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Healthcare, Biosciences and the businesses associated with those industries are the #1 target for cyber crime, with the average cost of a breach being $9.23 million. Why? Because their data has the highest value on the black market.

Our increasing digital connectedness is expanding both businesses and the threat landscape. Businesses who proactively protect their data through a cybersecurity, compliance and privacy program are seeing a competitive advantage in winning and renewing contracts.

CyberCompass, a local cybersecurity risk management company, helps businesses build cyber resilience across their business ecosystem of their people, processes, technology and vendors. We specialize in building cybersecurity risk management programs for vendors who need to comply with multiple regulations and provide proof to their clients and partners. See our case study on a rapid response for a client who had to prove compliance to keep their biggest contract.

BioAustinCTX and CyberCompass are coming together to bring you a Cybersecurity Webinar to help you best understand the cybersecurity, compliance and privacy expectations for your business. SAVE THE DATE for November 4 and be on the look out for more information coming soon.

Did you know October is Cybersecurity Awareness Month? Follow us on LinkedIn to learn ways you can better protect your people, processes, technology and vendors.


Local Events

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

October 6 – Happy Hour – Hosted by ATC & The HT Group

October 7 – Virtual Innovation Tour – Hosted by THBI

October 12 – Virtual U.S. FDI Mission with the City of Brampton – Hosted by ATC

October 14 – Sales Leadership Roundtable – Hosted by ATC

November 8 – CEO Summit 2021 – Hosted by ATC

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

Oct 5
8am CDT

Global sourcing for optimized 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 7
1:30pm CDT

THBI Virtual Innovation Tour

Join in for the Austin stop of THBI’s Innovation Tour. The meeting will bring together industry executives, economic developers, academic institutions, and policy makers to highlight the life science industry in the different regions. Each meeting will host a panel of speakers that represent the local life science environment. After the panel’s remarks, we will open up the meeting for a round table discussion. These meetings are closed to THBI members and invited guests only, and we hope you can join us. 

Oct 14
8am CDT

Avoiding Regulatory Trouble & Responding To Government Inquiries: Anti-Fraud & FDA Update for Manufacturers

Join Gardner Law and Fredrikson & Byron’s White Collar & Regulatory Defense Group for a half-day webinar to learn about the latest anti-fraud and FDA cases, what it takes to design and maintain an effective compliance program and perform investigations, and how to respond to a government investigation.

Oct 14
9am CDT

Challenges of Control Drug Product Development

This webinar will focus on exploring the challenges handling controlled substances. We will provide some real-life examples of the challenges and explore how we solve them at Recipharm. We will discuss these points from two different perspectives: a practical viewpoint and keeping the development process simple.

Oct 18
7pm CDT

China’s Medical Device Market

The medical device market in China is expected to expand by 6.2% between 2020-2025, reaching a market value of $38.4 billion by 2025. This webinar will provide an overview of China’s medical device market, opportunities, access requirements, IP considerations, and regulatory updates. We’ll clarify China’s public healthcare system and private hospital system roles, and how to sell into each.

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
2pm CDT

TMDA CEO Fireside Chat

Join this online event to hear from CEO’s in your field and see a Network Directory Demo.
Oct 26
11am CDT

Fast Track Your Phase 1 Clinical Trials

This Webinar and supporting White Paper look at the differences between the three regulatory bodies, and how speed and cost can both be improved by selecting the right location or mix of locations for your clinical trial, without the need to sacrifice quality.
Oct 27
11am – 4pm CDT

Bioscience & Biotechnology Virtual Career Fair 2021

Prior to the event, students and employers can view who is attending. Students can pick their top employers and employers can mark potential hires. Employers and Job Seekers can chat online during the event. Registration for employers and job seekers is still open.
Nov 3
10am CDT

How to Get the Best from Supplier Audits

Any one vendor can introduce risk to the entire study, its patients, or results. Today’s sponsor must have a philosophy as well as clear procedures to develop and implement a risk-based approach to vendor GCP qualification and auditing. Join us for a roundtable discussion where a panel of experienced auditors will share their expert advice and innovative solutions that avoid problems and help both clinical trial Sponsors and Vendors to manage and prepare for vendor qualification assessments.

Nov 4
9am CDT

Getting it right! Considerations for immuno-oncology and vaccine studies and the bioanalytical tools used

Choosing the right bioanalytical platform for your immunology or vaccines clinical trial is critical to data collection. But navigating the intricate bioanalytical process and selection of assay platforms can be difficult. What do these platforms look like in use, and how should you go about selecting the right one? This webinar will demystify the bioanalytical requirements for clinical studies and will discuss the most common bioanalytical platforms used during clinical trials to measure vaccine responses and levels of inflammatory mediators in biological fluids.

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 – 5pm CST

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 the TMDA Supplier Summit. 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. All suppliers and those seeking suppliers welcome!

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

Epilepsy, Video Games, and Virtual Reality

Co-founder of an Austin-based wellness gaming company funds collaborative efforts by UT Health Austin clinicians and researchers across The University of Texas at Austin to improve postsurgical outcomes in patients with epilepsy

3 Medical Device Reimbursement Strategies to Recoup Your Investment

Quality and patient care are of the utmost importance to manufacturers…it’s the ultimate reason why your product even exists. Read this new blog post that will walk you through three important considerations of a reimbursement strategy that benefits not just your company and investors’ bottom line, but also the main beneficiary of your device: the patient.

National News

Wearable biosensors are transforming clinical research to the benefit of patients, sites and sponsors alike. Deploying sensors can make studies more convenient for participants, accelerate recruitment and radically expand opportunities to collect objective patient data. However, the novel approach creates new challenges that sponsors need to address to realize the promise of wearable biosensors. Download the whitepaper to learn more.

In recent years, scientists have realized the role bacteria can play in cancer growth and resistance to chemotherapy drugs – but these tiny microbes could prove useful in treating the disease, too. Abi Millar examines the promises and limitations of therapeutic bacteria an as approach to treating cancer.

The structural complexity of modern biologics presents packaging manufacturers with a new challenge when it comes to ensuring the drug remains stable throughout its designated shelf life. To find out more, Darcy Jimenez unpacks key developments in biologics packaging that are helping patients to store and administer treatments at home. 

The Food and Drug Administration has suspended testing of an experimental BioMarin Pharmaceutical gene therapy for the rare inherited disease phenylketonuria due to safety concerns reported in preclinical testing. In a study meant to test the durability of BioMarin’s gene therapy, researchers found evidence the virus delivering the corrected gene had fused itself into the genomes of six mice that later developed liver cancer. 

International Industry Interests

The Novo Nordisk Foundation, which operates separately from Novo Nordisk, is collaborating with The Broad Institute of Harvard on mining genetic data to gain an understanding of how variants drive disease. The Foundation is putting up $47.5 million toward the initiative, which aims to connect Danish researchers with genetic data that will provide insights into disease mechanisms, with the initial focus on Type 2 diabetes and obesity.


Payor Communication Task Force

CDRH established the Payor Communication Task Force to facilitate communication between device manufacturers and payors to potentially shorten the time between FDA approval or clearance and coverage decisions. By communicating earlier, manufacturers may design their clinical trials to produce the data required for regulatory approval or clearance and for positive coverage determinations, which may expedite patient access.

Payors include public payors such as Centers for Medicare & Medicaid Services (CMS), private health plans, health technology assessment groups, and others who provide input into coverage, procurement, and reimbursement decisions.

For questions, additional information, or to request our presence at an event, please email us at Please note, all formal speaking requests will need to follow the procedures outlined here.

Opportunities to Obtain Payor Input – Early Payor Feedback Program

CDRH has a voluntary opportunity for medical device sponsors to obtain payor input on clinical trial design or other plans for gathering clinical evidence needed to support positive coverage decisions. All regulatory discussions will continue to follow the processes established within the CDRH Q-Submission Program. Organizations willing to join CDRH meetings are listed below. CDRH has an open request for additional coverage organizations that evaluate clinical evidence and make coverage recommendations or decisions for payors and health plans to join this opportunity.

If you have any questions about this opportunity, please email

Parallel Review with Centers for Medicare and Medicaid Services (CMS)

In 2011, FDA and CMS introduced the Parallel Review Pilot Program (Parallel Review), which established a mechanism for FDA and CMS to simultaneously review the submitted clinical data to help decrease the time between FDA’s approval of a premarket application and the subsequent CMS national coverage determination (NCD). 

For questions or additional information on the Parallel Review, contact

AMA Coding Questions

The American Medical Association (AMA) is responsible for the Current Procedural Terminology (CPT®)External Link Disclaimer, which is part of the coding process and offers doctors and health care providers a uniform language for coding medical services and procedures.

Please email CDRH Payor Communications with your specific question, and if your question falls under the purview of the American Medical Association (AMA), we will put you in contact with them.

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. 


New Nonprofit Seeks To Find The Lost Women Of Science

Journalist Katie Hafner and bioethicist Amy Scharf are investigating and promoting the achievements of little-known female scientists through a new educational nonprofit organization called the Lost Women of Science Initiative. Partners include Scientific American magazine, public media organization PRX, the Gordon and Betty Moore Foundation, Schmidt Futures, and Barnard College, and the first podcast will be a four-part series on pathologist and pediatrician Dorothy Andersen, who discovered cystic fibrosis.

Ideas by female biomedical scientists are often overlooked — why that has serious consequences

Biomedical researchers’ race, gender, ethnicity and age affect if their ideas and inventions will be embraced by the larger scientific community, and innovations by female, Black and Hispanic scientists are especially underutilized, according to a working paper distributed by the National Bureau of Economic Research. Female innovators aren’t as well-connected as men, their innovations are less likely than those of men to be adopted by men, and one result is a comparative dearth of biomedical products for women, researchers say.

Meet the women making waves in AI ethics, research, and entrepreneurship

Briana Brownell moonlights as a science communicator and by day runs Pure Strategy, which uses an automated neural intelligence engine to parse unstructured data. Brownell is one of six VentureBeat Women in AI Award winners shaking up the artificial intelligence sector.

Free Women’s Health Publications from the FDA

The FDA Office of Women’s Health (OWH) has over 40 publications designed to give women timely health information in a clear, easy-to-read format. Download a fact sheet or booklet for yourself. Order free copies for the women in your community. These are published in multiple languages.

Oct 27
11am – 4pm CDT

Bioscience & Biotechnology Virtual Career Fair 2021

Prior to the event, students and employers can view who is attending. Students can pick their top employers and employers can mark potential hires. Employers and Job Seekers can chat online during the event. Registration for employers and job seekers is still open.

Cassava Sciences Senior Director/Director of Regulatory Affairs

The Senior Director/Director of Regulatory Affairs will be responsible for leading the overall regulatory strategy for Cassava’s’ development programs. This individual will be the regulatory lead internally and externally with program oversight and assist in developing procedures to ensure regulatory compliance. Appointment as Director, Senior Director or above will depend on the level of experience.
  • BS Degree in a scientific discipline is required; an advanced degree (Masters, PharmD, PhD) is desirable.
  • A minimum 8-10 years of experience in Regulatory Affairs is required. Experience in development of neurology products is a plus.
  • Comprehensive knowledge of applicable regulations and experience with requirements for IND/CTA, NDA/MAA, and interactions with Health Authorities is required.
  • Proven ability to work successfully and influence within a cross-functional team/partnership environment with a high level of professionalism.
Deadline to apply: 11/15/2021

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.


Multiple Positions
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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

Multiple Positions
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Black Diamond Networks

Multiple Positions

Commissioning Agents (CAI)

Multiple Positions

FDA Quality and Regulatory Consultants (FDAQRC)



Multiple Positions
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Molecular Templates

Multiple positions
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Multiple Positions

Skills Alliance

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Syneos Health

Multiple positions
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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)