Interrupting the Medtech Status Quo

A simple design that eases use can overcome challenges faced when changing established medical procedures, said a winner of the 2018 Medical Design Excellence Awards.

Image of Minne Ties courtesy of Summit Medical LLC

As a facial trauma surgeon, Dr. Alan Johnson hated using wires and arch bars to immobilize jaws to help heal jaw fractures. “This is commonly known as ‘having your jaw wired shut,’ "Johnson told MD+DI. “It’s miserable for patients, time consuming and risky for surgeons, and an inefficient use of healthcare resources for the health system. The wires are painful to patients’ gums. The application of the wires puts surgeons and their teammates at risk for sharps injuries. And, the techniques used to apply wires consume large amounts of time in the costly operating room.”

Such frustrations led Johnson, a board-certified head and neck surgeon who studied under Minnesota's Earl Bakken Medical Device Center Innovation Fellowship, to invent Minne Ties Agile MMF. Recognized in the 2018 Medical Design Excellence Awards (MDEA) with a silver award in the ER and OR Tools, Equipment, and Supplies Category, Minne Ties is a noninvasive system for maxilla-mandibular fixation. “Minne Ties have been a success because of their simplicity: in simplest terms, they're simply the mating of a blunt-ended suture with a zip-tie,” said Johnson. “The devices are intuitive and easy for surgeons to learn.”

He said the design was created after numerous hand-made prototypes were assembled to assess the feasibility of the concept of using a zip-tie style device to close the jaws into occlusion. “Up to 20 different sequential prototypes informed the design,” he explained. “The materials and design were ultimately selected to mimic suture materials and wires that surgeons typically use. The Minne Ties handle like a thick suture. As such, clinician adoption of the devices has been relatively straightforward.”

Minne Ties can help address some of the common challenges with jaw surgery and recovery. Previous approaches “employed wires ‘twisty-tied’ around teeth, leaving sharp wire edges in the mouth to poke the gums,” said Johnson. As an alternative solution, Minne Ties are “smooth-edged devices that don’t abrade the surrounding soft tissues.”

Also, removing traditional wires can “cause injury to the gums as the wires are sharp and twisted,” he said, while “Minne Ties are smooth polymer strands that slide smoothly through the teeth.”

Dental hygiene is still challenging with the jaw wired shut, he said. “This remains a challenge with Minne Ties, although rinsing the mouth with mouthwash is likely less abrasive and painful with Minne Ties compared with wires.”

 

Entries are now being accepted for the 2019 Medical Design Excellence Awards. Don't miss the November 1 deadline for the Early-Bird Price of $399. Entries will be accepted through December 21, 2018. 

 

Minne Ties are currently being used at many level 1 and level 2 trauma centers, said Kevin McIntosh, president of Summit Medical LLC, manufacturer of the product. “We have also enjoyed conducting workshops at large number of major teaching institutions who will be ushering in a new wave of future Minne Ties users.” Johnson recently demonstrated Minne Ties at both the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNSF) Annual Meeting in Atlanta and the American Association of Oral and Maxillofacial Surgeons (AAOMS) Annual Meeting in Chicago.

When asked whether it is challenging to introduce a new device that changes established medical procedures, Kevin McIntosh, president of Summit Medical, said “It’s very challenging introducing a new device that interrupts the status quo or comfort zone of anyone, especially caregivers that have learned a specific way to perform a procedure and operate under financial scrutiny from their facility. The simple design and ease of application when using Minne Ties has helped us overcome these challenges. Our solution addresses many of the current clinical and economic challenges for the health care provider and mitigates the many risks surgeons face each time they provide the MMF procedure.”

 

Above: "The Minne Ties handle like a thick suture," said inventor Dr. Alan Johnson.

 

There can be supply-chain challenges. “We set out to provide a value to the care process and have successfully validated those value propositions through clinical application and surgeon feedback. The validation of the value is a great start to overcoming individual user adoption; however, we then face new and often times more difficult challenges gaining hospital supply chain approval,” said McIntosh. “In many cases the supply-chain management of a hospital or hospital system can influence patient care much more [than] most people are aware. Even when a surgeon determines a certain product is the best way to provide patient care and value analysis committees have approved the product, supply chain becomes a significant hurdle for the new technology.”

Recognition in the MDEAs has also helped get the word out. “The Medical Design Excellence Award is an incredible recognition and, again, validates the significance and impact our solution will have on the industry,” said McIntosh. “We feel extremely honored to be recognized at a national level. We use this recognition in our talks and presentations to reinforce that the device has merit and is being discovered en masse across the country.”

Daphne Allen

Daphne Allen is editor-in-chief of MD+DI. She previously served as executive editor of Pharmaceutical & Medical Packaging News, which serves as the pharmaceutical and medical device channel of Packaging Digest. Daphne has covered medical device packaging, labeling, manufacturing, and regulatory issues as well as pharmaceutical packaging for more than 20 years. She is also a member of the Institute of Packaging Professionals's Medical Device Packaging Technical Committee. Follow her on Twitter at @daphneallen.

 

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