helping patients who cannot be fed orally
Gastrostomy tubes, or G-tubes, deliver food directly into a patient’s stomach when they cannot be fed orally. In the United States, there are over 566,000 G-tube placements annually, including 22,600 in children.
Existing G-tube devices are labeled as low-profile “buttons” that sit flush against the skin, or “non-button” devices that protrude significantly from the abdomen. They are fixed in the stomach using either a painful rigid internal bumper or an inflatable balloon. But all of these devices are susceptible to dislodgement by simple tugging or balloon failure, which can lead to significant pain and discomfort, tissue injury, and costly emergency procedures.
The University of Michigan has designed the Buddy Button, a one-size-fits-all, low-profile g-tube that is customizable for each patient at bedside. The initial focus is on the pediatric population, but it can also be used for adult patients.
The Buddy Button has an innovative, non-balloon style fixation mechanism that reduces pain during insertion and prevents unintended dislodgements. Additionally, the internal fixation “bumper” mechanism is not inflated or under pressure, minimizing leaks and allowing for longer use (at least 6-8 months) between G-tube changes
Significant Need
Current G-tubes can be painful to insert, are highly susceptible to dislodgement, and can protrude uncomfortably from the stomach, especially in pediatric patients. The Buddy Button is a low-profile tube that improves patient comfort and reduces hospital expenses.
Competitive Advantage
The Buddy Button offers painless insertion and removal and reduces the incidence of dislodgement. This lessens the medical, emotional, and financial stress on patients, caregivers, and clinicians. The one-size-fits-all feature lowers hospital inventory needs and increases cost savings.
Commercialization Path
- Intellectual Property – Filed invention report with the U-M Office of Technology Transfer. Submitted provisional patent application.
- Commercialization Strategy – Plan to license to existing G-tube manufacturer.
- Regulatory Pathway – Class II Medical Device, 510K pathway for FDA marketing approval.
- Engage Investors – Seek further funding through venture capital, angel funds, and grants.
- Product Launch Strategy – To be determined by licensee
Milestones
- Obtain provisional patent
- Develop functional prototypes
- Bench testing
- Customer discovery
- Refine product
- Regulatory studies and FDA submission
- Licensing
- Q316 Update: $50,000 follow-on funding
