How Your Life Science Organization Can Survive and Thrive the Chaos and Complexity of Cybersecurity

November 4, 2021 12pm-1pm CST

BioAustinCTX Lunch and Learn has gone virtual!

Fact: 60% of small businesses fail within 6 months of a breach.

Life sciences organizations, from small to large, can affordably become cyber resilient but many can’t find the right expertise or know where to start.

BioAustinCTX is excited to have Robert Felps, CEO of CyberCompass who has helped life science organizations to get cyber resilient. Robert will share his experience and lead an interactive discussion on cybersecurity challenges and opportunities you are facing. Attendees will have the opportunity to get a quick check on their cyber resilience to understand the exposure your organization is facing.

This virtual lunch and learn event is sponsored by BioAustinCTX and is open to both members and non-members across the great State of Texas. Registration seats are limited so register today.

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TMDA is thrilled to launch its new Marketplace Network Directory!! 

The Texas Medical Device Alliance (TMDA) Board developed an exciting new tool that connects medical device and life science professionals and allows them a space to showcase their companies and services.  Called the TMDA Network Directory, participants can enter information on their organizations, including location, contact information, descriptions, videos, demos and more.

This tool is a unique channel to maximize connections, build exposure for your brand, raise awareness and learn about other partners, collaborators and opportunities in the industry. For more information on this free tool, visit

How Do I Get Started? It’s easy!

  1. Just go to
  2. Click on Create your Free Profile
  3. Select between a Basic (free), Silver Sponsor ($500), Gold Sponsor ($1000) or Premium Sponsor ($2500)
  4. Enter information on your business, including map location, address, business tagline, descriptions, images, website, social media information and much more. Business content entry increases with service level purchased. For more information on pricing, please click on

TMDA Directory Sponsor Example

Increase your business awareness and get connected today by creating your profile!

Participants can join as a Company, Individual or Service/Vendor Providers. Their designation will allow for easier searchability. Here is a sample of a Service Provider profile. For more information, please contact us at


Local Events

November 4 – How Life Science Organizations Survive the Chaos and Complexity of Cybersecurity – Hosted by BioAustinCTX

November 8 – CEO Summit 2021 – Hosted by ATC

November 9 – Annual Policy Summit – Hosted by THBI

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

November 17 – Disrupt Diabetes Summit – Hosted by Health Tech Austin

Nov 2
7:30 am CDT

The Pulse Breakfast – Accessing Alternative Sources of Capital (IN PERSON)

Bob Rauker, CEO of Plano-based medical device company Belluscura, one of two Dallas-area life science companies to go public in London this summer, will outline the reasoning for and benefits of accessing capital this way in a fireside chat with Rachel Carroll, President & Managing Partner of Edison Group, a global independent equity research and investor relations company.

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
8am CDT

Creating Analytics for Business Improvement

Given the ongoing complexity in the healthcare marketplace and the need for constant business performance improvement to reduce costs and increase revenue, new, real time, dynamic tools, and metrics help make decision making easier for those who work in the healthcare industry. We’ll be presenting success stories and thoughtful insights on the ongoing changes in the industry,  how the better use of data can improve patient care, drive performance improvement, and increase revenue.

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 4
2pm CDT

Biosecurity – What Should We Be Concerned About?

Biosecurity risks are a wide and diverse field that isn’t limited to what’s in your labs. There are many different types of players across the globe. Join our two experts to learn much more.

Panelists: Yong-Bee Lim, PhD, Fellow, Council of Strategic Risks
> Kathleen Vogel, PhD, Director + Professor, School for the Future of Innovation in Society, ASU

Nov 7 – 12
All Day

Global Entrepreneurship Week Fort Worth

Each November, Global Entrepreneurship Week (GEW) reaches millions of people of all ages and backgrounds through local, national and global events and activities. During the week each November, speakers, panels, competitions, showcases and networking make up the thousands of events held around the world.

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. 

Nov 8
10 am CST

Accelerating Clinical Trials with Best-in-Class Technology

Traditional methods of setting up trials and managing large volumes of clinical data rely on time-consuming, repetitive manual processes. Today, our industry is increasingly adopting technology solutions to automate end-to-end clinical trials, from protocol to submission. As a result, it’s vital for organizations to be armed with the right knowledge and strategy when selecting solutions and vendors, in order to avoid pitfalls and pave the way for successful implementation. Register for this webinar to hear thought leaders from Formedix and eClinical Solutions discuss metadata management, study automation, and ultimately how to gain faster insights with Clinical Metadata and Data Repositories.

Nov 9
1:45 pm CST

Annual Policy Summit

Each year, THBI hosts the annual Summit and Luminary Awards events to highlight the world-class innovation taking place across the state and to educate state policy leaders. This fall, we are excited to plan for the first in-person event since the 2019 Fall Summit. This event will include a half day conference and will host conversations highlighting health policy initiatives and issues impacting patient access, research and development, and the future of the healthcare and life sciences industries in Texas. The event will also highlight industry leaders who have furthered innovation in Texas with the presentation of the annual Luminary Awards at a dinner following the Summit. The Luminary Award honors individuals for their contributions and efforts to further the development of the life science industry in Texas. 

Nov 11
8 am CST

Move Faster and Break Nothing with Med Devices, SAMD and DTX

This event will feature a mix of industry leaders and pioneers sharing first-hand lessons learned from their pioneering case studies accelerating the development of medical device software at the dawn of the age of digital health. During this webinar, they will share best practices and worst practices learned through their leading edge efforts. They will discuss a variety of tech industry approaches to leverage such as fast feedback loops (e.g., agile and Lean Startup), design thinking, and non-traditional leadership approaches, and how to best fuse those approaches with the constraints and decades of experience already known in regulated MedTech.

Nov 11
8 am CST

Manufactured in the USA: Choosing a US-based CDMO

In this webinar, we’d like to introduce Avéma Pharma Solutions, a contract manufacturer with the capabilities that pharma companies need when selecting a CDMO including in-house R&D capabilities, formulation development, full analytical labs, process scale up and transfer expertise, development and validation of analytical methods, pilot scale and commercial manufacturing capabilities, and regulatory support. As an organization focused on speed to market, we can help you launch your products quickly, efficiently and cost effectively.

Nov 16
3:30 pm CST

Founders Guide to Startup Accounting

Founders Circle is a discussion forum for life science startup founders and C-level executives. This series is facilitated by industry experts and investment professionals and centers on business challenges that all early-stage life science companies face. Discuss innovative growth strategies and learn from the experiences of an exclusive network of your peers.

Nov 17
11 am CST

Disrupt Diabetes Summit

Thought Leaders and Innovators Are Coming Together To Share Their Knowledge, Experience, Research, and Insights about Disrupting Diabetes.

Nov 18
All Day

Raising Capital True Quality Summit Series

The Raising Capital True Quality Summit Series is designed to help early-stage medical device, MedTech, and digital health company leaders learn best practices and expectations for raising their first rounds of funding. Discussions will dive into what investors are looking for when they make their decisions, the changes that COVID has made to the investment landscape, how to avoid pitfalls that many first-time founders make on their path to funding, and much more. The day-long, virtual event will feature sessions and panel discussions from investors, partners, strategics, and company leaders who have been through the process.

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

ReCode Therapeutics Raises Oversubscribed Series B Financing Round of $80 Million

The proceeds from the Series B financing will be used to drive ReCode’s lead programs in primary ciliary dyskinesia (PCD) and cystic fibrosis (CF) into human clinical studies, expand the pipeline of treatments for patients with life-limiting genetic respiratory diseases, advance its LNP platform for organ-specific delivery of RNA and gene correction therapies and increase internal manufacturing capabilities. ­

4 Examples of Continuous Improvement in Quality Management in Life Sciences Companies

We all know that quality management isn’t a “set it and forget it system,” but how do you actually make continuous improvement in quality management a reality in your life sciences company? We’ve put together some examples of continuous improvement in quality management that provide the inspiration that you need to take your company to the next level.

National News

Digital Control: Putting Solutions Into the Hands of Patients

Patient engagement solutions are key to clinician-patient interaction, improving compliance, enabling real-time reporting, and reducing visits to the doctor and hospital. Hear from industry thought leaders in this free article.

FDA Clears 5-Minute Test for Early Dementia

The US Food and Drug Administration has given marketing clearance to CognICA, an artificial intelligence–powered integrated cognitive assessment for the early detection of dementia. Developed by Cognetivity Neurosciences Ltd, CognICA is a 5-minute, computerized cognitive assessment that is completed using an iPad. The test offers several advantages over traditional pen-and-paper-based cognitive tests, the company said in a news release.

The Best QMS Software: The Pros and Cons of the 5 Top Options

Choosing a quality management software that fits your life science organization’s unique needs is essential to getting to market faster. Here’s an overview and side-by-side comparison of the top 5 QMS options to ensure you make the best decision for your company.

Keytruda Approved as First-Line Advanced Cervical Cancer Therapy

The FDA has approved Merck’s Keytruda as a first-line therapy for advanced cervical cancer. Keytruda (pembrolizumab) can be used in combination with chemotherapy, with or without bevacizumab, to treat patients with persistent, recurrent or metastatic cervical cancer where the tumor expresses a certain level of PD-L1.

International Industry Interests

Cleanroom Standard EN 17141:2020 and Biocontamination: What Do You Need to Know?

EN 17141:2020 Cleanrooms and associated controlled environments – Biocontamination control, introduced in August of 2020, is the new European standard that replaces EN ISO 14698-1:2003 and EN ISO 14698-2:2003. If you distribute medical devices in Europe, overlooking this new standard may mean risking non-compliance. Whether you’re a new startup or an established manufacturer, complying with EN 17141:2020 will help to proactively identify risks, establish and implement a plan, and trend and monitor microbiological test results.

3 FAQ about CE Marking Medical Device Manufacturers Want to Know

Every medical device needs a CE Marking in order to be sold in the EEA, even devices with the lowest-risk.

Before you begin the process of obtaining that CE Marking, there are a few key questions commonly asked by medical device manufacturers that you should know the answers to, especially if you want to fast-track your medical device to market

IEC 62366 Explained: What You Need To Know About Usability Engineering

Usability engineering (UE)—or human factors engineering (HFE), as it’s also known—is focused on designing a user interface (UI) that allows people to quickly understand how to interact with a product in the most efficient and error-free manner. Usability engineering is also a high priority in the medical device industry. Devices that lack an intuitive design and fail to take into account the user-device interaction can jeopardize patient and user safety. 

9 Best ISO 13485:2016 Training Programs in 2021

The caliber of your team’s ISO 13485:2016 training has a significant impact on the success and effectiveness of your quality programs. Our quality experts have curated this list of courses that have helped teams like yours dramatically improve their quality management system processes.

Costa Rica Holder Guide

The Costa Rica Registration Holder (CRH) is the physical or legal entity who manages the sanitary registration of an EMB (Equipment or Biomedical Material) or Medical Device and who acts as the primary point of contact with the Ministry of Health (MoH). In addition, the holder is in charge of submitting any regulatory requirement to the authorities. In other words, the CRH plays a key role as your partner during the life cycle of the sanitary registration in Costa Rica. Similarly, the Product Holder is another relevant party involved in this regulatory process. The Product Holder owns the EMB with a specific commercial name. In most cases the Product Holder is the legal manufacturer.


Ultimate Guide to Quality Assurance and Regulatory Affairs in Medical 3D Printing

This document aims to guide users in the medical device industry through every stage of the product development process, from evaluating manufacturing methods and 3D printing technologies to specific regulatory requirements for commercializing and marketing end-use 3D printed medical devices. Throughout the document are Formlabs and Greenlight Guru resources to support users in each step of the process.

World Pharma Packaging Insight 2021

World Pharma is pleased to present a complimentary digital copy of their latest publication. It provides the latest industry thinking in all areas of pharmaceuticals and is essential reading for those who want to stay ahead of the competition.

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.

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. 


Nov 18
2pm CST

A conversation with co-founder and CEO of Mothers in Science

Recent research shows that new mothers are nearly 3 times more likely to leave their STEM careers than new fathers or their childless peers. Dr. Isabel Torres will discuss the invisible structural barriers that silently push women in STEM away from their career track and explain why motherhood should be at the center of discussions and interventions to close the gender gap in STEM.

How to Speak TECH to NON-TECHS

Getting approvals and funding often depends on non-tech leaders understanding you.
Learn 5 Techniques to use tomorrow!
Reesa Woolf, PhD

With CEO hire, this Boston biotech boasts an all-woman C-suite

Dana-Farber Cancer Institute’s Luba Greenwood was named Kojin Therapeutics’ first CEO, joining Chief Scientific Officer Kay Ahn, Vice President of Biochemistry Lynn Abel, and founder and Head of Discovery Biology Vasanthi Viswanathan on the startup’s all-female executive team. The company is growing faster than expected, is hiring chemists, biologists and computational biologists, and is putting the finishing touches on a 15,000-square-foot facility in Boston’s Seaport District.

Trailblazing women who broke into engineering in the 1970s reflect on what’s changed – and what hasn’t

Engineering in the U.S. has long been — and continues to be — a male-dominated profession. Fifty years ago, it looked like that might change. In 1970, the percentage of women majoring in engineering was less than 1%. In 1979, that number was 9%. Today, only 21% of engineering majors are women.

Manager of Regulatory Affairs in Austin, TX area

My client is an industry-recognized leader in their medical technology space and delivers world-class medical devices through innovative engineering and manufacturing. They have multiple locations nationwide including their own manufacturing operations. They offer excellent benefits and PTO, as well as a competitive salary! This is a high-visibility role with opportunities for personal and professional growth! They are looking for someone with hands-on experience in EU-MDD and EU MDR including UDI and EUDAMED. Other required skills include the development of clinical trial protocols, coordinating submissions and applications, monitoring post-market activities, and providing input to the NPD and Manufacturing teams.

Alafair Biosciences, Inc Seeking Quality Engineer

Quality Engineer to support VP Quality & Manufacturing in all things Quality / Manufacturing / Design controls, etc. for Engineering / R&D and for Manufacturing. Bachelor’s degree required, preferably with a couple of years QMS experience.
Deadline to apply: 11/15/2021

Nuclein, LLC Seeking a Director of Systems Engineering

This position will be involved in supporting a next-generation molecular diagnostic device platform. This role will manage manufacturing and R&D related initiatives, including designing, defining, and documenting systems to support the company’s platform throughout the development lifecycle, as well as assisting with FDA submissions within an IVD medical device framework. In this role, you will have the opportunity to collaborate with functional leaders in software, bioinformatics, assay development, lab automation, sequencing, integration, and documentation from sample receipt to clinical report generation. The Director of Engineering will report to the VP of Engineering.
  • B.S. or M.S. in Engineering or a Life Science with 5-10 years in Systems or Process Engineering involving software and hardware
    implementations for life science products, in vitro diagnostics, or medical devices under design control (21 CFR Part 820, ISO 13485) in a regulated environment.
  • Understand and generate deliverables related to design controls in support of a regulated industry.
  • At least 10 years of experience with IVD medical device products
  • Background in nucleic acid-based diagnostics technology and experience with next-generation sequencing are highly desirable. Other system development experience in complex clinical diagnostic development environments is a plus.
  • Excellent verbal and written communication skills.
  • Enjoy working independently and collaboratively in a fast-paced environment and able to adapt to change. 
  • Experience in and success with influencing and working through others to achieve results within in a complex matrix organization.

Attogene Corporation Seeking Lab Technician (Contract Positions)

Previous experience in a laboratory environment as a Lab Assistant or Junior Lab Tech
Familiar with following technologies: Lateral Flow, ELISA, Enzyme assays, PCR, Nucleic Acid isolation, Cell culture

Deadline to apply: 11/30/2021

Genotox Laboratories Seeking Lab Technical Supervisor

Lab technical supervisor reports to the Genetic testing lab Manager and is responsible for managing the genetic testing service workflow to ensure the test accuracy and efficiency. Lab technical supervisor provides leadership and support to the genetic testing service team.

The Genetic Testing Lab Technical Supervisor should have proficient knowledge in the following areas:

DNA and RNA extraction
PCR and real time PCR
Biological sample handling
Basic experimental design
Molecular Biology
CLIA requirements

Must have a Bachelor’s degree in life science or post-graduate degree (preferred)

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

QA Consulting, Inc. Seeking Sterilization Subject Matter Expert Consultant

The primary responsibility of this position is to assist clients with validation of sterilization processes, biocompatibility testing,
cleanroom validation, and cleaning/disinfection validation for reusable medical devices within a Quality Management System
framework. This position requires independent utilization of sound validation techniques and strategies, including but not
limited to ethylene oxide, radiation, and steam sterilization methods, understanding of principles of cleanroom validation and
validation of disinfection and cleaning methods for reusable devices. Must possess a keen understanding of industry
standards and guidance to assist clients with root cause failure investigations in sterilization, and biocompatibility. The
Consultant must interact with other consultants, clients, laboratories, and experts outside QA Consulting to communicate and
implement company and client objectives. Client and project management skills are required. Contact for more information
Deadline to apply: 11/30/2021

PharPoint Research Seeking Biostatisticians

Are you looking for a meaningful career in the clinical research industry and passionate about improving world health? PharPoint Research, an award-winning Clinical Research Organization (CRO) based in North Carolina, is looking for talented Biostatisticians at all levels to join our team. Biostatisticians are critical to our team and serve as statistical professionals in analyzing and summarizing the results from clinical trials and in working with stakeholders at all levels to ensure the quality, efficacy and integrity in the data reporting and project activities executed. As a PharPoint Biostatistician, you will work on interesting projects in a variety of therapeutic areas!
– Master’s degree in Biostatistics, Statistics, Math or related discipline; P.h.D preferred
– One year related work experience in a clinical research environment
– Knowledge of the drug development process and FDA and ICH guidelines
– Knowledge of basic statistical design, analysis, and programming techniques utilized in clinical research
– Knowledge/experience with Statistical software packages (SAS preferred)
– Remote applicants considered

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)



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Molecular Templates

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Multiple Positions

Skills Alliance

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Syneos Health

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UT needs your help

The IC2 Institute is exploring the impact of Dell Medical School (DMS) across Central Texas. We ask members of BioAustinCTX, especially C-level executives, to reach out to Dr. Gregory Pogue if you are willing to participate in a brief focus group and/or provide feedback on your experience with DMS and the impacts it has created. We would like to host the focus group in early December – please let us know your availability and interest. Thank you!

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)