Home Tonometer
The University of Arizona

    Eniko Enikov - PI
  Vasco Polyzoev – EL
  Emre Toker - Mentor
What partners will we need?

                              Key Opinion
                                Leaders

                                            Ophthalmologists


Manufacturing     Home                      Distribu
 Contractors    Tonometer                     tors

                                              Patients


                            FDA/Reimbur
                              sement
                              Experts
Why do we need them?

Manufacturing Contractors   Provide equipment and capacity for mass production
Key Opinion Leaders         Initial publications to establish credibility and create
                            awareness of product benefits; Provide research data for
                            FDA application

FDA/Reimbursement Experts   Assist with FDA approval and reimbursement policies in
                            order to expedite market penetration

Distributors                Enable rapid product introduction
Who are they?

Manufacturing Contractors     Electronics: Advanced Circuits, Sierra Circuits, Pactron;
                              El. Parts suppliers: Digikey, Mouser, Newark;
                              Force Sensors: Futek, SMD;
                              Plastic parts: Creative Plastics, The Tech Group, Copper
                              State Plastics, Plastifab;
Key Opinion Leaders           Dr. Gholam Peyman, Dr. Mandy Conway, Dr. Jean
                              Hausheer, Dr. Sean Mccafferty;
                              American Glaucoma Society, FitEyes.com;

FDA/Reimbursement Experts     Market Ready RX, Nerac, Parexel, Avalere, The FDA
                              Group LLC;

Distributors                  Lombart Instrument, Calcoast Ophthalmic, Optics Inc.,
                              Veatch Instruments
What are the incentives/impediments
                         to partnerships?


Manufacturing Contractors   Potentially entering the medical device industry - use as
                            quality statement/Meeting quality, pricing and schedule
                            expectations
Key Opinion Leaders         Publications of research, Recognition as leaders/Cost

FDA/Reimbursement Experts   Leverage success to attract more novel device
                            customers/Cost

Distributors                New product offering/Wait for FDA, competitors
What are the risks of partnership?


Manufacturing Contractors   Ability to support small scale production first and
                            ramping up fast upon demand creation
Key Opinion Leaders         Control over outcomes and publications

FDA/Reimbursement Experts   None


Distributors                Competing devices in their portfolio, Lower margins,
                            Intermediary between us and our customers
What is the cost of partnership?


Manufacturing Contractors   The cost of tooling and custom machines if they remain
                            with the manufacturer
Key Opinion Leaders         Clinical trials, Conference participation costs, Cost of
                            effective online presence, Ads
FDA/Reimbursement Experts   Consulting fees


Distributors                ~25-30% margin requirement, Travel and training costs
Tonometer lecture 8 resources

Tonometer lecture 8 resources

  • 1.
    Home Tonometer The Universityof Arizona Eniko Enikov - PI Vasco Polyzoev – EL Emre Toker - Mentor
  • 3.
    What partners willwe need? Key Opinion Leaders Ophthalmologists Manufacturing Home Distribu Contractors Tonometer tors Patients FDA/Reimbur sement Experts
  • 4.
    Why do weneed them? Manufacturing Contractors Provide equipment and capacity for mass production Key Opinion Leaders Initial publications to establish credibility and create awareness of product benefits; Provide research data for FDA application FDA/Reimbursement Experts Assist with FDA approval and reimbursement policies in order to expedite market penetration Distributors Enable rapid product introduction
  • 5.
    Who are they? ManufacturingContractors Electronics: Advanced Circuits, Sierra Circuits, Pactron; El. Parts suppliers: Digikey, Mouser, Newark; Force Sensors: Futek, SMD; Plastic parts: Creative Plastics, The Tech Group, Copper State Plastics, Plastifab; Key Opinion Leaders Dr. Gholam Peyman, Dr. Mandy Conway, Dr. Jean Hausheer, Dr. Sean Mccafferty; American Glaucoma Society, FitEyes.com; FDA/Reimbursement Experts Market Ready RX, Nerac, Parexel, Avalere, The FDA Group LLC; Distributors Lombart Instrument, Calcoast Ophthalmic, Optics Inc., Veatch Instruments
  • 6.
    What are theincentives/impediments to partnerships? Manufacturing Contractors Potentially entering the medical device industry - use as quality statement/Meeting quality, pricing and schedule expectations Key Opinion Leaders Publications of research, Recognition as leaders/Cost FDA/Reimbursement Experts Leverage success to attract more novel device customers/Cost Distributors New product offering/Wait for FDA, competitors
  • 7.
    What are therisks of partnership? Manufacturing Contractors Ability to support small scale production first and ramping up fast upon demand creation Key Opinion Leaders Control over outcomes and publications FDA/Reimbursement Experts None Distributors Competing devices in their portfolio, Lower margins, Intermediary between us and our customers
  • 8.
    What is thecost of partnership? Manufacturing Contractors The cost of tooling and custom machines if they remain with the manufacturer Key Opinion Leaders Clinical trials, Conference participation costs, Cost of effective online presence, Ads FDA/Reimbursement Experts Consulting fees Distributors ~25-30% margin requirement, Travel and training costs