Take your Idea. Develop your Product. Test it, Sell it, and Exit.


Innovative clinical minds face difficulties actualizing great product ideas because of the complexities associated with healthcare product development. A successful healthcare innovation development process involves integrating many complex disciplines at the highest level of quality in order to provide patients with the safest and most effective treatment options. As a result, many innovators never begin to develop their ideas because of intimidation or lack of resources. Some innovators go through the stressful and costly undertaking of an improvised development process that ultimately leads to a less than optimum product and poor financial returns.  In order to solve this problem,  we created a comprehensive platform to efficiently translate ideas into effective and successful healthcare products.

Our product development and 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.


Our Capabilities

  • Needs Analysis

  • Concept Generation & Screening

  • Product Clinical Fundamentals

  • Intellectual Property

  • Business Strategy

  • Market Analysis

  • Regulatory Analysis

  • Reimbursement Analysis

  • R&D Strategy & Execution

  • Prototyping & Proof of Concept

  • Testing

  • Quality Management

  • Fundraising

  • Operations Strategy & Execution

  • Clinical Trial Design

  • Acquisition Strategy & Execution

Our Experience

Our engineering group has an extensive successful track record in ground up innovation, design, development and testing of medical devices with expertise in mechanical, electrical, materials and acoustic systems. Our engineers have been awarded patents and been involved with the commercialization of devices in the fields of: 

  • Cardiovascular:

    • Cardiovascular implants

    • TransCatheter heart valves

    • Powered surgical instruments

    • High-volume disposables

    • Endoscopic instruments

    • Transcutaneous stimulators

    • Electro-diagnostic monitors

    • Intravascular and intracardiac drug delivery, and other implants and diagnostic devices.

  • Peripheral vasculature: Arterial and venous devices therapeutic and diagnostic.

  • Neurovascular: Minimally invasive drug delivery and implant devices.

  • COPD: Diagnostic and therapeutic minimally invasive devices and implants.

  • Ophthalmic: Implants.

  • Urology: Transurethral minimally invasive devices and diagnostics.

  • Gynecology: Transurethral minimally invasive therapeutic devices, implants and diagnostic devices.

  • Robotics: Minimally invasive surgery, nanotechnology devices.

  • Odontology: Minimally invasive devices.

  • Obesity: Minimally invasive devices and implants.

 

 


Our Product Development Process

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. Our Product Development Guide has more information. 

  • Planning Phase - 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. 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.

  • Development Phase - Engineers and clinicians execute the plans and strategies generated during the Planning Phase that detail prototype development and testing to yield a commercially viable and clinically tested product that addresses the Need. The Development Phase is typically structured with sequential pre-clinical (animal) and clinical (first-in-man) milestones.

  • Delivery Phase - The Delivery Phase is specifically catered to the innovators value event goal that is typically commercial sales or acquisition.


Our Advantage

  • Balanced and effective multi-disciplinary leadership

  • Proven needs-driven and value-based methodology

  • Unmatched clinical trial established processes

  • Broad field medical device technology, IP and product development experience

  • Network of clinical key opinion leaders and medical device industry professionals

  • Access to over +110 GCP government-certified clinical research sites in Colombia —ideal for first-in-man testing

Our Facility & Resources

Our product development personnel is strategically located in the heart of Silicon Valley in the San Francisco Bay area. We have access to various product development tools: Fabrication tools, CAD design software, simulation software, electronic design software, testing equipment, laminar flow hood for clean assembly, and wet lab for ex-vivo simulation testing. Our medical device development team is strategically assembled to most efficiently meet the requirements of each project. We have an established clinical trial network in Colombia that is ideal for first-in-man testing.