Velentium of Katy, TX at COMPAMED 2022 in Düsseldorf -- MEDICA - World Forum for Medicine
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Company news

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03 Aug 2022

2021 Awards Roundup

2021 was an exciting year for Velentium. Between receiving investment from Great Point Partners, expanding intelligent testing services in the energy sector, building bunk beds for Sleep in Heavenly Peace, and appearing in Forbes and Fortune magazines, we won a few awards, too. We are thrilled to announce that we were presented with multiple awards in 2021:

#1,424 Fastest Growing Business Nationwide – Inc. 5000
Entrepreneurs of the Year: Co-founders Dan Purvis & Tim Carroll – EY Gulf Coast Region
#113 Fastest Growing Business in Texas – Inc. 5000
#1 Houston’s Most Innovative Company, won jointly with Spark Biomedical – Houston Business Journal
#5 Best Places to Work, Medium Sized Businesses – Houston Business Journal
Gold Medal: Education – Cybersecurity Excellence Awards
Silver Medal: Healthcare Companies of North America – Cybersecurity Excellence Awards
Honorable Mentions: Pandemic Response and Established Excellence – Fast Company’s World Changing Ideas
#30 Fastest Growing Companies in Houston – Houston Business Journal
#38 Alumni-Led Businesses – Texas A&M Aggie 100

Achieving these awards is possible thanks to the amazing people who make Velentium the company that it is. Our staff and leadership earned these accolades by embodying our core values of Honorable, Results++, and Humble Charisma, enabling us to be a winning company. Cheers to 2021 – let’s make 2022 even better!

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03 Aug 2022

Case Study: Building a Partner Ecosystem to Win the Fight Against Opioid Withdrawal

Effective Opioid Response
In the yearlong period ending April 2021, over 100,000 Americans died from drug overdose, the vast majority from synthetic opioids. An estimated 4 million of the 11 million still addicted won’t seek treatment for fear of withdrawal.

Spark Biomedical – a leader in wearable neurostimulation solutions – launched with a vision to solve the opioid crisis. Presented with a pressing need to address the growing opioid epidemic, top minds in the field came together to identify a clear clinical pathway and bring the concept to fruition. As the idea matured, Spark tapped Velentium when it needed a sophisticated design house to scale the technology. Spark also collaborated with Galen Data and Greenlight Guru to help build its Sparrow Therapy System™ – a wearable neurostimulation device for treating opioid withdrawal.

Today, the clinically proven solution offers patients facing opioid withdrawal an FDA-cleared, drug-free, targeted therapy option for tackling this daunting problem. Together, a team of entrepreneurs, medical researchers, and scientists, took an existing concept (neurostimulation technology) and transformed the solution to combat the opioid crisis and support millions of Americans suffering from withdrawal.

 

Changing Lives for Better World
The Sparrow non-invasive earpiece and patient controller work by stimulating two key nerves on and around the ear that connect to the brain’s central reward, decision-making, emotion, and stress regions. Stimulation triggers endogenous (natural) opioid release known as endorphins, which fill the brain’s vacant opioid receptors that then release dopamine. This neurochemical process helps to reduce or eliminate withdrawal symptoms like nausea, vomiting, tremors, anxiety, high pulse rate and bone/joint aches, among others.

During its journey toward FDA clearance of the adult treatment, Spark discovered that in addition to the millions of adults who suffer from opioid withdrawal, there are 35 thousand infants born each year opioid-dependent – known as Neonatal Opioid Withdrawal Syndrome (NOWS). Knowing the first days of life are a critical developmental period for all infants, the company immediately widened its scope to include NOWS, leveraging its tAN® therapy into a neonate version, the Sparrow Fledgling™. Initial clinical proof-of-concept results exceeded expectations, dramatically reducing the need for morphine in the neonatal detox process and reducing NICU stays by over two weeks. Results were so compelling that the Sparrow Fledgling was granted FDA Breakthrough Device Designation in 2021 to fast-track time to market. Currently, the Sparrow Fledgling device is beginning phase two clinical trial and is funded by a $2.5M NIH Heal Initiative grant.

Over the past 3 years, Velentium has provided critical support to the Sparrow Therapy System™, partnering with Spark during every stage from initial design through final production, in preparation for commercial release. Leveraging solutions provided by Greenlight Guru and Galen Data, the partnership enabled the team to bring the medical device to market in less than two years through rapid development and change management from clinical trial through full commercial production.

Together, Spark and Velentium were recognized for their partnership and were joint recipients of the Houston Business Journal’s 2021 Most Innovative Company Award.

 

Building a Partner Ecosystem
Spark’s partnership with Velentium, Galen Data, and Greenlight Guru paid dividends almost immediately. Initially, it took 18 months for Spark’s first-gen product to be fully compliant and approved for market. Leveraging Velentium’s design and manufacturing capabilities, Galen Data’s solution for medical device-to-cloud connectivity, and Greenlight Guru’s eQMS, the timeline for the company’s second-gen product was reduced to nine months.

Velentium took over all aspects of design and successfully supported Spark’s limited commercial release (including updating their mobile app for the Apple app store). The team has also stayed on to assist with future iterations of the project, including improvements to the existing unit, a bedside unit that plugs into the wall, the Sparrow Fledgling™ neonatal unit, as well as the second-gen device with immense improvements and optimization based on field feedback.

Disrupting a world where the only treatment choices were more opioids or abstinence that often causes severe withdrawal leading to relapse, Spark’s Sparrow Therapy System™ and its partner ecosystem empower physicians and patients with a fast and effective drug-free, systemic side-effect-free treatment option. Using Sparrow Therapy, 89% of participants experience mild or no withdrawal symptoms at 60 minutes of treatment and sustain relief throughout the detox period.

 

About Velentium

Headquartered in Houston, Texas with operations globally, Velentium is a professional engineering firm that specializes in the design and manufacturing of therapeutic and diagnostic active medical devices for companies of every size and stage, from Fortune 100s to startups. Velentium offers world-class expertise in software, usability, cybersecurity, mobile and cloud, electrical and mechanical development, regulatory, and systems engineering for medical devices. Velentium transforms IP into safe and secure products that will support healthcare professionals, patients, and communities, and ultimately, change lives for a better world. Velentium is ISO-13485 certified and an FDA-registered Manufacturer of Record.

Interested in partnering with Velentium to develop your project? Please contact us at NextStep@Velentium.com and help us fulfill our passion for changing lives for a better world.

For more information, visit http://www.velentium.com.

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03 Aug 2022

Health Sector Coordinating Council’s Recommendations for Enhanced MedTech Cybersecurity Receives Further Industry Endorsement

Velentium’s Director of Product Security helped draft industry standard

HOUSTON, TX – April 19, 2022 – Velentium, a professional engineering firm that specializes in the design and manufacturing of therapeutic and diagnostic active medical devices, announced today its support for new recommendations published by the Health Sector Coordinating Council’s Cybersecurity Working Group (CWG). Published in early March, “Model Contract Language for Medtech Cybersecurity (MC2)” is a new template for agreeing on cybersecurity contractual terms and conditions to reduce cost, complexity and time in the contracting process, while improving overall patient safety.

“Velentium welcomes this new tool into the med-tech arena, as it ultimately protects all parties involved in the healthcare process – from designers and manufacturers, to healthcare delivery organizations, to patients,” said Christopher Gates, Velentium’s Director of Product Security, who is a member of CWG. “The industry recognizes the complicated and uneven relationship and expectations between Medical Device Manufacturers (MDMs) and Health Delivery Organizations (HDOs), leading to potential patient safety implications. This template should begin to alleviate those tensions and lead to better solutions.”

“The HSCC’s Cybersecurity Working Group approached this project from a philosophy of continuous improvement,” Gates added, noting the broad consensus that the group had solicited from public sector cybersecurity organizations tasked with securing the nations critical infrastructure, in addition to the private sector collaboration it elicited from both MDMs and HDOs.

Two years in the making, this new Model Contract Language offers a reference for shared cooperation and coordination between HDOs and MDMs regarding the security compliance, management, operations, and services pertaining to medical devices, solutions, and connections. It deliberately avoids references to specific technologies and standards, instead pointing contract negotiators toward current resources and regulations. This approach helps ensure the MC2 remains forward-compatible with rapidly evolving technologies and legal innovations, such as the FDA’s recent update to its premarket submissions draft guidance on medical device cybersecurity.

Cybersecurity is a significant portion of Velentium’s service offering. In 2020, the company published the bestselling textbook Medical Device Cybersecurity for Engineers and Manufacturers, co-authored by Gates, with a similar goal of educating the industry on the vital need for a consistent focus on the topic, and the risks to patients, HDOs, and MDMs should cybersecurity continue to be treated as an afterthought. Shortly thereafter, Velentium designed and launched a formal training program on how to implement cybersecurity best practices and processes during design, development, production, and supply chain management, as well as pre- and post-market activities.

“Velentium’s clients understand that they have to design their medical device solutions with security in mind, right from the start of the project,” said Dan Purvis, co-founder and CEO of Velentium. “Materials like our textbook, training course, and the CWG’s model contract language allow all parties to understand their responsibilities. As there continues to be more uniformity and predictability between MDMs, HDOs, and group purchasing organizations in cross enterprise cybersecurity management expectations, the overarching results will be patient safety and a more secure and resilient healthcare system.”

 

To learn more about the Model Contract Language and how MDMs and HDOs can start utilizing this new tool, watch Velentium’s blog or social media for announcement of an upcoming webinar featuring Greg Garcia, Executive Director for Cybersecurity at the HSCC; Michelle Bentley, Manager of Security Resilience at Mayo Clinic; Axel Wirth, Chief Security Strategist at Medcrypt; and Velentium’s own Chris Gates.

 

To learn more about Velentium and keep up with the latest company updates and industry insights, visit www.velentium.com.

 

About Velentium

Headquartered in Houston, Texas with operations globally, Velentium is a professional engineering firm that specializes in the design and manufacturing of therapeutic and diagnostic active medical devices for Fortune 100 companies and startups. The company offers world-class expertise in software, usability, cybersecurity, electrical and mechanical development for medical equipment. Velentium transforms IP into safe and secure products that will support healthcare professionals, patients and communities, and ultimately, change lives for a better world. For more information, visit www.velentium.com.

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03 Aug 2022

Spark Biomedical and Velentium Honored by Fast Company as a 2022 World Changing Idea for Their Partnership in Developing the Sparrow Therapy System™

The companies partnered to design, develop and manufacture the medical device technology that provides a wearable neurostimulation solution for opioid withdrawal relief

 

 HOUSTON – May 4, 2022 – The winners of Fast Company’s 2022 World Changing Ideas Awards were announced this week, honoring clean technology, innovative corporate initiatives, brave new designs for cities and buildings, and other creative works that are supporting the growth of positive social innovation, tackling social inequality, climate change, and public health crises.

Spark Biomedical (Spark) – a leader in wearable neurostimulation and developer of the first drug-free, personalized, wearable solution for opioid withdrawal relief – and Velentium – a professional engineering firm that specializes in the design and manufacturing of therapeutic and diagnostic active medical devices – were among the honorable mentions in the North America and Health Categories for jointly designing and manufacturing life-saving, patient-ready neurostimulation devices that help adults and newborns safely and rapidly overcome opioid withdrawal.

The Sparrow Therapy System, developed by Spark Biomedical, is the first FDA-cleared, drug-free, non-invasive wearable neurostimulation solution for opioid withdrawal relief. The device is worn on and around the ear and explicitly designed to aid in the relief of opioid withdrawal symptoms by delivering gentle electrical stimulation to cranial nerve branches that in turn kick-start endogenous endorphin release and reduce symptoms. In addition to The Sparrow Therapy System, indicated for adult use, Spark has ambitiously developed a similar system, specifically designed to aid infants born into Neonatal Opioid Withdrawal Syndrome (NOWS). This system is currently in clinical trials and was recently awarded Breakthrough Device Designation by the FDA.

Now in its sixth year, the World Changing Ideas Awards showcase 39 winners, 350 finalists, and more than 600 honorable mentions—with climate, social justice, and AI and data among the most popular categories. A panel of eminent Fast Company editors and reporters selected winners and finalists from a pool of 2,998 entries across transportation, education, food, politics, technology, health, social justice, and more. In addition, several new categories have been added this year including climate, nature, water, and workplace. The 2022 awards feature entries from across the globe, from Switzerland to Hong Kong to Australia.

Fast Company’s Summer 2022 issue (on newsstands May 10, 2022) will showcase some of the world’s most inventive entrepreneurs and companies tackling global challenges. The issues highlight, among others, probiotics for coral reefs, easy-to-assemble kit homes for refugees or disaster survivors, a 3D printed vaccine patch, an electric truck, a system to heat homes from the waste heat of a name-brand factory, and prosecutor-initiated resentencing for overly long prison sentences.

"We are thrilled that the Sparrow Therapy System received an honorable mention by Fast Company,” said Daniel Powell, CEO of Spark Biomedical. “When the Spark team identified the pressing need to address the opioid epidemic then further pinpointed and clinically proved the neurological mechanism of action, we needed a likeminded partner to help us bring our much-needed wearable neurostimulation solution from concept to fruition. Pairing our future vision and scientific and technology expertise with Velentium’s engineering and manufacturing prowess is a vital component in addressing the opioid epidemic and ultimately changing the world.”

“It is inspiring to witness how many innovative companies call Houston home,” said Dan Purvis, CEO of Velentium. “As technology evolves, so does our expansive partner ecosystem – a unique network driving the success and future prosperity of the medical device industry. It has been a privilege to advance wearable technologies and auricular neural work alongside Spark. We’d like to congratulate all honorees recognized during this year’s awards. Let’s continue to change lives for a better world with great ideas like these.”

To learn more about the Sparrow Therapy System and the partnership ecosystem enabling transformative projects in the medical device industry, click here.

“We are consistently inspired by the novelty and creativity that people are applying to solve some of our society’s most pressing problems, from shelter to the climate crisis. Fast Company relishes its role in amplifying important, innovative work to address big challenges,” says David Lidsky, interim editor-in-chief of Fast Company. “Our journalists have identified some of the most ingenious initiatives to launch since the start of 2021, which we hope will both have a meaningful impact and lead others to join in being part of the solution.”

 

About the World Changing Ideas Awards

World Changing Ideas is one of Fast Company’s major annual awards programs and is focused on social good, seeking to elevate finished products and brave concepts that make the world better. A panel of judges from across sectors choose winners, finalists, and honorable mentions based on feasibility and the potential for impact. With the goals of awarding ingenuity and fostering innovation, Fast Company draws attention to ideas with great potential and helps them expand their reach to inspire more people to start working on solving the problems that affect us all.

 

About Velentium

Headquartered in Houston, Texas with operations globally, Velentium is a professional engineering firm that specializes in the design and manufacturing of therapeutic and diagnostic active medical devices for companies of every size and stage, from Fortune 100s to startups. Velentium offers world-class expertise in software, usability, cybersecurity, mobile and cloud, electrical and mechanical development, regulatory, and systems engineering for medical devices. Velentium transforms IP into safe and secure products that will support healthcare professionals, patients, and communities, and ultimately, change lives for a better world. Velentium is ISO-13485 certified and an FDA-registered Manufacturer of Record. For more information, visit http://www.velentium.com.

Interested in partnering with Velentium to develop your project? Please contact us at NextStep@Velentium.com and help us fulfill our passion for changing lives for a better world.

 

About Spark Biomedical

Spark Biomedical, Inc. is a leading U.S.-based wearable neurostimulation solutions developer devoted to the life-saving work of helping 36.3 million people worldwide overcome withdrawal, heal from addiction, and achieve the better quality of life they deserve. With opioid-related misuse and overdose deaths on the rise, the company's mission is to eliminate opioid addiction by working to address the full opioid addiction lifecycle, including withdrawal management, opioid-sparing, relapse prevention, and PTSD/trauma abatement.

Spark Biomedical is helping patients take the first step of overcoming acute opioid withdrawal with its FDA-cleared wearable technology, the Sparrow Therapy System — Transcutaneous Auricular Neurostimulation (tAN®) for Opioid Withdrawal Relief. Sparrow™ Therapy provides an easy, safe, and effective drug-free treatment option supported by clinical evidence. Next steps are underway with the launch of two NIDA-funded clinical trials to improve adult relapse rates and help infants suffering from Neonatal Opioid Withdrawal Syndrome (NOWS).

Learn more at sparkbiomedical.com or on LinkedIn.

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03 Aug 2022

Velentium Partners with the University of Colorado Boulder for Medical Device Cybersecurity Course and Capstone Project

Focused on embedded cybersecurity and secure product development, the engineering firm plans to expand the program to universities around the country

 

HOUSTON, TX and BOULDER, CO – July 6, 2022 – Velentium, a Houston-based professional engineering firm that specializes in the design and manufacturing of therapeutic and diagnostic active medical devices, today announced a successful completion of its initial embedded cybersecurity and secure product development course in partnership with the University of Colorado Boulder. The engagement also included a capstone project with a focus on machine learning and artificial intelligence in relation to threat modeling.

"Cybersecurity poses the greatest threat to medical technology and the healthcare industry as a whole, both presently and in the future,” said Dan Purvis, Velentium co-founder and CEO. “The most effective way to raise awareness of this issue and combat the threat is to educate the next generation of engineers at the university level. Velentium was eager to partner with an outstanding university like CU Boulder when the opportunity arose and was honored to work with some tremendous students throughout the course and project. Programs like this are essential to the future of our industry.”

Led by Garrett Schumacher, Cybersecurity Lead at Velentium and Adjunct Professor, the program gave students both classroom and hands-on experience in the medical device security realm. Through the lens of embedded cybersecurity and secure product development, the team examined how machine learning and AI could be applied to automate threat modeling techniques. While the new model remains in development, the project concluded that both can successfully be applied to this crucial area of cybersecurity combat.

“Although in the early stages, our team considers the research resulting from our course and capstone project to be a considerable win and a step forward for the industry that could lead to procedural innovations in the future,” said Schumacher. “Velentium is committed to educating the next generation of aspiring engineers and plans to expand this initiative to additional universities around the country, ultimately creating a certification course. It was a joy to work with some brilliant-minded students, and we were proud to hire two interns out of the CU Boulder program, providing opportunities for young engineers to enter the industry and experience career advancement.”

Rushikesh Dodamani and Renu Mani joined Velentium as interns after completing the course this semester and provided their thoughts on the experience at CU Boulder.

“Beyond theoretical concepts, this course allowed us to experience a hands-on approach for network devices and understand hardware hacking,” said Dodamani. “It also helped students understand different steps of the product development lifecycle and the issues present in each step, gaining insight in how to mitigate those problems. The most significant insight I learned during the course was never to give up while testing a device for vulnerabilities. Velentium helped us understand that there are multitudes of techniques to utilize, and in the process, learn something new and have fun while you’re at it.”

“I wanted to join Velentium as it is one of those unique companies that does everything in the product lifecycle from concept to market,” said Mani. “I strive to understand and implement what I had learned in the classroom in the real world. Another major factor would be the enthusiasm with which Garrett and other Velentium team members showed during instruction, which made us want to work with them as colleagues, and their wealth of knowledge which could help me start my career in cybersecurity.”

In addition to this university program, Velentium designed and launched a formal training program last year – Mastering Embedded Cybersecurity – on how to implement cybersecurity best practices and processes during design, development, production, premarket, and postmarket activities. The level one training and certification series followed the publish of the bestselling textbook Medical Device Cybersecurity for Engineers and Manufacturers, co-authored by Christopher Gates, Velentium’s Director of Product Security.

To learn more about the CU Boulder course, Velentium's training programs, or keep up with the company’s latest news and insights, visit Velentium.com or email nextstep@velentium.com.

 

About Velentium

Headquartered in Houston, Texas with operations globally, Velentium is a professional engineering firm that specializes in the design and manufacturing of therapeutic and diagnostic active medical devices for companies of every size and stage, from Fortune 100s to startups. Velentium offers world-class expertise in software, usability, cybersecurity, mobile and cloud, electrical and mechanical development, regulatory, and systems engineering for medical devices. Velentium transforms IP into safe and secure products that will support healthcare professionals, patients, and communities, and ultimately, change lives for a better world. Velentium is ISO-13485 certified and an FDA-registered Manufacturer of Record. For more information, visit http://www.velentium.com.

 

Interested in partnering with Velentium to develop your project? Please contact us at NextStep@Velentium.com and help us fulfil our passion for changing lives for a better world.

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