Soumettre la recherche
Mettre en ligne
Fundability Criteria Worksheet_MediCoventures_v3.1
•
Télécharger en tant que DOCX, PDF
•
1 j'aime
•
258 vues
Aaron Call
Suivre
Signaler
Partager
Signaler
Partager
1 sur 12
Télécharger maintenant
Recommandé
Health language siemens presentation
Health language siemens presentation
Chris Cummins
VeriTeQ Presentation at the Global Online CEO Conference July 2014
VeriTeQ Presentation at the Global Online CEO Conference July 2014
RedChip Companies, Inc.
VTEQ Presentation july 2014
VTEQ Presentation july 2014
RedChip Companies, Inc.
Iehr ciif sdk-slides-draft-h
Iehr ciif sdk-slides-draft-h
ckuyehar
Orthopaedic Device Industry Business Models: 2020 and Beyond
Orthopaedic Device Industry Business Models: 2020 and Beyond
April Bright
Analysis Guide for Medical Product Designers
Analysis Guide for Medical Product Designers
SOLIDWORKS
Vteq nov 2013-reduced
Vteq nov 2013-reduced
RedChip Companies, Inc.
MEDICAL DEVICE DEVELOPMENT_0327
MEDICAL DEVICE DEVELOPMENT_0327
Robert Stathopulos
Recommandé
Health language siemens presentation
Health language siemens presentation
Chris Cummins
VeriTeQ Presentation at the Global Online CEO Conference July 2014
VeriTeQ Presentation at the Global Online CEO Conference July 2014
RedChip Companies, Inc.
VTEQ Presentation july 2014
VTEQ Presentation july 2014
RedChip Companies, Inc.
Iehr ciif sdk-slides-draft-h
Iehr ciif sdk-slides-draft-h
ckuyehar
Orthopaedic Device Industry Business Models: 2020 and Beyond
Orthopaedic Device Industry Business Models: 2020 and Beyond
April Bright
Analysis Guide for Medical Product Designers
Analysis Guide for Medical Product Designers
SOLIDWORKS
Vteq nov 2013-reduced
Vteq nov 2013-reduced
RedChip Companies, Inc.
MEDICAL DEVICE DEVELOPMENT_0327
MEDICAL DEVICE DEVELOPMENT_0327
Robert Stathopulos
Icd 10 implementation and business final slideshare
Icd 10 implementation and business final slideshare
Michael Arrigo
Preparing and Implementing a Comprehensive ICD-10 Testing Strategy
Preparing and Implementing a Comprehensive ICD-10 Testing Strategy
Cognizant
Edwards Lifesciences 2015 Investor Conference
Edwards Lifesciences 2015 Investor Conference
EdwardsLifesciences
Nanobiz India Scouting Services
Nanobiz India Scouting Services
Robert Stathopulos
FDA Refused 510(k) Submissions
FDA Refused 510(k) Submissions
Joe Hage
Recommendation for PharmaLedger governance, operating model and Constitution
Recommendation for PharmaLedger governance, operating model and Constitution
PharmaLedger
FDA's 510(k) Modernization: What if Anything has Changed? Is Changing? Will C...
FDA's 510(k) Modernization: What if Anything has Changed? Is Changing? Will C...
Greenlight Guru
CRE Medical Final NSF I-Corps Presentation
CRE Medical Final NSF I-Corps Presentation
Stanford University
Design Considerations to Maximize Medical Device Cloud Connectivity
Design Considerations to Maximize Medical Device Cloud Connectivity
Greenlight Guru
Prescient Therapeutics Investor Presentation
Prescient Therapeutics Investor Presentation
Corey Hulls
Ethical solutions healthcare
Ethical solutions healthcare
ShyamalMukherjee9
Gammaglobulin I-Corps@NIH 121014
Gammaglobulin I-Corps@NIH 121014
Stanford University
Detailed Infrastructure Analysis PowerPoint Presentation Slides
Detailed Infrastructure Analysis PowerPoint Presentation Slides
SlideTeam
Medvantage Tech Overview
Medvantage Tech Overview
ezitizer
eHealthCare
eHealthCare
ShyamalMukherjee9
UCSF Life Sciences: Week 6 Devices Partnerships
UCSF Life Sciences: Week 6 Devices Partnerships
Stanford University
Metadata and ADaM
Metadata and ADaM
Kevin Lee
Infrastructure Improvement PowerPoint Presentation Slides
Infrastructure Improvement PowerPoint Presentation Slides
SlideTeam
Ventripoint Diagnostics Ltd investor presentation
Ventripoint Diagnostics Ltd investor presentation
ChadLevesque1
Investor presentation q1 2014(18 mar-2014)
Investor presentation q1 2014(18 mar-2014)
teradata2014
Somerset hills ymca- Rutgers Social Media Mini MBA Capstone Project
Somerset hills ymca- Rutgers Social Media Mini MBA Capstone Project
Kevin Flanders
Secure Log Management
Secure Log Management
Tamas Horvath
Contenu connexe
Tendances
Icd 10 implementation and business final slideshare
Icd 10 implementation and business final slideshare
Michael Arrigo
Preparing and Implementing a Comprehensive ICD-10 Testing Strategy
Preparing and Implementing a Comprehensive ICD-10 Testing Strategy
Cognizant
Edwards Lifesciences 2015 Investor Conference
Edwards Lifesciences 2015 Investor Conference
EdwardsLifesciences
Nanobiz India Scouting Services
Nanobiz India Scouting Services
Robert Stathopulos
FDA Refused 510(k) Submissions
FDA Refused 510(k) Submissions
Joe Hage
Recommendation for PharmaLedger governance, operating model and Constitution
Recommendation for PharmaLedger governance, operating model and Constitution
PharmaLedger
FDA's 510(k) Modernization: What if Anything has Changed? Is Changing? Will C...
FDA's 510(k) Modernization: What if Anything has Changed? Is Changing? Will C...
Greenlight Guru
CRE Medical Final NSF I-Corps Presentation
CRE Medical Final NSF I-Corps Presentation
Stanford University
Design Considerations to Maximize Medical Device Cloud Connectivity
Design Considerations to Maximize Medical Device Cloud Connectivity
Greenlight Guru
Prescient Therapeutics Investor Presentation
Prescient Therapeutics Investor Presentation
Corey Hulls
Ethical solutions healthcare
Ethical solutions healthcare
ShyamalMukherjee9
Gammaglobulin I-Corps@NIH 121014
Gammaglobulin I-Corps@NIH 121014
Stanford University
Detailed Infrastructure Analysis PowerPoint Presentation Slides
Detailed Infrastructure Analysis PowerPoint Presentation Slides
SlideTeam
Medvantage Tech Overview
Medvantage Tech Overview
ezitizer
eHealthCare
eHealthCare
ShyamalMukherjee9
UCSF Life Sciences: Week 6 Devices Partnerships
UCSF Life Sciences: Week 6 Devices Partnerships
Stanford University
Metadata and ADaM
Metadata and ADaM
Kevin Lee
Infrastructure Improvement PowerPoint Presentation Slides
Infrastructure Improvement PowerPoint Presentation Slides
SlideTeam
Ventripoint Diagnostics Ltd investor presentation
Ventripoint Diagnostics Ltd investor presentation
ChadLevesque1
Investor presentation q1 2014(18 mar-2014)
Investor presentation q1 2014(18 mar-2014)
teradata2014
Tendances
(20)
Icd 10 implementation and business final slideshare
Icd 10 implementation and business final slideshare
Preparing and Implementing a Comprehensive ICD-10 Testing Strategy
Preparing and Implementing a Comprehensive ICD-10 Testing Strategy
Edwards Lifesciences 2015 Investor Conference
Edwards Lifesciences 2015 Investor Conference
Nanobiz India Scouting Services
Nanobiz India Scouting Services
FDA Refused 510(k) Submissions
FDA Refused 510(k) Submissions
Recommendation for PharmaLedger governance, operating model and Constitution
Recommendation for PharmaLedger governance, operating model and Constitution
FDA's 510(k) Modernization: What if Anything has Changed? Is Changing? Will C...
FDA's 510(k) Modernization: What if Anything has Changed? Is Changing? Will C...
CRE Medical Final NSF I-Corps Presentation
CRE Medical Final NSF I-Corps Presentation
Design Considerations to Maximize Medical Device Cloud Connectivity
Design Considerations to Maximize Medical Device Cloud Connectivity
Prescient Therapeutics Investor Presentation
Prescient Therapeutics Investor Presentation
Ethical solutions healthcare
Ethical solutions healthcare
Gammaglobulin I-Corps@NIH 121014
Gammaglobulin I-Corps@NIH 121014
Detailed Infrastructure Analysis PowerPoint Presentation Slides
Detailed Infrastructure Analysis PowerPoint Presentation Slides
Medvantage Tech Overview
Medvantage Tech Overview
eHealthCare
eHealthCare
UCSF Life Sciences: Week 6 Devices Partnerships
UCSF Life Sciences: Week 6 Devices Partnerships
Metadata and ADaM
Metadata and ADaM
Infrastructure Improvement PowerPoint Presentation Slides
Infrastructure Improvement PowerPoint Presentation Slides
Ventripoint Diagnostics Ltd investor presentation
Ventripoint Diagnostics Ltd investor presentation
Investor presentation q1 2014(18 mar-2014)
Investor presentation q1 2014(18 mar-2014)
En vedette
Somerset hills ymca- Rutgers Social Media Mini MBA Capstone Project
Somerset hills ymca- Rutgers Social Media Mini MBA Capstone Project
Kevin Flanders
Secure Log Management
Secure Log Management
Tamas Horvath
PreSentation Cloud Conference
PreSentation Cloud Conference
cornflakes
WiFi hálózatok szeparációja
WiFi hálózatok szeparációja
Tamas Horvath
Slidereel 2012
Slidereel 2012
Missing Link
Balabit Sales Kick-off 2010
Balabit Sales Kick-off 2010
Tamas Horvath
En vedette
(6)
Somerset hills ymca- Rutgers Social Media Mini MBA Capstone Project
Somerset hills ymca- Rutgers Social Media Mini MBA Capstone Project
Secure Log Management
Secure Log Management
PreSentation Cloud Conference
PreSentation Cloud Conference
WiFi hálózatok szeparációja
WiFi hálózatok szeparációja
Slidereel 2012
Slidereel 2012
Balabit Sales Kick-off 2010
Balabit Sales Kick-off 2010
Similaire à Fundability Criteria Worksheet_MediCoventures_v3.1
The Medical Device Milestone Map
The Medical Device Milestone Map
Revital (Tali) Hirsch
Rapid Diagnostic Test Kit Manufacturing Plant Project Report.pptx
Rapid Diagnostic Test Kit Manufacturing Plant Project Report.pptx
Smith Anderson
CLEA - Claims Cognitive Assistant
CLEA - Claims Cognitive Assistant
Edward Vandenberg
Aditxt, Inc. (NASDAQ: ADTX) Presentation
Aditxt, Inc. (NASDAQ: ADTX) Presentation
RedChip Companies, Inc.
Product definition starting point for medical device manufacturing
Product definition starting point for medical device manufacturing
Katherine Dalton
Developing Product Requirements For Medical Devices
Developing Product Requirements For Medical Devices
Walt Maclay
Shared Service Centers: Risks & Rewards in the Time of Coronavirus
Shared Service Centers: Risks & Rewards in the Time of Coronavirus
Cognizant
Building public-trust-eccles-en-2038
Building public-trust-eccles-en-2038
Girma Biresaw
Detailed Project Report on Rapid Diagnostic Test Kit Manufacturing Unit Setup
Detailed Project Report on Rapid Diagnostic Test Kit Manufacturing Unit Setup
IMARC Group
07 vteq
07 vteq
RedChip Companies, Inc.
Requirements for reimbursement of new medical devices
Requirements for reimbursement of new medical devices
Mike Sanchez
Project Report on Surgical Gloves Manufacturing Plant
Project Report on Surgical Gloves Manufacturing Plant
IMARC Group
Effective Complaint Management: The Key to a Competitive Edge for Medical Dev...
Effective Complaint Management: The Key to a Competitive Edge for Medical Dev...
Cognizant
Kareo Award Write Up
Kareo Award Write Up
Claudia Toscano
Seb corporate presentation june 2013
Seb corporate presentation june 2013
TSXV-SEB
Aagami Inc. Research Services Presentation
Aagami Inc. Research Services Presentation
Godwyn Francis
Module 8: Purchasing & Project Management Essentials
Module 8: Purchasing & Project Management Essentials
Sam Pratt
Customer insight presentation s houston - boston march 2014
Customer insight presentation s houston - boston march 2014
Stuart Houston
Detailed Project Report on Setting up a Door And Window Frames Manufacturing ...
Detailed Project Report on Setting up a Door And Window Frames Manufacturing ...
JacksonHarolin
Best Practices and Points to Consider for Small-Medium Bio-Pharma Companies
Best Practices and Points to Consider for Small-Medium Bio-Pharma Companies
Covance
Similaire à Fundability Criteria Worksheet_MediCoventures_v3.1
(20)
The Medical Device Milestone Map
The Medical Device Milestone Map
Rapid Diagnostic Test Kit Manufacturing Plant Project Report.pptx
Rapid Diagnostic Test Kit Manufacturing Plant Project Report.pptx
CLEA - Claims Cognitive Assistant
CLEA - Claims Cognitive Assistant
Aditxt, Inc. (NASDAQ: ADTX) Presentation
Aditxt, Inc. (NASDAQ: ADTX) Presentation
Product definition starting point for medical device manufacturing
Product definition starting point for medical device manufacturing
Developing Product Requirements For Medical Devices
Developing Product Requirements For Medical Devices
Shared Service Centers: Risks & Rewards in the Time of Coronavirus
Shared Service Centers: Risks & Rewards in the Time of Coronavirus
Building public-trust-eccles-en-2038
Building public-trust-eccles-en-2038
Detailed Project Report on Rapid Diagnostic Test Kit Manufacturing Unit Setup
Detailed Project Report on Rapid Diagnostic Test Kit Manufacturing Unit Setup
07 vteq
07 vteq
Requirements for reimbursement of new medical devices
Requirements for reimbursement of new medical devices
Project Report on Surgical Gloves Manufacturing Plant
Project Report on Surgical Gloves Manufacturing Plant
Effective Complaint Management: The Key to a Competitive Edge for Medical Dev...
Effective Complaint Management: The Key to a Competitive Edge for Medical Dev...
Kareo Award Write Up
Kareo Award Write Up
Seb corporate presentation june 2013
Seb corporate presentation june 2013
Aagami Inc. Research Services Presentation
Aagami Inc. Research Services Presentation
Module 8: Purchasing & Project Management Essentials
Module 8: Purchasing & Project Management Essentials
Customer insight presentation s houston - boston march 2014
Customer insight presentation s houston - boston march 2014
Detailed Project Report on Setting up a Door And Window Frames Manufacturing ...
Detailed Project Report on Setting up a Door And Window Frames Manufacturing ...
Best Practices and Points to Consider for Small-Medium Bio-Pharma Companies
Best Practices and Points to Consider for Small-Medium Bio-Pharma Companies
Fundability Criteria Worksheet_MediCoventures_v3.1
1.
Fundability Criteria Worksheet
v3.1 This worksheet is beingprovided by MediCoventures, LLC. ©All rights reserved Proprietary and Confidential 6/24/15- 1 - Fundability Criteria Worksheet Using this worksheet: The following worksheet is intended to aid medical device entrepreneurs in evaluating various key criteria necessary to reach fundability. Adequately addressing these criteria is the first step in appropriately evaluating a company or technology not only for fundability but also to validate whether founders’ time or money should be spent on the effort. This worksheet becomes the basis for the company’s business strategy including determining the next de-risking activities that should be accomplished and will aid with developing the appropriate business model, business plan and investor documentations moving forward. Current Status Describe the current status and value proposition in regards to the company or technology today Fundability Criteria Perform an in-depth evaluation of the fundability criteria Criteria Scoring Quantitatively score the criteria 1 2 3
2.
Fundability Criteria Worksheet
v3.1 This worksheet is beingprovided by MediCoventures, LLC. ©All rights reserved Proprietary and Confidential 6/24/15- 2 - Company Name Founder(s) name(s) and contact information Corporate status (LLC or C Corp? State of Incorporation) Existing shareholders and equity held Total capital raised and spent to date THE PROBLEM What problem does your company/product address? VALUE PROPOSITION How are you going to convince someone they should pay cash for your product? Define the core value proposition(s) that you plan to offer with your product. (This should not be a list of features) MILESTONES List any successes achieved to date and list all upcoming milestones including funding needs. 1 Current Status
3.
Fundability Criteria Worksheet
v3.1 This worksheet is beingprovided by MediCoventures, LLC. ©All rights reserved Proprietary and Confidential 6/24/15- 3 - The following provides a general outline of key criteria needing to be evaluated in order to begin to determine if your idea/company can become fundable. References should be documented for all data/information gathered. 1. CUSTOMER VALIDATION 4 2. MARKET SIZE 5 3. COMPETITION 6 4. IP POSITION 7 5. TECHNICAL FEASIBILITY 8 6. REGULATORY PATHWAY 9 7. CLINICAL FEASIBILITY 10 8. REIMBURSEMENT 11 2 Fundability Criteria
4.
Fundability Criteria Worksheet
v3.1 This worksheet is beingprovided by MediCoventures, LLC. ©All rights reserved Proprietary and Confidential 6/24/15- 4 - 1. CUSTOMER VALIDATION Speak with and list as many relevant customers’ feedback as possible from each customer segment. http://steveblank.com/category/life-sciences/ 1.1 Patients (end users or direct beneficiaries of thetechnology) 1.2 Physicians (the medical professional closest to theproblem) 1.3 Providers (surgery centers, hospitals…etc.) 1.4 Payers (health insurancepayers, ACOs…etc.) 1.5 Purchasers (thestrategic companies who could potentially acquirethe technology) 1.6 Customer adoption risks
5.
Fundability Criteria Worksheet
v3.1 This worksheet is beingprovided by MediCoventures, LLC. ©All rights reserved Proprietary and Confidential 6/24/15- 5 - 2. MARKET SIZE Determine how large the problem is and how much is being spent on a solution currently. 2.1 Patients and/or procedures annually (global and in theUS specifically) 2.2 Anticipated average sale price (ASP) 2.3 Annual market size (number of procedures x ASP (current or anticipated)) 2.4 Annual market growth rate (is your product goingto growthe market morequickly?) 2.5 Revenues at 1% market penetration 2.6 Market risks
6.
Fundability Criteria Worksheet
v3.1 This worksheet is beingprovided by MediCoventures, LLC. ©All rights reserved Proprietary and Confidential 6/24/15- 6 - 3. COMPETITION List and describe who is addressing or trying to address the same problem. Competitor 1 3.1 Description/Image 3.2 Advantages 3.3 Disadvantages/limitations 3.4 Traction to date (funding, clinical data, sales, market share…etc.) 3.5 ASP, and Sales Model (bundled, discounted on volume, capital equipment…etc.) 3.6 Marketing, branding, positioning 3.7 FDA indications 3.8 IP status 3.9 Other/Notes Competitor 2 3.1 Description/Image 3.2 Advantages 3.3 Disadvantages/limitations 3.4 Traction to date (funding, clinical data, sales, market share…etc.) 3.5 ASP, and Sales Model (bundled, discounted on volume, capital equipment…etc.) 3.6 Marketing, branding, positioning 3.7 FDA indications 3.8 IP status 3.9 Other/Notes
7.
Fundability Criteria Worksheet
v3.1 This worksheet is beingprovided by MediCoventures, LLC. ©All rights reserved Proprietary and Confidential 6/24/15- 7 - 4. IP POSITION List and describe the patent landscape and patent status. Will you own the space? Are there blocking patents you may end up infringing on? 4.1 Patent Landscape 4.2 IP Risks List relevant,andpotentiallycompeting,patentsorotherdisclosures. Number/ Assignee Title Summary Image Filing date/ Status
8.
Fundability Criteria Worksheet
v3.1 This worksheet is beingprovided by MediCoventures, LLC. ©All rights reserved Proprietary and Confidential 6/24/15- 8 - 5. TECHNICAL FEASIBILITY Describe the technical feasibility of the technology. This is from the engineers’ and manufacturers’ perspective. 5.1 Why it will work technically 5.2 Technical Risks
9.
Fundability Criteria Worksheet
v3.1 This worksheet is beingprovided by MediCoventures, LLC. ©All rights reserved Proprietary and Confidential 6/24/15- 9 - 6. REGULATORY PATHWAY Determine the regulatory pathway strategy and potential risks associated with it. 6.1 FDA Classification (class I, II or III?) 6.2 Predicate devices (look at competitivedevices that haveindications you will mimic) 6.3 Product classification 6.4 Is your product GMP exempt? 6.5 If 510k, is clinical data required? (Why, what typeand how much?) 6.6 If PMA, is a De Novo possible? 6.7 What are the regulatory risks?
10.
Fundability Criteria Worksheet
v3.1 This worksheet is beingprovided by MediCoventures, LLC. ©All rights reserved Proprietary and Confidential 6/24/15- 10 - 7. CLINICAL FEASIBILITY Describe the evidence that suggests the technology could be clinically feasible. (e.g. site journals, clinical studies, clinical experiences) 7.1 Physician workflow (Describethecurrent workflow and how your technology integrates or disrupts thatflow) 7.2 Why it will work clinically? 7.3 What are the clinical risks?
11.
Fundability Criteria Worksheet
v3.1 This worksheet is beingprovided by MediCoventures, LLC. ©All rights reserved Proprietary and Confidential 6/24/15- 11 - 8. REIMBURSEMENT List relevantreimbursementcodesandcostsummaries basedonCMSorotherdata regarding CPTs, APCs, DRGs…etc. Existence of reimbursement codes does not guarantee coverage or sufficient payment. If cash paying, delve into data regarding payment behaviors and pricing for the consumer. 8.1 List reimbursement codes 8.2 What are the coverage policies associated with this treatment? (e.g. Blue Cross) 8.3 What is the payment allowed under these codes? 8.4 What are the reimbursement risks? 8.5 Notes
12.
Fundability Criteria Worksheet
v3.1 This worksheet is beingprovided by MediCoventures, LLC. ©All rights reserved Proprietary and Confidential 6/24/15- 12 - Score Criteria 0 1 2 3 1. Customervalidation No customer excitement to purchase Hesitant interest to purchase or Not enough customer feedback to-date Masses haveexpressed interest to purchase Significant customers have agreed to purchase and/or are willing to invest 2. Market size (US only) Less than 80M 80M-200M 200M -500M Over 500M 3. Competition Single dominant competitor or Value proposition insufficient to compete Crowded market space Differentiation will be difficult Competitors exist but clinical improvements are still being sought Value proposition will easily displace any competition 4. IP Position No patentability or Freedom to operate No or weak patent applications or Provisionals only Non-provisional(s) filed and pending or Issued patents, but weak Strong, issued patents 5. Technical Feasibility Physics would have to be bent Will require large investments/research, Development will be cost prohibitive Some challenges but will be overcomewithtimeandwithin a reasonable cost Simple and straight forward design with known materials and methods 6. Regulatory Pathway Unclear regulatory pathway PMA 510k -clinical data needed or De Novo 510k - no clinical data needed Exempt 7. Clinical feasibility Clinical success unlikely Others have tried and failed Clinical success is unclear. Large patient volumes or long time- frame trials required Clinical success is likely but will require special expertise and/or research Clear path to clinical success Others have been clearly successful 8. Reimbursement Reimbursement unlikely no cash paying incentives New application to CMS necessary priorto any payments being issued Reimbursement could fall under an existing codebut a new code will eventually need to be filed Reimbursement readilyaccepted or patients are very incentivized to pay cash TOTAL (product) 3 Criteria Scoring
Télécharger maintenant