Each of TransMed7’s technology pipeline concepts typically undergoes product development within a stand-alone business structure with finance and accounting systems, funding, and timelines that are separate from the TransMed7 Base Company.
This stand-alone business structure is called a “Project LLC”, and is designed to focus resources and priorities on evolving a specific technology to maturity under the guidance of selected members of TransMed7’s Clinical and Scientific Advisory Board.
The process of multiple TransMed7 Project LLCs operating simultaneously provides economies of scale, leveraging our highly experienced pool of scientists, engineers, quality assurance, regulatory, and clinical research personnel who lead every functional area of quality-compliant, best-practices product development under TransMed7’s leadership.
Clinical Research and Regulatory Submissions:
Where required or desired, TransMed7’s personnel design and conduct clinical research trials to obtain additional safety and efficacy data.
Regulatory submissions and remaining requirements for market release are then completed in the United States and O.U.S.
Medical Device Sales and Distribution:
As a medical device manufacturer, TransMed7 has full capabilities for development and sales/distribution of commercial-ready medical technologies.
Upon finalization and validation of device features and specifications, product development is completed through commercial manufacturing under TransMed7’s compliant quality systems.
TransMed7’s overarching goal is to provide transformational technology to clinicians for the benefit of their patients as rapidly as possible.
In some cases, this goal may be best achieved by choosing to work with one or more Strategic Partners who have strong interest and leverage in the field(s) of use for the technologies and are committed to bringing them to the healthcare market rapidly.
This path would be chosen if determined to be the most efficient way to provide critically needed medical technology to patients.
Partnerships with Developers of Adjunct Technologies:
TransMed7 partners very early in product development with providers of technologies (e.g. imaging, energy, diagnostics, connected care, and other forward-looking technologies) that ensure our innovation leadership far into the future. These adjunct technologies will complement, enhance, or be enabled by our technologies, and may contribute to the following:
- Lower the entry barrier for clinicians into a specific medical field
- Bridge the gap between home health care and provider care
- Expand use of our devices across medical specialties and geographies
- Enable use of TransMed7 technologies in emerging markets or remote locations without established, reliable power grid access
- Decrease the cost of developing and producing TransMed7 technologies
Parallel Path Approach:
Working in synergy with our network of healthcare professionals, TransMed7 generates new, disruptive (market dominating) medical device technologies while simultaneously achieving rapid, parallel development and market release of additional transformational technologies.
Acquisition of a Project LLC (by a Strategic Partner of choice) can be achieved at any of the points shown in the graphic below: