Newsletter May 2021

BioAustin | Texas Medical Device Alliance | Austin Health Tech

NEWSLETTER
MAY 2021

CONTENTS

LIFE SCIENCE INDUSTRY NEWS

INDUSTRY RESOURCES & FUNDING OPPORTUNITIES

WOMEN IN SCIENCE & WOMEN’S HEALTH

SPOTLIGHT

UPCOMING EVENTS

CAREER CORNER

VOLUNTEER OPPORTUNITIES

TEXAS LIFE SCIENCE ORGANIZATIONS

LIFE SCIENCE INDUSTRY NEWS

Wearable Biosensor Technology: Transforming Clinical Trials with Remote Data Collection

Wearables and other patient-centric portable devices that remotely collect individual biometric data are transforming clinical trials. The amassed aggregate health data confirms trial safety and can be leveraged to evaluate the effectiveness of a medical therapy or drug, while delivering many other vital operational and analytical advantages. MedPace provides the technology and expertise to incorporated biosensor data into multi-center, global trials.

SBA to Increase Lending Limit for COVID-19 Economic Injury Disaster Loans

The U.S. SBA is increasing the maximum amount small businesses and non-profit organizations can borrow through its COVID-19 Economic Injury Disaster Loan (EIDL) program. Starting the week of April 6, 2021, the SBA is raising the loan limit for the COVID-19 EIDL program from 6-months of economic injury with a maximum loan amount of $150,000 to up to 24-months of economic injury with a maximum loan amount of $500,000.

NAMSA to Provide Comprehensive, End-to-End Imaging Core Laboratory Solutions

With technology at its crux and a dedicated team of world-renowned physicians at the helm, NAMSA offers the highest quality Imaging Core Laboratory services in the CRO industry. Our expert imaging reviewers ensure quality and accuracy of image interpretation and analysis, and our highly efficient processes leave little for Sponsors to manage.

Survey shows Solid Medical Device Industry Performance Despite Pandemic Impact

Emergo by UL’s Global Medical Device Industry Outlook for 2021, which surveyed more than 1,600 manufacturers, showed companies performing at levels similar to those reported in our 2020 and 2019 industry surveys.

Smart diagnostic system awarded Red Dot Award

Medtech company Bloom Diagnostics has been awarded the Red Dot Award: Product Design 2021 for the functionality and aesthetics of its Bloom Lab device. The Bloom System aims to provide users with access to a range of bluetooth powered at-home smart tests, thereby relieving pressure on GPs and healthcare systems already under strain since the pandemic swept the world.

Climbing the PPE Plastic Mountain

The Covid-19 pandemic has created a huge amount of plastic waste in hospitals – largely a result of the additional PPE required to curb the spread of the virus. But what can be done to reduce the environmental impact of this plastic waste?

FDA clears Spinal Elements 3D additive manufactured interbody devices

The Lucent 3D implant has a strut-and-lattice structure with a bone graft chamber access lid that is designed for a surgeon to deliver large amounts of tightly packed graft inside the interbody structure.

In Our Neck of The Woods….

MedtoMarket Company Announcement – Promotion of Ryan Baird to COO, April 2 2021

MedtoMarket, Inc. is excited to announce the promotion of Ms. Ryan Baird to the position of Chief Operating Officer. Ms. Baird has been with MedtoMarket for over two and a half years as Executive Director of MedtoMarket and VP of Element Coworking. Ryan’s grit and leadership skills were shown with the challenges the Covid-19 pandemic presented in the spring of last year and she stepped up to lead the team through uncertainty. She has been vital in the successful growth of MedtoMarket’s 32,000 square foot flagship medical innovation center in Austin, Texas. In addition, Ryan Baird is a Board of Director, Director of Programming at Texas Medical Device Alliance (TMDA).

Panel Weighs Future Potential of City’s Health Care Innovation District

The battle over reconstructing Interstate 35, and the stalled Land Development Code update, are factors that continue to influence the shape and scope of the developing health care innovation district in the eastern section of downtown Austin. This was discussed at a recent Urban Land Institute Austin panel about development efforts planned around Dell Medical School at the University of Texas.

Luminex Corp, an Austin-based company being bought for $1.8B

Luminex Corp and Italian diagnostics company, DiaSorin SpA announced the deal on April 11. Luminex makes a wide range of testing equipment and is part of the rapidly growing multiplex diagnostics industry niche where one sample can be tested for multiple viruses.

UTD Symposium Marks “Meteoric Growth” in Bioengineering

Bioengineering researchers at UT Dallas are making advances that can improve and save lives. The university is culminating a year-long celebration of the Department of Bioengineering’s 10th anniversary with a symposium.

Everlywell Acquires PWNHealth and Home Access Health Corporation, Forming Everly Health

Everlywell, a leading digital health company, has acquired PWNHealth and Home Access Health Corporation and formed parent company Everly Health. Together, the combined companies support more than 20 million people annually in all 50 U.S. states, Canada, and Puerto Rico. The acquisition will enable the companies to scale their respective services while maintaining a strong commitment to data privacy and clinician independence.

Across the Pond….

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.

EU MDR Delay has not made new rules easier to stomach: Exec Poll

Members of Europe’s medtech industry reported in a recent survey that the EU’s Medical Device Regulation is challenging and costly, with three-fourths of respondents wanting clearer guidelines from the European Commission. The survey of 115 participants across Europe was conducted by the Munich- based software company Climedo Health.

Veraque announces new offices in Costa Rica!

If you are planning to sell medical devices in Costa Rica or you are already doing so, you need what we call a Sanitary Registration Holder. This holder plays a key role for your medical devices as the legal representative in Costa Rica, the sole point of contact for the ministry of health, reporter of adverse events, and the party that makes submissions to the ministry of health. Veraque can provide these services to you.

Brazilian regulators update economic monitoring requirements for some medical devices

Brazilian medical device regulator ANVISA has issued new regulations regarding economic monitoring of certain device types in order to boost transparency and establish reference pricing for these products. The new regulation, RDC 478/2021, repeals economic monitoring and reporting processes previously established under RDC 185/2006, and initially reduces the number of medical device types for which economic monitoring will be required. The new regulation is slated to take effect April 1, 2021.

Can IVD Manufacturers streamline production and improve quality processes with an industry-specific QMS?

Canterbury Scientific, an IVD company based in Christchurch New Zealand, recognized the limitations of a paper based QMS while managing several sets of regulatory requirements. Their QMS needed to be solid in order to help them keep abreast of quality and regulatory requirements. This case study describes the process to find a streamlined solution.

INDUSTRY RESOURCES & FUNDING OPPORTUNITIES

See what happened at Texas Medical Device Alliance (TMDA) Quarterly Meeting (15 Apr 2021):

Hiring & Setting the Right Culture for Small Businesses in a Remote World Moderated by Renee Rogers – Renee Rogers Coaching, and Panelist Speakers: Anna Carroll, MSSW – Everyday Feedback, Betsy Aylin – Bright Water Consulting

View TMDA discussion at: https://youtu.be/Eaw0vKkP42U

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

Watch the videos from TEXGHS @ SXSW 2021 https://vimeo.com/showcase/texghs-sxsw2021-demo-day

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 April 7. https://www.austinchamber.com/blog/austin-job-postings-report-march-2021

Central Texas Angel Network Application Deadline: Monday, May 3

The Central Texas Angel Network (CTAN) was founded in 2006 provides quality early-stage investment opportunities for accredited angel investors and assist entrepreneurs and early-stage growth companies by serving as a key source of funding, mentorship, strategic advice, and educational resources. Funding cycle info can be found at https://ctan.com/entrepreneurs/the-ctan-funding-cycle/

Beam Angel Network fundraising applications are open!

Beam Angel Network invests in high potential and exceptionally led Texas-based companies that happen to be founded by women. Funding Cycles run from February to November and targeted feedback is provided at each stage in the investment process for those not selected. Learn more at https://www.beamfounders.org/angel-network-about

WOMEN IN LIFE SCIENCE & WOMEN’S HEALTH

Women dominate FDA commissioner candidate list

Acting FDA Commissioner and longtime Center for Drug Evaluation and Research Director Janet Woodcock is no longer seen as a frontrunner for permanent FDA commissioner. Others who may be under consideration include Katherine Luzuriaga, director of the University of Massachusetts Center for Clinical and Translational Science; Florence Houn, vice president for global regulatory science at Celgene; Michelle McMurry-Heath, president and CEO of the Biotechnology Innovation Organization; Gayatri Rao, an executive at Rocket Pharmaceuticals; and former FDA officials Joshua Sharfstein and Luciana Borio.

Initiative aims to give women at MIT a boost in BioTech

Venture capitalists, biotechnology company executives, university faculty and policymakers in the Boston Biotech Working Group are working to increase the number of women on biotech company boards and help female faculty start their own biotech companies. The group’s founders have also launched the Future Founder Initiative for women on MIT’s faculty, offering entrepreneurship bootcamps, mentored pitch competitions, fellowships at venture capital firms and a commitment by VC firms to make female board representation a priority.

Highschooler Invents Life-Saving, Color-Changing Stitches

Dasia Taylor, 17 has applied for a patent for her invention: color-changing stitches that help detect surgical infections. These “smart” stitches detect infection in the wound by monitoring the color of the stitches. Using beets as a natural indicator of infection, the thread changes from bright red to dark purple when a surgical wound becomes infected. Taylor has been named one of the 40 finalists in the regeneron Science Talent Search.

Spotlight on Women in STEM

Temple Health and Bioscience District is a 5000 square foot lab and office facility in Temple, TX. Among the tenant companies that utilize THBD’s state-of-the-art equipment and harness diverse professional resources are two female-owned companies  making  waves  in  the  health  tech  ecosystem: ama  biotech and Sunthetics.

Association for Women in Science is celebrating 50 Years of Advocacy!

For 50 years, AWIS has created a safe space for women in science. In honor of their anniversary, they are asking for your support to continue their work of promoting equity for women in science by offering scholarships, career resources, professional development, networking and mentoring opportunities.

SPOTLIGHT

Artemis Communications

Artemis Communications, LLC provides #medtech strategic partnership within the disciplines of project management, public relations, marketing communications, content marketing, brand management and event marketing. We are experts in creating effective communication plans, road maps and sales tools that will meet your target customer, budget and timing. Partner with Artemis for success! Visit us

at www.artemisprojects.com.

The Morning Fix by 510k Café podcast

Join hosts Amy Shepherd and Julie Dye as they meet with medical technology leaders to discuss trends, innovations and the future of marketing and PR in the #lifesciences industry.

 Download and subscribe here: https://lnkd.in/esS6fs5

https://open.spotify.com/show/4FgBgjVQEpyDgYkS0ch7dk https://www.stitcher.com/show/the-morning-fix-by-510k-cafe Twitter.com/llc_artemis

 http://www.linkedin.com/in/amyashepherd https://www.linkedin.com/in/juliedye/

 #medicaldevice #medicaldevices #publicrelations #marketing

UPCOMING EVENTS

Austin Technology Council Calendar of Events

https://tinyurl.com/y9zzr6jv

Texas States Small Business Development Center Network Calendar of Events

https://tinyurl.com/ybf68aom

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

https://www.templebioscience.org/elearning/

NAMSA’s Podcasts Calendar of Events

https://namsa.com/resources/podcasts/biocompchatibility-podcast/

ISO 10993-18:2020 Chemical Characterization of Materials Workshop

https://namsa.com/events/iso-10993-182020-chemical-characterization-of-materials-workshop-may- virtual/
4 May 9am – 04:30pm central | Virtual

Protecting Medical Innovations in a Fast Paced World by Velocity TX

https://www.eventbrite.com/e/protecting-medical-innovations-in-a-fast-paced-world-tickets- 15064903832
5 May 11:30am-1pm Central | Hybrid – In-person and Virtual

Outsourcing in Clinical Trials, Europe 2021

https://www.arena-international.com/octeurope/
5-6 May 9am – 5pm CET | Virtual

RAPS 2021 EuroConvergence

https://tinyurl.com/v69723bk
10-12 May | Virtual

The Journey from Vial to Combination Product

https://tinyurl.com/4h2k5su6
12 May 10am-11am Eastern | Virtual

7 Steps to Improving Maintenance Strategies in your CMMS

https://tinyurl.com/54j8uz9b
13 May 10:00am -11:00am 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 https://biomedsa.org/biofest/
19 May 8:30am – 5pm central | Virtual

NAMSA Alternative Test Methods for Medical Device Sterilization Validation – An Industry Panel Discussion

https://tinyurl.com/zc5sp27s
20 May 11:00am – 12:00pm Eastern| Virtual

THBD E-Learning Series Webinar: What’s the Key to Creating a Clinical Advisory Board for Your Digital Health Startup?

https://www.eventbrite.com/e/creating-a-clinical-advisory-board-for-your-digital-health-startup- registration-152094345281
25 May 12:00pm – 1:00pm Central | Virtual

NAMSA Virtual Biological Safety Training – Course A

https://namsa.com/events/biological-safety-training-june-course-a/
8-9 June 8am-5pm Central | Virtual

NAMSA Training Series: Biological Safety – Course B

https://namsa.com/events/biological-safety-training-june-course-b/
22–23 June 8am-5pm Central | Virtual

Texas Medical Device Alliance (TMDA)

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

Register at: https://tinyurl.com/58xc33kh
15 July 2-4pm central | Tentative In-person Meeting (free)

BioNTX iC3 Summit 2021 – Save the Date!

22-23 Sept | In-Person

Texas Medical Device Alliance (TMDA)

TMDA Supplier Summit: Market Place Solutions from Bench to Bedside

Register at: https://tinyurl.com/yy7hy83y
21 October 2-4pm central | Tentative In-person Meeting (free)

VOLUNTEER OPPORTUNITIES

UT Biomedical Engineering Summer Externship

The University of Texas at Austin’s Engineering Career Assistance Center (ECAC) and the Biomedical Engineering Undergraduate Advisory Board (BME UAB) are facilitating summer externships with emphasis in the Biomedical Engineering field. Externship is a one-day job shadowing opportunity that allows employers and students to connect engineering curriculum to potential careers. It is a great opportunity for organizations to introduce their brand and inspire future engineers. This summer we are offering externships specifically related to biomedical engineering. Complete the following survey to express your interest and availability. If you have questions please reach out to: ENGR- [email protected]

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 [email protected] for questions or more information.

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. Please complete this survey to include your company on the map!

https://bioaustin.surveysparrow.com/s/austin-life-science-company-survey/tt-c071cf

 ATX Women in MedTech

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

BioAustinCTX

We are seeking volunteers to help collect and compile data to map the healthcare landscape in Austin. If interested, please reach out to Scott Collins at [email protected]

TEXAS LIFE SCIENCE ORGANIZATIONS

BioHouston

http://biohouston.org/

Temple Health & Bioscience District (THBD)

http://www.templebioscience.com/

Texas Healthcare and Bioscience Institute (THBI)

https://www.thbi.com/

Texas Biomedical Research Institute, San Antonio

https://www.txbiomed.org/

Texas Health Catalyst

https://dellmed.utexas.edu/thc

Texas Medical Device Alliance (TMDA)

https://texmda.org/

Texas Medical Device Alliance (TMDA) LinkedIn Group

https://www.linkedin.com/groups/6952028

The Health Cell, San Antonio

http://thehealthcell.org

TMCX/TMCX+, Houston

http://www.tmc.edu/innovation/innovation- programs/tmcx-plus/

Top Austin-Area Medical Device Companies

https://tinyurl.com/ya9v2s5u

Velocity Texas, San Antonio

https://velocitytx.org/

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

https://www.womeninbio.org/page/t

THANKS TO OUR TMDA SPONSORS

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)