LifeScience Alley Programs & Events

Advanced Topics in Combination Product Regulation

Sat, 01 Jan 2000 08:00:00 GMT

This session will review key features of the regulation of combination products in the United States. More advanced topics will also be explored, including FDA's perspectives on the underlying legal basis for combination product regulation, applicable FDA guidances, single vs. separate marketing applications, cross labeling, and FDA policies for review of 510(k)s for combination products.

Audience: Mid-level Regulatory Affairs professionals with a basic understanding of product jurisdiction and assignments at FDA.

Clinical Research 101

Sat, 01 Jan 2000 08:00:00 GMT

This program will provide a comprehensive introduction to clinical research. It is designed for those who are new to the medical device and/or diagnostic product industry, or who work in conjunction with this area and want to learn more about it. It will serve as a refresher course for those who may be working with new products or in new areas of responsibility, and a foundation for those working within other disciplines.

View the current program agenda (PDF). This full-day program includes lunch.

At the end of the Clinical Research 101 seminar, attendees will:
• Have a basic understanding of GCPs and why we need them
• Outline key sections of a clinical study protocol
• Understand the process of ''informed consent''
• Understand the key considerations for adverse events and protocol deviations
• Have an understanding of clinical site selection and center activation issues
• Know what documents to review when monitoring a clinical study.

Audience: Clinical Studies, Cross-functional team members

Key Elements of the Design History File (DHF) & Remediation of a DHF

Sat, 01 Jan 2000 08:00:00 GMT

DHF is a LIVING file. It needs to be nurtured and fed throughout the device life cycle. This program will define the content of a DHF for a product. A discussion of how to address DHF shortcomings to comply with the latest standards in older technologies or new technologies with incomplete files.

Topics to be covered are:
• What are the critical elements in a DHF?
• How do you structure and maintain the DHF so that it is manageable and not an out of control monster.
• Auditing an existing DHF for a technology. What it means to audit a DHF and the associated process as part of a due diligence.
• What to do if you inherit an incomplete DHF?

Audience: Product Engineers and Designers, Quality Assurance, Regulatory Professionals, Project managers, Entrepreneurial CEOs/VPs, and Investment groups seeking information to assess DHF risks in getting a new technology to market.

An Update on Fraud Prosecution and Trends involving Drugs and Medical Devices from the US Attorney's Office

Sat, 01 Jan 2000 08:00:00 GMT

Mr. Gerald Wilhelm, Assistant US Attorney, District of Minnesota, will provide an update on fraud prosecution and trends involving drugs and medical devices from the perspective of the US Attorney's Office.

Tactical Aspects of Market Access in Europe and Changes in the Dutch Healthcare System

Sat, 01 Jan 2000 08:00:00 GMT

Changes in the Dutch Healthcare System: The Dutch reimbursement process is undergoing a substantial revision during 2012. In this talk, Mr. Murrugarra will give an overview of the changes and how they will influence introduction of new Medical Devices in the Dutch Market.

The Tactical Aspects of Market Access & Reimbursement - People, Systems, and Evidence: In this talk, Mr. Verhasselt will give some insight behind the factors conditioning successful reimbursement. He will share from his hands-on experience of successfully establishing funding & reimbursement with premium price and/or adequate DRG coverage for several products in Belgium, France, The Netherlands and Switzerland. The focus will be on the requirements for evidence, but more importantly about the process to influence the right people to support the reimbursement.

LifeScience Alley Community Update & Member Welcome Breakfast

Sun, 22 Jan 2012 08:00:00 GMT

The LifeScience Alley Update and Welcome Breakfast is for new, recently renewed and prospective members of LifeScience Alley. Our staff will provide an update on current policy issues impacting the community, an overview of LifeScience Alley's services and the opportunity to ask questions and make suggestions to our staff.

You will come away from this meeting with a better understanding of the issues impacting your organization as well as how LifeScience Alley can enhance your career, provide forums to give back to the community and identify new business and technical opportunities.

Note: Registration will start at 7:30 a.m. and the event will start at 8:00 a.m. A hot breakfast will be served. Registration is complimentary.

An Introduction to Neuromarketing: Six Hard-Wired Design Principles

Sat, 01 Jan 2000 08:00:00 GMT

Come see how companies like Google are measuring their sales and marketing performance by targeting the decision making part of their customer's brain. Healthcare and medical device marketing managers have become increasingly challenged to differentiate their companies/organizations with attention-grabbing images among increasingly crowded multi-media communications tools. This is particularly true when they are spending a great deal of their annual marketing budget at tradeshows, exhibitions and events.

''The session will focus on how to stand out from the clutter. We will help attendees connect at a deeper (neuro) level, and thereby attract attention, connect with emotions, and create long-term memories,'' says John Driscoll. It will not only provide a basic understanding of how humans process sensory information, but also how to better design marketing/educational visual environments, that effectively communicate your message.

Learning takeaways include:
• Understand why traditional (graphic) design often fails to attract.
• Learn six new hard-wired techniques to draw attention.
• Immediately apply at least one technique to your current event/exhibit program.

Obtaining and Marketing Your 510(k) with Today's FDA, a 510(k) Workshop

Sat, 01 Jan 2000 08:00:00 GMT

Knowing how to get your 510(k) application through FDA quickly can save millions of dollars in unnecessary investment burn. Mark DuVal, a national authority on the 510(k) program is in Silver Spring, Maryland at FDA nearly twice a month negotiating 510(k)/IDE issues for his clients. He will teach you the basics and advanced knowledge of the 510(k) program. He will also provide insights in what FDA looks for in 510(k) submission and discuss the plusses and minuses of pre-IDE meetings. He will also cover when and how to appeal, learned in the trenches with FDA. Mr. Gardner will focus on pre-clearance/pre-approval communication, as well as the promotional issues companies face once they are on the market.

Please join us at this interactive 510(k) Workshop that will tackle the following questions:

510(k) PROSECUTION
• How do you obtain a 510(k) in today's environment at FDA? How to position your 510(k) submission. How you fashion the intended use statement and argue the technological characteristics are the same and do not raise ''new types'' of questions of safety and effectiveness. How to use the new concept of ''reference'' devices in your submission.
• How do you address the sufficiency of your performance data and respond to respond to requests for clinical data? Do you have pre-IDE meetings or not? Do you offer clinical data in your initial submission or not?
• What role does the Least Burdensome Guidance documents play and how to raise them?
• How to answer Additional Information (AI) letters and when and how to push back at meetings with FDA. When do you escalate matters and how? Whom do you involve?
• What to do when your things do not go right. How to prepare the appellate process at CDRH. When and how to appeal; who to take and how to prepare, what avenues to pursue and when.
• What avenues to pursue and when and who is involved? When do you consult/involve the Ombudsman?

MARKETING A 510(k) DEVICE
• Once you get your 510(k), how can you market a product with a general intended use statement when your product can be used in many indications (uses/patient populations)?
• What communication strategies to adopt pre-clearance and post-clearance.
• What to do when FDA disagrees with your promotional positioning.

The 510(k) submission is a strategic advocacy document. A proper understanding of 510(k) process from start to finish is mandatory to avoid problems along with understanding of promotional strategy is very much essential for all companies for success in this complex world of regulations. The key is complete and proper training from experts who have worked on hundreds of 510(k)s, de novo submissions, PMAs and combination products.

This 510(k) Workshop will also cover:
• A brief review of the statute, regulations and new and old guidance documents that are the underpinnings of the 510(k) program; along with insights on the direction CDRH is headed today with the 510(k) program
• An examination of common mistakes seen in drafting and prosecuting 510(k)s through the regulatory process - how to make the best submission possible the first time through

Audience: CEOs and executive management, Regulatory Affairs; Marketing, Clinical, Legal, R&D, Quality Assurance

Statistics for Quality Program 1: Basic Statistics - Making Decisions on the Basis of Data

Sat, 01 Jan 2000 08:00:00 GMT

Many individuals have taken Statistics 101 in school - and decided never to touch statistics again. But statistics can be practically useful and fun! To correctly apply statistical methods in industry, it is important to have a good grasp of the statistical fundamentals included in this seminar. All individuals can use these basic tools in everyday life to make improvements. They enable you to collect, analyze and interpret data to make better decisions.

The purpose of this seminar is to provide practical guidance on basic statistical tools and answer questions such as:

1. How to summarize the information contained in the data?
2. Is the data normally distributed?
3. What to do if the distribution is not normal?
4. How to play with variances?
5. How to construct confidence intervals for mean and standard deviations?
6. How much data to collect?
7. How far away are the individual values expected to be?
8. What to do if there are outliers?
9. How to use software to do basic statistical analysis?

Alternate Sterilization Methods

Sat, 01 Jan 2000 08:00:00 GMT

Conventional sterilization technologies, such as ethylene oxide and irradiation, have been established for more than 40 years. As medical device technologies evolve, new requirements for sterilization methods are now needed that can meet challenges in product development, supply chain, and regulatory aspects.

The seminar will discuss the implementation of alternate and nontraditional sterilization methods. Participants will learn about different sterilization methods, regulatory pathways, standards for sterilization validation and required testing in sterilization. Upon completion of this seminar, attendees would be able to:

• Address traditional methods (ethylene oxide, irradiation) versus nontraditional sterilization methods (Peracetic Acid / Hydrogen Peroxide vapor, Hydrogen Peroxide gas plasma, Ozone and other nontraditional sterilization methods);
• Understand FDA guidance documents, regulatory pathways and validation of nontraditional sterilization methods;
• Consider sterilization process development, packaging, and integration with manufacturing and supply chain;
• Compare aseptic processing versus terminal sterilization; and
• Understand latest developments in single use vs. reusable device sterilization.

Target Audience
Professionals who work in the following areas: manufacturing, microbiology, process engineering, product design, quality assurance, quality control, regulatory affairs, research and development, validation, or any personnel involved in sterilization

Seminar Testimonial
Ziva Abraham, President Microrite, Inc. ''Mike has a wealth of sterilization knowledge to share with the life science industry. Mike has over 25 years of very diverse sterilization experience and has worked for industry leaders Minntech, Johnson & Johnson and Getinge. Mike is a regular speaker with our Microrite Sterilization Strategies Seminars which provide hands on education for medical device, pharmaceutical and biotech professionals. His teaching style is always informative; he explains real industry challenges and recommends novel solutions. His presentations are factual, to the point and delivered in an interesting and fun way.''

Statistics for Quality Program 2: Comparative Experiments - Demonstrating Change or Equivalence

Sat, 01 Jan 2000 08:00:00 GMT

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!

The purpose of this seminar is to provide practical guidance to conduct comparative experiments, and answer questions such as:

1. What is wrong with the t-test and the F-test as usually practiced?
2. What to replace these tests with?
3. How to make multiple comparisons?
4. How much data to collect?
5. How to reduce sample sizes?
6. How to use software to design and analyze comparative experiments?

Regulatory Affairs 101

Sat, 01 Jan 2000 08:00:00 GMT

This program features speakers from the Food and Drug Administration as well as other industry experts who will provide a comprehensive introduction to the world of Medical Device Regulatory Affairs. This, LifeScience Alley's most popular program, is designed for those who are new to medical device regulation or who work in conjunction with the regulatory team and want to learn more about this important function within the company. It will also serve as a refresher course for those who may be working in new areas of responsibility and as a foundation for those working within other disciplines.

Topics covered will include:
• US regulatory history and overview of the FDA
• Clinical trials and IDE submissions
• 510(k) and PMA requirements and submissions
• International regulations and submissions
• Quality System Regulation overview
• Postmarket requirements: Complaint handling, MDRs, Vigilance
• Corrections and removals (Recalls)
• Advertising and promotional controls
• FDA Inspections
• FDA Enforcement

Statistics for Quality Program 3: Screening Experiments - The Heart of DOE

Sat, 01 Jan 2000 08:00:00 GMT

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.

The purpose of this seminar is to provide practical guidance on the effective use of screening experiments, by answering questions such as:

1. Why design experiments?
2. What are factorial designs?
3. What to think about to make the screening experiment successful?
4. How to evaluate a large number of factors with a fractional factorial design?
5. How to design robust products and processes?
6. How to easily implement screening experiments using software?

Statistics for Quality Program 4: Setting Specifications

Sat, 01 Jan 2000 08:00:00 GMT

One key objective in R&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 specification, 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.

The purpose of this seminar is to provide practical guidance regarding effective ways of setting specifications by answering questions such as:

1. How to set specifications when the only available data is the characteristic for which the specification is desired?
2. How to set specification by obtaining a functional relationship between an input and output characteristic?
3. How to set functional specifications when there are multiple input and output characteristics?
4. How to use software to implement the necessary statistical tools to develop specifications?

The Science of Market Development

Sat, 01 Jan 2000 08:00:00 GMT

This 1-day course will provide an in-depth, hands-on experience intended to provide a clear understanding of the roadmap to standard of care for medical technologies. It is designed to deliver key insights and practical tools that participants can use immediately to help accelerate market adoption and growth over the short and long term. The concepts and tools will be discussed in the context of both U.S. and international markets and their unique barriers. This course content is applicable to all medical technologies whether they are at concept, newly launched, struggling to meet growth expectations, or seeking growth in a mature market.

''Innovative and disciplined approach to a critical element of emerging growth businesses that goes to the foundation of resource prioritization, investment, expectations and outcomes.'' - Bob Paulson, Previously CEO of Restore Medical (Recently acquired by Medtronic)

Expected outcomes:
• Defining (and addressing) the key barriers to adoption that constrain higher growth rates
• Quickly recognizing the unavoidable boundaries that limit a market opportunity
• Understanding which technology characteristics can radically influence adoption
• Synthesizing high level variables to create more accurate revenue forecasts
• Quantifying trade-offs across investment options and their impact on revenue growth
• Practical tools and methods to accurately size the opportunity and forecast adoption and growth rates

The intended audience for this program includes seasoned medical device/technology marketing and market development professionals and leaders, senior leaders of small or medium size medical device companies, and anyone interested in gaining a better understanding of the elements and process of taking a medical technology to standard of care.

Statistics for Quality Program 5: Process Validation and Acceptance Sampling

Sat, 01 Jan 2000 08:00:00 GMT

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.
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:
1. How are attribute and variable sampling plans usually designed?
2. What is the most important information you need to know to design acceptance sampling plans and how to get it?
3. What is the practical approach to design acceptance sampling plans to reduce risks and costs?
4. What is the connection between acceptance sampling plans and process validation?
5. What is the practical approach to design a process validation study to reduce the risk of failing validation while reducing the cost of sampling?
6. How to use software to design sampling plans and validation studies?

Statistics for Quality Program 6: Managing and Improving Processes

Sat, 01 Jan 2000 08:00:00 GMT

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.

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:
1. What is the logic behind control charts and how to select the proper chart?
2. What are the four process capability and performance indices?
3. How to use these indices as an at-a-glance-display to manage and improve processes?
4. How to use variance components analysis to estimate the % of variability caused by each cause?
5. How to target variance reduction efforts most cost-effectively?
6. How to use software to implement this methodology?

Statistics for Quality Program 7: Measurement Systems Analysis

Sat, 01 Jan 2000 08:00:00 GMT

Measurement systems serve two decision-making purposes: they are used to make specification related (accept/reject) decisions, and to make product & 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.

The purpose of this seminar is to provide practical guidance to conduct measurement systems analysis and answer questions such as:
1. What are the acceptance criteria for measurement system variability and bias?
2. How do these criteria differ for destructive and non-destructive measurements?
3 . How to design measurement system validation studies?
4. How to statistically assess if the measurement system is adequate for the task?
5. How to improve the measurement system?
6. How to use software to conduct measurement systems analysis?

Heating the Midwest Conference

Sat, 01 Jan 2000 08:00:00 GMT

We hope you can join us for our inaugural conference, Heating the Midwest: Building the Vision, April 25 - 27, 2012, in Eau Claire, Wisconsin.

Interested in sponsoring the conference?
Contact Jeff Borling (jborling@apexgetsbusiness.com) about becoming a sponsor.

Preliminary Program

Wednesday, April 25, 2012: ''Understanding the Vision''
Pre-conference tour of thermal biomass businesses and installations, followed by an evening vendors' reception.

Thursday, April 26, 2012: ''Building the Vision''
Opening keynote address and plenary sessions, breakout sessions in the morning and afternoon, Expo. A Thermal Heating Fair for homeowners, businesses, and local government will take place in the evening, which will include educational breakout sessions.

Friday, April 27, 2012: ''Presenting the Vision''
Expo continues, general sessions and panel discussions, and closing remarks to include ''Advancing Biomass Thermal in the Midwest: Policy Challenges and Opportunities.''

To find out more information about the Heating the Midwest Conference, please visit the Conference website.

To reserve a hotel room at the Ramada Eau Claire with the discounted rate of $79/night, please say you are part of the ''Heating the Midwest'' room block. Phone number: 715-835-6121.

For registration: Please note that attendees do not have to be members of LifeScience Alley. Simply enter your organization in the ''Non-Member Organization'' field.

11th Annual MedTech Investing Conference

Mon, 09 Jan 2012 08:00:00 GMT

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.

Minnesota has long been one of the leading regions in the world for medical technology innovation. The MedTech Investing Conference has become the leading event for medical device investors, entrepreneurs and corporate business development executives. As in the past, this year's conference will feature industry leaders who will share their candid insights on the most critical issues in the sector today; while, at the same time, providing an intimate venue to network and to grow impactful relationships to help foster the development and financing of companies.

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.

LifeScience Alley members receive 50% off the general registration rate ($1,395) and Technology Start-up rate ($995). Be sure to enter discount code ''LSAWE2'' when registering at www.medtechconference.com. Note: The Technology Start-up rate and LifeScience Alley member discount are contingent upon verification and cannot be applied to academia rates. Discounts cannot be combined with any other offers.

For assistance with registration, please contact Cathy Fenn, Registrar at IBF by dialing (516) 765-9005, extension 210 or email cathy@ibfconferences.com.

For more information regarding sponsor, exhibit, or speaking opportunities, please contact Carissa Stavrakos, Executive Producer at IBF by dialing (516) 765-9005 or email carissa@ibfconferences.com