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Unformatted text preview: BME 416: BME 416: Development and Regulation of Medical Products
Professor Gerald E. Loeb Teaching Assistant Jeremy Fishel ….and some of the best guest lecturers in the business Invention Technology Push ⇛ ⇛ ⇛ ⇛ Market Pull Product Concept IP Research Basic Science Technology R&D GMP GLP IDE Prototype Development Preclinical Investigational GCP PMA Business Product Marketing Sales Reimbursement Surveillance Liability Origins of New Medical Devices Origins of New Medical Devices Academic Research Clinical Problem Solving Industrial Competition Progression to Rigor Breakthrough Technology Risk of New Treatment Known Risk of Disease Established Technology Empiricism Science-Based Innovation Characteristics
Many unknowns Unmet need Narrow indications No market Defined indications Track record of performance Evolved extrinsic factors Next-generational Drugs and Devices Differ Significantly! Drugs and Devices Differ Significantly!
Direct mechanism of action Site/organspecific therapy Uniform patient response to therapy (generally) High initial cost Automatic therapy Progressive efficacy improvement Nextgenerational costeffectiveness improvement Readily apparent response Drugs
Indirect mechanism of action Systemic treatment Variable patient response Dosing Sideeffects Metabolites, liver inactivation Costs accumulate over treatment Dependence on patient compliance Efficacy static Costeffectiveness relatively constant The observation, identification, The observation, identification, description, experimental investigation, and theoretical explanation of natural phenomena Success rests on science! Success rests on science!
“With the convergence of many scientific and technology breakthroughs, the pace of medical invention is accelerating, inspiring hope for better clinical outcomes with less invasive procedures and shorter recovery times, all in lower cost settings. There are powerful forces at work that are driving rapid fundamental change in healthcare delivery.” The Business of Science The Business of Science We are here to expand the boundaries of science and make a buck at the same time... The organized effort of individuals to produce and sell, for a profit, the goods and services that satisfy society’s needs The exchange of money for product, and the subsequent use of that money to produce and sell more product 2500 companies California Biomedical Industry Over 75 universities and private nonprofit research organizations Account for over 200,000 jobs 72% focus on devices and diagnostics 28% focus on biotech and pharma CBI Report Life Science Industry Clusters Source: Growing The Nation's Biotech Sector: A Regional Perspective, Battelle Technology Partnership, 2007 Southern California Biomedical Council January 15, 2008 UCSB Product Life Cycle Product Life Cycle
2 performance natural limit, technology 1 1 time Business Life Cycle Business Life Cycle performance profitable time Developing New Products Developing New Products requires a concerted and integrated effort by a range of experts often driven by marketing and manufacturing as well as research teams Teams the interface between Teams the interface between Business and Science Strategy and Tactics Intuition and Logic The Corporation and the functions A Balanced Approach A Balanced Approach Advocacy People Oriented Planning Generalist Facilitation Analytical Action Specialist Matrix Organization Matrix Organization
Product 1 Product 2 G&A S&M
Manuf/Ops Product 3 Defining the Product Defining the Product Both Customer and Company are Both Customer and Company are Important
Customer Needs Product Ideas Company Needs Evaluating customers’ needs Evaluating customers’ needs Who is the customer? Who are the users? What are the complaints about present products? What needs are not being met?
Venture Capitalists: “What is the pain?” Industrial Designers: “What are the requirements?” Evaluating company needs Evaluating company needs Profitability Image Strategic direction Capital situation Competitive environment Idiosyncratic factors Company Competency Company Competency What do we do well? What do we do badly? Where are we in the marketplace? What is our patent position? Who are our collaborators and allies? Vendor Competencies Vendor Competencies Can we get what we need to make the product?
cost of components reliability of vendors timelines critical points Competitor Competencies Competitor Competencies What are the strengths of competition? What are the weaknesses? What are the resources of the competition? What are the current market positions of competition? Can you Turn Ideas to Can you Turn Ideas to Products?
Company Vendor competency competency Ideas Technological Feasibility Competition 1. Characterize overall product 2. Plan the parts of the system 3. Plan the processes to make the elements 4. Plan the manufacturing procedures The set of organizations The set of organizations and rules that people invent to improve their quality of life. Healthcare is a huge part of quality of life, so societies have lots of organizations and rules that govern its delivery. Why medical Why medical products are so expensive… …and why they are worth it. Medical Implants: Some Examples Cardiac Rhythm Management Spinal Implants Deep Brain Stimulation Intraocular Lens Auditory Prosthesis Hip Implants Prosthetic Hip Joint Intravascular Stent Coronary Stents Drug Delivery Turning Turning an idea Investment into a business
Gross Profit Margin Non-Recurring Engineering: Production engineering Good Manufacturing Practice Regulatory approval Cost of Goods Academic Research Product Development Due Diligence Sales Marketing Clinical Support Intrinsic technology advances and extrinsic factors Intrinsic progressively improve ICD treatment efficacy and costeffectiveness. Evolutionary Improvements In Cost-Effectiveness
$/LYS (000) 50 40 30 20 10
00 Endocardial Leads < LOS Improved sensing Tiered therapy No EP study Epicardial 2 yr. battery Epicardial 4 yr. battery Increasing efficacy Costeffective Highly costeffective Cost saving
2000 Year -10 -20 1985 Case Example: Microelectronics advances sharply reduce internal current Case Example: drain to operate singlechamber bradycardia pacemakers, concurrently decreasing size and increasing functionality, reliability, and longevity. 35 Current Drain (μA) 30 25 20 15 10 5 0
30 Pacemaker Internal Current Drain vs. Year of Manufacture 22 Major increase in functionality 11 7
Discrete Components 7
Integrated Circuits 5 4 1965 1971 1974 1977 1980 1986 1995 Ohm, PACE, January 1997, pp 2-9 Case Example: Cardiac Pacemaker for Treatment of Bradycardia Case Example: Cardiac Pacemaker for Treatment of Bradycardia Technologic advances in leads/electrodes have reduced energy requirements to reliably stimulate the heart by two orders of magnitude.
(Composite effect of improved lead/electrode efficiency, stimulation patterns, increased understanding of stimulation physiology, and physician practice) Energy Consumption Per Pacing Stimulus (µJ) 80 70 60 50 40 30 20 10 0 75 50 25 25 6.2 2.2 0.75 1970 1975 1980 1985 1990 1995 Adapted from Ohm, Pace, Vol 20 1997 Intrinsic Example: Implantable Defibrillator (ICD) Intrinsic Example: Implantable Defibrillator (ICD)
Influence of ICD technology advance on costeffectiveness: Power Source Longevity
$/LYS (000) 35 30 25 20 15 10 5 0 Cost-Effectiveness 3 Year Longevity 8 Year Longevity Power Source Longevity “Clinicians and health economists need to be aware that the cost efficacy analysis should be used to guide the development of sensible clinical practice but it can easily be corrupted to a tool for crude rationing. Purchasers of health care should remember that, historically, technological advance has been the solution, not the problem.”
P. R. Roberts T. R. Betts J. M. Morgan
Wessex Cardiothoracic Center Southampton General Hospital, Southampton, U.K.
Eur Heart J, Vol. 21,issue 9, May 2000 Regulatory Process: Challenges Regulatory Process: Challenges Diversion of R&D funds from discovery to validation Favors incremental change over breakthroughs
Increased requirements drive up cost of trials Makes venture capital harder to raise Reduces effective life of intellectual property Shifts priorities to lowerrisk initiatives Getting products from ideastage to bedside in a timely manner.
Idea Testing FDA Medicare Patient The Goal The Goal Adapted from: Polidas, LLC So what is the recipe for So what is the recipe for success? Address areas of real and significant medical need Focus on the patient Create novel solutions Do high quality work Make rational and insightful decisions Know and follow society’s rules Deliver for shareholders and employees ...
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This note was uploaded on 06/08/2009 for the course BME 416 taught by Professor Loeb during the Spring '08 term at USC.
- Spring '08