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UCSF Life Sciences Week 2 devices

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UCSF Life Sciences Week 2 devices

  1. UCSF Lean Launchpad For Life Science and Healthcare Startups Medical Device Track Class 2 Customer Segments October 8, 2013 Allan May Chairman, Life Science Angels amay@lifescienceangels.com UCSF Lean Launchpad - Allan May ©
  2. MEDICAL DEVICE MARKETS ARE OFTEN - BUT NOT ALWAYS - MULTI-SIDED MARKETS  The patient is the beneficiary of the device or service and must receive a clinical benefit  The physician is the device user  The hospital or physician practice is the economic buyer  Medicare or private insurance payor is the ultimate influencer of what gets purchased  The FDA determines what can be legally sold  CMS determines what Medicare pays for UCSF Lean Launchpad - Allan May ©
  3. MEDICAL DEVICE CUSTOMER SEGMENTS IN A NUTSHELL  FOLLOW THE MONEY!!!  Understand whether the device is reimbursed   Being covered in the hospital DRG is NOT reimbursement, it is an expense Unless you are replacing a device currently being used within a DRG at a lesser cost  Determine who the payor is  Understand the funds flow process  Understand who gets paid  Same physician, or shifting specialties (and so some other physician will no longer get paid) UCSF Lean Launchpad - Allan May ©
  4. PHYSICIANS AS CUSTOMERS?  Physicians often decide what device to use   Depends on where the physician works; how she is paid Hospital-based physicians are influencers (at best)  The ability of physicians to influence hospital purchasing decisions is evaporating    Novare vs. Intuitive Surgical Same cost versus higher cost – Figure 8 Private practice physicians are purchasers  Actually multiple physician specialties often influence the course of therapy of a patient  EG, LCP Pacemaker - GP; cardiologist; interventional cardiologist; electrophysiologist  Physician turf battlers are common  E.g., cardiac surgeons versus interventional cardiologists UCSF Lean Launchpad - Allan May ©
  5. PATIENTS AS CUSTOMERS?   Competing trends are at work Patients are far better informed and increasingly request specific devices and procedures  Can impact where substantial data exists as to clinical outcomes and benefits     Prostate or breast cancer therapy choices But, the evidence requirement for new devices or procedures is daunting Physicians often recommend existing or standard devices and procedures until the adverse effects of new technology (and how to handle those effects) are well known Out-of-pocket or self-pay usually dooms device business models   Cosmetic versus therapeutic procedures Check out impact of reimbursement and market size – InvisiAlign http://provider.invisalign.com/Pages/pay.aspx UCSF Lean Launchpad - Allan May ©
  6. HOSPITALS AS CUSTOMERS?  Hospital purchases are increasingly governed by “New Technology Committees”, who’s purpose is to keep new technologies out of hospitals  Hospitals purchase devices that are reimbursed  Hospitals will only purchase devices that claim to lower costs where those cost benefits are proven by hard data  and often still require onsite trials to verify data generated elsewhere  Who is the Customer in the hospital?  What exactly is the purchasing process, and who all are involved in that process? UCSF Lean Launchpad - Allan May ©
  7. UNDERSTANDING CUSTOMERS REQUIRES UNDERSTANDING REIMBURSEMENT  Existing reimbursement code versus new code versus not reimbursed  Re-engineer your product or solution if possible to still achieve Product Market Fit while falling under an existing code  BTW, ditto for falling under 510k versus PMA (more later)  Understand the length of time it takes to get a new code and when you are able to effectively start  Understand who owns the patient and the physician referral process UCSF Lean Launchpad - Allan May ©
  8. INTERVIEWING PHYSICIANS  You need to view one or more target procedures to be effective in speaking with physicians  Take a prototype or mockup to hand/show them  Animations and CAD CAM is good but not good enough  Physicians are all difficult to interview effectively, but surgeons tend to be harder than non surgeons  Physicians are scientists and tend to answer exactly what is asked, not interpret what you meant to ask  Physicians often believe they are better than their peers and so don’t experience the complications or adverse events that others might  How do they perform the procedure? How would they do it better? What changes would they like? Why UCSF Lean Launchpad - Allan May ©
  9. PHYSICIAN – PATIENT GAINS  Same or better clinical outcomes in a less invasive setting  Invasive → less invasive → non-invasive   Often involves a reduction in expense Some procedures move out of hospital surgery to outpatient and then back  Opens up previously untreatable patients to therapy  Increases procedure speed (reduces complexity or time)  Count steps in the existing procedure versus yours  No Harm, No Foul solutions UCSF Lean Launchpad - Allan May ©
  10. PHYSICIAN – PATIENT PAINS  Reduces mortality  Reduces morbidity  Complications, adverse events  Increases durability of procedure   Balloon angioplasty → stents → Drug Eluting Stents But re-occurrence can generate additional physician revenue  Prevents losing patient to another specialty UCSF Lean Launchpad - Allan May ©
  11. MEDICAL DEVICE MARKET TYPES For Physicians and Hospitals  Existing   Better clinical outcomes; same physician If moves procedure to new physician (cardiac surgeon to interventional cardiologist), will provoke a turf war between supporters and saboteurs  Carotid stenting  Resegmented  Niche products aimed at specific patient populations have long been successful  New  If and when reimbursed, the solution is embraced  Clone  Often done regarding procedures; rare in devices due to IP UCSF Lean Launchpad - Allan May ©
  12. MEDICAL DEVICE COMPANIES AS ULTIMATE “CUSTOMERS”  Almost all innovation in medical devices resulted in acquisitions by major strategics  In-house R&D innovation is negligible  Is it still possible to build a major standalone medical device company?   Will there be another J&J, Medtronic, GE? Manufacturing is local; marketing, sales and customer support are global  What pain or gain do you provide to the acquiror?  Why can’t they just do the same thing without you? UCSF Lean Launchpad - Allan May ©
  13. MEDICAL DEVICE MARKET TYPES For Major Medical Device Companies  Existing   Better clinical outcomes; same physician If moves procedure to new physician (cardiac surgeon to interventional cardiologist), can fall outside of ability of major companies to leverage existing sales and marketing infrastructure   Resegmented     This is a good place for startups But major device companies are pretty good at this also The key is to spot holes in their IP New    Surgeons versus interventionalists The Holy Grail for startups Pioneering often requires startup to build its own sales and marketing channel to enable the major company to enter the market Clone  Probably not a place for startups to play UCSF Lean Launchpad - Allan May ©
  14. GAINS AND PAINS TO ACQUIRORS  Leverage existing corporate resources and customer call points  Gain entry with new widget to sell rest of line  Facilitate upselling  Increase market size  Add to sales and profits   Don’t cannibalize existing markets Eventually this will fail as reverse innovation becomes a reality  Create new markets  Increase share relative to competitors UCSF Lean Launchpad - Allan May ©
  15. UCSF Lean Launchpad For Life Science and Healthcare Startups Medical Device Track Class 2 Customer Segments October 8, 2013 Allan May Chairman, Life Science Angels amay@lifescienceangels.com UCSF Lean Launchpad - Allan May ©

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