BioAustin | Texas Medical Device Alliance | Austin Health Tech
NEWSLETTER
February 2021
Check out news & events in the life sciences and health technology community in this newsletter!
JOIN THE NEWSLETTER TEAM!
Contact Elisa Maldonado-Holmertz
TMDA 2021 Meeting Dates
Feb 18, 2-3:30pm, Medical Device Packaging & Validation – More to it than you think (Via Zoom)
Register today at: https://tinyurl.com/y2gyq7rl Apr 15, 2-3:30pm (Via Zoom)
Jul 15, 2-4pm (Tentative In-person Meeting) Oct 21, 2-4pm (Tentative In-person Meeting)
As always, if you have news, job postings, or other resources to share, please contact
Elisa Maldonado-Holmertz
LIFE SCIENCE INDUSTRY NEWS
In Our Neck of The Woods….
Mastering Medical Device Podcast
Host, Patrick Kothe, President & CEO at EM Device Lab, Inc., Austin, TX
We help medical device professionals deepen their knowledge of customers, the industry, and their role. Our main objective is to help you become expert in your current position, and through a better understanding of others within your company and the best practices in others in the industry, enable you to fast-track your career. https://tinyurl.com/y5ftmkfq
Zeteo Biomedical Collaborating On A Next Generation Intranasal Covid Vaccine
Zeteo Biomedical is collaborating with the NanoVaccine Institute at Iowa State University to develop a room temperature stable intranasal vaccine for SARS-CoV 2 (Covid 19). Zeteo is providing its ZEOx2 CygnusSD™ powder nasal delivery device technology and technical services to support the joint development program. The project is currently in a pre-clinical phase. https://zeteobiomed.com/resources/
UT Health Austin Doctors Make the Austin Monthly Magazine 2021 Top Doctors List
Thirty-one UT Health Austin physicians were recognized as Top Doctors in the January 2021 Issue of Austin Monthly magazine. These physicians were nominated by other licensed physicians as the best in their medical specialty or among the best in the nation in their medical specialty. Each physician nominee is carefully screened based on their educational and professional experience by a physician-led team of Castle Connolly researchers who select top doctors on a national and regional level. This is the third year that UT Health Austin physicians have seen an increase in the number of physicians recognized for this honor. https://tinyurl.com/y5grdzz3
Breakthrough Tips for Innovators
Often-overlooked regulatory and related reimbursement considerations for device companies pursuing the popular Breakthrough Device pathway from John Doucet, former FDA Policy Lead for the Breakthrough Device Program. https://tinyurl.com/yxb6xpn3
COVID-19 Vaccine Tracker
The worldwide endeavor to create a safe and effective COVID-19 vaccine is beginning to bear fruit. A handful of vaccines now have been authorized around the globe; many more remain in development. https://tinyurl.com/yxy2f96s
COVID-19 Therapeutics Tracker
Months into the COVID-19 pandemic, just three therapeutics have been approved to treat COVID-19: dexamethasone in the United Kingdom and Japan; Avigan (favilavir) in China, Italy and Russia; and Veklury (remdesivir) in the United States, Japan and Australia. https://tinyurl.com/y8bbkgzc
Across the Pond….
Asia Actual
Philippines announces new regulatory requirement for all medical devices. Previously, only Class A and specific Class B, C, and D devices were subject to these requirements. More details are available here. A Certificate of Exemption issued under the old Rules will remain valid until November 3, 2021, or for 2 years from issuance date, whichever is shorter.
NAMSA: HOW TO SUCCESSFULLY TRANSITION FROM IVDD TO IVDR: A ROADMAP OF PRIORITIES AND COMPLIANCE STRATEGIES
The European Union’s In Vitro Diagnostic Regulation EU 2017/746 (IVDR) has been in place since 2017, and with it, has come new challenges for the IVD industry throughout Europe. Given the scale of the regulation’s proposed changes, a five-year transition period has been underway since its publication with the date of application (DOA) of 26 May 2022. Upon this obligatory conformity date, all IVD products must meet the new requirements, including non-application of CE marks under the superseded In Vitro Diagnostic Directive (IVDD). https://tinyurl.com/y6jlv35f
Regulatory Globe EU Updates
Regulating medical devices in the UK
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets. This guidance is divided into sections on the different rules that apply in Great Britain, Northern Ireland, and the EU. Great Britain is England, Wales, and Scotland. – CLICK HERE
EU Commission notice regarding on-site audits
Commission Notice on the application of Sections 2.3 and 3.3 of Annex IX to Regulation (EU) 2017/745 and Regulation (EU) 2017/746 with regard to notified bodies audits performed in the context of quality management system assessment. Link to document EN
INDUSTRY RESOURCES & FUNDING OPPORTUNITIES
What We Already Know About Investing in 2021
In theory, investing is all about markets; in practice, it’s more about marketing. What will financial marketers sell in 2021? The same thing they always sell: whatever did the best last year. https://tinyurl.com/y3bkv7j9
Greenlight Guru Featured Topics
- How to Prepare your Medical Device Company for an FDA Inspection
- How Smart are Your Design Inputs?
- Why Your Medical Device QMS Should Match the Size of Your Company
- 21 CFR Part 11: A Complete Guide »
- The Ultimate Guide to ISO 13485:2016 Quality Management Systems for Medical Devices.
- Free training webinars to help you stay on top of your game
- Free checklists, templates, and e-guides to make your job easier
Austin Chamber of Commerce Job Postings Report
The monthly job market report is designed to provide insight into current employer demands, skills and occupations in the Austin MSA. The most recent report provides data through mid-December.
There were approximately 62,800 available job postings during the December 2020 monthly reporting period, a decrease of 3,700 postings compared to the previous month. There were 22,000 new (first-time) Job postings, a decrease of 1,200 postings compared to the previous month. https://tinyurl.com/y263ukx7
WOMEN IN LIFE SCIENCE & WOMEN’S HEALTH
Avestria: Investing in women’s health, female founders
Avestria is a venture capital company that typically invests in seed and Series A funding rounds for women’s health and female-led startups, according to Linda Greub, co-founder and managing partner. “We believe women’s health is ripe for innovation and investment, and we’re hoping that the interest in and amount of capital backing these ventures continues to rise,” she says.
Full Story: NVCA Blog
International Day for Women and Girls in Science – AWIS Virtual Career Fair
February 11 is the annual International Day for Women and Girls in Science Register today. (You don’t have to be an AWIS member to attend.) It takes just five minutes to register. Don’t miss this chance to find your next career opportunity and network with employers looking to hire. https://tinyurl.com/yxaqltjr
WIB Virtual Events Offer the Chance to Connect Virtually
Women In Bio welcomes you to attend any of the fantastic virtual events our dedicated chapters are holding — even if you don’t live near those chapters. We offer a variety of networking and learning opportunities that will engage, educate, and empower. View the full list of virtual events.
SPOTLIGHT
BSI is the business improvement company that enables organizations to turn standards of best practice into habits of excellence. For over a century BSI has championed what good looks like and driven best practice in organizations around the world. Working with 84,000 clients across 193 countries, it is a truly international business with skills and experience across a number of sectors including aerospace, automotive, built environment, food, and healthcare. Through its expertise in Standards Development and Knowledge Solutions, Assurance Services, Regulatory Services and Consulting Services, BSI improves business performance to help clients grow sustainably, manage risk and ultimately be more resilient and trusted. To learn more, please visit: www.bsigroup.com
UPCOMING EVENTS
Austin Technology Council Calendar of Events
Texas States Small Business Development Center Network Calendar of Events
Women in Business Virtual Calendar of Events
View the full list of virtual events.
Temple Health & BioScience District’s (THBD’s) E-Learning Series Webinars Library
https://www.templebioscience.org/elearning/
NAMSA’s Podcasts Calendar of Events
https://namsa.com/resources/podcasts/biocompchatibility-podcast/
Qosina Video Library – BIOMEDigital 2020 | MD&M West 2020
MedTech Innovator Live Weekly Webinar Series
https://www.youtube.com/channel/UCza4pwHPN-GQYTbi6FuE4rw
5 February 12pm central | Virtual (free)
THBD: Launch & Learn Fireside Chat featuring Verena Kallhoff, Ph.D interviewed by Lisa McDonald, MD
9 February 10am central | Virtual (free)
Clinical Decisions: Applying Advanced Optimization Data
9 February | 10am central | Virtual (free)
Evolving the Principles of Modern Trial Oversight: Life Sciences, Clinical Trials, Pharmaceutical,
Drug Discovery & Development
9 February 12pm central | Virtual (free)
Bayesian Statistics: Probablistic Methods for Uncertainty Quantification (series)
SWRI, San Antonio https://tinyurl.com/y6brl3r5
17 February 9am central | Virtual (free)
Drug development for start-ups and emerging pharma (Part 1 of 2)
17 February 9am central | Virtual (free)
Technology Transfer – A Systemic Approach
17 February 9-10am central | Virtual (free)
Mass Challenge: From Idea to IPO
18 February 2-3:30pm central | Virtual (free)
Texas Medical Device Alliance (TMDA)
Medical Device Packaging & Validation – More to it than you think: Package tolerance testing,
Sterilization, UDI, Labeling, and Ship Testing https://tinyurl.com/y2gyq7rl
23 February 12-1pm central | Virtual (free)
THBD: Learned Lessons from an Early Stage Entrepreneur: How to start a biotech company with just coffee.
23 February 9-10am central | Virtual (free)
Optimizing Upstream High-Throughput Biologics Development: Presented by Bristol Myers Squibb
22 March – 23 March | Online Summit
Medical Device Manufacturing & R&D Summit
http://www.s1.medicalmanufacturingsummit.com
16, 22 and 23 April | Online Summit
AMDM Annual IVD Regulatory Meeting and FDA Submissions Workshop
FDA IVD Submissions Workshop – Thursday April 22nd
AMDM IVD Regulatory Meeting – Friday April 16th & Friday April 23rd https://www.amdm.org/
VOLUNTEER OPPORTUNITIES
Science Fair Judges Needed for Science Fest 2021
BioAustin is looking for judges for the Austin Science Education Foundation Science Fair. www.austinscience.org Documentation will be made available to all judges prior to the first scheduled interviews. Category Award interviews will be stretched out over two weeks, from February 9-19, followed by Special Award interviews on February 22 and 23. Please contact Scott Collins at [email protected] for details.
Become a Talent Ambassador
Through the Talent Ambassador program, the Austin Chamber partners with nearby businesses who offer learning opportunities (guest speakers, internships, apprenticeships, etc.), and connects them to local schools, post-secondary institutions, and those facing barriers to employment.
Contact Kwee Lan Teo at [email protected] for questions or more information.
Call for Mentors – UT Austin Women’s STEM Program
The Association for Women In STEM at UT (AWIS at UT) is recruiting mentors for their 2021 mentorship program which pairs undergraduate students, grad students, and postdocs at UT with women in STEM careers for 1 year of meetups (starting Jan. 2021) scheduled at the pair’s convenience and guided by supporting materials. Sign Up at https://utexas.qualtrics.com/jfe/form/SV_b9NPyRLozuJtirX
BioAustin/TMDA/AHT/CCI/TX Health Catalyst/Capital Factory/ Health Tech Austin
We are mapping the Austin’s landscape in healthcare/life sciences/biotech/MedTech. Anyone interested in volunteering to collect/compile this information as a team? If you are, please contact Scott Collins at [email protected].
ATX Women in MedTech
Looking for volunteers to support community outreach, event management, PR, sponsorship and more. Email [email protected] for details.
BioAustin
We are seeking volunteers. If interested, please reach out to Scott Collins at [email protected]
TEXAS LIFE SCIENCE ORGANIZATIONS
ATX Women in MedTech
Austin Technology Council
https://www.austintechnologycouncil.org
Austin Health Tech Meetup
https://www.meetup.com/Austin-Health-Tech/
Austin Technology Incubator (ATI)
Beam Founders
BioAustin LinkedIn Group
https://www.linkedin.com/groups/6535301/profile
BioMed San Antonio
BioNorth
Capital City Innovation (CCI)
https://www.capitalcityinnovation.org/
Central Texas Angel Network
Health Technology Forum Meetup
https://www.meetup.com/HealthTechnologyForu m-Austin/
Bio El Paso-Juarez
Health Wildcatters, Dallas
BioHouston
Temple Health & Bioscience District (THBD)
http://www.templebioscience.com/
Texas Healthcare and Bioscience Institute (THBI)
Texas Biomedical Research Institute, San Antonio
Texas Health Catalyst
https://dellmed.utexas.edu/thc
Texas Medical Device Alliance (TMDA)
Texas Medical Device Alliance (TMDA) LinkedIn Group
https://www.linkedin.com/groups/6952028
The Health Cell, San Antonio
TMCX/TMCX+, Houston
http://www.tmc.edu/innovation/innovation- programs/tmcx-plus/
Top Austin-Area Medical Device Companies
Velocity Texas, San Antonio
Women in Bio-Texas (WIB-TX, Austin & Houston)
https://www.womeninbio.org/page/t
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)