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Dynamic Infant Head Support device

by Jessica Kell, MD

We have developed a Dynamic Infant Head Support device, an apparatus and method for preventing, inhibiting progression of, and/or correcting plagiocephaly, abnormal shape of the head, usually infants.

Watham, MA Medical Device

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About this project

The problem we solve:
Positional Plagiocephaly, asymmetry of the infant skull, has become an important medical concern, particularly since the initiation of the 1992 American Academy of Pediatrics “Back to Sleep” campaign. While placing infants supine for sleep successfully decreased the incidence of Sudden Infant Death syndrome by 50%, an unanticipated outcome is an exponential rise in the incidence of “positional" or “deformational" plagiocephaly, also known as “flat head syndrome;” occurring in as many as 1 in 5 infants. Recent and evolving research shows plagiocephaly to effect cognitive and motor development (at least through age 3). Facial, jaw, ear and eye alignment issues lead to problems with the temporomandibularjoint (TMJ), astigmatism, eustachian tube dysfunction, challenges with proper fitting of eyewear and sports-gear for the face and head as well as psychosocial/emotional distress. Current studies also propose an association between specific types of plagiocephaly and sleep apnea.

About our solution:
A number of devices and techniques have been developed in response to this emerging medical need; however, current devices are purely therapeutic. We have developed a Dynamic Infant Head Support device (US Pat. A-10345) to ensure better and more consistent outcomes in cranial shaping. Our innovation has both prophylactic and therapeutic strengths, as it is both an apparatus and a method for preventing, inhibiting progression of, and/or correcting plagiocephaly, an abnormal shape of the head of a human, usually an infant. The invention is an oval or doughnut-shaped pillow (with a central opening) formed of a pliable, elastomeric material. The pillow ring comprises a plurality of separate compartments, which are inflated and deflated individually and sequentially. The action provides variable gentle external pressures to the cranial vault--in order to minimize larger sustained pressures of the head against a static surface--as well as subtle changes in head position.
Progress to date: As described by its U.S. Patent 8,069,856, ours is a pneumatic pillow-like device, which provides gentle sequential inflation and deflation to gently lift varying portions of, and subtly turn, the neonate's head to mitigate the otherwise effects of sustained pressure and gravitational forces upon the pliable skull. The device is designed to correct, or prevent, the incidence of plagiocephaly. The concept design has been outlined in detail and printed in 3D model form. Various embodiments and prototypes have been configured. A continuation application with additional claims has also been filed.

About Our Team


Dr. Jessica Kell, MD
Pediatric Anesthesiology (Anesthesiology), Practicing Physician
Location: Norfolk, Virginia
Medical school: George Washington University
Bio: Dr. Kell is a Board Certified Anesthesiologist practicing pediatric anesthesiology at the Children’s Hospital of the King’s Daughters. Jessica Kell is the investor of the Dynamic Infant Head Support device. Jessica had attended medical school at George Washington University where she also did her residency at the affiliated George Washington University Medical Center. She is an Assistant Professor of Pediatrics at the Eastern Virginia Medical School.
Practice: Children's Specialty Group, PLLC
Hospital Affiliation: Children's Hospital of The King's Daughters
Title: Pediatric Anesthesiologist; Medical director, CHKD Health and Surgery Center at Princess Anne in Virginia Beach, Virginia; Assistant Professor, Department of Pediatrics at Eastern Virginia Medical Sch

About Team Members

Jeremy Krell
Founder & CEO of CEO in a Box, BS, DMD, MBA
Biography: Dr. Jeremy Krell is Founder and CEO of new business incubator consultancy firm CEO in a Box. Jeremy performs recruitment, capital introduction, and strategic management services for CEO in a Box on behalf of its client firms. Prior to CEO in a Box, Jeremy has 12 years of experience as an entrepreneur, with three successful exits. Jeremy has an Bachelors of Science degree from Brandeis University and two graduate degrees (DMD - Tufts University, MBA - University of Chicago).
Twitter: Krellx5
LinkedIn: https://www.linkedin.com/in/jeremykrell?authType=NAME_SEARCH&authToken=VEHQ&locale=en_US&trk=tyah&trkInfo=clickedVertical%3Amynetwork%2CclickedEntityId%3A39744575%2CauthType%3ANAME_SEARCH%2Cidx%3A1-2-2%2CtarId%3A1462455203030%2Ctas%3Ajeremy
Amanda Kasper
Director of Operations & Go To Market, BA, BS, MPH
Biography: Amanda Kasper is serving as the Director of Operations & GTM on the Dynamic Infant Head Support device. Amanda graduated from Drake University with a B.A. in Biochemistry, Cell & Molecular Biology, and a B.S. in Neuroscience, and obtained her Masters in Public Health from Northwestern University. Amanda is based in Chicago, where she currently works as a Clinical Enrollment Specialist for a drug-trial on Super-Refractory Status Epilepticus, a rare seizure disorder which can often be fatal.
LinkedIn: https://www.linkedin.com/in/akasper513?authType=NAME_SEARCH&authToken=WcwD&locale=en_US&trk=tyah&trkInfo=clickedVertical%3Amynetwork%2CclickedEntityId%3A28677507%2CauthType%3ANAME_SEARCH%2Cidx%3A1-1-1%2CtarId%3A1462455349163%2Ctas%3Aamanda
Richard Lufkin
Principal, Dynamic Infant Head Support device project, BA, MBA
Biography: Rick Lufkin is a serial entrepreneur who has been involved in founding and growing a wide range of life sciences companies. He is a director of Anima Cell Metrology, Inc., a startup biotech platform company with proprietary technology in in-vivo protein identification. He has held founder, general management, and/or corporate board member roles in a variety of organizations. Rick works with CEO in a Box as a Principal in charge of the Kell Patent project.
Tom Ramsey
Managing Director of CEO in A Box, BA, M.Sc., MBA
Biography: Tom is Managing Director of CEO in a Box. Tom performs corporate finance functions and conducts investor relations, in addition to structuring new B2B relationships for CEO in a Box. Tom has worked at Mercer Investment Consulting and Merrill Lynch. He has an undergraduate degree from the University of Michigan and two graduate degrees (from the London School of Economics and the University of Chicago).
LinkedIn: www.linkedin.com/in/tomramseychicago

About Our Company


CEO In a Box, LLC
Location: Watham, Massachusetts
Website: http://ceoinabox.co/
Facebook: https://www.facebook.com/CEO.in.a.Box/?fref=ts
Product stage: proto
Sales: Working on it
Employees: 10-20

How We Help Physicians

A number of devices and techniques have been developed in response to this emerging medical need. However, current devices are purely therapeutic while our innovation has both prophylactic and therapeutic strengths. To date, issues of compliance, cost, labor intensity, and the high level of medical skill necessary to effectively utilize current market devices and techniques present obstacles to their full and broad adoption,especially in underserved at-risk populations. Also, despite the use of available devices, results are not appreciable and a significant number of patients require surgical intervention to correct the underlying skull asymmetry with the attendant cost and risk associated with major surgery. The dynamic infant head support represents an exciting advance as a less invasive and more cost-effective solution for the prevention and treatment of flattening of the developing cranium.

Challenge Mission

Mission: This device furthers our mission by changing the way that doctor's prevent plagiocephaly among infants, committed to inspiring & assisting ambitious young minds in revolutionizing the market.
Use of funds: Innovation Development (Prototype /Product - Research, CAD model, Prototype, 2 renderings, Animation, Double-Diamond Innovation Strategy): $8500 Market Development: $6500 Sales: $5000 Compliance (Class 3, 510(k)): $5000
Intellectual Property Status: There is one issued patent (Dynamic Infant Head Support, US 20090070938 A1; Filing Date: September 19, 2007). There is also one continuation application expected to issue shortly.
Patent Link: http://www.google.com/patents/US20090070938
FDA Status: The initial assessment is that this will be a Class III medical device, with a 510(k) route to market.
Personal Message: What a great way to “shape” 21st century medicine! We are honored to present the Dynamic Infant Head Support--a superior solution for both the prevention and treatment of Plagiocephaly (i.e. Flat Head Syndrome). Head shape abnormalities are on the rise and may lead to cognitive/motor delays; jaw, eye and ear deformities; sleep apnea, psychosocial insecurity and parental anxiety. Please VOTE in support of this innovative device to benefit tomorrow’s infants and patient families. Thank you!

Supporters

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    05/20/2016 Amanda Kasper - Allied Health Professional

    Liked the project.

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    05/20/2016 Ariel Lufkin - Physician

    Followed the project.

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    05/20/2016 john pagliaro - Other

    Liked the project.

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    05/20/2016 Amanda Kasper - Allied Health Professional

    Followed the project.

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    05/20/2016 Ariel Lufkin - Physician

    Liked the project.

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    05/15/2016 Michael Ferm - Medical Student

    Liked the project.

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    05/15/2016 Ethan Krell - Medical Student

    Followed the project.

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    05/15/2016 Ethan Krell - Medical Student

    Liked the project.

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    05/14/2016 Ariel Moser - Private

    Liked the project.

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    05/13/2016 Meagan Livergood - Concerned Citizen

    Liked the project.

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    05/13/2016 Michelle Podbielski - Other

    Liked the project.

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    05/13/2016 Lorraine Volk - Nurse

    Liked the project.

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    05/12/2016 Gary Kell - Concerned Citizen

    Followed the project.

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    05/12/2016 Dr. Jessica Kell - Physician

    Liked the project.

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    05/12/2016 Dr. Jessica Kell - Physician

    Followed the project.

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    05/12/2016 Sheryl Makela - Private

    Liked the project.

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    05/12/2016 Gary Kell - Concerned Citizen

    Liked the project.

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Jessica Kell, MD
Physician
Pediatric Anesthesiologist; Medical director, CHKD Health and Surgery Center at Princess Anne in Virginia Beach, Virginia; Assistant Professor, Department of Pediatrics at Eastern Virginia Medical Sch
George Washington University

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