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UCSF Life Sciences Week 2 Diagnostics


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UCSF Life Sciences Week 2 Diagnostics

  1. UCSF Lean LaunchPad For Life Sciences October 8, 2013 Todd Morrill Customer Segmentation Diagnostics Cohort D-1 1
  2. Customer interviews
  3. Customer interviews • • • • Draw them out Don’t worry about money Use google to find prospects Don’t piss me off
  4. Today • Value Proposition • BMC fit and fitness • What is a Customer Segment • Our cross to bear…
  5. Value Propositions are NOT complex • • • • • More accurate results, faster! Higher sensitivity with less sample volume Accurate ranking of treatment options Easy-to-use cosmic ray gun Portable nuclear warhead But the environment is… • VP maps onto CS • • No Value Proposition, no Customer Segment • Too many value propositions, not a Customer Segment VPs for each ‘customer’ in the ecosystem, to the extent possible 5
  7. Who is a Customer? • • • • Someone who has a NEED which can be satisfied by your VPs Someone who has a WANT which can be satisfied Someone who can be IDENTIFIED Someone who can be DIFFERENTIATED
  8. © 2012 Steve Blank
  9. Customer Archetype: Joe “Dude” Marrama • Loves to ski, surf, rock climb • Salary ~100K/year • Looking for something to do when the surf’s blown out • Intimidated by cost and learning curve of kiting “Companies need to offer more entry level packages." Matt Sexton Founder Collegiate Kiteboarding Association
  10. Results: Our Customers • Professional Kite Surfers • Solely concerned with performance • Average Kite Surfer • Performance and cost sensitive • “One less thing to carry” effect • Prospective Kite Surfer • Cost sensitive • Learning barrier
  11. Meet Xing Xie International Graduate Student at Stanford • Engineering graduate student Xing Art – Receives financial package to cover tuition, fees, insurance and living expenses • Chinese 4-2-1 family – No siblings, spoiled by parents – High disposable income • 1st time to America – No credit score, SSN, or US address – Strong ties to his community in China • Academically responsible – Completes all homework on time • Financially responsible – Pays all bills on time and in full • Social network is similarly responsible
  12. Customer Segments? • • • • • • x Kids Boys Adults Kids under 10 with disposable income (and who are thirsty) Boys who like to watch machines working, like the juicer machine Dads and Moms who are walking past our stand in the afternoon Consider ‘Un-customer segments’ 12
  13. Good segmentation? Need vs Want
  14. Definitions: Four Types of Markets Existing Market Resegmented Market New Market • Existing Market – Faster/Better = High end • Resegmented Market – Niche = marketing/branding driven – Cheaper = low end • New Market – Cheaper/good enough can create a new class of product/customer – Innovative/never existed before • Clone Market • Local adaptation Clone Market
  15. Because you are here..
  16. Because you are special… hypothesize now CLINICAL TRIALS IP REGULATION REIMBURSEMENT 16
  17. Know your regulator • Food and Drug Administration (FDA) – Center for Devices and Radiological Health • • • • • USDA European agencies (EMEA, national level) Japanese Ministry of Health and Welfare Chinese (SFDA) Health Canada
  18. Regulation • Invitro diagnostic products (IVD) are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. [21 CFR 809.3] • IVDs are medical devices as defined in section 210(h) of the Federal Food, Drug, and Cosmetic Act, and may also be biological products subject to section 351 of the Public Health Service Act. Like other medical devices, IVDs are subject to premarket and postmarket controls. IVDs are also subject to the Clinical Laboratory Improvement Amendments (CLIA '88) of 1988. • What isn’t an IVD? – – In vivo Treatments
  19. Regulatory classes for diagnostics • Class I (low to moderate risk): general controls • Class II (moderate to high risk): general controls and Special Controls (510(k)) aka PMN – – – – – • Performance standards Postmarket surveillance Patient registries Special labeling requirements Premarket data requirements Class III (high risk): general controls and Premarket Approval (PMA) – – Under federal law, class III devices are subject to approval of a Premarket Approval Application (PMA). Devices that are not within a type marketed before the date of the Medical Device Amendments of 1976 – referred to preamendments devices – are classified into class III automatically under federal law.. In addition, the FDA classifies into class III devices intended to be used in supporting or sustaining human life or preventing impairment of human health, or that may present a potential unreasonable risk of illness or injury for which general controls and special controls are insufficient to provide reasonable assurance of the safety and effectiveness of a device, or for which there is insufficient information to make such a determination.
  20. Believe it or not… Regulators are part of your customer set 1. Find out which regulator and sub-agency is likely to be yours 2. Find out the process for regulation and validation 3. Map them into your ecosystem
  21. Who pays for healthcare?
  22. What is Reimbursement? • Reimbursement for procedures and services performed by providers is made by commercial payers or federal intermediaries acting on behalf of a halfdozen programs. Reimbursement is based on claims and documentation filed by providers using medical diagnosis and procedure codes. • Commercial payers must use standards defined by the U.S. Department of Health and Human Services (HHS) but are largely regulated state-by-state. Save for specific national mandates such as reimbursement for childbirth, commercial payers determine their own rules of medical necessity or payment and reimbursement fee schedules. Federal intermediaries are regulated as contractors by the Centers for Medicare & Medicaid Services (CMS). • The Current Procedural Terminology (CPT) code set is a medical code set maintained by the American Medical Association. The CPT code set (copyright protected by the AMA) describes medical, surgical, and diagnostic services and is designed to communicate uniform information about medical services and procedures among physicians, coders, patients, accreditation organizations, and payers for administrative, financial, and analytical purposes
  23. Like it or not… Reimbursers and code allocators are part of your customer set 1. Find out which code groups you may fit into 2. Find out the value for them 3. Find out the process for assignment and approval 4. Map them into your ecosystem
  24. Next week • Standard slides as per the syllabus • Plus – Ecosystem overview – Regulation overview – Reimbursement overview