TMDA Events
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FDA Medical Device Regulations -Including Emergency Use Authorization (EUA)
July 15 from 2pm – 3:30pm CDT
TMDA MedTech Supplier Summit: Market Place Solutions from Bench to Bedside
October 21 from 2pm – 5pm CDT
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CALLING ALL MEDICAL DEVICE SUPPLIERS
Participate in the TMDA MedTech Supplier Summit!!
Oct 21, 2-4pm – TMDA MedTech Supplier Summit: Market Place Solutions from Bench to Bedside
We are inviting suppliers/vendors providing products/services across the entire medical device life cycle to participate in our complimentary summit. All suppliers/vendors may give 2-5 minute pitch to all attendees. TMDA industry participants and attendees are typically start-ups and small to medium size medical device manufacturers.
Suppliers/Vendors may include, but are not limited to: device designers, validation testing labs, human factors testing, prototypers, contract manufacturers, regulatory consultants, quality consultants, etc.
SPOTLIGHT
Qualio – The #1 Cloud-based QMS for Life Sciences
Qualio’s quality management platform is ready-to-use and cloud-based. Ranked as the “easiest to use” and “fastest implementation” Qualio unites your teams, processes, and data all in one place so you can not only get to market quickly and scale successfully but be 100% audit-ready. Qualio is built to make FDA 21 CFR Part 820, 21 CFR Part 11, ISO 13485 & 14971 audit-readiness easy for your team. Customers love our simple and secure document management, training, quality events, design control, risk management, and audit-ready reporting that are actually “fun to use”. No joke… our customers actually call it fun! 😉
Learn more and request a demo at https://www.qualio.com.
From Lab to Launch Podcast
We feature innovators and entrepreneurs on the front lines of life sciences each week on our podcast From Lab to Launch. We’d love to hear your story and represent Texas! Learn more and apply here.
Upcoming Events & News
Live Webinar: Passing an Audit: Pro Tips from a QA Expert Panel. Register for this live webinar on Tuesday, June 15, 2021 at 1pm CDT to hear leading Quality experts at Qualio, MWA Consulting, and Cirris, discuss the best ways to approach and pass an audit.
News: Qualio raises $50M to expand accessibility of our cloud-based eQMS at global scale and fuel significant investment in product and engineering team growth. Ready more on our press page.
Would you like to be considered for our spotlight company? Fill out this application.
BioAustinCTX Highlights
UPCOMING EVENTS
NAMSA Training Series: ISO 10993-18:2020 Chemical Characterization of Materials
eClinical & Clinical Data Management Innovation Conference
Lyophilized Drug Product Case Study: Risk Mitigation of Primary Packaging through Physical and Chemical Testing
NAMSA Training Series: ISO 10993-18:2020 Chemical Characterization of Materials
Developing Effective Clinical Supply Chain Strategies Utilizing Forecasting Technology
Passing an Audit: Pro Tips from a QA Expert Panel
Microfluidic bubble sensors, Non-invasive liquid level sensors, and Autoclavable force sensors.
The Critical Role of Biostatistics in Streamlining the Preclinical to Clinical Pathway
Internal Audits: Outsource or Inhouse?
Biological Safety Training – June Course B
FDA Medical Device Regulations
Risk Management True Quality Summit Series
BioNTX iC3 Summit 2021 – Reignite!
TMDA Supplier Summit
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/
LIFE SCIENCE INDUSTRY NEWS
The Ultimate Guide to Design Controls for Medical Device Companies
This comprehensive guide walks you through every step of the process and gives specific recommendations on what you can start doing today to ensure compliance while getting your device to market faster.
State of Medical Device Report 2020
Medical device companies, more specifically product development and quality teams, are expected to deliver innovative, life-changing medical device(s) at a rapid pace, all while maintaining compliance and achieving true quality – no pressure. This report shares the results of hundreds of survey responses from medical device professionals across the globe. They shared helpful insights and critical information about how their companies are currently managing both their product development and quality activities.
Accelerate Critical Scientific Discovery
See the winners of the recent ATCC Innovation Challenge! Through this challenge, we called upon innovators throughout the scientific community to submit a proposal of how they are using ATCC products in a novel way in infectious respiratory disease research or COVID-19 research. After receiving numerous submissions, we are pleased to announce the four winners of the challenge below. We’re proud to be a part of the scientific community that is working toward solving the COVID-19 crisis and we look forward to these innovative ideas coming to fruition.
Software as a Medical Device
Technological advances in health care have placed software as an essential component of products and services for diagnostic and analysis of clinical conditions and diseases. Even when software has been included as part of medical devices, in recent years it has been an increased use of software as a medical device by its own. This situation has promoted the regulation of Software as a Medical Device (SaMD) by some regulatory agencies
Changing the Face of Patient Recruitment
As the pandemic forced some clinical trial sites to shut down and numerous ongoing studies to pause, patient recruitment also slowed to a crawl, piling one more challenge onto an area that traditionally is fraught with difficulty. Despite these challenges, the pandemic has
also had a positive effect on the patient recruitment process. Learn more in a study released by PharmaVOICE.
How To Eliminate The Gate In Medtech Product Development’s Phase-Gate Approach
Check it out to learn more about how Boulder iQ’s “Think Smart” approach to product development can save time – and money – in getting life sciences products to market. This process reorders the steps in product development to help speed up the processes that typically get bogged down in the traditional phase-gate approach to medical device development.
World Pharmaceutical Frontiers
Get the latest digital edition by WorldPharma. The publication provides the latest industry thinking in all areas of pharmaceuticals and is essential reading for those who want to thrive while navigating the impact of Covid-19.
Local Industry News
Bridging the Health Innovation-Impact Gap: How Dell Medical School Created A High-Value Accelerator
UT Austin’s Dell Medical School has created a brand-new type of accelerator, Texas Health Catalyst (THC), to advance the progress of impactful ideas from bench to bedside and tackle some of today’s biggest challenges.
Across the Pond
Outsourcing in Clinical Trials in Eastern Europe 2021
Arena International are pleased to announce our first ever Outsourcing Clinical Trials event to focus on the challenges specific to running trials in Eastern Europe. Taking place on our innovative virtual platform, this event brings together senior leaders from across the industry to discuss everything you need to know when running clinical trials in Eastern Europe.
INDUSTRY RESOURCES & FUNDING OPPORTUNITIES
Texas Health Catalyst Application
Do you have a discovery or idea for a product to improve health?
Make your project more attractive to potential funders and partners: Apply to Texas Health Catalyst for an opportunity to receive commercialization support and to work with mentors with experience taking health care products to market.
WOMEN IN LIFE SCIENCE & WOMEN’S HEALTH
2021 International Life Science Women’s Conference
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.
Is ‘Strategic Discrimination’ Happening in Medtech?
Gender economics experts weigh in on an interesting finding from this year’s Medtech Salary Survey. In comparing the 2021 findings to past reports, Pedersen noticed that the gender ratio in the medtech industry has improved dramatically over the past five years.
We Need More Women Founders, Now, More Than Ever
Women-led startups employ more women, and when considered as a group, are more likely to succeed. That’s why the NYU School of Business’s Endless Frontier Labs launched an initiative to fund women-founded startups: to help us reclaim our place as foundational contributors to global prosperity.
Celebrating Pioneering Women in Science
AWIS is highlighting contributions of Asian American and Pacific Islander women in STEM on their historical figures page. Learn more about these amazing women and share their accomplishments in the field.
Using nanobodies to block a tick-borne bacterial infection
Researchers led by veterinary biosciences professor Yasuko Rikihisa have developed llama-derived nanobodies derived that block Ehrlichia chaffeensis. The tick-borne bacterium is difficult to kill with standard antibiotics because it replicates inside immune cells, and Rikihisa’s engineered nanobody blocked three functions of a protein the bacterium uses to take over immune cells.
Plant-derived COVID-19 vaccine candidate starts rolling review with Health Canada
Health Canada has begun a rolling review of data on Medicago’s COVID-19 vaccine based on coronavirus-like protein particles grown in live Nicotiana benthamiana plants, which is easier to scale up and produces vaccine substance faster than egg-based production, and both vaccines and antibodies can be produced using the same platform, said Nathalie Landry, the company’s executive vice president of scientific and medical affairs.
Hockfield joins Repertoire BOD
Massachusetts Institute of Technology President Emerita Susan Hockfield has joined the board of directors at Repertoire Immune Medicines, which was formed in 2019 with the merger of Torque Therapeutics and Flagship Pioneering. Repertoire is developing immunotherapies for metastatic solid tumors and type 1 diabetes.
Career Connections
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.Karoleen Joseph, Seeking Opportunity
I finished my degree in Chemical Engineering along with a Business minor from Texas A&M in 2016. Since I have been working for a large organization as a Project Engineer III / Advanced Field Service Engineer I’ve gained experience in manufacturing and custom automation, and in the process of completing my PMP Certification. While I have grown and excelled at this company, I always knew that my passion was to work for an organization that contributes towards a better cause. I would be thrilled to work and grow with a company that contributes to the medical field in some way or form in the Austin or Round Rock area. I do understand I am making a field change (in a way) and some companies look for people that have prior experience in the field they are hiring for. However, I am extremely passionate about this change and I know I would be able to excel in it in a short period of time given the opportunity. Please contact me via email or LinkedInAbbott
Multiple Positions
View positions
Aeglea Biotherapeutics
Multiple positions
View positions
ALKU
Multiple positions
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AMDM IVD Job Board
https://www.amdm.org/jobs.html
Asuragen
Multiple Positions
View positions
Austin Technology Council (ATC) Jobs
https://www.austintechnologycouncil.org/jobs/
Babylon Health
Multiple Positions
View positions
Black Diamond Networks
Multiple Positions
www.blackdiamondnet.com
Commissioning Agents (CAI)
Multiple Positions
https://cagents.com/careers
FDA Quality and Regulatory Consultants (FDAQRC)
Luminex
Multiple Positions
View positions
Molecular Templates
Multiple positions
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Nuclein
Multiple Positions
www.nuclein.com/careers/
Skills Alliance
Multiple positions
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Syneos Health
Multiple positions
View positions
VOLUNTEER OPPORTUNITIES
Austin Chamber Talent Ambassador program
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.
BioAustinCTX
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
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
Austin Chamber of Commerce
https://www.austinchamber.com/economic-development/key-industries/life-science/
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)
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)