Bringing Technology and Product Development Best Practices Together for Successful Innovation

Transcription

1 Bringing Technology and Product Development Best Practices Together for Successful Innovation April 18 19, 2018 * Boston Convention & Exhibition Center Preliminary Agenda AGENDA AT A GLANCE Day One Wednesday, April 18 8:00 Registration and Refreshments 8:30 4:00 Track A R&D: New Technologies Track B Product Development: Strategy 10:00 10:15 Refreshment Break 11:45 1:30 Networking 2:30 2:45 Refreshment Break Day Two Thursday, April 10 8:00 Registration and Refreshments 8:30 4:00 Track A R&D: Technology Integration Track B Product Development: A Systems Approach 10:00 10:15 Refreshment Break 11:45 1:30 Networking 2:30 2:45 Refreshment Break

2 Track A: R&D: New Technologies What s New in Medical Materials Emerging technologies and materials that provide improvements for medical device manufacturers are crucial in medtech. What are the latest advances? In this session, we ll look at trends in polymers, adhesives, plastics, and soft materials, so you can keep up with the latest developments. Topics to be covered include: Trends in new medical materials Advances in medical electronics and biomaterials Reviewing FDA medical device classification and risk of materials Analyzing the effects of materials on investigation, testing, trials, and controls Day One Wednesday, April 18 Track B: Product Development: Strategy Using Cross Pollination to Drive Medtech Innovation Innovation comes from all corners and people. In this session, we ll look at exciting developments in industries such as alternative energy, aerospace, and automotive, and consider their crossover potential in medtech. Topics covered will include: How to identify an idea with crossover potential How to adapt technologies from other industries for use in medtech Examining why successful crossover technologies from the past have worked Considerations for applying technology to traditionally lower volume production runs Local Academic/University Technology Presentation (TBD) Biosensors for Diagnostic Testing The point of care biosensors market is exploding, especially with the rapid expansion of genomics testing for individuals. Medical biosensors can diagnose many diseases and conditions, and increasingly are being used to achieve targeted therapies in precision medicine to increase the efficacy of drugs. Topics to be covered include: Trends in commercial applications of medical biosensors New technologies and devices likely to be highly disruptive to the in vitro diagnostics market Recent examples in the medtech market Sensors for Hospital to Home Applications As wearable technology for in home monitoring has become more prevalent for medical devices, medtech has seen growth in sensors developed specifically with wearable products in mind. Many of these made for Marrying R&D and Business Goals Research and development leads to all kinds of exciting breakthroughs. But just because you can do something doesn t always mean you should. This session will focus on ensuring your R&D efforts support your company s broader business strategy. Topics covered will include: Identifying business priorities and using them to drive R&D efforts Ways to ensure your R&D efforts lead to viable projects Signs you re heading down the wrong path The Future of Innovation in the Value Based Care System Device manufacturers must innovate through a value lens by thinking backwards to find fertile ground for innovation. Where can you find value? What can device companies do? How can regulators help? Topics to be covered include: Addressing the value based care system limitations, especially for premium market leaders Re orienting R&D investment, at least partially, toward frugal innovation

3 wearables sensors remain in the commercial evaluation stage, but some examples are already becoming significant success stories. You ll learn about the latest in sensors for your next medtech product. Topics to be covered include: Force, pressure, and stretch sensors for motion capture and user interfaces Sensors for integration into apparel New design approaches to develop low power or flexible versions of existing platforms 11:45 1:15 How Artificial Intelligence Is Changing Medical Devices Machine learning and deep learning are poised to have a dramatic impact on the medical device field. The session will consider how artificial intelligence will change medtech in the coming years as well as look forward to what might happen once true artificial intelligence is here, and how that may change the development and application of diagnostic and therapeutic medical devices. Topics to be covered: Reviewing the evolution of AI in medical devices and how it will change medical device development and use Assessing applications for device development Using machine learning and deep learning in medical devices Is There Really Anything New in Lithium Ion Batteries? There have been a number of new developments in batteries for smartphones and other consumer products, but which advances are applicable in the medical realm? This session will explore new lithium ion technologies from other industries and evaluate their potential for use in medtech. Topics to be covered include: Lithium ion trends, and what s applicable for medical devices Exploring the tradeoffs do they help or hurt potential product development initiatives? Tying battery developments back to suppliers what s the risk to the manufacturer? Implications for wearables and implantables How can medtech companies develop sophisticated clinical and economic programs? Low Cost, High Impact Research No matter what the size of your R&D budget, it never seems like enough. This session will look at ways you can pinch pennies without sacrificing on innovation. Topics covered will include: How to identify and eliminate waste in your R&D budget Cost efficient tools to enhance innovation Tips to get the biggest bang for your research buck 11:45 1:15 Product Development Across Borders With product development teams today scattered across different facilities, countries, and even companies, how do you bring everyone together to create the best device possible? In this session, panelists will discuss how to navigate remote working relationships to ensure product development success. Topics covered will include: Tools for enhancing collaboration across distance Structuring your team for remote working success Avoiding pitfalls of remote teams Product Development Philosophies What s Yours? Many companies today are living through the advent of choosing from various new product development philosophies. Do you follow an agile or waterfall method? Amalgamating product development practices from both methodologies is tough. Choosing only one method is just as hard. Topics covered will include: What are the differences in philosophies and why does it matter? Decision tools for product development philosophies Can you use various methods depending on your product portfolio?

4 2:45 3:30 Development of a State Of The Art Robotic System: Lessons from the Field Designing a surgical robot for minimally invasive surgery can be quite daunting, especially with the myriad of advanced technologies that are available. This presentation provides an overview of key findings and considerations for designing surgical robotics and includes a view into the future. Topics covered will include: Trends is surgical robotics and a look at key market players Researching and identifying the need for medtech robotics Informing the design of the device 3:30 4:00 Building a Technology Stack for the Future Sometimes the problem is not coming up with new technologies, it s deciding which ones to pursue. In this session, we ll explore strategies for evaluating concepts for new medical devices and ensuring that only the strong survive. Topics covered will include: Failing fast to ensure future success Strategies for weighing your options What to do with concepts you don t immediately pursue A look at industry examples that you can apply 2:45 3:30 The Portfolio Viewpoint Establishing a portfolio management function is a big step for many companies. Medical device companies must adopt a more rigorous approach towards portfolio management to escape from the vicious circle of slipping timelines, escalating cost and insufficient resourcing of potential breakthrough innovation. This session will explore key elements of an effective product portfolio management process, helping the R&D department to be more effective. Understanding the goals of portfolio management Exploring the risks associated with improper balance of the product pipeline Integrating global market needs with existing internal capabilities 3:30 4:00 How Innovation Beyond Line Extensions Can & Should Happen Moving fast is critical in the medtech industry, especially with truly novel devices. This session will cover how and why innovation can and should be done at a startup pace, especially within larger companies. Topics to be covered: Enabling and encouraging innovative thinking Avoiding the stakeholder quagmire Charting a course to FIH (first in human study) through a large corporate quality system Clinical introduction Lessons for companies of any size pursuing innovation Track A: R&D: Technology Integration Evaluating New Technologies Using a Balanced Score Card Approach New technology abounds, but how do you find and confidently select a new technology to meet your specific product needs? In this session, you ll learn a proven multi step process to identify and assess available technologies to minimize risk while determining the best fit for your next product. Topics to be covered: Establishing key requirements and identifying candidate technologies from multiple markets Performing analyses to show that fundamentals of the technology can meet the product requirements Day Two Thursday, April 19 Track B: Product Development: A Systems Approach A Systems Approach to Better Product Development Medical devices are evolving and becoming more complex. In this evolution, you don t just need mechanical engineers and electrical engineers; you need software engineers, bioengineers, designers, industrial designers, marketing professionals, and more to work together. Making sure the points of a major system function on their own as well as part of an integrated system are keys to successful product development. Topics covered will include: Effective ways to integrate teams of disparate talent and age ranges Ways to improve internal communication and document management Helping team members know when to raise the red flag

5 Demonstrating the selected technology provides adequate performance over the expected range of conditions Assessing and Sourcing Technology for New Product Development and Manufacturing Understanding the risks associated with a new technology is key to determining if it s right for your application. Once assessed, how is componentry sourced? In this session, we ll discuss strategies for translating technology into the next groundbreaking medtech product. Topics to be covered: Understanding implications of multiple technology risks Determining that the technology can scale to volume manufacturing and distribution Looking at supply chain processes for bringing new technology on board Criteria for Choosing the Right Material for Your Device Selecting the best materials for use in your medical device is critical to optimizing your design for manufacturing, assembly, packaging, sterilization, and testing. Depending on the application and classification of a medical device and its accessories, the use of the right material will make all the difference. In this session, we ll look at a number of important factors to consider, so you can make the right choice for your device. Topics to be covered include: Criteria for design elements Conditions of cost, availability, reliability and supply chain Considerations for commercialization and speed to market Effective Prototype Development As a medical product moves close to production, a rigorous development and documentation process is required. You ll need to understand how to work with different materials and processes to bridge the gap between prototype and finished product. Topics covered will include: Detailing various methods of developing prototypes Reviewing limitations of prototypes and how they can effectively be tested and utilized in the development process Exploring the stages of prototype refinement and testing to support a pre submission meeting with FDA The Essentials of Medical Device Product Life Cycle Management Are you clear about the fundamentals of the medtech product life cycle? This session will help you understand the various needs and how you can help R&D deliver a more robust product to manufacturing. Topics covered will include: How you can help R&D can write validations reports so regulatory can use them more effectively Difficulties faced by executive, management and production personnel to move faster and more efficiently Ways to help regulatory teams get products faster global approvals A How To Guide for Engineers Customer Visitations What s it like for engineers to visit clinicians and potential product users without marketing along for the ride? This customer/r&d engagement process can be daunting for engineers, and often, translating what clinicians say into technical requirements is a tall order. Topics covered will include: Identifying problems vs. suggesting solutions The top do s and don ts and how to avoid common mistakes Tips for turning user need into design requirements Bridging User Needs & Design Requirements Your users can be your greatest source of inspiration, but how do you turn what they tell you into a viable product? In this session, you ll learn how to translate user needs into formal design requirements that pass regulatory muster. Topics covered will include: How to read between the lines of user feedback Best practices for drafting design requirements Meeting both design requirements and user needs 11:45 1:15

6 11:45 1:15 De Risking New Technologies on the Path to Commercialization To turn a great concept into a medical device masterpiece requires a deep understanding of how to properly develop the technology components that maximize user functionality while minimizing development risks that comes with an unproven set of technologies. It s important to develop products with the rigor required of medical devices and with the ability to scale to production at the end of development. Topics to be covered: Defining what technology needs to do Conducting a readiness assessment Why you need to evaluate, test and repeat often Determining the readiness to scale Juggling Competing Requirements Marketing wants one thing, manufacturing needs another, and regulatory affairs says there s no way you can do that with your device. Meanwhile, you ve got user needs and desires to balance. Welcome to the world of medical device product development. Topics covered will include: Identifying stakeholders Strategies for evaluating and prioritizing competing requirements Knowing when to draw the line 2:45 3:30 Evaluating & Selecting Sensors to Improve Device Performance Sensor requirements often include long term stability, precision, and reliability that are unparalleled, particularly in a regulated environment. These characteristics are crucial and are fundamental to your and your products success. Topics covered will include: Selecting an appropriate sensing technology to use or improve performance Testing considerations for prototypes Looking at ways to reduce sensor costs Satisfying the 510(k) Checklist Getting a device ready for 510(k) submission can be time consuming, costly, and full of challenges. But getting that letter from FDA stating you have successfully received market clearance can make it all worth it! In this session, you ll learn how to better prepare to facilitate a faster clearance. Topics covered will include: Setting up the product offerings in a family style and why that s important What are the key pieces you must have in place to go from design to 510K submission? When to start the plan to avoid pain points in time and money Quality by Design Increased product quality also benefits hospitals, payers, health care providers, and patients by generating confidence among them that the devices they rely on will perform as intended. The Case for Quality focuses on objective information about medical device quality, facilitates medical device innovation through data, processes, and analysis of device performance, and fosters strategies that focus stakeholder interactions on device quality. Topics covered will include: How to get faster approvals through FDA and the EU Notified Bodies Reducing costs and increasing profits by focusing on quality measures during medical device design and production Improving product quality 2:45 3:30 Document Management Best Practices One absolute in the medtech industry is the need to maintain documentation. This means documentation to demonstrate you have a compliant quality management system, you design and develop products to meet design controls, and you are addressing risk management issues. Topics covered will include: Ways to develop a document management strategy Why you shouldn t still be using paper Using internal auditing to ensure document management procedures are followed.

7 3:30 4:00 5 Tips for Getting New Products Through FDA Getting medical devices with new technology through the regulatory pathway is no easy task. In this session, you ll hear tips offered through case examples from companies with digital health products or other new devices that are moving the needle on innovation within a regulated environment. Topics covered will include: Challenges faced by disruptive devices Exploring innovative regulatory strategies Ways to assess regulatory burden 3:30 4:00 Moving New Technology and Products to Market Faster Efficient product development comes through the implementation of a systematic project management process. There are time honored strategies for accelerating time to market, but do these work with new technologies? Topics to be covered include: Organizing and planning the development process Streamlining the critical path to success Avoiding known pitfalls and focusing on better practices How to avoid regulatory compliance misses