FDA Medical Device Regulations & Trends
October 21 from 2pm – 5pm CDT
February 17, 2022 from 2pm – 4pm CDT
Why do pro athletes have coaches and doctors participate in CME courses? Because learning new things makes them more effective contributors. What are you doing to level up your game?
The Mastering Medical Device podcast will help you become more effective at your job and prepare you for advancement by discussing topics critical to deepening and rounding out your knowledge of the industry. The podcast is hosted by Pat Kothe, a local Austin medical device entrepreneur who has decades of experience in the industry. You will hear from experts inside medical device companies, those who support the industry, and customers. Each episode explores a topic important to becoming a top executive, including best practices in your functional area, what other people in your company do and how to work better with them, the view from a customer’s perspective, and how to incorporate new thoughts from people outside of the industry.
We invite you to click on one of the links below and listen to an episode that peeks your interest. By liking or subscribing to this free resource, you will be investing in your most important asset – you!
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August 3 – Women in Tech Roundtable: Overcoming Imposter Syndrome – Hosted by ATC
August 18 – Leadership Dinner: Debunking the Myths of Going Public with Toronto Stock Exchange & EY – Hosted by ATC
A disproportionate number of women suffer from imposter syndrome. Come learn what you need to understand about it, help your direct reports overcome it, and continue supporting success and growth for yourself and your team.
This webinar presents a rigorous and efficient, graphical, model-based, approach to developing and maintaining Product and Process FMEAs that will show your teams the way to ensure that failures aren’t forgotten, causes aren’t missed, and they are all properly guarded against with the appropriate analysis and testing. Register to find out how your FMEA Risk Analysis can get to this point: No misses. No gaps. No mistakes. No audit non-compliances. High value-add!
Toronto Stock Exchange and EY experts are assembling their expertise and clients who have been-there-done-that to answer your questions about taking your company public.
This webinar will give you an overview of the challenges and of Fill/Finish including sterilization and how to overcome them by working with SME’s from different companies and achieving a fast and reliable solution for bringing your product fast to the market.
The realm of metallurgy has been a part of our existence since humans started extracting metal from the Earth. This presentation will be a series of case studies that illustrate the science and engineering of metallurgy as they apply to real life scenarios.
This session is designed to equip senior leadership in clinical operations with a framework to select and evaluate innovation and manage change to optimize clinical trials not only for today but with lasting effect for the future. Rather than reviewing tactical decisions about point solutions, this session will give you tips and insights from key trial stakeholders on how to ensure your evaluation of technology starts with the end in mind and supports faster, safer, more efficient clinical trials.
6 steps to overcome labelling challenges in the life sciences industry: How to drive efficiency & control through digital maturity
In this webinar, Kallik’s CEO, Gurdip Singh, and Life Sciences labelling Specialist, Bob Tilling, will guide attendees through their digital maturity journey and how to best use technology to have the right information, on the right label, at the right time. By following the Digital Maturity Curve – a best practice, step-by-step methodology- life sciences manufacturers can take gradual steps into assessing their business landscape and transitioning to digital solutions.
In this webinar, we will explore how the Pharmaceutical industry’s use of propellants has evolved in the drive for greater sustainability including a reduction in the carbon footprint of inhalers, providing some context on the impact pMDIs have on the environment today while at the same time suggesting some areas for improvement.
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.
Austin Technology Council Calendar of Events
Texas States Small Business Development Center Network Calendar of Events
Women in Business Virtual Calendar of Events
Temple Health & BioScience District’s (THBD’s) E-Learning Series Webinars Library
NAMSA’s Podcasts Calendar of Events
LIFE SCIENCE INDUSTRY NEWS
Local Life Science Headlines
Lung Therapeutics, Inc., a clinical stage biopharmaceutical company developing novel therapeutics for orphan, pulmonary diseases and conditions, today announced the appointment of Sharon Morriss, PhD, as Senior Vice President of Clinical Development. In this critical role, she will be responsible for guiding Lung Therapeutics’ clinical programs and will serve as a key member of the company’s executive leadership team.
It is with great hope for a first in class treatment for Succinic Semialdehyde Dehydrogenase Deficiency we are very pleased to announce a license agreement between GC Pharma and Speragen to develop an enzyme replacement therapy. Also with joy we will be launching a newborn screening program to diagnose SSADHD patients at birth, for this often under and misdiagnosed disorder.
A recent scientific undertaking was taken to reduce toxic gossypol levels in cottonseed by selectively silencing the offending gene. The resulting Ultra-Low Gossypol Cottonseed is considered safe as food or feed. Field trials conducted over multiple years in multiple states confirm the stability and heritability of the trait with no diminution of fiber/seed yield, quality or agronomic performance.
The purpose of good documentation practices is to ensure your documentation can’t be misinterpreted. Consistency and accuracy in how your organization documents information is critical. Read on to learn more about: Where GDP fits into compliance with industry certifications Top GDP Do’s and Don’ts Tips to help your team follow GDP
Clinical trials have undergone significant change over the past year amid concerns over patient safety during the pandemic. The cost of delaying clinical trials is significant to companies, which is prompting many to adopt digital solutions. In response, experienced market players are developing more sophisticated and adaptable solutions that will allow CROs, clinical trials solutions companies, and sponsors to achieve trial objectives more quickly and easily.
An effective, connected quality management system (QMS) is the foundation for long-term regulatory compliance and market success. But there are so many options to choose from, and the wrong choice may leave you worse off than before. Before you get overwhelmed by the selection, read “6 Must-Haves for a Quality Management System” and see the things you should look for to ensure you’re choosing the QMS that will eliminate quality headaches.
A substantial proportion of patients with cancer use proton pump inhibitors (PPIs), and up to one-third of these patients are also using oral cancer treatments that could be adversely affected by concomitant PPI use, according to a cross-sectional analysis.
A small Phase1 gene therapy study designed to test safety has yielded bigger benefits – at least for the 135 children worldwide with aromatic L-amino acid decarboxylase (AADC) deficiency, or a deficiency in the enzymes that produce dopamine in the central nervous system. In the study, a healthy copy of the AADC gene given to children corrected the seizure-like episodes and in many cases, enabled the children to develop normal head control, sit independently, and walk with support.
International Industry Interests
IEC 62304 has been widely adopted by regulators across the world as the de facto standard for medical device software, so familiarity of the requirements and how to apply them is imperative. But we know this is easier said than done. Which is why we’re going back to the basics of IEC 62304 to explain key requirements of this standard in a simple, digestible format and give you actionable ways to comply with the rules that apply to your medical device software or SaMD
Maria Leptin will take over as president of the European Research Council in October, and she says her top priorities include convincing the European Commission to increase the basic science organization’s funding and launching outreach campaigns to teach the public about the value of basic research. Leptin will bring stability and scientific credibility to the organization, says Giulio Superti-Furga, scientific director of the Research Center of Molecular Medicine in Vienna, Austria.
ISO 10993-1, the international standard for biological evaluation for medical devices, is equally complex as it is critical for meeting high safety marks that ensure proper testing is done and risks are mitigated. FDA recommends the use of ISO 10993-1 alongside its guidance document to help manufacturers understand biocompatibility testing considerations and apply risk-based biocompatibility evaluations in product submissions to enter the US market.
INDUSTRY RESOURCES & FUNDING OPPORTUNITIES
Many of the life sciences trends that are driving innovation today were here pre-COVID, but the pandemic was an accelerant. For all that it took, it gave life science researchers and developers new momentum, and from that momentum, hope… Here are five ways that this new reality will play out for the life sciences industry in 2021 and beyond, helping to streamline the entire process from research to approval and delivery of the therapies that patients so desperately need.
This digital e-book aims to put the requirements in easy-to-understand terms and includes some helpful, actionable and practical tips you can begin to implement immediately. The goal of this guide is to provide you step-by-step guidance through each part of the FDA 510(k) submission process and help improve your time to market.
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.
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.
There are 2 upcoming dates: Tuesday, October 5, 2021 and Thursday, March 24, 2022.
WOMEN IN LIFE SCIENCE & WOMEN’S HEALTH
The Life Science Women’s Conference (LSWC) creates an environment where women working or desiring to work in all areas of life science companies and academia can gather to network and collaborate with other women with regard to entrepreneurship, professional development, inspiration, funding, career enhancement, scientific and technical updates.
Katalin Kariko may not be a household name outside biomedical circles, but her invention — BioNTech’s messenger RNA COVID-19 vaccine — is. Kariko did not win one NIH R01 grant for the first four decades of her career, but she never gave up, and she equates science to rowing, a sport in which the athlete doesn’t see the finish line but senses it.
Air Protein CEO and co-founder Lisa Dyson’s concern for climate change and how the food industry affects it began after she helped rebuild the education system in New Orleans in the wake of Hurricane Katrina and she says sustainability should be on the agenda of every CEO. “Innovation is all about making things better, doing things better. So why not do that?” she says.
2015 PharmaVOICE 100 honoree and health industry leader Kim Johnson has been appointed Global CEO of Ogilvy Health. Ms. Johnson will oversee Ogilvy’s health business spanning brand strategy, advertising, public relations, experience, medical education, HCP promotion, market access, and patient/consumer engagement.
The primary responsibility of this position is to advise on microbiological processes including sterilization methods, biocompatibility, cleaning, and biological evaluation reports within a Quality Management System framework. This position requires independent utilization of Quality Management System methods, including but not limited to: quality system implementation, project management, microbiological processes and deliverables, risk management, and post-market activities. The Consultant must interact with other consultants, clients, laboratories, and experts outside QA Consulting to communicate and implement company objectives. Client/supplier management and project management skills are required.
Application Requirements: Experience Required: 6-10 years in medical device Quality Assurance / Design Controls and Microbiology
Deadline to apply: 8/7/21
Responsible for selling Ambu Visualization products in assigned regional territory. Visualization – Pulmonary/Airway products (call points will include ICU/Critical Care, Anesthesia, Thoracic surgery, Interventional Pulmonology, and Emergency Department). Products not responsible for: GI, ENT/URO, Core products, EMS, and PMD product lines.
Application Requirements: Bachelor’s Degree in a related field Professional Level: Minimum of 1-3 years of applicable sales experience. B2B experience preferred, medical device experience a plus Experiencing in calling on one of the following hospital departments: ICU/Critical Care, Anesthesia, Thoracic surgery, interventional pulmonology, and Emergency Department Executive Level: Minimum of 3+ years of applicable sales experience Minimum of 2 years of medical device experience Experience in calling on multiple of the following hospital departments: ICU/Critical Care, Anesthesia, Thoracic surgery, interventional pulmonology, and Emergency Department Proven success launching disruptive technology in a hospital setting, preferred Proven ability to meet and exceed sales objectives Valid driver’s license, in good standing Excellent verbal and written communication skills Must live within assigned territory
Deadline to apply: 8/15/21
Black Diamond Networks Recruiting Seeking a Remote Regulatory Lead
Our Client is looking for a Regulatory Lead with 10+ years of regulatory experience in progressive leadership positions; experience with software-as-a-medical device (SaMD), cloud-based, analytics, and AI/Machine Learning technologies is ideal. A strong knowledge of FDA requirements relating to regulatory submissions and clinical investigations.This individual will provide hands-on leader responsible for driving all regulatory activities within the Company, including development and implementation of regulatory strategies aligned with the client’s vision and securing the approval of high-quality diagnostic and software-as-a-medical device (SaMD) products. This key role provides guidance, strategic insight, and counsel to the leadership team and engineering/research & development regarding guidelines on regulatory matters, ensuring the timely preparation of regulatory submissions and compliance in all aspects of quality systems. You will further define, shape and build the expanded resources and systems anticipated within regulatory to support growth and commercialization of our algorithms.
Deadline to apply: 8/15/21
The person in this role will assist in daily operations of our COVID testing, will interface with clients and will support laboratory staff. This part-time position is an opportunity to learn a broad set of skills in Quality Systems across differing regulatory environments. TeVido is team oriented with a collaborative culture. Perfect role for an at-home parent wanting to get back to work in a few years, a retiree looking for meaningful work or a student interested in biotech or business experience.
Application Requirements: Associates Degree or equivalent, Proficient in Microsoft Office (including excel), Excellent interpersonal skills with ability to communicate and collaborate effectively with colleagues, Strong multi-tasking and time management skills, Ability to work in a dynamic environment, Customer service experience
Deadline to apply: 8/31/21
Do you have the skills and the passion to move diagnostics and precision medicine forward? Learn more about career opportunities at Veravas. We have multiple positions open in the Austin area.
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.
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.
Austin Technology Council (ATC) Jobs
Black Diamond Networks
Commissioning Agents (CAI)
FDA Quality and Regulatory Consultants (FDAQRC)
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 reach out to Scott Collins
TEXAS LIFE SCIENCE ORGANIZATIONS
ATX Women in MedTech
Austin Technology Council
Austin Health Tech Meetup
BioAustin LinkedIn Group
BioMed San Antonio
Capital City Innovation (CCI)
Central Texas Angel Network
Health Technology Forum Meetup
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
Top Austin-Area Medical Device Companies
Velocity Texas, San Antonio
Women in Bio-Texas (WIB-TX, Austin & Houston)
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)