July 15 from 2pm – 3:30pm CDT
October 21 from 2pm – 5pm CDT
Greenlight Guru’s Medical Device Success Platform is the only all-in-one solution that helps you get your products to market faster, with less risk, and advance your success in-market.
The platform helps companies manufacture safer products and get to market faster, simplifies regulatory compliance and provides a single source of truth by connecting the management of all product development, regulatory and quality processes from documentation and design controls to submission and ongoing compliance.
Device makers across the globe are replacing reactive quality management tools and shifting their focus and efforts to ensuring successful product launches and in-market success of innovative, life-changing devices.
For more information, visit www.greenlight.guru.
Complete Guide to Bringing a Medical Device to Market
Are you a medical manufacturer looking for guidance on how to plan for a successful product launch? This complete guide walks you through a step by step process to streamline your plan and maintain regulatory compliance across global markets.
ISO 15223-1 4th Edition is Almost Here: How to Update Your Medical Device Labeling to Comply with New Requirements
This free, in-depth webinar is presented by committee member of ISO 15223-1, Leo Eisner, who will cover the latest updates to this standard for medical device symbols on labels, helping participants understand the changes to the 4th Edition and uncover actionable ways to comply with the new requirements.
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July 9 @ 12pm Live-N-Learn: How to Connect Your Passions with Your Career – Hosted by THBC
July 15 @ 7:30 am Sales Leadership Roundtable: Understanding Tech to Advance Your Career – Hosted by ATC
July 22 @ 7:30am Leadership Roundtable: Building Capabitilites to Become a Modern Digital Company – Hosted by ATC
July 27 @ 12pm Getting off to a Great Start: Tips for Building a Fundable Team – Hosted by THBC
Tune into our Arena-hosted webinar where Vice President, Catalyst Flex Growth Strategy, Betsy Brown, and Senior Vice President, Resourcing Operations, Kathy Bradrick discuss with guest speaker, Maggie Neptune key outsourced staffing strategies needed by mid-tier biopharma and life sciences companies to achieve study success before, during and in the wake of the pandemic while gaining a sponsor’s perspective on the benefits of a flexible resourcing model.
Modernizing Clinical Trials Using a Virtual Framework: A Scientific Perspective on Endpoint Measurement and Best Practices in Neuroscience
Learn about best practices to support the measurement of your clinical trial endpoints in our educational webinar. Through several diverse perspectives, we will discuss strengths of a patient-centric, decentralized framework as well as considerations for overcoming common scientific and operational challenges in neuroscience trials.
In this webinar, we’ll show you how to identify your most critical equipment and combine that with a plug-and-play solution for predictive production operations – giving you actionable insights that not only help you identify and prevent imminent events but also create an ideal maintenance strategy for your facilities.
In this webinar, you will get an overview of EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), UDI labeling requirements and deadlines. We will also discuss the key differences between the US’s FDA UDI Rule and the EU’s MDR/IVDR.
Join BioAlberta and attendees from around the world at Bio Digital for an afternoon of live pitches and virtual networking showcasing the best of what Alberta companies offer. Hear from the Hon. Doug Schweitzer, Minister of Jobs, Economy and Innovation followed by a special presentation by Li Ka Shing Institute of Virology featuring Dr. Michael Houghton and Dr. Lorne Tyrrell plus pitches from our leading companies
Austin Technology Council Calendar of Events
Texas States Small Business Development Center Network Calendar of Events
Women in Business Virtual Calendar of Events
Temple Health & BioScience District’s (THBD’s) E-Learning Series Webinars Library
NAMSA’s Podcasts Calendar of Events
LIFE SCIENCE INDUSTRY NEWS
Local Life Science Headlines
Southlake Biotech OncoNano Medicine Raises $50M in Series B to Accelerate Cancer Tech Toward Commercialization
The investment was led by Advantech Capital, a PE fund based in China that focuses on TMT, pharmaceuticals, and healthcare. This combined with the support from the Cancer Prevention and Research Institute of Texas (CPRIT), which granted OncoNano $9.97 million last year, will support Phase 3 clinical trials for the biotech’s technology that can diagnose and treat cancer with high specificity.
Precision medicine is becoming a reality with genomic biomarkers that help answer questions about which therapy to choose, who should be given treatment and what dose of drug to use. Learn the potential applications of genomic biomarkers and techniques used to support biomarkers in clinical trials.
Pharma needs to gear up for the 2 billion Gen Zers about to enter the marketplace. Learn to appeal this hardworking generation that is about to be vying for your jobs.
The Food and Drug Administration’s decision on Monday to approve a new Alzheimer’s medication over the fierce objections of its scientific advisers sets into motion one of the most controversial drug introductions in years. For its manufacturer, Biogen, the new drug is poised to be a blockbuster. For just about everyone else, it is likely to further inflate high U.S. health care costs.
Would you describe your company as quality focused? For many, the answer is that they’re more focused on compliance. Don’t get me wrong, compliance is still important, but many companies are missing the mark when it comes to the regulations.
International Industry Interests
Last May the 31st 2021, the Ministry of Health in Mexico released an update to the Health Supplies Regulation. There are several amendments impacting different health supplies and in this document we will present a summary for those affecting Medical Devices.
Without an understanding of certain regulatory changes and how they impact your business, it can be easy to be out of compliance without even knowing it. This 5,000+ word ebook provides an in-depth analysis of some of the major changes happening in the industry, and offers some recommendations for you to consider when managing these changes.
When it comes to managing medical device risk, it’s imperative you’re using the most up to date risk-based best practices and methods. And we have a resource tailored to fit all of your medical device risk management needs: The Definitive Guide to ISO 14971:2019 is a 12 chapter guide that walks you through every step and recommended process from the latest version of the standard.
INDUSTRY RESOURCES & FUNDING OPPORTUNITIES
Attn: Austin area startups & entrepreneurs. Apply to Texas Health Catalyst @ Dell Medical School to receive consulting and customized guidance for your health product idea or discovery. The program is a great starting point for startups looking to explore collaborations with Dell Med clinicians and local healthcare industry mentors. All Austin area companies and entrepreneurs are eligible to apply including UT Austin spinouts. Areas of interest: Therapeutics, Devices, Diagnostics/Research Tools, Digital Health/Software.
The Health Cell, San Antonio’s premier networking and leadership development organization for healthcare and bioscience professionals, is calling for presenter nominations for its annual innovative storytelling event.
The State of the Industry is a once-a-year opportunity to bring your pioneering work, research, product, or company into the spotlight for a broad audience of regional and global leaders.
There are 2 upcoming dates: Tuesday, October 5, 2021 and Thursday, March 24, 2022.
Acquiring adequate investment capital during the startup process is critical. In order to reach that wonderful day when you are revenue positive and self-sustaining, you have to make it through the “valley of death,” that famous period between initial “seed” or “family & friends” funding and adequate capitalization to reach positive cash flow. Here are a few tips from the founder of Boulder IQ.
Greenlight Guru just published their 2021 Risk Management Benchmark Report based on their latest original research study. Dive into the data to uncover findings that shed light on the industry’s risk landscape. Discover how best-in-class organizations are overcoming the major hurdles affecting medical device companies.
WOMEN IN LIFE SCIENCE & WOMEN’S HEALTH
Through a series of interactive online gender equity discussions led by NPA and partner organizations, raise and seek paths forward on barriers in the postdoctoral community toward gender equality, recognizing that women and gender-diverse people do not start in the same position as men.
The Life Science Women’s Conference (LSWC) creates an environment where women working or desiring to work in all areas of life science companies and academia can gather to network and collaborate with other women with regard to entrepreneurship, professional development, inspiration, funding, career enhancement, scientific and technical updates.
Microaggressions pose one of the greatest challenges to women in STEM, says research fisheries biologist Brooke Penaluna, who notes that while she and her husband both have doctorates, she is addressed by her first name and her spouse is addressed as doctor. Child care is also treated differently by employers of mothers than of fathers, says Penaluna, who stresses that STEM benefits from being inclusive of parents as well as people of varied ethnic backgrounds.
“Not the Science Type,” a 4-part documentary streaming on Apple TV and Google Play, features microbiologist Jessica Taaffe, chemical engineer Jayshree Seth, nuclear engineer Ciara Sivels, and 15-year-old inventor Gitanjali Rao. The women have followed different paths to success in male-dominated fields, and the series explores the negative effects of stereotypes on STEM diversity, equity and inclusion.
Beginning in 2007, Genentech has been making a concerted effort to increase the representation of women in its senior leadership ranks. It has made tremendous progress. The four lessons from its success are: 1) Data drives the process; 2) everyone is accountable; 3) small actions add up; and 4) if you can’t prove it, it didn’t happen. Making significant change requires shifts in behaviors, perspectives, and processes, and that takes time.
CTN is currently searching for a dynamic, passionate, and collaborative Executive Managing Director to co-lead the organization at a pivotal point in its history. This is a fantastic opportunity for a results-oriented and inspiring leader to work alongside the founder/executive national director of CTN. This person will support our organization as we seek to strengthen infrastructure, deepen existing relationships, and put in place the systems, procedures, and policies needed to support a rapid expansion of programs and services.
For further details, read the full job description. To apply, please send a cover letter as an email to firstname.lastname@example.org and attach a resume. Applications will be reviewed on a rolling basis. Help us find the perfect fit!
We equip underserved jobseekers with 21st-century skills and connect them to Digital Marketing careers across the US. With a focus on underserved communities, we amplify the online presence of small businesses, while launching the careers of jobseekers.
What if, there was a one-stop shop for candidates and companies looking for top medical device opportunities and talent, worldwide Increase your network with more than 150,000 medical device industry professionals to access exclusive top talent and list incredible jobs in the medical device industry. The job board will always be free to job seekers, and hiring companies will receive their first 90 days of unlimited job postings free.
Austin Technology Council (ATC) Jobs
Black Diamond Networks
Commissioning Agents (CAI)
FDA Quality and Regulatory Consultants (FDAQRC)
We partner with nearby businesses who offer learning opportunities (guest speakers, internships, apprenticeships, etc.), and connect them to local schools, post-secondary institutions, and those facing barriers to employment.
We are seeking volunteers to help collect and compile data to map the healthcare landscape in Austin. If interested, please reach out to Scott Collins
TEXAS LIFE SCIENCE ORGANIZATIONS
ATX Women in MedTech
Austin Technology Council
Austin Health Tech Meetup
BioAustin LinkedIn Group
BioMed San Antonio
Capital City Innovation (CCI)
Central Texas Angel Network
Health Technology Forum Meetup
Health Wildcatters, Dallas
Austin Chamber of Commerce
Temple Health & Bioscience District (THBD)
Texas Healthcare and Bioscience Institute (THBI)
Texas Biomedical Research Institute, San Antonio
Texas Health Catalyst
Texas Medical Device Alliance (TMDA)
Texas Medical Device Alliance (TMDA) LinkedIn Group
The Health Cell, San Antonio
Top Austin-Area Medical Device Companies
Velocity Texas, San Antonio
Women in Bio-Texas (WIB-TX, Austin & Houston)
THANKS TO OUR TMDA SPONSORS
With warm regards,
Amy Shepherd, Christine Scheve, Dana Abramovitz, Elisa Maldonado-Holmertz, Gretchen Upton, Joe Skraba, Lance Anderson, Ryan Baird, Sandie Roth, Scott Collins, and Tim Sullivan, on behalf of BioAustin, Texas Medical Device Alliance (TMDA), and Austin Health Technology (AHT)