Tag: Healthcare

Science Center and Alira Health Establish Strategic Partnership to Accelerate MedTech Commercialization

Chris Cantz

PHILADELPHIA, PA – The University City Science Center, a Philadelphia-based nonprofit with over 60 years of experience advancing the commercialization of promising technologies, and Alira Health, a leading international healthcare and life sciences advisory firm, are joining forces to support Philadelphia-based life sciences and medical technology startups.

Through this partnership, Alira Health will leverage its expertise and deep connections within the healthcare and life sciences industry to support Science Center portfolio companies including members of the [email protected] incubator and the Launch Lane cohort. Alira Health will offer a suite of advisory support, including expertise related to regulatory and clinical affairs, market access, reimbursement, in addition to health economics and outcomes research (HEOR).

“The Science Center’s partnership with Alira Health is a significant value-add for our portfolio companies, enabling them to more efficiently transition their technologies into the marketplace,” says Science Center President & CEO, Tiffany Wilson. “As we push further into the MedTech space, gaining access to Alira Health’s expertise is a win for Philadelphia’s life sciences ecosystem and positions our companies for the best chance of success.”

“Our partnership with the Science Center reinforces our commitment to fostering entrepreneurs in the development of innovative technologies in MedTech,” said David Uffer, Senior Partner and VP of MedTech, Alira Health. “The suite of programs they have developed to further their mission of supporting companies on their path to commercialization is exemplary in the Greater Philadelphia market. We are pleased to offer our practice leaders across our service offerings to advance this effort.”

In addition to individualized pro bono support of Science Center portfolio companies, David Uffer will hold office hours at the June 17th Venture Café Thursday Gathering focused on the MedTech sector. More info here.

The Science Center offers a suite of commercialization programs that are collectively designed to identify, support, and commercialize the most promising technologies. Supporting life sciences, MedTech, and tech-enabled startups, the Science Center helps put teams into place, identify early resources, and connect founders with its vast network of academic and research institutions and industry partners. Over the last ten years, the Science Center has supported over 600 startups and invested $13.4 million with over $1 billion raised in follow-on funds.

About the Science Center
Located in the heart of uCity Square, the Science Center is a mission-driven nonprofit that commercializes promising technology, cultivates talent and convenes people to inspire action. For over 50 years, the Science Center has supported startups, research, and economic development across the emerging technology sectors. As a result, Science Center-supported companies account for one out of every 100 jobs in the Greater Philadelphia region and drive $13 billion in economic activity in the region annually. By providing the right help at the right time, the Science Center is turning bright ideas into businesses and nurturing a workforce to support our 21st century economy. Visit sciencecenter.org to learn more.

About Alira Health
Alira Health is an international advisory firm on the frontlines of healthcare transformation. They provide a suite of integrated services designed to help healthcare and life science companies innovate and grow across their solutions lifecycle.

Alira Health was founded in 1999 and is based in Framingham, MA, U.S. Offices are located in San Francisco, CA, U.S.; Paris, France; Barcelona, Spain; Munich, Germany; Milan, Italy; and Basel and Geneva, Switzerland.

Learn more at https://www.alirahealth.com/.

Fairmount Partners Advises Greenleaf Health in Sale to Validant

Chris Cantz

London, UK – Global Healthcare Opportunities, or GHO Capital Partners (GHO), the European specialist investor in healthcare, acknowledges the announcement from its portfolio company, Validant, regarding the acquisition of Greenleaf Health.

Validant, a leading global quality, compliance and regulatory consulting group (the Group), has acquired Greenleaf Health, Inc. (Greenleaf), a leading U.S. Food and Drug Administration (FDA) regulatory consulting firm. Concurrent with the acquisition, Validant announced the appointment of Patrick Ronan, founder and former Chief Executive Officer (CEO) of Greenleaf, as the new CEO of Validant.

Greenleaf Health provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies researching, developing, and manufacturing innovative solutions to pressing global public health challenges. Greenleaf’s team of experts draw on a combined total of more than 300 years of FDA experience to deliver reliable, objective advice to FDA-regulated companies. Founded in 2007, Greenleaf is headquartered in Washington, D.C.

Validant’s acquisition of Greenleaf is another important step in its international growth strategy, focused on combining best-in-class regulatory and quality providers, and accelerating their growth with further investment. The accelerated growth strategy is supported by GHO Capital, the European specialist investor in healthcare, having partnered with Validant since December 2018. Today’s announcement follows Validant’s December 2020 acquisition of Oriel STAT A MATRIX, a New Jersey-based global consultancy and training firm; November 2020 acquisition of IDEC, a leading regulatory consultancy in Japan; and the acquisition of DataRevive in 2019, a regulatory strategy and consultancy for global clients, based in Washington D.C.

Commenting on the announcement, The Partners at GHO Capital, said: “We are delighted to welcome the entire Greenleaf team to Validant. They bring a wealth of complementary experience and expertise to the Group and the combination is set to benefit the customers of both companies. We would like to take this opportunity to thank Brian Burns for his support and leadership in overseeing the rapid growth of Validant. We are excited to continue this trajectory under Patrick’s leadership and believe that his experience and passion will help consolidate our position as the leading global life science regulatory consultancy.”

Patrick Ronan brings more than 25 years of leadership experience to his role as CEO of Validant. Prior to founding Greenleaf in 2007, Patrick served as Vice President of Regulatory Policy & External Affairs at Novartis Pharmaceuticals Corporation, where he supervised U.S. regulatory policy issues and advised all therapeutic areas on FDA-related regulatory matters.  Patrick’s extensive experience includes leadership roles at the FDA where he served as Chief of Staff and Assistant Commissioner of Legislation; on Capitol Hill, where he served as a member of the Professional Staff to the Committee on Energy and Commerce; and the Washington, D.C.-based Biotechnology Innovation Organisation (BIO).

Patrick Ronan, newly appointed CEO of Validant, commented: “Greenleaf Health enhances the expertise and capabilities of Validant as we work to support clients and their evolving global regulatory needs. I am excited to serve in the role of CEO and bring our teams together as we create a platform for continued growth and success.”

Fairmount Partners provided investment banking and advisory services, and Goodwin Procter provided legal advice to Greenleaf Health, Inc.

OMM provided legal advice, RSM Global provided financial and accounting advice, and Deloitte provided tax advice to Validant.

 

About Fairmount Partners

Fairmount Partners (www.fairmountpartners.com) is an independent merger and acquisition advisory firm focused on emerging growth and middle-market companies. Fairmount helps its clients complete mergers and acquisitions; raise funds for growth, acquisitions and liquidity; and design and improve their corporate development strategies. Fairmount’s clients include successful entrepreneurs, private equity-sponsored enterprises, and global public companies. Since 2003, Fairmount has completed more than 240 transactions, representing over $12 billion in aggregate value, in 20 countries throughout North and South America, Europe, Asia and Australia.

For further information, please contact Neal McCarthy at [email protected].

The Next-Gen Technology Landscape of the Healthcare Sector

Amanda Nardi

Contributed by Cigniti Technologies.

The healthcare sector is expected to touch $390.7 billion by 2024. Let us discuss the next-gen technologies that are going to impact the healthcare sector.

  • Internet of Things (IoT): Sensor-embedded devices exchanging information over the internet (IoT devices) are finding their way across technology landscapes. These have found usage in the healthcare sector and are making a profound impact on the health of users. By redefining or reshaping diagnostics, disease management, and preemptive care, IoT devices, including the wearables, will become more common in future. To ensure the success of these devices so that they are able to manage life threatening conditions, healthcare software testing should be the norm. Let us understand how IoT devices can be of help in the healthcare sector in the days to come.
    • Tracking locations in real-time: One of the major challenges the healthcare staff needs to grapple with is locating medical devices in real time. For example, portable devices like nebulizers, scales, defibrillators, and ECG devices, among others, are often moved across the healthcare facility. They are often left at places where finding them can become a challenge, especially when there is an emergency. However, should these devices or apparatus be equipped with IoT sensors, they can be easily monitored in real-time. This can help the stakeholders to monitor and manage the healthcare environment.
    • Share health data: Physicians are often challenged by the lack of data concerning the vital parameters of patients. These may include blood pressure, heart rate, and calories burnt, among others. In the absence of such data, carrying out correct diagnosis can become difficult leaving the patients in limbo. However, wearable IoT enabled devices can allow the sharing of vital parameters of patients leading to a quicker and accurate diagnosis. To make sure these devices perform to their optimum and do not suffer from glitches, conducting healthcare application testing becomes a critical requirement.

As IoT based devices capable of providing real-time data become commonplace, efficient diagnostics and care will increase. They will help healthcare professionals in saving lives with the help of data, analytics, and better decision making.

  • 3D Printing: This technology is used to create physical objects from digital data. The examples of 3D-printed prosthetics and human heart model are helping amputees and medical professionals, respectively. The global market for this technology is expected to reach $2,319.5 million by 2020. Let us discuss the latest innovations in 3D printing.
    • Prosthetics: One of the major challenges amputees face in wearing prosthetics is a lack of customization. Prosthetic devices made in the assembly line are made as per general measurements. This is where 3D printing has come as a godsend for physically-challenged patients. Here, patients’ exact specifications concerning the body part(s) are obtained digitally and personalized variants of prosthetics are built. These provide greater maneuverability to the patients, helping them lead their lives with ease.
    • Tissue engineering: The technology helps to recreate damaged tissues and intricate body parts – printed ears, hands, livers, eyes, or hearts. This can be of great help in trauma cases where patients have lost a body part, organ, or tissue. Tissue engineering helps to create functional constructs for damaged tissues or organs. Here, engineered materials combined with stem cells can create the required cell type.
    • Surgical tools: Surgery is becoming more precise with less incisions to be made. This calls for personalized surgical tools to help surgeons in making precise incisions and implanting medical devices. 3D printing with its disruptive application can bring about greater personalization and cost benefits.
  • Artificial Intelligence: This is defined as machines induced with intelligence having the ability to mimic human brain functions. The healthcare sector can benefit immensely by embracing AI. It can drastically improve patient outcomes with medical professionals leveraging AI-enabled medical knowledge. AI-enabled systems can help medical professionals with real-time, relevant, and quality information to derive suitable inferences. These can help in reducing the cost of treatment, elimination of unnecessary procedures, streamlining workflows, and building patient-centric treatment protocols.

AI systems can help in diagnosing chronic health conditions like diabetes, coronary heart disease, and cancer, among others, within minutes. They can do so by analyzing the vital parameters of patients saved in electronic records. Thus, the systems can reduce the need for unnecessary biopsies or even surgeries to diagnose a condition. However, these systems must be subjected to intense healthcare compliance testing to ensure they function as per the expected outcomes.

  • Liquid biopsy: Today, the diagnosis and monitoring of cancer are costly, time-consuming, painful, and invasive. With liquid biopsy, cancer cells can be extracted from a blood sample without having to conduct costly and painful recurring biopsies. The technology will help to monitor tumors in a non-invasive manner even better than a CT scan.

Conclusion

The healthcare industry is going to face disruption thanks to the advent of advanced technologies. To ensure these technologies perform to their optimum and deliver expected outcomes, they should undergo healthcare QA testing. Moreover, since technology is not always flawless and can engender a number of glitches, even driven by human factors, healthcare tech QA can be of help. It can ensure continuous testing of the devices or built-in software as part of the delivery pipeline. Healthcare tech QA can lead to reduced technical errors, better compliance with regulations, and save lives.

 

Future of Caregiving is Here

Amanda Nardi

Written by Joe Cellucci, Founder & CEO, Xverity, Inc.

Support for care-dependent older adults has basically remained unchanged and largely disjointed for generations. The usual care circle has included a physician who diagnoses and prescribes medications and unpaid family member(s), possibly supplemented with professional home health and social care aides who help with daily needs and routine tasks. Traditionally, there has been little or no communication among them often resulting in confusion and conflicting care protocols.

Although the principal players haven’t changed, the conventional caregiving model is being challenged by the convergence of unprecedented forces building to a perfect storm:

  • Aging population – 76 million Baby Boomers will be older than 65 by 2030 and older Americans will make up 21% of the population.
  • Multi-morbidities – Nearly 80% of Medicare beneficiaries have at least 2 chronic conditions, more than 60% have at least 3 and estimates are that 26% of the US population will be living with multiple chronic conditions by 2030.
  • Aging in place – 76% of Americans age 50 and older prefer to remain in their current residence and 77% would like to stay in their community as long as possible.
  • Rising health care costs – Medical expenses for the elderly more than double between the ages of 70 and 90, exceeding $25,000 annually for a person in his or her 90s based on Medicare data.
  • Families are half the size they were 50 years ago, and adult children are employed, making caregiving difficult. In addition, nearly half of adults live, on average, 700 miles from family.
  • Looming caregiver crisis – Experts project that by 2030 there will be only 4 potential caregivers available for each person 80 or older, down from a high of more than 7 in 2010.

The fallout from these forces has placed a heavy burden on the historically disconnected, inefficient US healthcare system, creating a need and opportunity for innovation. In response, rapidly emerging assistive technologies deployed within the hospital and beyond its walls are now enabling healthcare providers to assure older patients with chronic conditions an uninterrupted, efficient continuum of quality care at lower costs.  The new model also emphasizes the criticality of engaging and empowering the caregiver, the care recipient and other members of the care circle.

This scenario illustrates the utopian vision for digital home care: Charlotte Wilson, 70, a tech-savvy diabetic who lives alone in her “smart” home, is awakened each morning by a housekeeping robot when it detects that Charlotte is in her lightest sleep phase.  She takes her 3-D printed medication containing all the drugs prescribed for the day; puts on biofeedback clothing made of fabric that continually monitors her vital signs and moods, indexes her overall health well-being, and enables her to move about without a walker; beams her three grandchildren into her home for a quick visit using holographic technology, and rides to her doctor’s appointment in an autonomous vehicle available on demand. Charlotte is digitally connected to an interactive, personalized ecosystem that anticipates and adapts to her needs, is accessible on demand 24/7, and is designed to assure safety, security and peace of mind for her and for the members of her caregiving circle. Sensors are continually monitoring her for problems with balance, signs of depression or prolonged periods of loneliness so that appropriate remedies can be dispatched.

Plausible?  Absolutely! From my vantage point as a serial entrepreneur in solutions technology and founder of Xverity, Inc., a technology-enabled caregiving services company, I believe it’s  conceivable that under the right circumstances, AI and robotics will make it possible to provide care for seniors without a human even being present.

At Xverity, we’ve created CAREGIVERASSIST SM   , a high-tech/high-touch caregiving ecosystem to support caregivers and care recipients. Our primary goals are to help relieve some of the stress caregivers experience, especially those who hold full time jobs, and avoid the feelings of isolation and dependency that lead to bouts of depression among older adults. Addressing the social determinants of health is at the core of our solution for continuous, quality caregiving.

Subscribers access the CAREGIVERASSIST  Services Hub built on a SaaS platform for on-demand, direct access to an array of needed services such as transportation, home delivery of prepared meals and groceries, home maintenance and repair, medication alerts and refills, in-home monitoring and communication devices and a host of other social services to keep the care recipient engaged, comfortable, safe and secure with dignity.  Also available is a prepaid card to pay for transactions, keep track of purchases made through the Hub and mitigate fraud risks by people who prey on older adults.  A monthly statement of transactions is a useful record of eligible expenses reimbursable under Medicare. Recognizing the value of non-clinical services, CMS now offers social determinants of health benefits such as meal delivery, rides to the grocery store, or a service that would make a care-dependent older adult’s home environment more conducive to healthy living.

For added peace of mind in the event of a question or a need for an intervention, CAREGIVERASSIST  provides 24/7 access by voice, web or text to a Help Center staffed by trained advisors.

The Internet of Things Genie is out of the bottle, allowing communication pathways between devices, timely sharing of actionable data and remote command and control of multiple diagnostic, monitoring and telemedicine treatment systems.  Much of the futuristic technology needed to help reduce hospital readmissions and avoid unnecessary visits to the ER by older adults already exists and is being applied at an accelerated rate in virtually every area of caregiving for adults with chronic illnesses and disabilities.