Thanks to all who responded to our survey. There was overwhelming support for a Q4 BioBash.

SAVE THE DATE for Tuesday, November 16, 6-8pm at the Bullock Texas State History Museum*.

AND a big thanks to our first BioBash sponsor, Austin’s fully virtual Invited MBA. See the Spotlight section for more information. Invited MBA is offering discounts to the BioAustinCTX membership and newsletter readers.
*If Covid restrictions prevent meeting in person, the BioAustinCTX BioBash will be postponed to Q1 2022.

What can we do while we wait? There were several suggestions for smaller in-person or virtual events which are great ideas.  In order to bring what you want and need, please answer these few questions.

These would be short, under 10 minute presentations.

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The Invited MBA is a 12-week, fully virtual mini-MBA program built around award-winning competitive business simulations and action learning projects. We’re offering members of the BioAustin Community (through this newsletter) an exclusive $200 tuition credit. Additionally, the first 10 BioAustinCTX members who are accepted and enroll will be awarded an automatic $1,000 scholarship for the fall cohort, final application deadline is September 9th! Both individual professional members and employees of corporate members qualify. 

FDA Quality and Regulatory Consultants (FDAQRC) provides trusted compliance solutions to pharmaceutical, biotech, and medical device companies. From routine audits to inspection readiness to Quality Management System development, our Quality Assurance expertise spans all GxPs including: GCP, GLP, GcLP, GMP, GVP, GMP and GDP. FDAQRC employs a staff of dedicated home-based Project Managers and Auditors and has a global network of more than 200 consultants. Our team has expertise in all areas and includes QA credentialed and former FDA professionals. Since 2009, FDAQRC has worked to establish long-standing professional relationships with both clients and consultants worldwide. FDAQRC understands client needs and strives to match them with the most highly knowledgeable and trained consultant to assure each deliverable meets our high expectations. For more information, visit us at


Local Events

September 9 – HR Round Table: Changes to the Texas Sexual Harassment Law – Hosted by ATC

September 16 – HR Roundtable: The IT Workforce – Overcoming Short and Long Term Challenges – Hosted by ATC

Sept 31 – Oct 1 – BioNTX iC3 Summit 2021 – Reignite! – Hosted by BioNTX

October 1 – Annual BioHouston Chili Cook-off – Hosted by BioHouston

Nov 10 – 11 – 2021 Texas Life Science Forum – Hosted by BioHouston

Sept 2
12pm CDT

Partnering with Payers & Health Systems

Exploring different models that payers, providers, and manufacturers employ towards working with small companies; what are the health systems looking for. Free webinar.
Sept 9
8am CDT

Aseptic Fill / Finish: A Holistic Approach

This webinar will give you an overview of the challenges and of Fill/Finish including sterilization and how to overcome them by working with SME’s from different companies and achieving a fast and reliable solution for bringing your product fast to the market.
Sept 9
12pm CDT

Sales & Market Access

Selling into hospitals, when to / how build a sales force or partner with a distributor, best practices for marketing post-COVID. Free webinar.
Sept 14
8am CDT

Do You Need a Metallurgist?

The realm of metallurgy has been a part of our existence since humans started extracting metal from the Earth. This presentation will be a series of case studies that illustrate the science and engineering of metallurgy as they apply to real life scenarios.
Sept 14
10am CDT

Fundamental Principles for Today’s Clinical Trials

This session is designed to equip senior leadership in clinical operations with a framework to select and evaluate innovation and manage change to optimize clinical trials not only for today but with lasting effect for the future. Rather than reviewing tactical decisions about point solutions, this session will give you tips and insights from key trial stakeholders on how to ensure your evaluation of technology starts with the end in mind and supports faster, safer, more efficient clinical trials.
Sept 15
10am CDT

6 steps to overcome labelling challenges in the life sciences industry: How to drive efficiency & control through digital maturity

In this webinar, Kallik’s CEO, Gurdip Singh, and Life Sciences labelling Specialist, Bob Tilling, will guide attendees through their digital maturity journey and how to best use technology to have the right information, on the right label, at the right time. By following the Digital Maturity Curve – a best practice, step-by-step methodology- life sciences manufacturers can take gradual steps into assessing their business landscape and transitioning to digital solutions.
Sept 16
8am CDT

Why a Global Labeling System is becoming critical for Medical Device Manufacturers

Today’s global medical device market is creating challenging conditions for device manufacturers. In this information packed session, PRISYM ID speakers will share insight into why continuing with international medical device manufacturing without the support of a true GLS, will create continual challenges, and why now is the time to take a different approach.
Sept 16
12pm CDT

Device Security

MedTech Innovator is the industry’s nonprofit global competition and accelerator for medical device, digital health and diagnostic companies. Our mission is to improve the lives of patients by accelerating the growth of companies that are transforming the healthcare system. Join them for a free webinar about device security.
Sept 21
9am CDT

Understanding the New IEC 60601-1 Amendment 2 Requirements

Medical device standards are updated often. This can make it difficult for medical device manufacturers to keep up with the latest changes, impacting their quality systems and technical documentation, product development schedules, and time to market. Are you ready to meet the new IEC 60601-1 Amendment 2 requirements?
Sept 21-24
All Day

Get to Market Summit Series

No matter where you’re at in the process, there’s a lot to plan to successfully get your device in the hands of end users and to maintain regulatory compliance across global markets. From napkin drawing to product launch, industry experts at this event will help guide you through processes, considerations, and regulations to make sure you’re equipped with the knowledge and tips to bring your device to market (and stay there). And it’s free!
Sept 23
9am – 12pm CDT

Increasing Diversity in Clinical Trials

There are many patient communities across various races and ethnicities that are often underrepresented in clinical trials, which creates significant gaps in the safety and efficacy data of new therapies. We’d like to advance the discussion and understand how stakeholders in clinical trials can effectively promote diversity and align with the latest FDA guidance to proactively increase the participation of underrepresented patient populations.
Sept 27
8am CDT

Improving inhaler technique with electronics: connected inhalers

During the webinar, participants will gain an understanding of how connected inhalers can help to pave the way to be a win-win situation for patients, the pharmaceutical industry and healthcare providers. Participants will also see how important flow inhalation measurement technology is in response to the most common mistakes while using an inhaler.
Sept 27
10am CDT

Accelerating technology transformation to build resilient healthcare enterprises

Join this session with Anant Adya, SVP and Business Head for Cloud, Infrastructure & Security Services, Infosys and other speakers to hear their perspectives on how well-orchestrated technology investments can help build resilient and agile healthcare enterprises.
Sept 28
8am CDT

Face the future of manufacturing through predictive maintenance data management towards a more sustainable future with metered dose inhalers

Industrial automation components are subject to wear, that can lead to lower efficiency and performance, increase of energy use or even the complete failure. Predictive maintenance technologies can determine when maintenance should be performed and can provide cost savings over traditional time-based preventive maintenance, because tasks are planned only when necessary.

Sept 28
9:30am CDT

Towards a more sustainable future with metered dose inhalers

In this webinar, we will explore how the Pharmaceutical industry’s use of propellants has evolved in the drive for greater sustainability including a reduction in the carbon footprint of inhalers, providing some context on the impact pMDIs have on the environment today while at the same time suggesting some areas for improvement. 
Sept 30 – Oct 1
All Day

BioNTX iC3 Summit 2021 – Reignite!

Launched in 2014, the iC3 Life Science Summit serves as a forum for leaders to discuss strategic issues, exhibit the broad spectrum of North Texas life science products and services, and to network with each other to grow business through collaborative efforts. Register now for this in person event.
Oct 5
8am CDT

Global sourcing for optimised cost and supply in clinical trials

The comparator sourcing industry has doubled over the past five years, with the need for secure and transparent sourcing of comparator and non-investigational medicinal products (NIMPs) expected to continue to rise, globally. Join our webinar to discuss actionable steps for your sourcing strategy to ensure your trial remains in budget and progresses according to expected timelines.

Oct 5
11am CDT

Collaboration Pushing Medical Device Technology Boundaries

Case studies for optimizing design and manufacturing processes in surgical and cardiac devices. Register today to take part of this informative webinar that will increase your toolbox of experience for leveraging existing solutions. Our goal is to make your medical devices consistently more robust while reducing size and maintaining aggressive cost targets.

Oct 6
9am CDT

Innovative Assays for Immunotherapy Drug Discovery Programs

In this webinar, we discuss the key players targeted in immunotherapy and how these cells and processes can be assessed in vitro. We also provide approaches for selecting the most appropriate assay for your target of interest and requirements. In addition to showcasing innovative in vitro assays for immunotherapy drug discovery, this webinar will also summarise the current challenges, considerations, and emerging areas within the field. There will also be a live Q&A session where you’ll be able to put your questions to our expert.

Oct 7
12pm CDT

FDA Innovating Patient Access & Payer Task Force

Regulatory strategy at a high-level, FDA initiatives for patient access and payer task force, as well as new trends in the space that can impact early stage companies.

Oct 21
12pm CDT

Corporate Social Responsibility and DEI

MedTech Innovator is the industry’s nonprofit global competition and accelerator for medical device, digital health and diagnostic companies. Our mission is to improve the lives of patients by accelerating the growth of companies that are transforming the healthcare system. Join them for a free webinar.
Oct 21
2 – 4pm CDT

TMDA Supplier Summit

This summit is tentatively set to meet in person. Discuss medical device marketing with an audience Q&A session. Register today to reserve your spot.
Nov 8
1 – 9pm CST

CEO Summit 2021

CEO Summit, presented by Workhorse Marketing is an afternoon to evening forum where over 150 of Austin’s leading technology CEOs network, learn about cutting-edge best practices, share expertise with peers, and begin projects that will continue to make Austin a place for small to enterprise tech companies. ATC is committed to promoting and supporting the growth of the Austin tech ecosystem. In this spirit, the day is filled with panels, breakouts, happy hours, and networking. The CEO Summit is an exclusive event for C-Suite executives only. 
Feb 17, 2022
2 – 4pm CST

TMDA CEO Fireside Chat

Join us in person for our CEO fireside chat and networking event.

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

NAMSA’s Podcasts Calendar of Events


Local Life Science Headlines

Houston’s robust life sciences ecosystem is about to welcome a new coworking space for early-stage biotech startups. K2bio will offer experienced biotech research managers, staff and other resources in a state-of-the-art facility just south of the 610 loop, including a mix of shared and private research laboratory spaces. The facility officially opens in September.

Nanoscope Therapeutics Inc., a clinical-stage biotechnology company developing gene therapies for treatment of retinal degenerative diseases, has dosed the first patient in its Phase 2b clinical trial of MCO-010, an ambient-light activatable optogenetic monotherapy to restore vision in patients with retinitis pigmentosa.

National News

Effective September 5, Lilly Bio-Medicines will split into two units: Lilly Neuroscience and Lilly Immunology. Anne White, senior VP and president of Lilly Oncology, will lead Lilly Neuroscience as senior VP and president.

Medpace’s newest infectious disease physician discusses how the pandemic might impact future clinical research.

The Food and Drug Administration won’t approve FibroGen’s anemia pill without the company conducting further clinical study on its safety, casting doubt on the medicine’s future in the U.S. The future of roxadustat in the U.S. hinges on what exactly the FDA is requiring, and whether Fibrogen and AstraZeneca are willing to follow through with additional study.

The FDA has relaxed a clinical hold on clinical trials of Novartis’ intrathecal formulation of spinal muscular atrophy (SMA) gene therapy Zolgensma, allowing a new phase 3 trial to get underway. Zolgensma (onasemnogene abeparvovec) is already approved as an intravenous treatment in babies and very young children for the rare muscle-wasting disease, but the new OAV-101 IT version is designed to unlock use of the drug in older SMA patients.

International Industry Interests

Under the EU MDR, post-market surveillance (PMS) is a critical quality control measure designed to identify risks associated with a device after being used for some time. This whitepaper provides valuable insights and tips to help conduct an effective PMCF study to ensure that better, lower-risk products are being brought to market, reducing unavoidable residual risks to acceptable levels. 
It may be surprising to learn that 40% of trading on Toronto Stock Exchange (TSX) and TSX Venture Exchange (TSXV) combined comes from outside of Canada… with a majority coming from the United States (U.S.). For innovative U.S. companies looking to raise growth capital, the Canadian markets can be a gateway to North American capital.
Last August 13th 2021, COFEPRIS announced a new version of the so called ECAR program. This is basically an initiative from the authority to minimize the backlogged Medical Device applications. The main drawback is that the deadline to apply for it was August 20th 2021. Even though this alternative has expired, it is expected to be offered again. In this article, we will discuss details about the program and how it will benefit Medical Device manufacturers from all over the world.
Launching a product in the market is one of the biggest accomplishments for a medical device manufacturer, but this key milestone doesn’t mark the end of your responsibilities. In the EU market, specifically, manufacturers are required to perform scrupulous postmarket surveillance (PMS) activities for as long as a device is on the market to ensure product safety and efficacy for patients.
ExeVir, just announced that the first subjects have been dosed in its Phase I clinical study. ExeVir launched a year ago and having its lead compound in clinical development is a milestone. Studies recently demonstrated that the compound neutralizes the Delta variant, as well as all current COVID-19 variants of concern.


Bring life-saving medical devices to market faster with Qualio Design Controls

The biggest challenge medical device companies face today is bringing quality products to market quickly. Product development teams struggle with losing velocity because of fragmented tools and data sources they must depend on to ensure safe products. We’re excited to announce Design Controls, a new product in Qualio built on ISO 13485 and CFR 820 in harmony with ISO 14971, that enables product development and quality teams to work together and ship high-quality, life-saving products faster.

5 Major Total Quality Management Principles for Medical Device Startups

Are you ready to improve manufacturing output? Are you satisfied with your organization’s current approach to TQM? A bulletproof TQM strategy outlines the strategies manufacturers follow to improve product quality and, by association, customer satisfaction. Without a quality management system (QMS) in place, the process is highly inefficient and laborious, to say the least. Learn more about the major TQM principles medical device startups need to be aware of.

Learn How to Prepare for an FDA Inspection

If FDA called tomorrow to announce their plans to visit your facility next week, would you be prepared? Would you know what you need to do to get ready? Here are 5 tips & pointers to help your company get prepared for an FDA inspection.

The Ultimate Guide to CAPA for Medical Devices

The corrective and preventive action (CAPA) process is the heart of any quality management system. And yet, year after year, CAPA is the #1 reason device makers receive 483’s from FDA. This doesn’t have to be the case. Use this guide to help you implement and maintain a healthy CAPA system, in order to avoid the common pitfalls such as being reactive versus proactive, poor root cause determination, and more.

3 Life[cycle] Hacks for Integrating Risk Management throughout all Device Phases

Too many companies still treat risk management as a “checkbox” activity. They look up the regulations, only to apply them as a high-level list of to-dos for the team to check off as they develop the product. But this compliance-only mentality doesn’t do risk management justice, and it isn’t the best way to focus on bringing a safe, high-quality medical device to market. Check out this blog to learn how to integrate risk management into everything.

Call for Presenters

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.

Texas Health Catalyst Application

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. 


Sept 15
1pm-3pm CST

AWIS Virtual Career Fair

The Association for Women in Science Virtual Career Fair aims to connect AWIS members and all women in science with employers seeking top talent. This aligns with AWIS’ work toward equal inclusion and advancement of women in science positions at all levels, from early career to senior leadership.
Sept 20 – 21
All Day

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.

The Visionary List: Meet The Women Over 50 Shaping The Future Of Science, Technology And Art

Forbes’ 50 Over 50: Vision list “highlights women over the age of 50 who are bringing breakthrough technologies and creative thinking to science, art, technology and healthcare,” writes Maggie McGrath. The list includes Cedilla Therapeutics President and CEO Alexandra Glucksmann, Pfizer Head of Vaccine R&D Kathrin Jansen, and Harvard University professor of biologically inspired engineering Jennifer Lewis, among other movers and shakers in life sciences, health care, art and other fields.

How Humacyte CEO built a successful women-led company

Laura Niklason co-founded regenerative medicine company Humacyte in 2004 with Juliana Blum and Shannon Dahl, but she continued working as a professor of anesthesia and biomedical engineering Yale University until last November, when she stepped up as CEO. Obtaining funds for a company with an all-female executive team in a field that was enduring growing pains at the time wasn’t easy, but the company’s board was built primarily from Niklason’s existing network, and she says she leaned heavily on them.

Reducing the gender bias in clinical trials

A study of women’s participation in cardiovascular clinical trials revealed that only 38% of participants were women. But if women comprise 50 percent of the population, that should be reflected in clinical trials too. See how Dr. Ki Park is working hard to make things better for her female patients by dedicating much of her research to women’s cardiovascular health.

Oct 27

Bioscience and Biotechnology Career Fair

The University of Texas at Austin is hosting a virtual career fair for interested employers and graduate programs to meet more than 300 students with experience and interest in the biomedical, biotechnology and life sciences industries. The even is free but you must register by mid-September.

Part-time Contract with Mainstream Medical Devices

We are seeking a part-time contractor for Design History File Writing for Class 1 devices. If interested in more information, please contact Dana Wilcox, CEO Mainstream Medical Devices, LLC.

Veravas Careers

Do you have the skills and the passion to move diagnostics and precision medicine forward? Learn more about career opportunities at Veravas. We have multiple positions open in the Austin area. Controller Senior Account Executive – Laboratory Segment Senior Account Executive – Pharma Segment Senior Account Executive – Research Segment

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.

The Global Medical Device Job Board

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.


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Aeglea Biotherapeutics

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AMDM IVD Job Board


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Austin Technology Council (ATC) Jobs

Babylon Health

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Black Diamond Networks

Multiple Positions

Commissioning Agents (CAI)

Multiple Positions

FDA Quality and Regulatory Consultants (FDAQRC)



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Molecular Templates

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Multiple Positions

Skills Alliance

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Syneos Health

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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.


We are seeking volunteers to help collect and compile data to map the healthcare landscape in Austin. If interested, please fill our volunteer form.


ATX Women in MedTech

Austin Technology Council

Austin Health Tech Meetup

Austin Technology Incubator (ATI)

Beam Founders

BioAustin LinkedIn Group

BioMed San Antonio


Capital City Innovation (CCI)

Central Texas Angel Network

Health Technology Forum Meetup m-Austin/

Bio El Paso-Juarez

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

TMCX/TMCX+, Houston programs/tmcx-plus/

Top Austin-Area Medical Device Companies

Velocity Texas, San Antonio

Women in Bio-Texas (WIB-TX, Austin & Houston)


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)