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:

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.  

  • 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.

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.

  • 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.

  1. Product Labeling

  2. Product IFU

  3. Medical Reporting Process

  4. Establishment Registration

  5. Quality System Registration

  6. Non-Clinical Device Testing

  7. Mechanical System Testing

  8. Screw Testing

  9. Corrosion Testing

  10. Biocompatibility Testing

  11. End-user (cadaver) test

Clinical Study Design

  1. Literature review

  2. Power calculation (# of subjects in the study

  3. Study protocol

  4. Investigator's manual

  5. Patient's informed consent

  6. Case report form (CRF)

  7. Statistical analysis

  8. Data management

Clinical Trial Set-up

  1. SIte(s) selection

  2. Coordination of budget(s) with selected site(s)

  3. Site introduction

  4. Pre-trial visit

  5. Drafting of clinical trial agreement (CTA) and interactions with site's legal counsel(s) and administrative staff.

  6. Protocol approval

  7. Site initiation visit

Clinical Study Management

Clinical Study Monitoring

Logistical Services

Legal Representation

  1. Import of medical products into Colombia

  2. Product storage

  3. Product management

  4. Domestic shipments to/from site

  5. Product disposal/return

  6. Ongoing reporting

Project Management

Regulatory Management


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


  • Need Statement

  • Disease State Analysis

  • Existing Solutions Analysis

  • Gap Analysis


  • Market Analysis

  • SWOT Analysis


  • Initial Assessment


  • Initial Assessment


  • Generate Initial Concepts**

  • R&D

  • R&D Initial Activities

Intellectual Property

  • IP Landscape Evaluation**

Clinical Studies

  • Initial Clinical Plan


  • Initial Cost Projections


  • Assign Management Team


  • Exit Strategy Proposal

PHASE II - Addressing The Need


  • Stakeholder Analysis

  • Value Proposition


  • Identify Advantages

  • Pricing Strategy*


  • Identify FDA class

  • Identify FDA pathway*

  • Identify Out of US pathway*


  • Reimbursement Analysis

  • Identify Payers

  • Evaluate Strategic Options

  • Identify Proxy Devices


  • Generate Concrete Concepts

  • R&D

  • R&D Plan

  • R&D Milestones Identification

  • Prototyping

  • Testing

Intellectual Property

  • Freedom To Operate Analysis

  • IP Implementation Plan

  • Provisional Patent Submission


  • Operating Plan

  • Financial Model

  • Staffing Plan

  • Market Model*

  • Cost Projections

  • Proxy Company Analysis*


  • Quality Plan*

Clinical Studies

  • Pre-Clinical Strategy

  • Clinical Strategy

Business Model

  • Business Model

  • Incorporation*

  • Legal Documents*

Sales & Marketing

  • Sales and Distribution Model


  • Financial Model*

  • Identify Comparable Companies

  • Funding & Capital Milestones

  • Company valuation

  • Identify Investors


  • 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.).