Medical Device Plastics and Adhesives –  A Design Approach

A successful Medical Device development approach for both adhesives and polymers includes a roadmap for product design. Although there are numerous ways to bond materials, often the designer is faced with bonding dissimilar materials and a difficult design where only an adhesive is the right bonding solution.  Without a proven methodology to follow, product teams find themselves in a failure loop, without a methodology to resolve bonding challenges and to prevent downstream problems.  With unsolved failures, often the product team, or company, faces a “shut down” situation.  The steps for adhesive/polymer bond success include design evaluation, an understanding of adhesive fundamentals, chemical compatibility, joint design principles, regulatory issues, testing, and processing.  A case study of a Medical Device moving from single-use to multi-use requirements will be provided.  This design approach includes key factors for success and a roadmap to aid in project management and risk mitigation.

JoAnne Moody, MS

President, Zeta Scientific LLC

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Electricity & Nanoparticles – Could These be Future Cancer Therapies??

Folarin Erogbogbo

Asst. Professor, Biomedical Engineering, San Jose State University

April 30, 2019

Cancer has a major impact on every society and innovative solutions are desperately sought after for the “hard to treat” cancers. Two promising approaches to treating cancer include tumor treating fields and nanoparticles.

Tumor Treating Fields (TTF) are mild electrical fields that pulse through the skin and interrupt cancer cells ability to divide. TTFs have been approved by the FDA for the “difficult to treat brain cancer” glioblastoma.  While TTFs have been commercially approved for GBM, the effects of TTFs on many cancer types are mostly unknown.

Nanomaterials are materials controlled by manipulation of size and shape at the nanometer scale (atomic, molecular, and macromolecular scale) that produce structures, devices, and systems with at least one novel/superior characteristic or property. There is generally excitement when a superior property of materials on the nanoscale that can revolutionize the world are discovered, however undesirable properties (such as toxicity or inefficiency) can dim their prospects of real-world applications.

This presentation will focus on 1) introduce lay audiences to the use of TTF as a medical device and 2)  highlight innovative approaches to creating and understanding nanomaterials for cancer.

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The Opioid Epidemic: Its Magnitude, Origins, Complexities, and Permanence

The Opioid Epidemic: Its Magnitude, Origins, Complexities, and Permanence

Elliot J Krane, Chief of Pediatric Pain Management, Professor, Departments of Anesthesiology & Pediatrics  Stanford Children’s Health

We all read and hear about the opioid crisis on virtually a daily basis. It is presently responsible for the deaths of tens of thousands of Americans every year, but as a public health issue it is far from the largest preventable cause of premature death. Its origins date to the early 2000s, and have been largely attributed to the pharmaceutical industry, overprescribing, and the culture of medicine to combat pain. However, while these phenomena have some role to play in our present circumstance, the true origins are far more complicated and ingrained in our present economic and political realities. The opioid crisis is sadly here to stay for the foreseeable future.

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A New Approach to Cancer Immunotherapy

A New Approach to Cancer Immunotherapy

Lingbing Zhang

Despite great progress has been made in cancer care, late-stage cancer still represents a great challenge to modern medicine. Part of the challenge may be because more than80% of late-stage cancer patients develop cancer cachexia. Cancer cachexia significantly reduces patient’s response and tolerance to cancer treatment. More importantly, the syndrome dramatically reduces patient’s quality of life thus brings enormous suffering both to patients and their families. Due to the lack of treatment, the syndrome directly kills 30% of cancer patients. Despite great efforts have been made to develop treatments for cancer cachexia, all previous drug projects for cancer cachexia have failed in clinical trials. We have conducted a series of elaborate studies to explore how the tumor affects the host and inflicts cancer cachexia. Findings from our studies reveal a new cause of cancer cachexia—tumor-induced immune disorder. This new mechanism is shockingly consistent with and supported by strong clinical evidence. Our approach to the development of therapeutics for cancer cachexia is focused on modulating the immune disorder, and thus pioneering a new direction to develop cancer immunotherapy. In this event, we will discuss this new approach to cancer immunotherapy, through which we aim to develop breakthrough therapies of late-stage cancer patients with cachexia.

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Next Generation Optical Imaging

Event Description:

Eye disorders and vision loss are among the costliest conditions to diagnose and treat in the global economy. Eye diseases are impacting 1.3B+ people costing $3 trillion/year in healthcare (direct and indirect costs) globally. The population in developed countries suffering from eye diseases is increasing due to demographic trends and the increased incidence of diabetes. The growing middle class in emerging markets requires a high quality and affordable solution. Ophthalmologists and optometrists lack a reliable early diagnostic device for disease diagnosis. Typical methods provide diagnosis only after the eye has suffered irreparable damage. Optical Coherence Tomography (OCT) has revolutionized ophthalmic diagnostics. We will discuss next-generation OCT-based disruptive technologies for early diagnosis of ocular pathologies such as macular diseases, diabetic retinopathy, and glaucoma. Next-generation optical imaging devices could diagnose diseases before the onset of irreversible vision loss by providing ultra-high resolution images and real-time retinal blood circulation maps. We will present an overview of the current advances in ophthalmology as well as our innovative solutions. We will also discuss applications of OCT and optical imaging for other pathologies.

Event Speaker:
Manish D. Kulkarni, PhD

Event Speaker Title: 
CEO

Event Speaker Company: 
Diagnostic Solutions & Systems


Clinical Trials: “One Drug’s Journey” or “Orphans in the Wilderness”

Clinical Trials: “One Drug’s Journey” or “Orphans in the Wilderness”

Drug development and approval are frightfully complex, expensive, and time-consuming. Making mountains of drug raises additional challenges. Working this process as a first-timer adds more complication. David will share an overview of drug development, policies supporting development of therapies for neglected or orphan diseases, and the challenges for developing a potentially life-saving drug.

David Larwood, CEO, Valley Fever Solutions


ADHD and Virtual Reality

ADHD and Virtual Reality

Attention Déficit Hiperactivity Disorder affects between 5%-7% of the world population on average. Its implications are not only to people who suffers it, but also to people who live and interact with them, which results into more than a billion people indirectly affected. As a child ADHD it affects on the family circle, school and friends, and as an adult it can have big implications on the personal and professional life. Nowadays Virtual Reality has evolved enought to transition from laboratory environments to homes, enabling its potential benefits to use for therapeutical purposes at a low cost. We are going to talk about how ADHD in United States, Europe and México are perceived and its implications on a person life, from childhood to adulthood. But also we will talk about Virtual Reality and its uses as a therapeutical tool for some neurodisorders suchs as ADHD and fobias (Fear of heights as example given).

Event Speaker:
Josep Maria Tomas Sanahuja

Event Speaker Title: 
CEO

Event Speaker Company: 
Miyabi Labs


Cardiometabolic Disease among South Asians: Findings from the MASALA Study

Title:  Cardiometabolic Disease among South Asians: Findings from the MASALA Study

Speaker: Dr. Alka Kanaya, Professor of Epidemiology and Biostatistics, University of California, San Francisco

Date: 02/12/2019

Brief Description:

South Asians comprise almost one-quarter of the world’s population and are the second fastest growing ethnic group in the United States. We have created a prospective cohort of South Asians called the Mediators of Atherosclerosis in South Asians Living in America (MASALA) study, which is closely tied to the Multi-Ethnic Study of Atherosclerosis (MESA) for valid cross-ethnic comparisons. We have followed this cohort for approximately 6 years and have learned that there are specific sociocultural, behavioral and biologic factors that are associated with higher disease risk as well as protective factors and sources of resilience in this distinct ethnic group.

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Embracing Change: Your Connected Medical Device Is Never Finished

Title: Embracing Change: Your Connected Medical Device Is Never Finished

Speaker: Aaron Joseph, Principal Consultant, Sunstone Pilot, Inc.

Date: February 5, 2019

Traditional approaches to medical device development focus on tightly controlling a final product design. In the modern healthcare environment of software-intensive, connected medical devices, there is no final design and companies must become adept at frequently updating their products. Only by embracing change can companies address the modern challenges of connecting to complex, evolving software and rapidly changing cybersecurity risks. This presentation will describe how to structure medical device development for rapid design iterations to speed up product development and to ensure devices remain safe and secure after product launch. Learn how to configure design control processes to support efficient software patches to address interoperability, cybersecurity, OS upgrades, and bug fixes. We will discuss techniques medical device companies can leverage to minimize the cost of change during product development and throughout the product life cycle.

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