How Can bioaccess.™ Help You Develop and Succeed with your Medical Device
Our product development and clinical experts have extensive experience in designing and conducting early stage healthcare 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. Read about our product development services here.
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:
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.
Objective: 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.
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.
Objective: 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.
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.
Objective: Demonstrate the device's safety and efficacy in humans and as a result generating clinical and commercial value. We will address the following items during this clinical phase:
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)
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
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.
The following are the two high-level phases of development for a medical device:
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
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 publicly available data. Exclusive of any external service fees.
About The Author
Julio G. Martinez-Clark is CEO of bioaccess.™, a U.S.-based contract research, regulatory, and market access consulting company focused on Latin America. Julio holds a bachelor’s degree in electrical engineering (B.S.E.E.), and a master’s degree in business administration (M.B.A.).