C-level executive;…

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Bringing the Immunity-to-Change™ process to the scientific community

Community member post by Erica Lawlor and Cheryl Vaughan How can scientists whose careers were formed in an incentive system that cultivates competitive and territorial behaviors be helped to meet the expectations of collaborative research frameworks? A team-based approach that transcends disciplinary boundaries may be a tall order for scientists who “grew up” in a…

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Specialist Series: Your Elevator Pitch: Don’t leave home without it!

Written by Melissa Marshall Have you ever walked away from a conversation about your work with an important individual and thought, “Darn. I wish I would have explained that better or said it this way instead…”? Or maybe you had an unexpected interaction with someone who asked about your work and you just started rambling…

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Specialist Series: Patents

What is a U.S. patent? A patent is a property right. The property right granted is an exclusionary right, i.e., the right to exclude others from making, using, offering for sale, or selling an invention. In the US, generally this exclusionary right lasts for 20 years from the date of the initial filing of an…

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