TMDA Save the Date
Meeting October 20

Please plan to join us for the next TMDA meeting on October 20, 2022.  Topic for the meeting is Reimbursement: How to get a New Reimbursement Code.

The meeting will be in-person at Maestro Logistics from 3pm to 4pm CT with a networking Happy Hour after the presentations.

More details to come!

Be a Part of the Newsletter

Send us your job postings, news, resources and events to share with the community.

Submit your information today to be a part of next month’s newsletter.

SPOTLIGHT

Medical Product Outsourcing’s conference series—the MPO Summit—has provided the medtech industry with the most comprehensive programs for more than 15 years. This year, the MPO Summit returns to Austin, Texas, and will simultaneously highlight the appeal of the region for medtech while tackling a number of the most significant issues for today’s medical device companies.

This interactive networking and educational event will partner local experts with out-of-state industry thought leaders—OEMs, contract manufacturers, suppliers, consultants, members of the investment community, and academia—for a unique forum to discuss critical industry topics and offer tools to compete and grow in today’s challenging business climate.

REGISTER TODAY! 

For questions, please contact Howard Revitch, group publisher, at 201-965-5116 or [email protected], or Sean Fenske, editor-in-chief, at [email protected].

UPCOMING EVENTS

Local Events

Sept 8
5:30-9 PM

2022 BioMedSA Award for Innovation in Healthcare & Bioscience

The BioMedSA Award for Innovation in Healthcare and Bioscience celebrates local and national innovators in the healthcare and bioscience industry, including patient care, education, research and development, leadership, public policy and medical technology.

In 2022, the Innovation Award will be presented at a formal dinner in San Antonio, where healthcare and bioscience industry leaders can come together to celebrate healthcare innovation. The dinner will highlight and contribute to the collaborative spirit of the life science industry in San Antonio. Old associations will be rekindled in person and new relationships formed as industry leaders interact during the social hour preceding the dinner and the networking time after the dinner.

Sept 13
12 PM

UT Austin College of Natural Sciences Technology & Science Career Fair IN PERSON

The fair offers employers a great opportunity to meet diverse undergraduate and graduate students from all majors, promote your open positions, and build your brand with UT Austin students.

Sept 14
12-1 PM

ATC Unplugged: Learning from the Past to Prepare for the Future

NASA’s Lessons Learned Program was designed to educate new generations of NASA engineers on mistakes of the past in order to prevent future accidents, a lesson that can be taken to heart across industries involving teamwork by highly specialized teams.

Sept 15
8:30-10 AM

Get the Most Bang for Your Benefits

In this Austin Tech Roundtable, experts from Excel Benefits will share advice on how employers can look outside the box to pick and design plans that meet employee needs and promote workforce wellness, while protecting their bottom line.  

Sept 21
8 AM

Institute for Biomedical Entrepreneurship (IBE)

The IBE is a non-profit celebrating 5 years of helping entrepreneurs accelerate the flow of ideas to the marketplace. The IBE program is a 5 day experiential program that includes a mix of classroom work and hands on project work. Advisors work with participants over the 5 day program to develop and refine their pitch and present to an investor panel on the final day. Since its inception, the IBE has helped over 40 companies launch and over 50 corporate projects see success in the marketplace.

Sept 21
11 AM

UT Austin College of Natural Sciences Technology & Science Career Fair VIRTUAL

The fair offers employers a great opportunity to meet diverse undergraduate and graduate students from all majors, promote your open positions, and build your brand with UT Austin students.

Sept 22, 7:30AM-6:30PM
Sept 23, 8AM-2PM

2022 iC3 Life Science Summit

The BioNTX iC³ Life Science Summit serves as the forum where leaders come together to discuss strategy, exhibit the broad spectrum of North Texas bioscience research, and where the latest innovation, products and services can be seen. Attendees range from the startup community through large multinationals representing industry sectors such as biotech, pharmaceuticals, healthcare companies, academic research institutions, innovators, and leaders. Also attending will be business development executives, vendor partners, investors, and talent seeking new opportunities.

Webinars & Virtual Events

Sept 8
11 AM

Clinical Considerations for Software and AI/Machine Learning

Innovate smarter and not harder by taking key considerations including when an AI solution may be needed and identifying appropriate research questions and best practices for engineering and deploying the model effectively based on industry and the FDA’s SaMD (Software as a Medical Device) regulation guidance. 

Join Proxima Clinical Research’s subject matter expert, Director of Regulatory Affairs, Isabella Schmitt, MBA, RAC, who will expand on clinical considerations for software and artificial intelligence (AI) and machine learning (ML). For all of those interested in learning about this timely topic, register for this free, in-depth webinar now!

Sept 8
11 AM

Driving Value from Tax: Cash Incentives Available to Texas Life Sciences Companies

Join us to learn about Federal and State incentives available for companies in the life sciences industry.

Sept 22
10 AM

Biostatistics in IVD Clinical Research – Decoding the Biostatistical Black Box

During this webinar, NAMSA’s Principal IVD Biostatistician will examine the benefits of including biostatistics early and often in a clinical trial, provide insight on how to prevent unnecessary delays and walk through two real-world case studies.

Sept 21-23
All Day

Redefining Early Stage Investments (RESI) Boston Conference

The Redefining Early Stage Investments (RESI) conference series connects start-ups and early-stage investors and strategic channel partners. RESI maximizes fundraising companies’ efforts to find partners who are a fit for their technology and stage of development. RESI is uniquely cross-border and cross-domain, connecting start-ups with 10 categories of global investors across the silos of drugs, devices, diagnostics and digital health (4 Ds). RESI caters to both the earliest stage start-ups, those seeking grants, seed and angel capital, and the early-stage firms who seek series A and B funding. RESI is a unique and powerful tool for sourcing assets and advancing innovation across early-stage life science and healthcare.

Local News

CPRIT Oversight Committee Approves Over $89 Million in Grants

The Oversight Committee of the Cancer Prevention and Research Institute of Texas (CPRIT), approved a large slate of awards totaling over $89 million for cancer research, prevention and product development.

“The awards approved today by the Oversight Committee illustrate the depth and breadth of CPRIT’s impact in the Texas fight against cancer,” said CPRIT CEO Wayne Roberts. “From recruitment grants bringing the brightest cancer researchers to Texas, to supporting lifesaving prevention programs across the state and providing critical investments in developing new cancer-fighting drugs, CPRIT touched all the bases for a home run against cancer.”

Apply to Pitch at the Texas Life Science Forum

If you are a life science entrepreneur who would like to pitch in front of 400+ venture capitalists, corporate innovation groups, angel networks, industry leaders, academics and service providers, then the 11th Annual Texas Life Science Forum is for you! 

The Texas Life Science Forum is the premier networking event for life science businesses in Texas.  Hosted by BioHouston and Rice Alliance for Technology, it brings together venture capitalists, corporate innovation groups, angel networks, industry leaders, academics and service providers throughout the country to network with the Houston region life sciences community.

INDUSTRY RESOURCES

ICH Q10 toolkit

A collection of helpful resources for pharmaceutical quality professionals, designed to help them interpret, understand and work towards the requirements of ICH Q10, the international guidelines for the modern pharmaceutical quality system (PQS).

ISO 13485 toolkit

A bundle of helpful resources for medical device quality professionals. Contains everything you need to understand and apply the requirements of ISO 13485, the core international medical device quality management standard.

Apply to Eosera’s Pitch Competition for a Chance to win $10,000

Elyse Stoltz Dickerson, CEO of Eosera, Inc., got her start by winning a pitch competition which helped propel her business forward in the early days. Now, Eosera wants to pay it forward and give another female-led, Texas-based, smart, young company the same opportunity. With the help of our incredible partners, we are offering $10,000 to one lucky winner at the pitch event in November.

Expanding Your Market: Submitting U.S. EUA COVID-19 Products for EU IDVR Compliance

Access NAMSA’s latest White Paper, “Expanding your Market: Submitting U.S. EUA COVID-19 Products for EU IVDR Compliance,” as we discuss how to select the best strategy for IVDR compliance, the necessary steps to enter the EU market in an accelerated manner, and how to apply these certification processes to other devices.

Understanding FDA’s Special 510(k) Program

When medical devices are modified by the manufacturer, those changes still need to be evaluated by FDA, with the same reason as a new device: to protect the safety of patients and promote greater public health.

So, where do manufacturers turn when updating their own medical device? The answer is with a Special 510(k). Read this week’s featured blog post to learn about this program and how you can leverage it for your device

Austin Community College

Austin Community College biotechnology or computer science interns are available Email Kathryn Naughton for more information

BioNTX Job Board

Visit Bio North Texas job board for available job posting in the North Texas region.

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.

Abbott

Multiple Positions
View positions

Aeglea Biotherapeutics

Multiple positions
View positions

ALKU

Multiple positions
View positions

AMDM IVD Job Board

https://www.amdm.org/jobs.html

Asuragen

Multiple Positions
View positions

Austin Technology Council (ATC) Jobs

https://www.austintechnologycouncil.org/jobs/

Babylon Health

Multiple Positions
View positions

Black Diamond Networks

Multiple Positions
www.blackdiamondnet.com

Commissioning Agents (CAI)

Multiple Positions
https://cagents.com/careers

FDA Quality and Regulatory Consultants (FDAQRC)

Join the FDAQRC CAREER NETWORK

Luminex

Multiple Positions
View positions 

Molecular Templates

Multiple positions
View positions

Nuclein

Multiple Positions
www.nuclein.com/careers/

Skills Alliance

Multiple positions
View positions

Syneos Health

Multiple positions
View positions

VOLUNTEER OPPORTUNITIES

University of Texas at Austin, Department of Molecular Biosciences

We are seeking industry partners to provide information about the desired types of skills that companies seek in UT students applying for positions or internships. We will have a virtual event in early or mid August to gather this information. You must have knowledge of hiring and skills at your company. Contact Karen Browning for more information.

BioAustinCTX Seeking Grant Writing Volunteers

BioAustinCTX is seeking volunteers to assist with Grant Writing:
• Determines grant proposal concept by identifying and clarifying opportunities and needs, studying requests for grant proposals (RFPs), and attending strategy meetings.
• Prepares grant proposals by determining concept, gathering and formatting information, writing drafts, and finalizing.
• Supported by the BioAustinCTX Board

BioAustinCTX Seeking Volunteers

BioAustinCTX is seeking help with our PR/comms/marketing strategy as our content will increase in 2022. Please complete our volunteer form and indicate what areas you are interested in volunteering in.

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.

BioAustinCTX

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

TEXAS LIFE SCIENCE ORGANIZATIONS

THANKS TO OUR TMDA SPONSORS

With warm regards,
Cathy Diehl, Gretchen Upton, Hector Torres, Joe Skraba, Kristin Whitson, Lance Anderson, Mea Amor, Ryan Baird, Scott Collins, and Tim Sullivan, on behalf of BioAustinCTX and Texas Medical Device Alliance (TMDA).