UC Irvine Applied Innovation Center Lunch-n-Learn Presentation @ The COVE Friday August 4, 2017 “Defining a Commercially Viable Product” A Case Study: Phase – 0 to Phase 2 Manas Kanungo Int’l Medical Marketing (IMM) USA, LLC I love a challenging role – where I can learn and create innovative, sustainable global solutions that enhance health outcomes. Manas Kanungo Confidential 1
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UC Irvine Applied Innovation Center
Lunch-n-Learn Presentation @ The COVE Friday August 4, 2017
“Defining a Commercially Viable Product”
A Case Study: Phase – 0 to Phase 2
Manas Kanungo Int’l Medical Marketing (IMM) USA, LLC
I love a challenging role – where I can learn and create innovative, sustainable global solutions that enhance health outcomes.
Manas Kanungo Confidential 1
Career Summary Define, Plan, Execute Innovative Solutions - Enter & Grow Int’l Markets
Manas Kanungo Confidential 2
15+ Yrs in Hospital, Lab, POL, POC Medical Device, Diagnostic industry
Small - Large companies: Start-ups, BioTek, Quidel, Roche, Bayer, Abbott
Built, coached, supervised, led direct, in-direct, matrixed teams
Multi-country, multi-segment VOC qual/quant market, ethnography research
Unique ability to cross boundaries between diseases, therapies, technologies, providers, payers, patients for impactful, competitively sustainable solutions
Lived, worked out of 3, traveled in 50+ countries US citizen with work visas for Brazil and India Native English w/business fluency in Portuguese, Hindi, Oriya; basic Spanish
Sept Feedbacks: 5 Countries UK: Nov GUI, Dec Formative
In Field: 13 mths May – July ‘2010 Nov ’10 – Jan ‘11 May – June ‘11 Sept– Dec ‘11
UK • Frimley Hospital • Barnet Hospital • Kings Cross College
• Royal Free Hosp * Chlesea/ Westmr • North Middlesex * Kings College • Royal London Hosp * Homerton NHS
126 Admins, Purchasers; Nurses, POCCs, Lab,
Endos, Diabetologists
• Feedbacks: Sept 19 – 20 (3 POCCs) • GUI & Formative: 12 + 12 HCPs Nov 1-3; Dec 13-15
Germany • Charite Berlin * Martin-Luther • Vivantes * Diab Clinic Berlin
France • CHU Nantes • La Pitie Salpetriere • Ambroise Pare
• Le Havre Hospital • Reims Hospital • Bichat Hospital
• Feedbacks: Sept 22 – 23 (7HCPs)
China • Peking University Hospital • Shanghai Huashan • Shanghai No. 6 Hospital
• Feedbacks & GUI: Sept 26 – 30 (17 HCPs)
Japan • Japanese Red Cross Medical Center • Eiju General Hospital • Fukushima Medical University Hosp
• Feedbacks: Oct 4-6 (12 HCPs)
Brazil
• Santa Casa de Misericordia • Hospital Nipo Brasileiro • Hospital Clinicas • Hospital Alemao Oswaldo Cruz • Albert Einstein Hospital • Hospital Beneficia Portuguesa
• Darcy Vargas * Hospital Pasteur • Lefort • Sabara • Santa Paula • Pro-Cardiaco • HCN - Niteroi
101 Admins, Purchasers; Nurses, POCCs, Lab,
Endos, Diabetologists
• Feedbacks & GUI: Sept 26 – 30 (16 HCPs)
Canada • St. Mary’s Hospital Centre Montreal • Verdun Hospital Centre Montreal
• San Francisco: Dry Run Sept 1 (3 HCPs)
USA • RUSH Hospital Chicago • Montefiore, Bronx NY • MUSC, Charleston, SC • VA Hospital, Madison
Page 25
Regulatory Compliance: (Internal or External) QA Enforcement or Accreditation
Motivation
Hospital Budget & Infrastructure – IT and POCC (Automation, EMR, LIS, HIS, Wireless)
Low
XP-H Pegasus
P2-H
Enabled by New Precision Hospital Strip
“Aspiring” Middle Market “Networked” Market
“Status-Quo” Market
High
Low High
“Low Compliance” Market
or
XP-H will fill an important gap, by meeting the needs of “Aspiring” Hospitals motivated for QA or Accreditation, but without budget or infrastructure
Hospital Portfolio Map
There are more # of “Aspiring” middle-
market hospitals than large hospitals.
Page 26
“Networked” “Aspiring” “Status-Quo”
Meter System that meets needs PXPw + PWeb XP-H P2-H
Hospital
Hospitals with sufficient budget and infrastructure for IT and POCCs
Hospitals with less budget and no infrastructure for IT or POCCs
Any Hospital
Lab Role, and status of Enforcement of QA/QC Procedures
High degree of lab control of quality and training.
QA/QC SOPs for POC glucose testing throughout hospital are highly coordinated.
Emerging lab control for quality and training.
Emerging coordination & SOPs for hospital wide QA/QC of POC glucose monitoring systems
Little or no lab control of quality and training.
Little or no QA/QC SOPs for hospital wide POC glucose monitoring systems
Meter role in certification
Hospital certification relies heavily on automated meter features & software to integrate with networks, processes, and procedures
Hospital certification is a combination of policies, procedures, and manual processes, aided by meter features
Hospital certification depends on manual process to meet minimal requirements
Purchase Decision Making Process
Hospital-wide meter selection process.
Individuals external to the point of use have primary influence (purchasing, lab, hospital administrator)
Moving towards hospital-wide selection process, may have some departments coordinated.
Endos, nurses, and some times labs have influence on meter decision making.
Purchase Decisions made by point-of-use department or ward.
Endos and nurses are primary decision makers for meter selection.
Characteristics of “Aspiring” middle-market Hospitals
• Patient results on meter, reports, with IDs • Hypo/Hyper alerts, readings, guidance for next steps
Laboratory • Lab Managers & Technicians • POCCs
• Meter set up • QC: readings, reminders, lockout, exception reports • Operator Training Compliance • Data export, consolidation, reports
Nurses
• Head Nurse • Floor / Ward Nurse • Diabetes Specialist Nurses (DSN) • Nurse / Health Care Assistants
• Perform patient tests, use results for therapy • Perform QC tests • Patient results w/traceability to record, act on • Operator Training Compliance • Guidance messages for next steps
Page 28
Meeting Accreditation and Standards Requirements .. 4 Relevant Areas Across 9 US & Int’l Standards
Patient Care Standards How to Meet This Requirement
• Accurately Identify Patients • Match patient with a number, name, and/or birth date
• Record Results for the right Patient • Enter and confirm Patient ID before testing
• Retrieve Patients’ Results • Search and retrieve patient results using IDs
• Define Critical Results & Guidelines, follow Protocols for Clinical Care
• Method to identify and alert out-of-range patient results, and provide guidelines for next steps
• Evaluate Patient data to Improve Care • Consolidate data, generate statistical & trend reports
*Joint Commission Int’l (JCI); Clinical Pathology Accrdn; CPA-POCT Addendum; Canadian Int’l Lab & Blood, Biomedical Lab, POCT; Brazil RDC & ONA; China POCT
No Standard requires a “networked” system ….any device can be used for this process
There are 4 main areas relevant to bedside testing, across 9 Int’l Standards …
…. Where streamlining the process to meet these requirements will make a difference…