Speeding Towards Commercialization Gra 121808 Final

Speeding towards Commercialization

Commercialization Services: The difference between a great idea and a commercial success ,[object Object],[object Object],[object Object],[object Object]

Secure BioMed Evaluations ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Secure BioMed Evaluations ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Lassiter & Associates ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Lassiter & Associates ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Building a Strong Foundation… Solid Technology Strong Market Demand Seasoned Management Team Risk Assessment / FMEA Manufacturing Process Regulatory Requirements Involvement of Thought Leaders Reimbursement Potential Quality Control Unmet Need Protected IP Adequate Funding Investment Potential Synergistic Technology? Successful Medical Device Company

How We Can Help! Solid Technology Strong Market Demand Seasoned Management Team Risk Assessment / FMEA Manufacturing Process Regulatory Requirements Involvement of Thought Leaders Reimbursement Potential Quality Control Unmet Need Protected IP Adequate Funding Investment Potential Synergistic Technology?

Timeline to Commercialization: Step 1 – Finding Money Market Validation + Regulatory Pathway Analysis + Manufacturing + Reimbursement 12 to 24 months 4 months Average Time for Part Time Efforts by Inventors & Staff SBME / Lassiter Team Lost Time in Commercialization The most important aspect of a successful medical device company is getting to market quickly!

How do we help? ,[object Object],[object Object],[object Object],[object Object],[object Object]

Our package of feasibility services ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

How we can Help: Regulatory Support ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Proof of concept and identification of potential regulatory hurdles

How we can Help: Manufacturing Analysis ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Game plan for process safety and validation are mandatory for an FDA approved process

How we can help: Reimbursement Support ,[object Object],[object Object],[object Object],Allows you to expedite the approval process

How we can help: Market Validation ,[object Object],[object Object],[object Object],[object Object],Proof of marketability is a key component of investor presentations and the business plan. Is there sufficient demand? What is the unmet need? Who will use and in what cases? What objections will have to be overcome? What alternative solutions will compete for market share? How do demand and interest vary by country?

How we can help: Market Validation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

How we can help: Market Sizing ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Snapshot of a Successful Medical Device Company with Us on Your Team…. ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Our Work… Your Work…

What you get: Commercialization Study Deliverables Mitigates of risk through extensive failure analysis Medical Advisory Board Clinical Trial Leaders Indentifies regulatory hurdles Expedites the approval process Indisputable proof of marketability Drives realistic revenue forecasts Early insight to preferable manufacturing pathway

What you get: A n expedited path to commercial success Faster to funding. Faster to market. Faster to profitability. From a good idea…. To a well funded company…

Speeding Towards Commercialization Gra 121808 Final

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Speeding Towards Commercialization Gra 121808 Final