TMDA Events
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TMDA MedTech Supplier Summit:
Market Place Solutions from Bench to Bedside
February 17, 2022 from 2pm – 5pm CDT
Note: If you are a supplier, pls contact [email protected]
BioAustinCTX Webinar
If you missed our webinar “How Your Life Science Organization can Survive and Thrive the Chaos and Complexity of Cybersecurity”, you can access the recording here.
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SPOTLIGHT
At Maestro Logistics, our mission is to support the technological advancement of the medical device industry by meeting the needs specific to smaller, market-disrupting companies. We provide post-manufacturing services with a focus on cost-effectiveness, accuracy, time-to-market, and risk mitigation. With no minimum charge for our services, start-ups can finally move out of a home-based operation, take advantage of our established systems and processes, and gain regulatory peace of mind.
As an ISO13485:2016 certified partner, we ensure successful market launches by avoiding time, product, and compliance losses, ultimately providing the most direct route to commercialization. Visit our website to learn more about what the team at Maestro can do for you! www.MaestroLGX.com
UPCOMING EVENTS
Local Events
Jan 6 – Sales Leadership Roundtable – Hosted by ATC
Multiple Dates Available – Gamify Health Apps for Robust User Engagement– Hosted by MINDSHOP
Multiple Dates Available – Crypto & Blockchain Technology for Health Professionals & Others – Hosted by Nurse Legacy
Multiple Dates Available – Develop a Successful Healthcare Tech Startup Business Today! – Hosted by Atechup.com
Multiple Dates Available – Telemedicine Entrepreneurship Training & Workshop – Hosted by Atechup.com
Available
Gamify Health Apps for Robust User Engagement
Do you know the difference between mHealth gaming and gamified mHealth? Gamification refers to methodologies on how to booth engagement and retention for a specific purpose. In this sharing TechTalk, we shall discuss how gamification can be integrated into the mobile health solutions: challenges and opportunities.
Available
Crypto & Blockchain Technology for Health Professionals & Others
Have you been wondering how to start in the crypto space? Is the world currency changing from fiat currency to digital currency? Would you be able to use cryptocurrency to pay for groceries, clothes, vehicles etc… Earn while you Learn about this growing block chain technology in a membership reward program that pays rewards to members based upon the value of membership package purchased.
Available
Develop a Successful Healthcare Tech Startup Business Today!
Always wanted to start an Healthcare Tech Startup? Now we have a complete blueprint for you start your own Healthcare Tech Startup Business. During our tech startup program you will learn and navigate through tools, software, hardware, platforms, resources, projects, processes, methods and strategies to penetrate your own Healthcare Tech Startup Business into different market.s and industries. For more information visit our website at Atechup.com
Available
Telemedicine Entrepreneurship Training & Workshop
Telemedicine means to provide with healthcare solutions over distance remotely with information technology. The telemedicine industry is a very promising industry with high demand in the coming years. Make an investment today and receive the proper training and market insights for delivering your own telemedicine startup into the market
How To Design a Digital Health App
In the world of digital health apps, patient-centered design is king. FREE ebook upon registration!
✅ 2+ hour instructor-led training (Self-paced using Teach:able Platform)
✅ Certificate of Completion – powered by The Mindshop School
✅ Hands-out materials and unlimited access to the recorded session
Meet and Greet the Author: Heather Hedden
Heather Hedden, author of The Accidental Taxonomist, is a Data and Knowledge Engineer in the professional services team of Semantic Web Company, makers of PoolParty software for taxonomy, ontology, and knowledge graph management. Heather has been a taxonomist for over 26 years in various organizations and as an independent consultant. She is a sought-after speaker at knowledge conferences, and her taxonomy courses, offered through Hedden Information Management, are considered standard curricula for anyone entering the field.
Striking a Balance: Family Caregiver Conference
The Striking a Balance: Family Caregiver Conference is celebrating its 20th anniversary with a Saturday in-person, keynote speaker event, luncheon, and information and resource fair. This conference brings together local resources and national speakers to aid and educate family caregivers living in Central Texas.
Creating Analytics for Business Improvement
Through the use of curated, cleaned, enhanced and analyzed data, our clients are enabled to make business decisions by taking a continuous improvement approach. This creates a workflow process that allows them to take better care of their patients, while also presenting an enhanced work environment for their employees. 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.
Complex Manipulation of Needles for Medical Devices
Mikron Automation is the industry leader in needle handling and complex needle manipulation for medical devices. Transforming an imprecise cannula into one with complex geometries with fine dimensional tolerances of up to ±200 microns has become a differentiating strength of Mikron. Its specialised knowledge and process understanding helps ensure its systems repeatably produce quality needle products for complex drug-delivery devices. This webinar will showcase some of the unique capabilities of Mikron that have helped complex medical devices meet their intended use and therapeutic purpose.
TMDA MedTech Supplier Summit: Market Place Solutions from Bench to Bedside
The 3rd Annual Life Science Women’s Conference
Imagine revitalizing yourself by engaging with and learning from some of the best and brightest women in the life sciences. Imagine that, when you speak, others listen intently and enter into important conversations with you, giving you new ideas, perspective, and motivation. Imagine making that life-changing connection in the sunny city of Tampa, FL.
The Life Science Women’s Conference (LSWC) creates an environment where women (working, or desiring to work in, all areas of life science) can network and collaborate with regard to entrepreneurship, professional development, inspiration, funding, career enhancement, scientific and technical updates.
Identify the obstacles women working in the life sciences face and work to remove them alongside us. We help alleviate the human resource and talent shortage that the life sciences face, while helping to ensure women reach their full potential. The event is March 1st & 2nd, 2022. All are welcome.
Gateway 2022
Austin Technology Council is kicking off the first in-person SXSW in two years with its signature Gateway party. Join hundreds of other Austin-area and visiting techies for an evening of networking and all-around fun.
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
https://www.templebioscience.org/elearning/
NAMSA’s Podcasts Calendar of Events
https://namsa.com/resources/podcasts/biocompchatibility-podcast/
LIFE SCIENCE INDUSTRY NEWS
Local Life Science Headlines
North Texas Pharma Executive and Philanthropic Leader Honored with 2021 Dennis Stone Award
John Q. Adams Sr. was presented with the 2021 Dennis Stone Award in recognition of his leadership and commitment to strengthening the biotechnology and public health sectors within the North Texas region. Mr. Adams received the award at the 2021 iC3 Life Science Summit.
BioLabs Introduces First Location in Central US
BioLabs is partnering with Lyda Hill Philanthropies to introduce the first BioLabs location in the central United States and the first life science co-working space in Dallas. Construction is nearing completion and the facility is scheduled to open in late-January 2022
National News
Data and Technology: The Key to Patient-Centric Clinical Research
Patient-centricity has become a driving force in clinical research. Patients expect trials to be built around their needs as a factor of participation, while regulators expect to see more diverse patient populations in trials and a greater depth of voices captured in the data collected.
‘Zombie’ Cells a New Treatment Target for Alzheimer’s?
Scientists have identified a potential new target for Alzheimer’s disease (AD) treatment. Investigators led by Miranda E. Orr, PhD, assistant professor of gerontology and geriatric medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina, have detected a rare population of potentially senescent cells, also known as “zombie cells,” in the brains of patients with AD.
Opportunities in value-based drug pricing
Efforts to pay for a drug based on its value were limited by logistics, but recent deals for cancer drugs by Pfizer and Takeda could be a step forward.
Exploring the potential of 3D printing in drug manufacturing
From personalised medicine to the democratisation of drug access, XIL Health founder and CEO Susan Lang believes 3D printing can bring many benefits to drug manufacturing.
New Approaches for Rare CNS Drug Development
Developing a rare central nervous system therapy requires delicate decisions around patient identification, treatment delivery, and measuring safety and efficacy.
Pandemic Relief Spurs National Health Spending to Record Level
A new report shows US health spending has hit a record level, attributed mainly to the country’s reply to COVID-19. National health expenditures (NHE) increased 9.7% to a record $4.1 trillion, or $12,530 per person, in 2020, compared to growth of 4.3% in 2019, according to a report by government experts published today in Health Affairs.
Lilly to Kick Off 2022 With Completion of Much Anticipated FDA Filing for Alzheimer’s Candidate
During an investor meeting this week, Eli Lilly announced its plans to file its Alzheimer’s candidate donanemab earlier than expected. Originally projected for some time next year, the drug company now hopes to submit regulatory submission in the first quarter of 2022. This may give Lilly a leg up on its competitor Biogen, which earned accelerated approval for Aduhelm in June.
International Industry Interests
Explaining the Role of PRRC under MDR & IVDR: Your Questions Answered
There are plenty of new requirements to be aware of in both the EU MDR and IVDR. Read this featured blog where we are answering some of the most pressing questions regarding the PRRC role, their responsibilities, and what medical device companies need to know in order to comply with the new requirements:
How South African Scientists Spotted the Omicron COVID Variant
On Friday Nov. 19, Raquel Viana, Head of Science at one of South Africa’s biggest private testing labs, sequenced the genes on eight coronavirus samples – and got the shock of her life. The samples, tested in the Lancet laboratory, all bore a large number of mutations, especially on the spike protein that the virus uses to enter human cells.
Costa Rica Classification and Grouping Guide for Medical Devices
In Costa Rica, the Ministry of Health (MoH) is the entity in charge of developing the laws and regulations for medical devices or EMB (Equipment and Biomedical Material) –both terms are considered synonymous in this document and used interchangeably. The classification of such devices or EMBs is designated based on the level of risk and results in 4 classifications (class I, II, III and IV) based on Chapter II of the Official Decree 34482-S. In this guideline, we will summarize the referred regulation to correctly classify and group a medical device in Costa Rica.
INDUSTRY RESOURCES & FUNDING OPPORTUNITIES
Help your small business grow and succeed
The South West Texas Region SBDC and SCORE Austin have partnered together to bring you expert content to help your small business grow. Sign up for all sessions or pick the ones that apply most to you.
Jan 4 – Starting a Business Successfully
Jan 13 – Ditch the Imposter Syndrome
Jan 14 – Writing a Business Plan
Jan 18 – You are the Brand
Jan 18 – COVID Business Town hall: The Global Supply Chain Distribution
Jan 19 – E-mail Marketing Essentials for Your Business
Jan 20 – Advanced Shopify
Jan 26 – HR Solutions
MedTech Innovator 2022
Each year, MedTech Innovator recognizes the 50 best-in-class startups and scaleups across the medtech industry. Companies selected for this honor receive a slot in the MedTech Innovator Showcase. The MedTech Innovator Showcase provides high profile visibility at leading conferences and media, access to healthcare investors, stakeholders, decision makers; a network of mentors and peers; and participation in a customized virtual curriculum. Companies that have raised up to a Series C companies are eligible to apply.
Application deadline is January 31
CPRIT Releases Three Product Development Research Funding Opportunities
CPRIT invests in startup and early-stage companies in Texas (and those willing to relocate to Texas) to foster development of novel cancer therapeutics, medical devices, diagnostics, tools and other non-traditional oncology products. Details on CPRIT’s available Product Development Research grant funding opportunities for cancer-focused companies can be found below.
CPRIT has announced the release of three (3) Requests for Applications (RFAs) for cancer Product Development Research grants.
FY 2022.2 Product Development RFAs:
- Texas Company Product Development Research Awards (TXCO)
- Company Relocation Product Development Research Awards (RELCO)
- Seed Awards for Product Development Research (SEED)
The application period for the TXCO, RELCO and SEED funding opportunities is December 1, 2021, through January 26, 2022. Complete RFAs detailing deadlines, requirements and instructions are available in the Funding Opportunities section of CPRIT’s website
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.
WOMEN IN LIFE SCIENCE & WOMEN’S HEALTH
Join WIB leaders as we discuss and take questions about all of the benefits our membership offers!
Have you taken full advantage of your WIB membership? Whether you are interested in professional development, networking, fundraising, diversity in the workplace, or STEM — we have a program for you! Our Membership Committee leaders will lead a discussion on how to get the most out of WIB — from MAPS to EWIB, from Boardroom Ready to STEM. We will share connection points that will help ignite your career, followed by a speed networking session introducing you to members from across the country.
New research reveals a hidden obstacle for women in academia
A new study by a team of researchers at Stanford Graduate School of Education finds a widespread implicit bias against academic work that simply seems feminine — even if it’s not about women or gender specifically. Scholars whose dissertation abstracts had words like parenting, children or relationship, for example, had slimmer career prospects than people who used words like algorithm, efficiency or war.
Space Force Association launches Committee on Women in Space, names renowned scientist Dr. Lois Wardell to lead effort
Lois Wardell, Ph.D., has been named to a newly created leadership role the United States Space Force Association. Dr. Wardell’s specific focus will be to launch the new SFA’s Committee on Women in Space. Wardell’s experience in the space industry and across several scientific disciplines makes her uniquely qualified for this important role.
Surveys of scientists show women and young academics suffered most during pandemic and may face long-term career consequences
Two surveys conducted by SciOPS found work and personal disruptions caused by the COVID-19 pandemic have had an outsized effect on female and early-career scientists and “are likely aggravating already existing disparities and potentially altering career trajectories,” write four leaders of the multi-university project. Tenure clock extensions, affordable child care and funding for early-career female researchers “could enable broader participation, capacity and production for all scientists,” the team leaders write.
Meet 20 extraordinary women who are supercharging biopharma R&D
Endpoints News received hundreds of nominations for this year’s list of the top 20 women who’ve had a profound impact on biopharmaceutical research and development, and the final list includes “scientists, CEOs, researchers and professors who are supercharging the discovery and development of new therapies,” write Nicole DeFeudis and Amber Tong. “Our conversations with this year’s honorees offer a glimpse into how these women became leaders, breaking down barriers in labs and C-suites,” they write.
Austin Community College
Austin Community College biotechnology or computer science interns are available Email Kathryn Naughton for more information
Attogene Corporation is seeking a Lab Technician
This is a contract position.
Requirements:
- 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: March 31
Nuclein is seeking a Quality Control Engineer
Nuclein is seeking a Quality Control Engineer who will be integral to the development, commercialization, and maintenance of next-generation molecular diagnostic devices. Reporting to the QA Manager, this individual will lead the Quality Department’s Test Team, guiding daily operations and providing supervision to the test technicians. The QC Engineer will help develop and deploy and continuously improve Test Team methods and SOPs to support product development and manufacturing under QSR medical device design controls. The QC Engineer will ensure that the Test Team can support product design change control as well as manufacturing process control.
The successful candidate will have:
• At least 4 years of increasingly responsible experience working as a QC Engineer in medical device or biotech product development and manufacturing (IVD experience a plus)
• Have working knowledge of regulated quality, 21 CFR 820 and ISO 13485, design controls, inspection methods, good working knowledge of statistical methods, design verification and validation, and process validation and control
• Experience leading a small team of technicians; able to work in fast‐paced projects in controlled environments (e.g., laboratory or manufacturing settings).
Qualifications:
• B.Sc. in Engineering or Science related field or equivalent applicable experience
• Ability to lead projects and participate as a testing and quality subject matter expert in team environments
• Excellent written and verbal communication skills – able to train others in quality principles and operations
• Applicable knowledge of Microsoft Office (including Excel) along with general computer experience in order to use and expand corporate data/document/project systems and install, operate, and monitor test equipment
• Ability to read and interpret mechanical drawings (GD&T), electrical schematics (ANSI), and software specifications/flow charts (ISO)
• Ability to sit, stand, walk, bend, and lift up to 25 lbs.
Deadline to Apply: January 30
Nuclein is seeking a Director of Systems Engineering
This individual will be integral to the development and commercialization of next-generation molecular diagnostic devices. They will be part of the QA Department while collaborating with other departments (e.g. biology, engineering, etc.). This person will help develop and deploy quality processes, including design controls, testing methodologies, and SOPs within the product development. The Quality Engineer will collaborate to develop test plans and report, release and acceptance criteria, supplier and product qualification processes, and support product transfers to manufacturing, including sampling plans, line QC data and reporting strategies.
The successful candidate will:
• Have experience with medical devices, 21 CFR 820 and ISO 13485, design controls, inspection methods, statistical methodologies, design verification and validation, and process validation
• Operate independently and efficiently with minimal supervision
• Be experienced with quality management systems and product commercialization process
• Be capable of creating/updating procedures to align with regulatory compliance and standards
• Drive continuous improvement throughout the supply chain by highlighting non-conformances and leading cross-functional root cause analysis
• Be able to perform SPC, product and manufacturing validations, and risk analysis
• Be experienced working collegially in small teams and fast‐paced projects
• Exhibit a high level of attention to detail
Qualifications:
• B.Sc. in Engineering or Science related field or equivalent applicable experience
• At least 4 years of experience in medical devices (IVD), ISO 13485 environment
• Experience working with IVDs (PCR technology/platform a plus)
• General understanding of supplier control processes and regulatory compliance
• Ability to lead projects and participate as a quality subject matter expert in team environments
• Have excellent written and verbal communication skills – able to train others in quality principles and operations
Deadline to Apply: January 30
SCIE Solutions LLC
We are looking to partner with med devices companies looking to grow and expand their operations in the Central Texas Region.
SERVICES OFFERED. SCIE Solutions provides end to end operations and supply chain infrastructure to our partners. SCIE Solutions offers a wide range of services enabling our partners to focus their resources on their customers while the SCIE Solutions team manages their operations and global supply chain. Achieving strategic objectives on service levels, risk management, price competitiveness and quality is our focus. Our partners range from bootstrapping startups to regulated aerospace and medical device companies.
BioNTX Job Board
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)
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
Life Science Conferences, LLC
BioBash 2022 Volunteers Needed
BioAustinCTX Seeking Grant Writing Volunteers
• 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
UT needs your help
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
ATX Women in MedTech
Austin Technology Council
https://www.austintechnologycouncil.org
Austin Health Tech Meetup
https://www.meetup.com/Austin-Health-Tech/
Austin Technology Incubator (ATI)
Beam Founders
BioAustin LinkedIn Group
https://www.linkedin.com/groups/6535301/profile
BioMed San Antonio
BioNorth
Capital City Innovation (CCI)
https://www.capitalcityinnovation.org/
Central Texas Angel Network
Health Technology Forum Meetup
https://www.meetup.com/HealthTechnologyForu m-Austin/
Bio El Paso-Juarez
Health Wildcatters, Dallas
STAR Park
Austin Chamber of Commerce
https://www.austinchamber.com/economic-development/key-industries/life-science/
BioHouston
Temple Health & Bioscience District (THBD)
http://www.templebioscience.com/
Texas Healthcare and Bioscience Institute (THBI)
Texas Biomedical Research Institute, San Antonio
Texas Health Catalyst
https://dellmed.utexas.edu/thc
Texas Medical Device Alliance (TMDA)
Texas Medical Device Alliance (TMDA) LinkedIn Group
https://www.linkedin.com/groups/6952028
The Health Cell, San Antonio
TMCX/TMCX+, Houston
http://www.tmc.edu/innovation/innovation- programs/tmcx-plus/
Top Austin-Area Medical Device Companies
Velocity Texas, San Antonio
Women in Bio-Texas (WIB-TX, Austin & Houston)
THANKS TO OUR BIOAUSTINCTX SPONSORS
THANKS TO OUR TMDA SPONSORS
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)