Research and Development
Device Innovation: Current Challenges
"Necessity is the mother of invention”.
The proverb holds especially true for innovation in medicine. The physician is the primary driving force for innovation, inspired by the limitations and challenges faced in everyday practice. The goal may be to improve the outcomes of existing procedures. Or to enable new procedures that currently cannot be done. There is certainly no shortage of physician-inspired ideas.
But, there is a shortage of pathways for the physician to take an idea from concept to proof-of-concept.
There are currently two pathways for device innovation. One is through an existing medical device company. The limitations of this pathway are a restricted R&D budget that is dependent on profit margins from sales and alignment with the marketing goals of the company. Device companies will typically only select "better mousetrap” ideas that are likely to generate a rapid, predictable return on investment.
The other pathway is a medical device “start-up”. The limitation of a start-up is the need to create a team and infrastructure from scratch. This requires an enormous time commitment and substantial investor funding, usually from venture capital (VC).
Today, both industry and VC-investment pathways are threatened by two recent developments:
1) Growing multi-level regulatory hurdles that drive up the costs of device development.
2) A steady decline in device reimbursement associated with health care reforms.
This - coupled with the reality that the physician innovator is unlikely to find the time or have the finances to explore either pathway - results in ideas that never have a chance for development. Particularly affected are those ideas that industry and investors consider “risky”. These are precisely the ideas that may lead to the next paradigm shift in how we treat disease.
The Endovision Solution
Endovision offers an alternative pathway for device innovation through a non-profit “incubator” model that is physician-controlled. Importantly, the non-profit model removes all potential conflicts-of-interest inherent to industry and investor-sponsored ventures. The goal is to provide endoscopists around the globe with an easily accessible, practical pathway to incubate "better-way" ideas. Endovision is non-biased, which means the value of the idea is defined solely by the potential benefit to the patient. physician-controlledPrototypes are generated by Endovision’s engineers specialized in the gastrointestinal device space and tested in bench-top and animal models to establish “proof-of-concept”. Once established, devices are licensed to industry for commercialization.
Devices conceived or selected for development by Endovision should meet the following 4 prerequisites:
1) Novel: meeting a need not addressed by current technology
2) Simple: Design should be technically straightforward, intuitive, and simple enough to be performed by the community provider.
3) Easy: Deployment of the device to achieve the desired therapeutic outcome should be easy easy to learn without the need for specialized training.
4) Cost effective: Endoscopic therapy should be inherently cost effective compared to the costs of surgery and hospitalization. Minimizing the device and overall procedure costs of endoscopic intervention will help drive adoption.
Endovision is developing prototypes of enabling tools for endoscopic resection of cancerous and precancerous growths. Please contact Endovision for more information on these projects.
Clinical outcome studies
The benefits of endoscopic treatment may appear intuitive and self-evident. However, lack of acceptance by the greater medical community, are significant barriers to dissimation. Prospective clinical studies are needed to validate the beneficial impact of endoscopic technology on outcome parameters such as success, complications, avoidance of surgery, and quality of life, as well as the potential savings in cost of health care.