Concept: GoNo Go

1
(No Transcript)
2

• Concept Go/No Go
• University Intellectual Property Agreement
• - Negotiate!!!
• - Patient Protection
• Business Plan
• - Capitalization
• - Administrative Consultation
• (Lita Nelson, MIT)

3
Pedisedate Development Program

• IV. Partnerships
• Scientific Partners
• 1. Researcher
• 2. Grant Writer
• 3. Statistician
• 4. Experts
• - Pat McGrath, PhD
• - Charles Gropper
• - S. Barker, MD
• B. OEM
• 1. Pulse-Ox
• 2. Capnometer- Oridion
• 3. Nitrous Oxide Dispensing Equipment- Porter
• C. Product Development/Manufacturer

4
Pedisedate Development Program

• V. Clinical Trials
• FDA
• 1. Investigate Device Exemption (IDE)
• 2. IRB
• 3. 510K Approval

5
Phase 1 Summary of Trials Alpha Prototyping of
Research

• - Acceptance Will kids put this on?
• Architecture and color choice
• Lays groundwork for beta prototyping/Clinical
  Trials

6
Phase I Advice

• Nurture NIH relationships Program/Institute
  Directors
• Develop Manufacturing/Product Development/Scienti
  fic Relationships
• - Progress to Phase II relies on Phase I Progress
  Feasibility
• - Hired Consultant to interphase product
  development work Phase II grant
• - IRB issues

7
(No Transcript)
8
Funding Issues
- Receive up to 750K - Possibility of audit -
Overhead rate may not meet internal standards -
Not a nuts bolts way to fund your company
9
Team Composition

• - Patent Protection
• Manufacture/Product Development Group
• - OEM Companies
• Academic Researchers

10
Researchers

• - Patricia McGrath PhD
• David Polinar MD
• - Charles Gropper PE
• Loralie Brennen RN, MS
• Stephen Brown, MD
• Susan Schneiweiss, MD

11
Product Development

• - David Chastain - Principal Investigator
• - Allan Cameron- Senior Industrial Designers
• - Zivthan Dubrovsky- Junior Engineer
• - Thorben Neu- Junior Industrial Designer
• Kevin Young- Senior Industrial Designer
• John MacNeill- CAD Engineer
• Bruce MacRae- Junior Model Maker
• Rich Ciccarelli- Senior Model Maker

12
Funding

• - NIH - Phase I SBIR Grant
• NIH - Phase II SBIR Grant
• NIH Phase II SBIR Supplemental Grant
• - Albert Einstein Society
• Ben Franklin Foundation
• Delta Airlines
• Marriott Hotels

13
(No Transcript)
14
Background

• Continuum worked with Geoffrey Hart to create an
  anesthetic device for use by children in need of
  painful medical procedures.
• Our product development goals were to create a
  device that
• 1. Allayed the fear and anxiety of the children
• 2. Distracted/entertained the children-
  non-pharmacological value
• 3. Monitored vital functions for healthcare
  provider.

15
Phased Development Process

• Concept Evaluation Go or No-Go
• - Understanding the Field of Use
• - Qualitative Research
• - End user child
• - Other Stakeholders parents, healthcare
  providers

16
Phased Development Process

• Concept Evaluation Go or No-Go
• Benchmark Evaluation
• - (Porter-Brown mask)
• Economic Evaluation
• - Business Plan

17
Field of Use Results

• Architecture
• Should allay childs anxiety
• Should be a form children could identify
  with/relate to a previous positive experience
  toylike
• Non-confining and open less threatening
• System should give child control

18
End User Research

• Form, Texture, Color
• 1. Toy industry evaluation
• 2. International Toy Fair, NYC
• 3. Fortune 100 Research Firm
• 4. Gender Issues
• B. Results
• 1. Colors Blue/Red-Cranberry
• 2. Texture Transparency I-Mac like
• 3. Architecture Open v. Closed Unilateral v.
  Helmet

19
Behavioral Considerations

• - Comfort Familiar, non-threatening architecture
• Anxiety-free Toy-like, open
• In-control choices
• - Open ear pieces
• - Color of headset
• - Choice of interactive program

20
System Integration and Form

• Monitors
• 1. Pulse-Oximeter
• 2. Capnometer
• 3. Anesthesia Administration/O2/Volatile
  Anesthesia Analyzer
• Incorporation of Interactive Component
• 1. Connect/Amplifier

21
Detail Design Requirements

• Address the emotional and anesthetic needs of
  kids and parents,
• Provide the healthcare workers with a
  state-of-the-art anesthesia delivery and
  monitoring system.
• The design should allow low-volume prototyping
  with the ultimate goal of mass-production

22
OEM

• - Masimo Pulse Oximetry
• Oridion Capnometry
• - Porter Anesthesia Delivery/Scavenging

23
(No Transcript)
24
Clinical Trials/Phase II
- Safety Phase Pre-op Setting - 100 children,
Boston MA

• - Randomized Clinical Trial
• 100 children, Toronto Sick Childrens Hospital
• Emergency Medicine Setting

25
Evaluate Research Partner

• Is a pre-existing research structure in place
• PIs who are freed from clinical duty
• Data Collectors
• Data Entry
• Statistician Support
• History of previous NIH-quality projects

26
Evaluate Research Partner

• Evaluation of the research site
• Patient census evaluation which documents
  aqequate numbers of appropriate patients for
  enrollment
• Census evaluation to be distributed to and saved
  by all research team members

27
Evaluate Research Partner

• Contracts in place to protect the project
• Pharmaceutical
• Industry model

28
(No Transcript)
29
Public Relations
- Package and Tell the Story!
30
Commercialization Keep Trying!

• - Academic Conferences
• Trade Shows
• Allied Industries
• Cold Contacts

31
For Information Geoffrey A. Hart MD 8
Marlborough St Boston, MA 02116 Phone 617-
247-3865 Email geoffhart_at_aol.com