MD&M West brings together medtech engineers, business leaders, disruptive companies, and innovative thinkers to create powerful solutions and life-changing medical devices. From 3D printing and biomaterials to robotics and digital health, MD&M West is the largest medtech expo for suppliers and buyers to discover innovation and explore new technologies.
KEYNOTES: Rey Parel, Angel Investor, Director of Advanced Technology, mFluiDx
Rey Parel is an emeritus member of the Society of Plastics Engineers, a board member of the SPE Golden Gate Section, San Francisco, CA, and a senior member of AIChE and ASME. He is an angel investor and director of several medical device start-ups in the United States and Canada, primarily focused on early detection of infectious diseases and cancer. He has a BSChE from UP College of Engineering and an MS in plastics engineering from UMass Lowell. He has devoted himself since 1985 to a career in plastics and medical devices. He has more than 30 years of experience in the advanced technologies that enable the successful transition to manufacturing of microfluidics-based point-of-care (POC) diagnostic devices, and over 20 years of direct involvement with biotechnology start-ups. This involvement encompassed the scale-up and commercialization of a wide array of leading-edge products, including PCR, instrument-free amplification, DNA sequencing, NGS, lab-on-a-chip, lab-on-a-disc, organ-on-a-chip, immunoassay, cell counting, sample prep, high density array, POC diagnostics, and prognostic testing. He was at the very beginning of the biotech revolution, with his involvement in then groundbreaking new technologies such as PCR and microfluidics. His mission in life is to promote the “gospel of predictive medicine.” He was an early proponent of prognostic medical devices as a way to attain medical emancipation for everyone. He believes in predictive medicine as a pathway to reducing the repressive cost of healthcare worldwide, among others.
Keynote: The Science of Predictive Healthcare and the Role of Nanopolymers & Medical Plastics
Predictive medicine has its roots in early warning systems and diagnostic early detection. Prognostic devices are a new genre of diagnostic devices that not only detect and diagnose diseases but predict and, in many ways, prevent the onset of diseases. Imagine a point-of-care device that can detect brain natriuretic peptide (BNP), a cardiac marker that is produced by the heart in very minute quantities before the advent of arrhythmia. Then the doctor can prevent the disease by changing the patient’s lifestyle, diet, and exercise. The first forays in predictive medicine more than a decade ago have a spawned a new generation of predictive methods and prognostic medical devices.
Outsprint Your Competition to Market Launch by Streamlining Your Collaboration Roadmap
Traditional “waterfall” approaches to new product development are no longer viable as new technology drives the pace of medtech devices faster than ever before. Device companies must move toward higher levels of collaboration in order to reduce time-to-market schedules, coupled with revised strategies on product specifications and iterations to reduce scope, risk, and ultimately time.
Panel: Connected Device Design — Using Best Practices During the Product Development Process
Hardware design, software design, cloud architecture, usability engineering, wireless protocols, artificial intelligence and machine learning, cybersecurity.… the list of things you need to know seems endless when it comes to designing a connected medical device. While an existing product might look the same before it transitioned to a connected device, it is fundamentally different as it is part of a larger network of products and processes in a wider ecosystem. And, of course, new products have many of the same decision criteria. Join this panel of experts for a robust discussion about where you need to focus your efforts in the early design phase to get the best results.
Blockchain, the Metaverse & Medtech
The healthcare sector globally is under increasing pressure due to the explosive growth of data in the form of electronic health records, clinical trials, mobile apps, wearables, health surveys, and more. Physicians are on the front line and are most aware of the pressing needs. Artificial intelligence has emerged as a tool for medical devices, but the technology can be complicated, and blockchain technology simplifies consent processes for patients and healthcare organizations. Blockchain technology can help solve the underlying root causes of the issues in healthcare, such as self-sovereign identity, security of data and health record management, fraud, consent, management, and so on. It needs to be the base technology used to solve the overall management challenges experienced by healthcare today.
Panel: The Promises of Additive Manufacturing for Production
The promise of creating production parts using additive manufacturing (AM) has moved from a limited, niche application to become practical across multiple industries. From dental to rocket engines to medical, the number of applications and the volume of production has steadily increased. A panel of industry experts will cover how various AM technologies and materials have enabled this growth, current applications, and challenges we are still facing.
The 3Rs of EO Sterilization: Sustaining the Continued Safe Use of EO
Ethylene oxide (EO) sterilization technology plays a vital role in enabling critical medical products and devices to safely reach patients worldwide. For many medical devices, sterilization with EO is the only method available to effectively sterilize without damaging the device during the sterilization process. The same properties that make EO an effective sterilant require that it be carefully controlled to protect workers, communities, and patients. In this talk, experts will go through the 3Rs of an EO sterilization program that Sotera Health businesses Sterigenics and Nelson Labs implemented to support customers in reducing EO use. The benefits of reducing the amount of EO for employees, customers, and communities can include: continued safe usage of EO, lower EO-residuals in products, reduction in required aeration time resulting in improved customer supply chain efficiencies, reduced cycle time resulting in additional capacity for manufacturers, and reduced fugitive emissions.
Panel: What Entrepreneurs Need to Know About Investing in the Medical Sector
All companies require financing, and the sources of that financing vary depending on the need, stage, and type of enterprise. This panel brings together a spectrum of investors including angels, traditional VC, and corporate VC to discuss the challenges and opportunities unique to the medical device space.
Building Consensus Solutions to Wicked Problems in Medical Device Packaging
Medical device packaging experts and stakeholders around the globe are hard at work developing consensus-based solutions to medical device packaging issues and challenges faced by industry and clinicians. Learn from leaders from the AAMI Packaging working group about the latest developments in international standards for medical device packaging, including the recently published new edition of ISO/TS 16775 and amendments under development for the ISO 11607 series. Attendees will also hear about other collaborative efforts through the Kilmer Innovations in Packaging group (KiiP) to solve wicked problems in medical device packaging – highlights include what’s going on with the Wicked Stability group.
From ctDNA liquid biopsy techniques (that detect cancer at the very early stages and can pinpoint the location of the tumor) and metabolomics biosensors (that prevent stroke through a combination of bioelectronics, data science, and AI) to tumor-hunting nanobots and CRISPR-based scissors (that cut out defective genes before the onset of the disease), these methodologies are making expert-level preventive care accessible to the millions of people at-risk. Even in the COVID-19 pandemic, medical-grade plastics have made a significant impact — the most exciting development is the use of medical nanopolymers formed into carriers that protect the mRNA-based vaccine from being destroyed by the body’s own defenses, before it can do its job. The engine that is driving all of this is medical plastics.
Stanton Rowe, CEO, NXT Biomedical
Stanton J. Rowe is CEO of NXT Biomedical, a medical device incubator funded by Deerfield Capital, Johnson & Johnson, and Edwards Lifesciences. Stanton recently retired from Edwards Lifesciences, where he was chief scientific officer since 2008 and where he also served as corporate vice president, advanced technology. He joined the company in 2004 when Edwards acquired Percutaneous Valve Technologies, a company he helped to found in 1999 and served as its president and CEO. This company developed the first transcatheter aortic valve replacement.
Previously, Rowe was corporate vice president for Datascope and was vice president at Johnson & Johnson’s Interventional Systems Division (JJIS) in Warren, NJ, responsible for the company’s coronary stent development efforts. At JJIS and the related Cordis Corporation, Rowe held a variety of positions with increasing levels of responsibility, including leading the company’s business development, advanced technology, worldwide clinical research, and marketing groups. He is on the board of directors of NovaSignal and Anuncia. He is also on the board of directors for the Discovery Science Center in Orange County, as well as on the advisory boards for the engineering, business, and biomedical engineering schools at UC Irvine. He also sits on the biomedical engineering advisory board of UC Davis and Texas A&M. Rowe received a bachelor’s degree from the University of Alabama.
Keynote: Innovation Requirements: More than Materials Science and Biomedical Engineering
The three-legged stool of medical device innovation requires great technical capability, of course, but also a deep understanding of the related medicine (anatomy, pathology, procedural knowledge, outcomes, standard of care, clinical trials), and the business of innovation (patents, fundraising, management, strategy). These elements will be highlighted as the story of TAVR development is told — the twists and turns of technology challenges, patents, difficult fundraising, difficult regulators, and tough strategic choices. Join leading industry innovator, Stan Rowe, as he discusses:
How to think about customer needs when customers do not know what they need.
Innovation roadblocks — some are technical, some are market-related.
If you know the customer you serve, decisions about strategy are so much easier.
For more information about the show, visit here .