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    <title>LifeScience Alley Programs &amp; Events</title>
    <link>http://www.lifesciencealley.org/programs_events/</link>
    <description>LifeScience Alley Programs &amp; Events</description>
    <language>en-US</language>
    <pubDate>Fri, 12 Mar 2010 01:08:58 GMT</pubDate>
    <lastBuildDate>Fri, 12 Mar 2010 01:08:58 GMT</lastBuildDate>
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      <title>Unique Challenges of Marketing Biomedical Products: A Case Study</title>
      <description>Biotech products present unique marketing challenges.  This program will present a case study that details those challenges faced by BioE when defining and differentiating the company's cord blood processing system.  Gail Chrysler, RN, MBA, Vice President Cellular Technologies &amp; Clinical Affairs, will discuss the unique marketing needs faced by BioE, what was behind the decision to revamp their product's positioning and how their efforts impacted positioning and sales of their product.  Co-presenting will be Sandra Hansen Tollefson, Associate Creative Director at BioE's agency partner, StoneArch Creative. Sandra will discuss the creative process, share the tactics and detail the rationale behind the new positioning.</description>
      <link>http://www.lifesciencealley.org/programs_events/detail.aspx?id=478</link>
      <pubDate>Sat, 01 Jan 2000 08:00:00 GMT</pubDate>
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      <title>The Perfect Storm in Medtech: Will the U.S. Remain the Global Leader?</title>
      <description>LifeScience Alley will honor Josh Makower, MD, with a Luminary Award at a luncheon on March 17.  His keynote: &lt;B&gt;''The Perfect Storm in Medtech: Will the U.S. Remain the Global Leader?''&lt;/B&gt;  One of the country's most well-respected medtech entrepreneurs and most prolific inventors, Makower is known for founding ExploraMed biomedical incubator, co-creating Stanford University's Biodesign program, serving as a partner at New Enterprise Associates (NEA) and recently selling his company Acclarent for $785 million, making it one of the largest acquisitions of a privately-held medical device company in 2009.&lt;br&gt;&lt;br&gt;His passion is around keeping our medtech edge in the U.S.  Over the past 40 years the medical device industry has produced many technologies such as angioplasty, pacemakers, and others which have improved the quality of life of millions, while providing jobs and a core of economic growth within the U.S.  Today, however, the depressed financial climate, increasing hurdles for reimbursement, patent reform, and now, fundamental changes at the FDA threaten the delicate medtech ecosystem that has placed the U.S. ahead of all other countries in this area.  Reflecting on his experiences across several of his ventures, Josh will provide a medical entrepreneur's perspective on these issues and lay out his ideas for turning the tide.&lt;br&gt;&lt;br&gt;We thank the law firm of &lt;a href=http://www.faegre.com/&gt;Faegre &amp; Benson LLP&lt;/a&gt; for being the Lead Founding Sponsor of the LifeScience Alley Luminary Series.&lt;br&gt;&lt;br&gt;If you are interested in becoming a sponsor for this Luminary Luncheon, or future Luminary programs, please contact &lt;a href=mailto:dboyle@lifesciencealley.org&gt;Dana Boyle&lt;/a&gt;.</description>
      <link>http://www.lifesciencealley.org/programs_events/detail.aspx?id=459</link>
      <pubDate>Sat, 01 Jan 2000 08:00:00 GMT</pubDate>
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      <title>510(k) Under Assault - March Update from Washington D.C.</title>
      <description>In the last three weeks both the FDA and the Institute of Medicine (IOM) have held public meetings on the premarket clearance process for medical devices.  In this program Vincent Ventimiglia and Ralph Hall with the Washington D.C. and Minneapolis offices of Baker &amp; Daniels will provide the latest information following these critical FDA and IOM Meetings.  They will identify key emerging issues from the medical device industry's perspective and identity the next steps in the evaluation process.&lt;br&gt;&lt;br&gt;Prior to serving as Senior Vice President with B&amp;D Consulting's health and life sciences practice Vincent Ventimiglia was Assistant Secretary for Legislation at the U.S. Department of Health and Human Services (HHS).  He has also served as Health Policy Director for the U.S. Senate Committee on Health, Education, Labor, Pensions, as Policy Director for the U.S. Senate Committee on the Budget, and as the Director of Government Affairs at Medtronic, Inc.&lt;br&gt;&lt;br&gt;Ralph Hall has extensive experience in the areas of FDA, health care law and corporate compliance, the design and implementation of regulatory compliance programs, and with FDA enforcement actions.  Prior to rejoining Baker &amp; Daniels, Ralph was the Senior Vice President and Deputy General Counsel - Litigation and Compliance for Guidant Corporation. Ralph also serves as a Distinguished Visiting Practitioner and Professor at the University of Minnesota Law School where he teaches FDA law, corporate compliance, negotiation and alternative dispute resolution. &lt;br&gt;&lt;br&gt;&lt;B&gt;Topics&lt;/B&gt;&lt;br&gt;&amp;#8226; 	Understand what the FDA, IOM, and Congress are doing right now - who's in and who's out?&lt;br&gt;&amp;#8226; 		Indentify key issues for medical device companies&lt;br&gt;&amp;#8226; 		Understand the next steps in the evaluation process and what we can do</description>
      <link>http://www.lifesciencealley.org/programs_events/detail.aspx?id=482</link>
      <pubDate>Sat, 01 Jan 2000 08:00:00 GMT</pubDate>
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      <title>Statistics for Quality Program 1: Comparative Experiments - Demonstrating Change or Equivalence</title>
      <description>Statistics for Quality is a series of programs geared toward technical individuals who deal with data and make decisions based upon data. This includes scientists, engineers, technicians, and personnel from research and development, manufacturing, quality, analytical, engineering, supply management, and regulatory affairs departments. Statistics ''green belts'' and ''black belts'' will also benefit. &lt;font color=red&gt;If you wish to register for all six Statistics for Quality programs and save 10%, please follow the bundle link above.&lt;/font color&gt;&lt;br&gt;&lt;br&gt;&lt;B&gt;Program 1: Comparative Experiments - Demonstrating Change or Equivalence&lt;br&gt;March 19, 2010&lt;/B&gt;&lt;br&gt;&lt;br&gt;A common situation in industry is to conduct experiments to demonstrate that a change, perhaps an improvement, has occurred, or that no change has occurred, thereby establishing equivalence. Thus, comparative experiments are conducted to show that the new process has less variability than the old, that the new formulation is better than the old, or to show that two product designs or two measurement methods are equivalent. Such problems are often analyzed using a t-test, an F-test or an ANOVA. Such hypothesis tests, when blindly applied, can lead to disastrous results. For one company, this SOP caused an unnecessary delay of three months and an unnecessary expenditure of over $250,000! &lt;br&gt;&lt;br&gt;&lt;B&gt;The purpose of this seminar is to provide practical guidance to conduct comparative experiments, and answer questions such as:&lt;/B&gt;&lt;br&gt;&amp;#8226; What is wrong with the t-test and the F-test as usually practiced?&lt;br&gt;&amp;#8226; What to replace these tests with?&lt;br&gt;&amp;#8226; How to make multiple comparisons?&lt;br&gt;&amp;#8226; How much data to collect?&lt;br&gt;&amp;#8226; How to reduce sample sizes?&lt;br&gt;&amp;#8226; How to use software to design and analyze comparative experiments?</description>
      <link>http://www.lifesciencealley.org/programs_events/detail.aspx?id=463</link>
      <pubDate>Sat, 01 Jan 2000 08:00:00 GMT</pubDate>
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      <title>Avoiding Inadvertent Loss of European Patent Rights</title>
      <description>This presentation will begin with an overview of how the European patent system works. US inventors and assignee companies are often quite unaware of how very draconian the absolute novelty requirements are for European patents. US rules, in contrast, are extremely forgiving to the patent applicant. &lt;br&gt;&lt;br&gt;Based on the European Patent Convention and specific case law of the Boards of Appeal of the European Patent Office, this presentation will provide principles and guidelines for avoiding unnecessary loss of European patent rights. A number of  illustrative cases will be discussed where US patentees have lost their European patents. Development testing is one area where US inventors are caught unawares and inadvertently lose their European patent rights.  &lt;br&gt;&lt;br&gt;The presentation will also deal with other special aspects of patenting medical device inventions at the European Patent Office, including what is patentable and non-patentable in the medical device field. &lt;br&gt;&amp;#8226; Overview of the European Patent System&lt;br&gt;&amp;#8226; Avoid losing your European patent rights&lt;br&gt;&amp;#8226; US patent law is lenient to inventors&lt;br&gt;&amp;#8226; European patent law is draconian and considers disclosing acts in the US&lt;br&gt;&amp;#8226; Pre-patenting testing in developing medical devices</description>
      <link>http://www.lifesciencealley.org/programs_events/detail.aspx?id=453</link>
      <pubDate>Sat, 01 Jan 2000 08:00:00 GMT</pubDate>
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      <title>The Evolving Healthcare Industry: Effectively Navigating through Complexity</title>
      <description>The healthcare marketplace constitutes over two trillion dollars in the United States and several trillion spent throughout the world.  With growing demand for medical technology and the aging of the population, the scale and complexity of the healthcare supply chain is expected to dramatically increase over the next two decades.  The healthcare sector is comprised of several markets for goods and services, including physician services, hospital services, insurance, pharmaceuticals, medical devices, and information technology. This offering aims to provide a survey of the health sector to understand the scale, market opportunities, and barriers to entry within this expanding and global industry.&lt;br&gt;&lt;br&gt;&lt;B&gt;KEY TOPICS&lt;/B&gt;&lt;br&gt;&amp;#8226; Historical overview of the healthcare sector &lt;br&gt;&amp;#8226; Physician services market &lt;br&gt;&amp;#8226; Hospital services market &lt;br&gt;&amp;#8226; Insurance market &lt;br&gt;&amp;#8226; Medical devices and pharmaceuticals market &lt;br&gt;&amp;#8226; Healthcare information technology market &lt;br&gt;&amp;#8226; International healthcare markets &lt;br&gt;&amp;#8226; Impact of U.S. health reform initiatives &lt;br&gt;&lt;br&gt;&lt;B&gt;TUITION&lt;/B&gt;&lt;br&gt;$1,195&lt;br&gt;&lt;br&gt;&lt;B&gt;Tuition Discounts:&lt;/B&gt; Three or more people from the same company can submit their registrations together for a specific program and receive a 15% discount off the registration price. &lt;font color=purple&gt; LifeScience Alley members can receive a 10% discount on a single registration (reducing tuition to $1,075.50).  Contact Lauren Steffel to receive additional information at 952-542-3077.&lt;/font color&gt;</description>
      <link>http://www.lifesciencealley.org/programs_events/detail.aspx?id=444</link>
      <pubDate>Sat, 01 Jan 2000 08:00:00 GMT</pubDate>
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      <title>Comparative Effectiveness Research: Solution to Health Care Mess or Barrier to Innovation?</title>
      <description>Dr. Kent Bottles, President of the Institute for Clinical Systems Improvement (ICSI), will deliver an informative presentation on Comparative Effectiveness Research (CER). Although CER has been around for decades, it is suddenly on the front pages of the Wall Street Journal where the Courage study on cardiac stents is explored in great detail.  The proponents of CER, such as President Barack Obama and Budget Director Peter Orzag, think it is common sense that payers should only pay for medical care that clearly benefits the patient.  And if the estimates that 30% of medical care is unnecessary are accurate, then CER offers a way to solve the problem of the high cost of medicine and the impending bankruptcy of Medicare.  The skeptics of CER worry that it will stifle innovation and that politically and socially Americans are not ready for an institution like the UK's NICE.  It is a sure bet that rationing will come up during this spirited discussion that will involve audience members.</description>
      <link>http://www.lifesciencealley.org/programs_events/detail.aspx?id=479</link>
      <pubDate>Wed, 17 Feb 2010 08:00:00 GMT</pubDate>
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      <title>Conducting Market Research on a Budget</title>
      <description>Think you can't afford market research? Think again!  Whether you are a small start-up company or a larger company facing tight budgets, you can still obtain valuable insights by conducting affordable market research.  &lt;br&gt;&lt;br&gt;This seminar will discuss practical budget-conscious marketing research options such as Do-It-Yourself programs, utilizing Advisory Boards, modified study designs, and discussions on which methodologies are the most effective in today's marketplace. Case studies and a question and answer period will also be included.</description>
      <link>http://www.lifesciencealley.org/programs_events/detail.aspx?id=480</link>
      <pubDate>Sat, 01 Jan 2000 08:00:00 GMT</pubDate>
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      <title>Statistics for Quality Program 2: Screening Experiments - The Heart of DOE</title>
      <description>Statistics for Quality is a series of programs geared toward technical individuals who deal with data and make decisions based upon data. This includes scientists, engineers, technicians, and personnel from research and development, manufacturing, quality, analytical, engineering, supply management, and regulatory affairs departments. Statistics ''green belts'' and ''black belts'' will also benefit. &lt;font color=red&gt;If you wish to register for all six Statistics for Quality programs and save 10%, please follow the bundle link above.&lt;/font color&gt;&lt;br&gt;&lt;br&gt;&lt;B&gt;Program 2: Screening Experiments - the Heart of DOE&lt;br&gt;March 26, 2010&lt;/B&gt;&lt;br&gt;&lt;br&gt;Product and process development requires identification of key factors that control product and process performance. Screening experiments efficiently identify key factors and interactions. They provide a way to optimize product and process designs, and to troubleshoot manufacturing. Screening experiments are the most important class of designed experiments (DOE), and help shorten development cycle time and costs. Unfortunately, much product and process development proceeds using one-factor-at-a-time or other ad-hoc experimentation strategies - approaches that provide less information at higher cost.  On the other hand, screening experiments, properly applied, have resulted in reducing development cycle times and designing robust measurement systems.&lt;br&gt;&lt;br&gt;&lt;B&gt;The purpose of this seminar is to provide practical guidance on the effective use of screening experiments, by answering questions such as:&lt;/B&gt;&lt;br&gt;&amp;#8226; Why design experiments?&lt;br&gt;&amp;#8226; What are factorial designs?&lt;br&gt;&amp;#8226; What to think about to make the screening experiment successful?&lt;br&gt;&amp;#8226; How to evaluate a large number of factors with a fractional factorial design?&lt;br&gt;&amp;#8226; How to design robust products and processes?&lt;br&gt;&amp;#8226; How to easily implement screening experiments using software?</description>
      <link>http://www.lifesciencealley.org/programs_events/detail.aspx?id=464</link>
      <pubDate>Sat, 01 Jan 2000 08:00:00 GMT</pubDate>
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      <title>The Science of Market Development</title>
      <description>Only 12% of medical technologies generate significant returns to their investors, and 50% fail outright.&lt;br&gt;&lt;I&gt;-''Patient Capital: How Venture Capital Investment Drives Revolutionary Medical Innovation,'' National Venture Capital Association's Medical Industry Group. www.nvca.org&lt;/I&gt;&lt;br&gt;&lt;br&gt;Navigating a medical technology to achieve its full commercial potential with limited resources is a significant challenge. In such a complex market, management must usually rely on incomplete and imperfect information to guide critical decision making. &lt;br&gt;&lt;br&gt;Dymedex Consulting has developed unique methods for reducing uncertainty and enhancing your odds of commercial success. They have personally orchestrated over 100 unique medical technology adoption assessments in more than 20 different geographies. Based on this pioneering work, Dymedex has identified and statistically validated the factors that predict failure of - and drive rapid success of - medical technologies.&lt;br&gt;&lt;br&gt;This course content is applicable to all medical technologies whether they are at the concept stage, newly released, struggling to grow, or seemingly on the fast track.&lt;br&gt;&lt;br&gt;&lt;B&gt;&lt;I&gt;''Innovative and disciplined approach to a critical element of emerging growth businesses that goes to the foundation of resource prioritization, investment, expectations and outcomes.''&lt;br&gt;           Bob Paulson - CEO, NxThera &lt;/I&gt; &lt;/B&gt;&lt;br&gt;&lt;br&gt;Attendees will learn specific techniques and insights that have been proven to enable better strategic decision making:&lt;br&gt;&amp;#8226; Defining (and addressing) the key barriers to adoption that constrain higher growth rates&lt;br&gt;&amp;#8226; Quickly recognizing the unavoidable boundaries that limit a market opportunity&lt;br&gt;&amp;#8226; Understanding which technology characteristics can radically influence physician adoption&lt;br&gt;&amp;#8226; Synthesizing high level variables to create more accurate revenue forecasts&lt;br&gt;&amp;#8226; Quantifying trade-offs across investment options and their impact on revenue growth&lt;br&gt;&lt;br&gt;The intended audience for this one-day in-depth program includes seasoned medical device/technology marketing and market development managers, and senior leaders of small to medium size medical device companies. Anyone responsible for setting strategic direction and delivering top-line performance in uncertain markets will benefit from this content-rich program.</description>
      <link>http://www.lifesciencealley.org/programs_events/detail.aspx?id=475</link>
      <pubDate>Sat, 01 Jan 2000 08:00:00 GMT</pubDate>
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      <title>Where Farm Meets Pharma: Xenotransplantation Product Manufacturing and Regulations</title>
      <description>A future cure for diabetes potentially hinges on cell therapies.  Xenotransplantation of porcine islet cells is a highly anticipated cure.  Transmission of infections from donor organs and tissues is a well-recognized cause of disease in allotransplantation.  Similarly, concern regarding infectious transmission of disease through organs or tissues following xenotransplantation has led to public and regulatory agency debate as to whether the field of xenotransplantation should be permitted to progress.  The FDA has addressed these concerns through a series of guidelines outlining manufacturing requirements of xenotransplantation products.  FDA guidance has contributed to a recent international Communique sponsored by the World Health Organization and a consensus statement by the International Xenotransplantation Association.&lt;br&gt;&lt;br&gt;Source animal and cell production facilities that are Designated Pathogen Free (DPF), meeting FDA guidelines including manufacturing under cGMP regulations, are a crucial step in making xenotransplantation a clinical reality.  We have established a DPF swine herd for use in xenotransplantation pre-clinical and clinical studies, and have maintained the facility and swine breeding stock at DPF status.  Key components in establishing the manufacturing process were; 1) developing the appropriate environmental, containment, and standard operating procedures to maintain and monitor the production herd, 2) introduction of DPF animals into the production facility, 3) developing manufacturing procedures to harvest porcine pancreata for subsequent islet product preparation prior to transplantation into diabetic patients.</description>
      <link>http://www.lifesciencealley.org/programs_events/detail.aspx?id=481</link>
      <pubDate>Sat, 01 Jan 2000 08:00:00 GMT</pubDate>
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      <title>Alley Chats - Pace Analytical Life Sciences</title>
      <description>Join your fellow LifeScience Alley members for an evening of high impact networking hosted by &lt;a href=http://www.pacelabs.com/&gt;Pace Analytical Life Sciences&lt;/a&gt;.  Event price of $25 includes complimentary hors d'oeuvres. &lt;br&gt;&lt;br&gt;Alley Chats is a members-only networking and resource building event. By attending Alley Chats, you will develop new relationships to help you do your job better and generate potential new partnerships and ideas.  This is also an opportunity to share your expertise and knowledge with others.  &lt;br&gt;&lt;br&gt;Many thanks to our host, &lt;a href=http://www.pacelabs.com/&gt;Pace Analytical Life Sciences&lt;/a&gt;, and our sponsor &lt;a href=http://www.slwip.com/&gt;Schwegman, Lundberg &amp; Woessner, PA&lt;/a&gt; for making Alley Chats possible.&lt;br&gt;&lt;br&gt;&lt;B&gt;&lt;font color=purple&gt;One sponsorship still remains - &lt;a href= https://www.lifesciencealley.org/content/documents/Alley%20Chats%20Sponsorship%20Overview%20&amp;%20Sign-up%202010.pdf&gt;click here for details&lt;/a&gt;. Please contact Frank Jaskulke at 952-746-3814 with questions or to reserve your spot.&lt;/B&gt;&lt;/font color&gt;</description>
      <link>http://www.lifesciencealley.org/programs_events/detail.aspx?id=461</link>
      <pubDate>Sat, 01 Jan 2000 08:00:00 GMT</pubDate>
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      <title>Statistics for Quality Program 3: Setting Specifications</title>
      <description>Statistics for Quality is a series of programs geared toward technical individuals who deal with data and make decisions based upon data. This includes scientists, engineers, technicians, and personnel from research and development, manufacturing, quality, analytical, engineering, supply management, and regulatory affairs departments. Statistics ''green belts'' and ''black belts'' will also benefit. &lt;font color=red&gt;If you wish to register for all six Statistics for Quality programs and save 10%, please follow the bundle link above.&lt;/font color&gt;&lt;br&gt;&lt;br&gt;&lt;B&gt;Program 3: Setting Specifications&lt;br&gt;April 9, 2010&lt;/B&gt;&lt;br&gt;&lt;br&gt;One key objective in R&amp;D is to establish specifications for final product, in-process and raw material characteristics. There are two fundamentally different ways to set specifications: based upon functional relationships, and based purely upon data collected on the characteristic for which the specification is desired. Despite the fact that considerable attention is devoted to this subject in industry, specifications are often rather poorly set. This can result in setting arbitrary specifications, for characteristics that may or may not even be important. Once set, the specifications can be difficult to change. Badly defined, sometimes mismatched specifications lead to costly consequences.&lt;br&gt;&lt;br&gt;&lt;B&gt;The purpose of this seminar is to provide practical guidance regarding effective ways of setting specifications by answering questions such as:&lt;/B&gt;&lt;br&gt;&amp;#8226; How to set specifications when the only available data is the characteristic for which the specification is desired?&lt;br&gt;&amp;#8226; How to set specification by obtaining a functional relationship between an input and output characteristic?&lt;br&gt;&amp;#8226; How to set functional specifications when there are multiple input and output characteristics?&lt;br&gt;&amp;#8226; How to use software to implement the necessary statistical tools to develop specifications?</description>
      <link>http://www.lifesciencealley.org/programs_events/detail.aspx?id=465</link>
      <pubDate>Sat, 01 Jan 2000 08:00:00 GMT</pubDate>
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      <title>Design of Medical Devices Conference</title>
      <description>The University of Minnesota's Institute for Engineering in Medicine's Medical Devices Center, the Institute of Technology, and the Academic Health Center present the 9th annual Design of Medical Devices Conference. The conference will be held April 13-15, 2010 at the Radisson University Hotel, 615 Washington Ave. SE, Minneapolis, Minnesota 55414, adjacent to the University of Minnesota campus.&lt;br&gt;&lt;br&gt;&lt;b&gt;Conference Goals&lt;/b&gt;&lt;br&gt;&lt;ul&gt;&lt;li&gt;Promote the medical device industry&lt;br&gt;&lt;li&gt;Provide a forum to bring medical device designers, manufacturers, researchers, and representatives from the public sector together to share perspectives on medical devices&lt;br&gt;&lt;li&gt;Raise funds from corporate sponsorships to endow graduate fellowships in medical device design&lt;/ul&gt;&lt;br&gt;&lt;b&gt;Format/Topics&lt;/b&gt;&lt;br&gt;The world's premiere medical devices conference consists of three-days of multiple scientific poster sessions and technical/scientific sessions with topics such as:&lt;br&gt;&lt;br&gt;&lt;ul&gt;&lt;li&gt;Live Surgery&lt;br&gt;&lt;li&gt;Cardiovascular Engineering&lt;br&gt;&lt;li&gt;Neuroengineering&lt;br&gt;&lt;li&gt;Nano/MEMS Devices&lt;br&gt;&lt;li&gt;Medical Electronics&lt;br&gt;&lt;li&gt;Technology Assessment&lt;br&gt;&lt;li&gt;Human Factors&lt;br&gt;&lt;li&gt;Orthopedics&lt;br&gt;&lt;li&gt;Surgical Simulators&lt;br&gt;&lt;li&gt;Health Informatics&lt;br&gt;&lt;li&gt;Surgical Tools&lt;br&gt;&lt;li&gt;Government Funding&lt;br&gt;&lt;li&gt;Legal/Regulatory Issues&lt;br&gt;&lt;li&gt;Innovation and Design&lt;br&gt;&lt;li&gt;Tissue Engineering&lt;br&gt;&lt;li&gt;Healthcare Reform&lt;br&gt;&lt;li&gt;Medical Technology&lt;br&gt;&lt;li&gt;Engineering in Urology&lt;/ul</description>
      <link>http://www.lifesciencealley.org/programs_events/detail.aspx?id=471</link>
      <pubDate>Mon, 01 Feb 2010 08:00:00 GMT</pubDate>
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      <title>Statistics for Quality Program 4: Process Validation and Acceptance Sampling</title>
      <description>Statistics for Quality is a series of programs geared toward technical individuals who deal with data and make decisions based upon data. This includes scientists, engineers, technicians, and personnel from research and development, manufacturing, quality, analytical, engineering, supply management, and regulatory affairs departments. Statistics ''green belts'' and ''black belts'' will also benefit. &lt;font color=red&gt;If you wish to register for all six Statistics for Quality programs and save 10%, please follow the bundle link above.&lt;/font color&gt;&lt;br&gt;&lt;br&gt;&lt;B&gt;Program 4: Process Validation and Acceptance Sampling&lt;br&gt;April 16, 2010&lt;/B&gt;&lt;br&gt;&lt;br&gt;Acceptance sampling plans are routinely used to accept or reject incoming raw material lots, in-process lots and finished product lots. There is often some misunderstanding in industry regarding how best to design such plans and the protection that they provide. One purpose of this seminar is to remove these misconceptions and to present a practical approach to design acceptance sampling plans. Process validation studies are routinely conducted to provide assurance that the process is ready to be used for manufacturing. Many different approaches are used in industry to design and analyze process validation studies.&lt;br&gt;&lt;br&gt;&lt;B&gt;The purpose of this seminar is to provide practical guidance for the design of process validation studies and acceptance sampling plans, by answering questions such as: &lt;/B&gt;&lt;br&gt;&amp;#8226; How are attribute and variable sampling plans usually designed?&lt;br&gt;&amp;#8226; What is the most important information you need to know to design acceptance sampling plans and how to get it?&lt;br&gt;&amp;#8226; What is the practical approach to design acceptance sampling plans to reduce risks and costs?&lt;br&gt;&amp;#8226; What is the connection between acceptance sampling plans and process validation?&lt;br&gt;&amp;#8226; What is the practical approach to design a process validation study to reduce the risk of failing validation while reducing the cost of sampling?&lt;br&gt;&amp;#8226; How to use software to design sampling plans and validation studies?</description>
      <link>http://www.lifesciencealley.org/programs_events/detail.aspx?id=466</link>
      <pubDate>Sat, 01 Jan 2000 08:00:00 GMT</pubDate>
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      <title>Statistics for Quality Program 5: Managing and Improving Processes</title>
      <description>Statistics for Quality is a series of programs geared toward technical individuals who deal with data and make decisions based upon data. This includes scientists, engineers, technicians, and personnel from research and development, manufacturing, quality, analytical, engineering, supply management, and regulatory affairs departments. Statistics ''green belts'' and ''black belts'' will also benefit. &lt;font color=red&gt;If you wish to register for all six Statistics for Quality programs and save 10%, please follow the bundle link above.&lt;/font color&gt;&lt;br&gt;&lt;br&gt;&lt;B&gt;Program 5: Managing and Improving Processes&lt;br&gt;April 23, 2010&lt;/B&gt;&lt;br&gt;&lt;br&gt;Control charts are implemented in manufacturing with the hope of improving manufacturing processes, but control charts can deliver on this promise only if the manufacturing process meets certain criteria. Capability and performance indices can be used as an at-a-glance-display to rapidly determine whether the process meets these criteria, namely, where control charts may be the effective process management tool and where other statistical tools need to be used. Variance components analysis is one such statistical tool that provides the detailed information necessary to make cost effective process improvements. Using the ideas presented here the manufacturing department of one company was able to quickly develop and implement a focused quality improvement plan. The quality department of another company reduced their voluminous quarterly quality reports while getting greater management attention to the true quality issues. &lt;br&gt;&lt;br&gt;&lt;B&gt;The purpose of this seminar is to provide practical guidance on the use of statistical tools to cost-effectively manage and improve processes by answering questions such as:&lt;/B&gt;&lt;br&gt;&amp;#8226; What is the logic behind control charts and how to select the proper chart?&lt;br&gt;&amp;#8226; What are the four process capability and performance indices?&lt;br&gt;&amp;#8226; How to use these indices as an at-a-glance-display to manage and improve processes?&lt;br&gt;&amp;#8226; How to use variance components analysis to estimate the % of variability caused by each cause?&lt;br&gt;&amp;#8226; How to target variance reduction efforts most cost-effectively?&lt;br&gt;&amp;#8226; How to use software to implement this methodology?</description>
      <link>http://www.lifesciencealley.org/programs_events/detail.aspx?id=467</link>
      <pubDate>Sat, 01 Jan 2000 08:00:00 GMT</pubDate>
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      <title>Don't Take the Risk! Not All Software are Created Equal</title>
      <description>CEOs, Inventors, Engineers, Engineering Managers, and Regulatory Managers - don't miss this powerful half-day seminar that will provide a mind-exchange on the hot topic of software risk management. Dr. Darkazanli of Boston Scientific will lead a team of experts in a session where you will:&lt;br&gt;&lt;br&gt;&amp;#8226; 	Learn how Dr. Birali - of the University of Minnesota's Department of Supercomputing - and his team are using High Performance Computing for simulation-based design and optimization of medical devices.&lt;br&gt;&amp;#8226; 	Find out the software risk management issues for medical devices - ask Dr. Andy Anderson, Regulatory Affairs Principal Advisor at Regulatory and Clinical Research Institute, Inc. (RCRI) about regulatory considerations.&lt;br&gt;&amp;#8226; 	Discuss software validation considerations with Russell Olson, Regulatory Affairs Senior Principal Advisor, RCRI, Inc. &lt;br&gt;&amp;#8226; 	Learn Design Verification Test considerations with Greg Schultz co-founder and co-owner of Design Solutions, Inc.</description>
      <link>http://www.lifesciencealley.org/programs_events/detail.aspx?id=483</link>
      <pubDate>Sat, 01 Jan 2000 08:00:00 GMT</pubDate>
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      <title>Statistics for Quality Program 6: Measurement Systems Analysis</title>
      <description>Statistics for Quality is a series of programs geared toward technical individuals who deal with data and make decisions based upon data. This includes scientists, engineers, technicians, and personnel from research and development, manufacturing, quality, analytical, engineering, supply management, and regulatory affairs departments. Statistics ''green belts'' and ''black belts'' will also benefit.  &lt;font color=red&gt;If you wish to register for all six Statistics for Quality programs and save 10%, please follow the bundle link above.&lt;/font color&gt;&lt;br&gt;&lt;br&gt;&lt;B&gt;Program 6: Measurement Systems Analysis&lt;br&gt;April 30, 2010&lt;/B&gt;&lt;br&gt;&lt;br&gt;Measurement systems serve two decision-making purposes: they are used to make specification related (accept/reject) decisions, and to make product &amp; process improvement decisions. Large measurement variability and inaccuracy can lead to wrong decisions and significantly increase product and process development cycle times and costs. With a single application of measurement systems analysis, one company reduced measurement standard deviation by over 50%, resulting in smaller sample sizes and faster product development. A second company avoided costly wrong decisions and delays by the proper analysis of method transfer data.&lt;br&gt;&lt;br&gt;&lt;B&gt;The purpose of this seminar is to provide practical guidance to conduct measurement systems analysis and answer questions such as:&lt;/B&gt;&lt;br&gt;&amp;#8226; What are the acceptance criteria for measurement system variability and bias?&lt;br&gt;&amp;#8226; How do these criteria differ for destructive and non-destructive measurements?&lt;br&gt;&amp;#8226; How to design measurement system validation studies?&lt;br&gt;&amp;#8226; How to statistically assess if the measurement system is adequate for the task?&lt;br&gt;&amp;#8226; How to improve the measurement system?&lt;br&gt;&amp;#8226; How to use software to conduct measurement systems analysis?</description>
      <link>http://www.lifesciencealley.org/programs_events/detail.aspx?id=468</link>
      <pubDate>Sat, 01 Jan 2000 08:00:00 GMT</pubDate>
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      <title>BIO International Convention</title>
      <description>The &lt;a href=http://convention.bio.org/&gt;BIO International Convention&lt;/a&gt; is the largest global event for the biotechnology industry and attracts the biggest names in biotech, offers key networking and partnering opportunities, and provides insights and inspiration on the major trends affecting the industry.   The event features keynotes and sessions from key policymakers, scientists, CEOs, and celebrities.  For the past nine years, Minnesota has had a strong and growing presence at BIO.&lt;br&gt;&lt;br&gt;As the largest state affiliate of &lt;a href=http://www.bio.org/&gt;BIO&lt;/a&gt;, LifeScience Alley works in partnership with the Minnesota Department of Employment and Economic Development (DEED) and the BioBusiness Alliance of Minnesota to have a strong presence for our state.  We hope you will consider joining Minnesota's bio business leaders in Chicago for BIO 2010 and take advantage of this great opportunity to deliver your message to 15,000+ conference participants at the Minnesota Pavilion.  &lt;font color=purple&gt;Exhibitor information is now available.&lt;/font color&gt;  &lt;a href=https://www.lifesciencealley.org/content/documents/2010_BIO_sponsorship.pdf&gt;Click here to download information.&lt;/a&gt;  To reserve your place or ask questions, please contact Sarah Walbert, Bioscience/Medical Device Specialist, DEED at 651-259-7442 or &lt;a href=mailto: Sarah.Walbert@state.mn.us&gt;Sarah.Walbert@state.mn.us&lt;/a&gt;    &lt;br&gt;&lt;br&gt;For BIO convention registration information, go to &lt;a href=http://convention.bio.org/register/&gt;http://convention.bio.org/register&lt;/a&gt;   (Note that you must be a member of BIO to receive the discounted registration rate).</description>
      <link>http://www.lifesciencealley.org/programs_events/detail.aspx?id=472</link>
      <pubDate>Sat, 01 Jan 2000 08:00:00 GMT</pubDate>
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      <title>Effective Project Leaders = Successful Projects</title>
      <description>There are many challenges to leading a successful project. The overarching issue, however, comes down to your ability to lead others. It's more critical to learn how to manage upward, downward and side to side than ever before. &lt;B&gt;That's exactly what you'll learn in this training workshop.&lt;/B&gt; It's not about working harder. Instead it's about honing your ability to learn and lead. Then it's about creating the conditions so that others enjoy success all around you.&lt;br&gt;&lt;br&gt;Project leadership skills and tools are the focus of the class rather than pure project management or administration tools. The class is highly interactive, providing everyone the opportunity to both learn from and share their experiences and knowledge. At the end of each topic, the class identifies key points that can be taken away from the class and productively used tomorrow! &lt;br&gt;&lt;br&gt;&lt;B&gt;Focus Areas&lt;/B&gt;&lt;br&gt;&amp;#8226; Define the project&lt;br&gt;&amp;#8226; Create the Credible Schedule&lt;br&gt;&amp;#8226; Manage Scope Creep&lt;br&gt;&amp;#8226; Communications is the Currency of Leadership&lt;br&gt;&amp;#8226; Build and Manage Team&lt;br&gt;&amp;#8226; Anticipate and Manage - Risk and Opportunity&lt;br&gt;&amp;#8226; Execute to Plan&lt;br&gt;&amp;#8226; Close the Project &lt;br&gt;&lt;br&gt;The target participant for this workshop include moderate to experienced project leaders and mangers from manufacturing, logistics, marketing, product development, quality assurance, IT, finance, and other domains. This is a great chance for project leaders to interact with peers from other domains and better understand shared issues and challenges. &lt;br&gt;&lt;br&gt;&lt;I&gt;''PLS's Project leadership class focused on the critical balance between people, tasks, communication and personal accountability.  In one day, it highlighted many of the key learnings I have experienced over 25 years of leading projects.  Appropriate for experienced senior project leaders, entry level project leaders and senior management.  A great class to use as to kick off a large project.''&lt;/I&gt;&lt;br&gt;&lt;B&gt;- IT ERP Business Integration Project Leader, Fortune 500 Food Company&lt;/B&gt;&lt;br&gt;&lt;br&gt;&lt;I&gt;''I found the Project Leadership class led by PLS to be extremely helpful in developing my skills in program management.  Unlike other courses I've taken, the PLS class focuses on actionable skills rather than abstract theory.  Those skills are reinforced with group work on case studies throughout the class. The group left energized and ready to go apply new knowledge back on their various projects.''&lt;/I&gt;&lt;br&gt;&lt;B&gt;- Sr. Product Development Manager, St. Jude Medical&lt;/B&gt;&lt;br&gt;&lt;br&gt;&lt;B&gt;For those participants that are PMI certified, this course is accepted for 8 hrs of PDU credit. &lt;/B&gt;&lt;br&gt;&lt;br&gt;&lt;B&gt;&lt;font color=purple&gt;Fees will be waived for the 4th participant from the same company. &lt;/font color&gt;&lt;/B&gt;Please contact Lauren Steffel &lt;a href=mailto:lsteffel@lifesciencealley.org&gt;lsteffel@lifesciencealley.org&lt;/a&gt; to enroll the 4th attendee or to inquire about additional registrants. &lt;br&gt;&lt;br&gt;Course materials will be sent by PLS instructors prior to the start of the workshop. Project Leadership Services, Inc. (PLS) provides consulting services focused on project leadership, mentoring, temporary management, and business process re-engineering.  &lt;a href=http://www.plsweb.net&gt;Visit their website.&lt;/a&gt;</description>
      <link>http://www.lifesciencealley.org/programs_events/detail.aspx?id=477</link>
      <pubDate>Sat, 01 Jan 2000 08:00:00 GMT</pubDate>
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      <title>Game Changing Negotiations in the Medical Industry</title>
      <description>Negotiation is the art and science of securing agreements between two or more parties. It is a skill that is central to all occupations and one that is used every single day. This course offers negotiation strategies for health care professionals designed to provide immediate benefits to many stakeholders in this complex industry. It will provide you with knowledge of a wide variety of powerful and practical negotiation skills, and an opportunity to practice these skills in several experiential exercises.&lt;br&gt;&lt;br&gt;&lt;B&gt;KEY TOPICS&lt;/B&gt;&lt;br&gt;&amp;#8226; Stakeholders in the multi-trillion dollar health care sector in active negotiations &lt;br&gt;&amp;#8226; Creating and Capturing Value in Negotiation &lt;br&gt;&amp;#8226; Strategies &amp; tactics of distributive (win-lose) negotiations &lt;br&gt;&amp;#8226; Strategies &amp; tactics of integrative (win-win) negotiations &lt;br&gt;&amp;#8226; Understanding the dynamics of conflict in a negotiation &lt;br&gt;&amp;#8226; Learning your conflict management style and the impact it has on your choice of strategies &amp; tactics in negotiation &lt;br&gt;&lt;br&gt;&lt;B&gt;TUITION&lt;/B&gt;&lt;br&gt;$1,195&lt;br&gt;&lt;br&gt;&lt;B&gt;Tuition Discounts:&lt;/B&gt; Three or more people from the same company can submit their registrations together for a specific program and receive a 15% discount off the registration price. &lt;font color=purple&gt; LifeScience Alley members can receive a 10% discount on a single registration (reducing tuition to $1,075.50).  Contact Lauren Steffel to receive additional information at 952-542-3077.&lt;/font color&gt;</description>
      <link>http://www.lifesciencealley.org/programs_events/detail.aspx?id=470</link>
      <pubDate>Sat, 01 Jan 2000 08:00:00 GMT</pubDate>
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      <title>9th Annual MedTech Investing Conference</title>
      <description>As the rapidly growing US approval window closes from increasing regulatory hurdles, medical device start-ups are adopting OUS (Outside the US) strategies to accelerate time to market.  The goal of the MedTech Investing Conference is to unite national VCs, corporate investors and other private equity investors to provide deal flow, co-investing, syndication opportunities and to provide emerging growth companies with access to this investor base.  This year's conference will focus on Navigating the Changing Landscape and will address topics such as Investment Trends, Regulatory Issues and Global Opportunities. International Business Forum and LifeScience Alley co-present this conference each year as a central gathering for leading MedTech VCs, CEOs, Strategic Players, and Investment Bankers to facilitate deals, share information, address concerns and explore new opportunities.  &lt;br&gt;&lt;br&gt;&lt;font color=purple&gt;LifeScience Alley members receive 50% off the general registration rate ($1,295) and Technology Start-up rate ($895).  &lt;/font color&gt;Be sure to enter discount code ''LSAWB'' when registering at &lt;a href=http://www.medtechconference.com/&gt;www.medtechconference.com&lt;/a&gt;.  For more information please contact Carissa Stavrakos, Executive Producer at IBF by dialing (516) 765-9005 or email &lt;a href=mailto:carissa@ibfconferences.com&gt;carissa@ibfconferences.com&lt;/a&gt;.&lt;br&gt;&lt;B&gt;Note: The Technology Start-up rate and LifeScience Alley member discount are contingent upon verification.  Discounts cannot be combined with any other offers.&lt;/B&gt;</description>
      <link>http://www.lifesciencealley.org/programs_events/detail.aspx?id=474</link>
      <pubDate>Sat, 01 Jan 2000 08:00:00 GMT</pubDate>
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      <title>Finding Business Opportunities Through Knowledge of Anatomy and Physiology</title>
      <description>Innovations in medical technology are one of the world's leading areas of economic growth. To successfully drive this growth, leaders of future healthcare firms will need to work with an interdisciplinary team of clinicians, managers, and scientists. But, the clinical language of health care is often a barrier for development and effective management of complex medical initiatives.&lt;br&gt;&lt;br&gt;This course aims to enhance interdisciplinary team efforts by providing managers with a fundamental understanding of the human body through analysis of two body systems: the respiratory and endocrine systems. A learning template is presented for non-clinician managers to examine and understand anatomy and physiology, plus current clinical practice for the selected body systems. Students will discuss business cases from the joint perspectives of a clinician and medical technology manager.&lt;br&gt; &lt;br&gt;Participants will receive a copy of the book Principles of Anatomy and Physiology by Gerard J. Tortora and Bryan H. Derrickson.&lt;br&gt;&lt;br&gt;&lt;B&gt;KEY TOPICS&lt;/B&gt;&lt;br&gt;&amp;#8226; Basic terminology of anatomy and physiology &lt;br&gt;&amp;#8226; Epidemiology for managers: how common is this disease? how important is this body system? &lt;br&gt;&amp;#8226; Respiratory system (asthma &amp; COPD) &lt;br&gt;        - Anatomy and physiology &lt;br&gt;        - Identifying business opportunities &lt;br&gt;&amp;#8226; Endocrine system (diabetes) &lt;br&gt;        - Anatomy and physiology &lt;br&gt;        - Identifying business opportunities &lt;br&gt;&lt;br&gt;&lt;B&gt;TUITION&lt;/B&gt;&lt;br&gt;$1,345&lt;br&gt;&lt;br&gt;&lt;B&gt;Tuition Discounts:&lt;/B&gt; Three or more people from the same company can submit their registrations together for a specific program and receive a 15% discount off the registration price. &lt;font color=purple&gt; LifeScience Alley members can receive a 10% discount on a single registration (reducing tuition to $1,210.50).  Contact Lauren Steffel to receive additional information at 952-542-3077.&lt;/font color&gt;</description>
      <link>http://www.lifesciencealley.org/programs_events/detail.aspx?id=469</link>
      <pubDate>Sat, 01 Jan 2000 08:00:00 GMT</pubDate>
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