Our clinical group has extensive experience in designing and developing medical technologies. We have the capabilities to offer a complete clinical testing and verification pathway from production ready prototype to acute and chronic animal experiments to first in man and feasibility clinical trials with the highest clinical research standard. We are familiar with the regulatory pathways and its overall impact in bringing a product to market.
The core of our development process is a systematic roadmap to identify, strategize and execute need-driven, value-based medical innovations. We customize our process around specific project needs to achieve maximum efficiency, efficacy and cost savings to deliver a successful product.
bioaccess.™has the ability to support medical innovators in the following areas of its medical device product development:
1. Project Planning
The Planning Phase is composed of plans and strategies that validate and address the need identified by the innovator. The plans and strategies will serve as an organized roadmap for the Development and Delivery Phases.
To validate and address the need identified by the innovator
Deliverable: Project Plan Report
A clear and concise report will be generated including all the elements needed for the development of a medical device that is successful clinically, commercially viable, technically feasible and meets regulatory requirements. The elements are separated in sections in order to sequentially validate the need and address it. Please see Appendix I for additional details.
2. Investor Presentation
Integrating the components within the Planning Phase will yield a clear and concrete “pitch” plan that will explain the innovators vision and compel investors, partners and employees to invest in the project.
To prepare innovators to present and defend the opportunity to potential investors and partners.
Deliverable: Investor Presentation
A slide presentation will be generated including topics required to convey the opportunity and address typical investor requirements. Please see Appendix II for additional details.
We will focus on gathering the technical requirements that are generally required for submission to the different regulatory bodies. Our goal will be to compile a dossier for submission to Colombia's INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) so that a first-in-human clinical study is conducted in a qualified clinical research center in Colombia.
To demonstrate the device's safety and efficacy in humans, and as a result, generating clinical and commercial value.
Clinical Trial Set-up
Coordination of budget(s) with selected site(s)
Drafting of clinical trial agreement (CTA) and interactions with site's legal counsel(s) and administrative staff.
Site initiation visit
Clinical Study Management
Clinical Study Monitoring
Import of medical products into Colombia
Domestic shipments to/from site
Patient recruitment campaign
Adjudication of adverse events
Clinical Product Readiness
Regulatory consulting services in preparation for submission to regulatory bodies.
Medical Reporting Process
Quality System Registration
Non-Clinical Device Testing
Mechanical System Testing
End-user (cadaver) test
Clinical Study Design
Power calculation (# of subjects in the study
Patient's informed consent
Case report form (CRF)
4. Continued Full Project Execution
Additional to the mentioned services we can provide full product execution. We can manage every element to ultimately reach a value event goal, whether it is commercial sales or acquisition.
PHASE II - Addressing The Need
Identify FDA class
Identify FDA pathway*
Identify Out of US pathway*
Evaluate Strategic Options
Identify Proxy Devices
Generate Concrete Concepts
R&D Milestones Identification
Freedom To Operate Analysis
IP Implementation Plan
Provisional Patent Submission
Proxy Company Analysis*
SALES & MARKETING
Sales and Distribution Model
Identify Comparable Companies
Funding & Capital Milestones
Assign Management team
*Using publically available data. Exclusive of any external service fees.
PHASE I - Validating The Need
Disease state Analysis
Existing Solutions Analysis
Generate Initial Concepts**
R&D Initial Activities
IP Landscape Evaluation**
Initial Clinical Plan
Initial Cost Projections
Assign Management team
Exit strategy proposal
Presentation Outline (typical slides for a thorough and effective presentation)
The Clinical Need
Marketing and Sales
Timeline: History, Milestones, and Prior Funding
Value Proposition (detailed for key stakeholders)
Detailed Financials (revenue and expenses breakdown)
Break-even Analysis (base-case versus bare bones case)
Pipeline of Potential Clients (with likelihood of closing each one and potential revenue)
Capital Structure (ownership of founders and current investors)
Competitors (capital raises/investors)
Headcount (numbers of employees, projections, key hires needed)
Proprietary Aspects (not included in core deck)
Questions to be considered when generating pitch deck
What is the core problem the business is trying to solve?
What is the solution it has developed?
What key benefits will the solution deliver to its target customers?
The clinical need
What is the need being addressed?
Why is this need important?
How is the need currently being addressed (if at all)?
In what ways are current solutions inadequate?
What is the proposed solution to the need?
How will it be used (and by whom)?
How does it better address the need than what is currently available?
What is the value proposition?
Who is the target customer?
What is the market size?
How fast is it growing?
Who are the primary competitors?
How will the company differentiate itself from the competition?
What are the barriers to entry?
How will the company protect its IP?
How strong is its IP positions?
How will the company prove (or has it proven) that the solution is technically feasible?
What are the risks that must be addressed and how will they be mitigated?
How will the product be manufactured and where?
How will the company get its product cleared/approved for the market?
What will be required to demonstrate safety and efficacy?
How will the company collect safety and efficacy data?
Where will the studies be performed and who will be the key investigator?
What other endpoints will be studied and why?
What is the reimbursement pathway?
What codes will be used?
How much resistance is anticipated?
How will the company make money, including its anticipated pricing and margins?
What will be the timing and frequency of revenue realization?
What volume of business is needed to make the model viable?
Sales and Marketing
Why will customers be compelled to use the product?
How will the company close sales?
How will the product reach customers?
What are the company’s financing needs?
What does it intend to do with the money raised (according to what timeline)?
How (and when) will it generate a return for investors?
How are investors most likely to achieve liquidity for their investment?
When is an exit most likely to occur?
Who are the key individuals that make up the company?
What specific qualifications do they bring to bear?
Common questions asked by investors
Technology or service concept
Is the product/service concept clear? Does it make sense?
Is there sufficient proof of principal or evidence of feasibility?
Are there adequate proprietary aspects – patents, trade secrets, or other barriers to entry?
Can it be manufactured at a reasonable expense?
Are there regulatory issues?
Market size and dynamics
How large is the market, realistically? What is the actual addressable population?
Does the company have a realistic potential to obtain substantial revenues in the market?
Is the decision making of purchasers and users well understood?
Are there reasonable marketing and sales costs? Sales cycles? Distribution systems?
Are the business relationships between referral sources, purchasers, providers, and consumers well understood?
Does the company have a strong competitive position?
Is the technology/service consistent with market, regulation, and reimbursement trends?
Is the management team smart? Are they knowledgeable about this business?
Does the management team have a proven record, particularly in this business?
Do managers have high levels of honesty and integrity? Can they be trusted?
Do they have reasonable expectations for the business, particularly for the difficulties of product/service development, rate of company growth, capital requirements, ultimate business size and profitability?
Business model and financial requirements
What are realistic revenue and expense projections for the company?
How much capital will be required to reach positive cash flow?
What are realistic expectations for the timing and sources of this cash?
What are the realistic exit opportunities for investors in this deal?
How are investors most likely to realize an exit? What scenario seems most likely?
For acquisition candidates, what companies are most likely to be interested? What other acquisitions have the made recently? Does the company have an established relationship with one or more of these companies? Why would these companies acquire a technology in the space rather than developing it themselves?
What timeline is most realistic for achieving an exit?
What are the major factors likely to influence whether or not the exit is realized?
Valuation and deal structure
Will the valuation of the investment in this deal afford a high probability of substantial return (40 percent or greater internal rate of return)?
Will the deal allow for enough capital to be put to work to make the investment worth the time and effort?
Who will be the co-investors? Are these parties good to work with?
How can this investment be structured to minimize the technological and financial risk?
Business planning and teams
What will be the equity ownership of each of the founders?
How will equity and stock options be distributed to key employees?
What is the process through which these decisions will be made?
What will be the responsibilities of the founders and early employees?
What roles will the founder and early employees play as the company evolves and grows?
Who will be the CEO (and will they be an interim CEO to be replaced by a permanent CEO)?
What are the desired attributes of early employees?
How and from where will important hires be recruited?