Client: Marie Pavini, MD; Assistant ICU Medical Director at Rutland Regional Medical Center, Vermont
Waking up in the ICU can be a disorienting experience. In their delirious state, some patients will reflexively pull out their IV lines, naso or gastric tubes or breathing tubes. Restraining these patients either physically or through sedation prevents the early mobilization necessary for staving off muscle atrophy and can lead to longer hospital stays. Physical restraint can also cause the patient extreme anxiety. Dr. Marie Pavini, the assistant ICU Medical Director at Rutland Regional Medical Center in Vermont, came to TREAT with an early prototype for “Exercise Restraint”, a restraining device that would not only prevent self-extubating but also allow the patient some beneficial mobility.
TREAT engineering experts worked with Dr. Pavini to develop her next generation prototype, focusing first on solidifying the market requirements that would determine what features would be designed into the device. After some initial prototype development with TREAT, Dr. Pavini used her TREAT funds to engage an engineering design firm for further refinement.
Other TREAT resources provided business development services such as guidance on engaging potential partners or licensees for her technology, regulatory requirements and patent filing while funds were used for customer discovery efforts at medical conferences and engaging a licensing consultant. TREAT also provided clinical evaluation expertise on developing a pilot study and constructing an IRB submission.
Since Dr. Pavini’s TREAT engagement, she has completed a successful pilot study and a multi-site clinical trial is in the works. In addition, her first-generation product is positioned to enter the manufacturing phase and distribution, moving forward with each milestone achieved to the day when ICU patients will benefit from her device.
“TREAT instructed me for the initial clinical, product development and business steps and then taught me that I can find my way past any hurdle. My development team encouraged initiation and hard work – methods I continue to use successfully.”
- Date January 8, 2018