BioAustin | Texas Medical Device Alliance | Austin Health Tech

MAY 2021

Check out 2 new funding opportunities, as well as the news & events in the life sciences and health technology community in this newsletter!

Contact Elisa Maldonado-Holmertz

TMDA 2021 Meeting Dates & Topics

Apr 15, 2-3:30pm – Hiring Well & Setting the Right Culture for Small Businesses in a Remote World Register:

Jul 15, 2-4pm – FDA Medical Device Regulations – Quick Pace Changes in the light of EUA Oct 21, 2-4pm – Supplier Summit or Medical Device Marketing (TBD)

As always, if you have news, job postings, or other resources to share, please contact
Elisa Maldonado-Holmertz


Establishing an Innovative Educational Program for Training the Next Generation of Cardiovascular Perfusionists

In partnership with Texas Heart Institute, the Texas Center for Pediatric and Congenital Heart Disease is now offering a first-of-its-kind educational program that allows student perfusionists a clinical experience unlike any other.

How to Create a Quality Management Plan

Read Greenlight Guru’s blog post for a blueprint you can use to create a quality management plan that enables your company to achieve quality goals, redirects you if you go off course, and places your medical device in a position to excel in the marketplace.

Think Fast! Challenging the Phase-Gate Paradigm to Improve the Time to Market

Medical device development is a regulated activity, and rightfully so. The provisions of the FDA Quality System Regulation, international standard ISO 13485 and similar oversight regulations have significantly improved the quality of medical device designs…

Quick Turnaround Ethylene Oxide Sterilization

Ethylene Oxide (EO) sterilization is a method routinely used for product that needs to be sterile. EO is particularly great for products that are plastic, have electronics, or sensitive to high amounts of humidity, the gas can penetrate through almost all materials other than metal making it very effective…

Avoiding Failure to Launch

A venture capitalist once said that in his experience no really good idea failed due to lack of resources. In my over 25 years of experience, nothing could be further from the truth!

What is the Safer Technologies Program (STeP) and Can Your Device Use It?

Watch Jon Speer’s conversations with the world’s leading medical device quality and regulatory experts from anywhere! Give our first episode a watch and subscribe to our YouTube channel to watch future podcast videos!

3 Valuable Outcomes of a Culture of Quality

Does your medical device company have a culture of quality? Quality is the heartbeat of everything we do as medical device professionals. When we put quality first, we’re ultimately putting our patients first and our businesses in a position to succeed. Read this week’s new blog post to learn why you must establish a culture of quality and three valuable outcomes that your company will benefit from in doing so.

Patient Power

Personal Journeys of Courage

Unflagging Courage

When providers, pharma, and researchers tap into the power of advocacy groups that concentrate on the patient voice, an entirely new perspective can be exposed that ultimately may improve outcomes.

Bringing Health Equity to All Patients

Health equity has long been an issue for communities of color. This past year, the Black Lives Matter movement and recognition of the impact of COVID-19 on many communities has shed new light on the problem of health inequity.

Advocacy Cheerleader

Pharmaceutical companies can learn about and share the importance of individualized access to treatment options and ways to overcome challenges from the patient experience perspective from me.

The Patient Knows Best

The patient voice is crucial throughout the entire healthcare process, but especially relevant in creating spot-on patient education.

Education is Key

What pharma could learn from me is that my experience has value. That I’m more than a chart, a number, or a diagnosis. That my journey has taught me lessons that I can pass along to health professionals, caregivers, and clients.

Virtual Patient Care: Starting to Shine

Virtual patient care has moved from healthcare’s bit player to co-star, and it won’t be giving up that role

anytime soon.

A Family Affair

It’s becoming increasingly clear that for pharma to reach its full potential, Patient Advocacy groups must be recognized not only as a source for finding patients for clinical trials but rather as valued partners throughout the entire drug development process.

Decentralized Clinical Trials: The Way Forward

COVID-19 prompted the need for the industry to address patient needs in the clinical trial space, and companies along the drug development paradigm pivoted successfully to the benefit of patients.

Becoming a Patient Partner

As an important part of the healthcare system, pharma already has a role in educating doctors and consumers about their products. Yet, further opportunities for finding pearls of wisdom exist within the stories not only of patients, but also their families and caregivers.

Chief Patient Officers

More and more companies are elevating patient-facing roles to the C-Suite, as a result, these key roles continue to expand and evolve to address the goals of patient-centricity and patient engagement.


In Our Neck of The Woods….


BioAustin & ACC’s Bioscience Incubator (ABI) Survey

ABI bridges the gaps in the “research to product” cycle, creating an innovative work environment for life science entrepreneurs. BioAustin is the Central Texas Life Science Industry Organization for networking, collaborating, and advancing the entire life science community. Please complete this brief survey to learn more  about  the  companies in our community. science-company-survey/tt-c071cf

Zeto Biomedical Receives US Patent

Zeteo Biomedical has been granted a US Patent for its latest innovations in sublingual delivery of vaccines, drugs and biopharmaceuticals.

COVID-19 Vaccine Tracker

The worldwide endeavor to create a safe and effective COVID-19 vaccine is beginning to bear fruit. A handful of vaccines now have been authorized around the globe; many more remain in development.

COVID-19 Therapeutics Tracker

Months into the COVID-19 pandemic, just three therapeutics have been approved to treat COVID-19: dexamethasone in the United Kingdom and Japan; Avigan (favilavir) in China, Italy and Russia; and Veklury (remdesivir) in the United States, Japan and Australia.


Across the Pond….


MDCG 2021-1

MDCG 2021-1: Guidance on harmonized administrative practices and alternative technical solutions until EUDAMED is fully functional.

New Notified Body designated under MDR

ISTITUTO SUPERIORE DI SANITA (NB0373) has received its designation under MDR. Check their scope.

EU MDR & IVDR True Quality Summit Series

Featuring 20 insightful sessions with industry leaders.


Quality Engine (QE) is your individual and professional search engine for the various service providers in the Healthcare, Medical, In-vitro Diagnostic and Combination Devices sectors.

Wellcome Trust leader changing academic research ecosystem

Frustration with the academic research system eventually led Anne-Marie Coriat to Wellcome Trust, where as head of UK/EU research landscape she can reshape how the academic research system operates through funding and policy. “One of my major focuses is looking at ways we can better support careers in research, not only by increasing the diversity of those who enter academia, but also by helping people pursue a breadth of careers in the system and not just the traditional PhD route,” Coriat said.

What is a Traceability Matrix and How Do I Create One for My Medical Device?

You’ve probably heard a traceability matrix is something you need as part of your medical device QMS, but do you know what that actually means and why having one is so important? Establishing and maintaining a traceability matrix during design and development will ensure your device reliably and effectively meets the needs of your intended user while also meeting regulatory expectations. Read this article to learn more and the steps you need to take to create one for your device!

Switzerland: MRA probably not updated by 26 May 2021

SWISS MEDTECH: “On 26 May 2021 the European Medical Device Regulation (MDR) will come into force, the same day that the corresponding Swiss Medical Device Ordinance (MedDO) enters into effect. All stakeholders must be aware that the Mutual Recognition Agreement (MRA) between Switzerland and the European Union (EU) will probably not be updated by 26 May 2021. It is also legally uncertain how the currently valid MRA of December 2017 will be interpreted by the EU Commission as of 26 May 2021.” SWISS MEDTECH has published some helpful documents for manufacturers, importers and distributors. Guidance for Importers and Distributors – Link Information on importing medical devices into Switzerland – Link

Thai FDA Guidance Published

On February 15th the Thai FDA published significant new guidance governing the (1) classification, (2) technical documentation requirements, (3) fee schedule and (4) transition plan for medical device registration. The new rules, which substantially increase the regulatory burden for the vast majority of medical devices, are effective immediately.

The EU Medical Device Regulation: Post Market Surveillance

The EU Medical Devices Regulation (MDR) goes into effect on May 21st. The MDR takes more of a life- cycle approach than the Medical Devices Directive (MDD), which focused on the pre-approval stage of medical device manufacturing. One area which shows significantly increased emphasis over the MDD is Post-market Surveillance…

Single VAT Declaration for EU possible now

As of 1st July 2021, there will be changes to VAT rules for distance sales and e-commerce deliveries within the EU!

Avoid 4 Sales Expansion Mistakes

Expanding into the European market can be a significant boon. Yet, why do so many American companies get it wrong? Read more >



See what happened at Texas Medical Device Alliance (TMDA) Quarterly Meeting (25 Feb 2021): Medical Device Packaging & Validation – More To It Than You Think

Moderated by Anne Holland, QC Consulting, and Panelist Speakers: Jennifer Gygi – Nelson Laboratories, Andrew Fronk – Bear Creek Consulting, Dana Wilcox – Mainstream Medical Devices, and Andrew Cockerham – Alafair Biosciences.
View TMDA highlights at:

View TMDA entire moderator/panelist discussion at:

See what happened at TEXGHS Global Health Security Demo Day (17 Mar 2021)

Watch the videos from TEXGHS @ SXSW 2021

Austin Chamber of Commerce Job Postings Report

The monthly job market report is designed to provide insight into current employer demands, skills and occupations in the Austin MSA. The most recent report was issued March 10.

Introducing BioFest Invest

BioFest Invest brings together potential investors from across the nation and Texas bioscience companies seeking investment funding, while sharing best practices, connections, and valuable advice. After a rigorous screening process, investors will have an opportunity to review selected company applications prior to the event to determine which companies they are interested in visiting. During the event, investors will be able to view company pitches and connect with company representatives live or after the event. Attendees will also have access to speakers and panelists on valuable topics relevant to bioscience companies. One-on-one networking meetings are available throughout the event via video chat rooms. Companies are encouraged to sign up online before the deadline, April 27, 2021.

The 2021 virtual BioFest Invest is free for attendees and investors. Participating companies seeking funding pay a fee of $150 for BioMedSA, BioAustin, BioHouston, BioNTX, and Bio El Paso-Juarez members or $250 for non-members, due upon acceptance.

BioFest Invest is currently seeking sponsors for this event. Sponsors will have the opportunity for recognition, speaking, and lead collection advertising at this event, while showing support for the bioscience industry in Texas. See for more details.

More information for the event, including registration, can be found at

VelocityTX is looking for Biotechnology and Medical Devices

VelocityTX is looking for startups focused on biotechnology and medical devices to join the 2021 BioGlobal Accelerator cohort. Only eight ventures will be selected.

This 16-week hybrid program (virtual and in-person sessions) runs from July 19 – Nov. 4 and is open to local, national, and international bioscience companies. The in-person segment of the accelerator will be located at the VelocityTX Innovation Center, a state-of-the-art facility in the heart of the growing innovation district of San Antonio, Texas.

Offerings include:

  • Coaching from four Entrepreneurs in Residence
  • Mentoring from 10 industry experts
  • Interactive technical sessions from over 40 expert speakers and facilitators
  • Networking with over 30 local economic development organizations
  • $12,000 cash for selected companies
  • $25,000 cash award to the winner of the program
  • And much more!

Applications must be submitted by Thursday, April 15 at midnight at do/accelerator/. For any questions, please contact


Trio of biotech execs join VC firm

Former Gilead Sciences Chief Financial Officer Robin Washington, former Ancestry President and CEO Margo Georgiadis, and former Livongo Health President Jennifer Schneider are venture capital firm General Catalyst’s new “endurance partners-in-residence.” They will work with portfolio companies from the startup phase onward, collaborating with founders “in a sustained way to create enduring businesses,” says Managing Partner Hemant Taneja.

Daphne Koller’s insitro looks to expand

Daphne Koller has been building insitro, a drug discovery firm centered on machine learning, since early 2018, and $400 million raised in a Series C round will help accelerate growth and expansion into drug development, Koller says. “There are specific target insights that have emerged from our biology platforms, that speak directly to mechanisms or targets that are readily being pursued by others, in many cases in adjacent indications or even in the same indication but for an all-comers patient population rather than ones with a genetic biomarker that our analysis has identified as being significant,” she explained.

6 Black women changing the trajectory of COVID-19

When pediatric surgeon Ala Stanford learned that Black people in Philadelphia were struggling to get COVID-19 testing, she gathered supplies, went into neighborhoods and administered tests herself, and eventually founded the Black Doctors COVID-19 Consortium. Morehouse Medical School President and Dean Valerie Montgomery Rice and Associate Dean Michelle Nichols set up a COVID-19 vaccination clinic on campus for local residents. Debra Fraser-Howze enlisted prominent Black pastors and founded Choose Healthy Life to provide COVID-19 education, testing, vaccines and infrastructure in Black communities.

McMurray-Heath: Act now to prevent the next pandemic

The next pandemic looms in the form of antibiotic-resistant microbes, and the Biden administration’s pandemic prevention plan must include a component to spur innovation in antimicrobials, writes physician-scientist and BIO President and CEO Michelle McMurry-Heath. More than 20 of the world’s top biopharmaceutical firms have pledged nearly $1 billion to the AMR Action Fund, but the federal government must play a part by addressing market risk and reimbursement barriers, McMurry-Heath writes.

Keep an eye on these 8 women VC investors

Eight women venture capitalists profiled by Forbes are investing their money in concepts led by women in the tech, life sciences, women-focused, immigrant and other arenas. All are pushing forward toward the day when the funding playing field becomes level for women and other underrepresented founders.

Can gene editing keep the world fed amid climate change?

Gene-editing technology CRISPR-Cas9 could play a key role in creating crops that are better able to stand up to climate change, according to a report from Australia’s University of Queensland. “CRISPR allows us to do things we can’t do through conventional breeding in terms of generating novel diversity and improving breeding for desirable traits,” researcher Karen Massel said.

Mammograms spot COVID-19 vaccine-related swelling

An article published online in the American Journal of Roentgenology explains how a recent COVID-19 vaccination can cause false-positives on mammograms and outlines steps health care providers can take. Lymph nodes can swell after a COVID-19 vaccination, and the Society of Breast Imaging suggests that any routine, annual breast screening be done before getting a COVID-19 vaccine, or waiting four to six weeks after the second dose for screening.

4 lessons a biotech CEO learned from failure

Biopharmaceutical industry veteran Leslie Williams learned important lessons through the founding and failure of ImmusanT, including the importance of periodically clearing your mind and staying optimistic but grounded. She also learned that compatibility with investors and board members reduce the risk of failure, and timing and luck matter.

FDA releases Data Modernization Action Plan

The FDA’s new Data Modernization Action Plan will focus on “the stewardship, security, quality control, analysis, and real-time use of data to accelerate the path to better therapeutic and diagnostic options for people and animals, better secure the food supply chain, and provide state-of-the-art tools to enhance and promote public health.” The plan is based on driver projects, promoting consistent and repeatable data practices, and fostering talent, write Acting Commissioner Janet Woodcock and Principal Deputy Commissioner and Acting Chief Information Officer Amy Abernethy.

Authors profile girls who live the Confidence Code

In their follow-up book to “The Confidence Code For Girls,” journalists Katty Kay and Claire Shipman and writer JillEllyn Riley tell the stories of 30 girls who took risks, built their confidence, and achieved goals. Building confidence “requires taking risks and embracing failing as necessary steps on the way to doing something cool, messy and gratifying,” Shipman said.


Under one roof, MedtoMarket provides a turnkey solution for medical innovation with its three divisions: M2M Labs, M2M Element Coworking and M2M Events. From bioskills research and training to expert AV capabilities and access to multi-use space, MedtoMarket provides everything a startup company needs to bring their visions to life. Our co-founders are practicing physicians. Therefore, startups receive feedback, connections, and resources. We help companies navigate the opaque and heavily regulated medical industry.

With our advanced A/V system and ability to broadcast internally or to an at-home audience, MedtoMarket’s response to hybrid and live streaming events has been successful. We use multiple camera angles, live Q&A through Zoom – or other conferencing platforms – and PowerPoint presentations to create interactive training sessions and meetings that aim to give attendees a full experience no matter how they are tuning in. Not only is this useful for our bioskills labs, but it is also handy for those hybrid meetings you want to host!

If  you  are  gearing  up  for  your  first  in-person  event,  but  still  want  to  create   a   safe   environment, MedtoMarket has four meeting rooms where the live stream can be broadcasted. With social distancing practiced, each room can seat from 20 people to 40 people which gives our groups plenty of opportunity to space out and feel safe. In addition to the labs and meeting space, we have an excellent lobby area for meals or social gatherings, perfect for your first happy hour back to normal!

Ready to get out of the house and into your own office? We also have a few spacious and quiet offices available for rent in our co-working division, dedicated to the life sciences industry. A membership with us means 24/7 keyless access to your office, free parking and easy access to Hwy 71 and I-35, to name a few.

If  you’re interested in seeing it all for yourself, please contact Lydia Portillo at to schedule a tour. Not ready to visit in person just yet? No problem! You can view our 3D tour to see the entire 32,000 square foot building. 3D Tour of MedtoMarket


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

9 April 12pm central | Virtual

Join The Central Texas Life Science Affinity Group for a Candid Conversation!

Featuring Aliya Aaron, MSHS, BSN, RN, Founder & CEO of Nursing Innovation Hub, Inc. Tune in for a candid discussion on choosing an alternative nursing career path, becoming an entrepreneur, and bringing expert insights to the development of new healthcare technologies. Register now at


12 April 6-7pm central | Virtual

Austin Technology Council – CEO Conversation with Greg Gilmore and Kiwi Camara



15 April 2-3:30pm central | Virtual (free)

Texas Medical Device Alliance (TMDA)

Hiring Well and Setting the Right Culture for Small Businesses in a Remote World

Register at:


16, 22 and 23 April | Online Summit

AMDM Annual IVD Regulatory Meeting and FDA Submissions Workshop

FDA IVD Submissions Workshop – Thursday April 22nd

AMDM IVD Regulatory Meeting – Friday April 16th & Friday April 23rd


26 April 9am central | Virtual (free)

Designing/Manufacturing small custom melts


27 April 12-1pm central | Virtual (free)

Partnering with Johnson & Johnson: Understand the Why, How, What & Needs

During this presentation, Ibraheem Badejo, Ph.D. and Senior Director of New Ventures at Johnson & Johnson, will detail external innovation strategies for engaging with early-stage companies to design transformative healthcare solutions. Badejo leverages his expertise in smart materials and biomaterials to support the medical device sector of J&J. Join us to glean insight from his expertise. Register now at


4 May 9am – 04:30pm central | Virtual

ISO 10993-18:2020 Chemical Characterization of Materials Workshop virtual/


19 May 8:30am – 5pm central | Virtual

Introducing BioFest Invest

BioFest Invest brings together potential investors from across the nation and Texas bioscience companies seeking investment funding, while sharing best practices, connections, and valuable advice. Companies are encouraged to sign up online before the deadline, April 27, 2021. More information for the event, including registration, can be found at


8-9 June 8am-5pm Central | Virtual

NAMSA Virtual Biological Safety Training – Course A


22–23 June 8am-5pm Central | Virtual

NAMSA Training Series: Biological Safety – Course B


15 July 2-4pm central | Tentative In-person Meeting (free)

Texas Medical Device Alliance (TMDA)

FDA Medical Device Regulations – Quick Pace Changes in the light of EUA

Register at:


21 October 2-4pm central | Tentative In-person Meeting (free)

Texas Medical Device Alliance (TMDA)

Supplier Summit or Medical Device Marketing (TBD)

Register at:


Become a Talent Ambassador

Through the Talent Ambassador program, the Austin Chamber partners with nearby businesses who offer learning opportunities (guest speakers, internships, apprenticeships, etc.), and connects them to local schools, post-secondary institutions, and those facing barriers to employment.

Contact Kwee Lan Teo at for questions or more information.

Call for Mentors – UT Austin Women’s STEM Program

The Association for Women In STEM at UT (AWIS at UT) is recruiting mentors for their 2021 mentorship program which pairs undergraduate students, grad students, and postdocs at UT with women in STEM careers for 1 year of meetups (starting Jan. 2021) scheduled at the pair’s convenience and guided by supporting materials. Sign Up at

BioAustin/TMDA/AHT/CCI/TX Health Catalyst/Capital Factory/ Health Tech Austin

We are mapping the Austin’s landscape in healthcare/life sciences/biotech/MedTech. Anyone interested in volunteering to collect/compile this information as a team? If you are, please contact Scott Collins at

ATX Women in MedTech

Looking for volunteers to support community outreach, event management, PR, sponsorship and more. Email for details.


We are seeking volunteers. If interested, please reach out to Scott Collins at


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


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)