In an insightful interview, Mansoor Meenai, Interim General Manager for META at ACINO, shares how ACINO’s state-of-the-art manufacturing facility aligns with the UAE's Vision 2030, emphasising industrial diversification and self-sufficiency. He discusses the facility’s unique features, sustainability initiatives, and the company's dedication to employee well-being, while also providing a glimpse into ACINO’s future plans for growth and innovation in the region. Excerpts:

How does Acino’s manufacturing site align with UAE's manufacturing strategy?

Acino's manufacturing facility aligns seamlessly with the UAE's Vision 2030 and industrial strategy with a focus on industrial diversification and self-sufficiency in pharmaceuticals, among other industries. By integrating advanced EU, GMP and GCC-certified production capabilities locally, we’re contributing to strengthening the UAE’s position to  become a global pharmaceutical hub. Our commitment to quality and innovation bolsters the nation's healthcare infrastructure, driving to economic growth and reduced dependency on pharmaceutical imports. Our 1,300-sqm manufacturing site has an annual production capacity of over 250 million tablets and 87 million capsules.

Mansoor Meenai

How does this facility distinguish itself from other players?

We seamless combine our international expertise with local engagement. Our facility stands out for its state-of-the-art technology, adherence to the highest international standards, and strategic integration with Pharmax Pharmaceuticals. The EU, GMP and GCC certifications reflect our commitment to quality and operational excellence. Additionally, our end-to-end solutions—from regulatory registration to commercialisation—ensure efficiency and effectiveness, distinguishing Acino as a trusted partner in the region.

How important is sustainability for pharma companies, and what efforts does Acino make in this area?

Sustainability is crucial for the pharma sector, impacting both environmental and societal well-being. At Acino, we prioritise sustainable practices such as using LPG for heating processes and implementing robust recycling and energy conservation programmes to monitor and control usage. These efforts not only reduce our carbon footprint but also ensure long-term operational resilience and alignment with global sustainability goals.

How are you also ensuring that the employees' mental health is well managed, considering the job can be taxing for many?

We prioritise our employees' mental health. We recently introduced a new wellbeing programme and we provide access to regular mental health workshops, as well as professional counselling services. We also foster a supportive work environment that encourages open communication, work-life balance, and stress management practices to ensure our employees' well-being is well managed. Acino has also transformed into a modern workplace over the years with hybrid and remote working policies to ensure our workforce can strike a better work-life balance while remaining productive.

What are your plans for the upcoming years?

We look forward to expanding our manufacturing capabilities, investing in advanced technologies, and enhancing our product portfolio to meet the region's evolving needs. We aim to strengthen our strategic partnerships, drive innovation, and contribute to the UAE’s vision of becoming a global pharmaceutical leader, ensuring sustainable growth and operational excellence.

Back to Management

Medlab Asia and Asia Health 2024 is set to welcome healthcare leaders and professionals to a melting pot of the latest products, technology, and innovations in medical laboratories and medical devices. Held in Thailand, the event is set to take place at the Queen Sirikit National Convention Center from July 10 to 12 and will also host one of the largest international medical conferences in Asia.

Medlab Asia and Asia Health provide a platform for entrepreneurs to forge business networks and seize opportunities amidst the challenges of the medical sector in Thailand and the broader Asian region. Additionally, the event will serve as a knowledge hub for medical professionals. With an expected attendance of over 10,000 visitors, the event aims to achieve a trade value of no less than 1,640 million baht. The exhibition will take place from, a new venue in the city's heart.

Kanyarat Kuysuwan, Deputy Director of Bureau of Medical Hub Industry Promotions at Department of Health Service Support, stated: “Prime Minister Settha Thavisin has unveiled the Thailand Vision, which aims to transform Thailand into a world-class industrial hub. This ambitious goal requires the collective efforts of executives and entrepreneurs to elevate Thai industries to the global stage. Among the sectors with the highest potential to attract investors and tourists from within and outside the country is Thailand's medical and healthcare industry. Our nation is well-equipped with advanced technology, skilled medical personnel, and high service standards at competitive prices. This progress can be leveraged to further establish Thailand as a Medical hub of medical and healthcare.”

Kuysuwan added: “However, to fully unlock the potential of the medical and health industry, entrepreneurs must continuously pursue development and stay abreast of modern academic knowledge and innovation. This is essential to enhance the competitiveness of the medical and healthcare sector in response to evolving trends and challenges within Thailand's health system. Therefore, Medlab Asia and Asia Health 2024 are a crucial platform for driving and elevating the medical industry to a higher level of value, encouraging entrepreneurs and medical professionals to advance their capabilities in the health business without restrictions. Additionally, it supports the vision of positioning Thailand as an international health hub.”

Rungphech Chitanuwat, Regional Portfolio Director - ASEAN, Informa Markets, organiser of Medlab Asia and Asia Health, stated: “In 2023, Medlab Asia and Asia Health achieved remarkable success, generating a trading value of US$37.5 million, or approximately 1,312.5 million baht, for medical laboratory and medical device. This represents a 5.93 per cent increase from the previous year. According to a McKinsey research report, the ASEAN region is anticipated to see investments in healthcare technology reach up to USD 100 billion by 2025, driven by factors such as an ageing population, the rise of non-communicable diseases (NCDs), and an increasing demand for healthcare access.”

With ongoing government support and private investment, ASEAN's medical device and laboratory market is poised for sustainable growth, positively impacting the health and well-being of millions of people, according to Chitanuwat, that the advancements in medical devices, diagnostic technologies, and digital health platforms have expanded medical services across all sectors.

“Medlab Asia and Asia Health stand out as the leading platform for the medical laboratory and device industry in ASEAN, offering unparalleled opportunities for entrepreneurs, industry experts, and healthcare professionals to create networking, connect businesses, share knowledge, and stay updated on the latest medical advancements. This year, the event will feature over 350 exhibitors from 28 countries and is expected to draw more than 10,000 visitors, with a target trade value of at least 1,640 million baht.”

This year’s edition of Medlab Asia and Asia Health will be held in conjunction with CPHI South East Asia 2024, covering the medical laboratory, device, and pharmaceutical industries to drive the healthcare market comprehensively. All three events are organised under the theme ‘International Healthcare Week’, focusing on enhancing system development and comprehensive healthcare, with the primary goal of improving public health access and integrating innovative technology into the public health system for better population health and economic stability, according to Chitanuwat.

Bernice Jenvdhanaken, Business Development Manager at the Polish Investment and Trade Agency, emphasised Poland’s strong presence at the event. “Poland is a major European producer of medical devices and equipment, holding approximately 15 per cent of the market share, with over 60% of its revenue from exports. Our key trading partners include Germany, Denmark, the US, the UK, and France. We are now looking to expand into Asian markets, seeking business opportunities at Medlab Asia and Asia Health 2024.”

This year’s exhibition will feature various medical innovations, including advanced diagnostic tools, new disease testing kits, AI-integrated medical devices, and more. It covers medical laboratory tools, diagnostic kits, equipment, consumables, medical services, and cutting-edge technologies for medical imaging, sterilisation, emergency medicine, rehabilitation, and medical IT systems. A new zone dedicated to digital health and AI will also be introduced.

A key highlight of the event is the medical conference designed to enhance the careers and knowledge of healthcare professionals. The conference will feature leading speakers covering topics such as Laboratory Management, Molecular Diagnostics, Clinical Microbiology, Anatomic Pathology, Clinical Chemistry, Haematology, Digital Health, Future Health, Hospital Management, Patient Safety, Total Radiology, and Sterilisation and Decontamination. Attendees will earn CME, CMTE, CPD, and CNEU credits.

Business seminars will also be held, focusing on medical device reimbursement, national health funds, and doing business in Asia, offering insights into medical device business opportunities in Thailand and Asia. The three-day conference is expected to attract over 4,000 attendees.

Visit the official website to register and learn more: Medlab Asia and Asia Health 

Back to Management

With healthcare costs soaring, and the push towards value-based care intensifying, Population Health Management (PHM) undeniably stands as a transformative force. Yet, in its pursuit of better outcomes, a critical question looms: Do all individuals reap the benefits equally, or do disparities persist? As we strive for progress, addressing this imperative is paramount.

The latest trends in PHM strategies offer pathways towards optimization, holding the key to meeting these objectives. By leveraging innovative approaches such as predictive analytics, personalized interventions, and targeted community outreach, we can work towards a future where healthcare is not just accessible, but truly equitable for all.

An impressive 14.1 per cent growth rate from 2024 to 2033 is expected in the Population Health Management Market, according to Market.us, surpassing $118.6 billion by 2033. This forecast highlights the enormous development potential in the industry going forward. The Population Health Management Market is characterized by several key trends, chiefly the use of novel technology, innovative approaches, and the prioritization of healthcare services for all by suitable financial and care models.

It is no surprise that healthcare organizations are shifting away from general data analytics toward more specialized analytics in 2024. This change offers insights catered to certain healthcare situations, which improves patient care and increases operational efficiency.

Data comes out as essential for achieving several business goals in the healthcare industry, according to a recent Arcadia and HIMSS survey.

Real-time analytics become popular because they improve patient communication, streamline operations, and allow for prompt decision-making. North America, particularly the US, leads the world in healthcare analytics because of its well-established system, cutting-edge infrastructure, and broad range of IT-based solutions, which are driven by rising health data and government efforts to reduce costs.

Recognizing the impact of social determinants on health outcomes, PHM strategies increasingly incorporate Social Determinants of Health (SDOH) data into risk stratification and intervention planning. By considering factors such as socioeconomic status, housing stability, access to transportation, and food insecurity, healthcare organizations can better understand patients' holistic needs and tailor interventions accordingly.
 

Predictive analytics play a crucial role in risk stratification, enabling healthcare providers to identify individuals at high risk of developing certain health conditions or experiencing adverse outcomes. By leveraging historical data, demographic information, and clinical indicators, predictive models can identify patients who would benefit most from targeted interventions and proactive care management.

Artificial Intelligence continues to be here. We also believe we will see AI helping to further automate manual processes that will deliver greater care team productivity and efficiency. Analyzing complex data to generate suggestions for the next best action to take. Predicting population health needs. This is what’s exciting about the potential of AI. Yet, along with AI’s benefits will come risks. Protecting the security of private health information is one.

The proliferation of digital health technologies, such as wearables, remote monitoring devices, and telehealth platforms, has transformed PHM by enabling continuous data collection and remote patient engagement. These technologies facilitate proactive interventions, early detection of health issues, and ongoing management of chronic conditions outside traditional healthcare settings.

Value-based care models are creating incentives for healthcare providers to prioritize cost containment and population health outcomes improvement. Preventive care, care coordination, and patient involvement are prioritized in PHM initiatives that are in line with value-based care to improve health outcomes and cut down on needless use of medical resources.

Effective PHM requires cooperation between social service providers, community groups, and healthcare practitioners. By facilitating information exchange, care coordination, and referrals between various healthcare institutions and community resources, collaborative care networks guarantee that patients receive all-encompassing, individually tailored treatment.

We are still exploring these trends one step at a time. Population Health Management is leading us towards a healthcare system where everyone's health matters.

References available on request.

Jennifer Orisakwe is a health researcher and data storyteller, who loves to explore the ways actions (and inactions) of healthcare stakeholders affect decision-making and outcomes.

Back to Management

As the Baby Boomer generation ages, the United States is on the precipice of a seismic demographic shift. By the year 2040, the number of people living in the US over the age of 65 is expected to more than double to 80 million, while the number of people over the age of 85 — the group often in need of the most care — will nearly quadruple from 2,000 to 2,040. This is not just affecting healthcare at home, but also abroad, as the world’s population faces a similar trend. Virtually every country in the world is experiencing this significant social transformation, as we see exponential growth in the number and proportion of senior and elderly populations.

In many ways, this is a credit to modern medicine. We are now able to provide better care for larger segments of the population than ever before and, as a result, we are living longer and healthier. However, as we see this steady increase in these populations, our healthcare system will have to rise to the challenge of maintaining and even surpassing that same level of care, which presents a problem given the current state of our overburdened and understaffed healthcare system. If we are to meet the needs of our aging population, we will have to transform the way in which healthcare is performed and delivered on a nationwide scale.

Hospitals and medical facilities all over the country are stretched thin. Between staff shortages, razor-thin budgets, and the rising demands on the time and resources of our healthcare professionals, we are faced with a serious issue regarding the effective delivery of healthcare services and treatment. We are delaying appointments, waiting longer to be seen and when we finally do get in front of a doctor, we are usually unsure of how much it’ll cost and how much time the doctor even has for us. This is not the fault of the physicians, many of whom are now forced to push a never-ending line of patients through their offices to treat as many as they can. Healthcare is losing its personal touch. It is becoming more about numbers and less about building personal relationships.

Healthcare has a delivery problem. Care is becoming less convenient, less accessible, and less effective. Patients are going longer between appointments or forgoing treatment altogether due to the hassle and difficulty associated with navigating a fractured and slow-moving system. This is dangerous for patients of all ages, but particularly our senior and elderly populations who are more likely to suffer from chronic illnesses.

Regular visits and check-ups are our primary means of taking proactive measures against larger and more complicated health problems that can arise. These conditions that would have been either alleviated or otherwise prevented with more accessible and convenient healthcare, now become needless drains on our healthcare resources and, most importantly, the continued health and well-being of the patient.

Digital health technologies have emerged in the years since COVID-19 to become integral tools in our efforts to revolutionize the level of care available to the public. Virtual and mobile healthcare services provide the potential to effectively transform not only the way in which doctors and patients interact but also how individuals engage directly with their own personal health. The highest levels of treatment and care are available in the comfort of patients’ homes, while medications and prescriptions are delivered directly to their doors. This is a particularly important paradigm shift in healthcare delivery for senior and elderly populations that have difficulty reaching important appointments and picking up vital prescriptions. This means that seniors will no longer have to wait weeks or months to be seen by doctors and will never again have an interruption in their medication schedules that can lead to serious illness and degradation of their health.

Both patients and healthcare providers stand to benefit from the further development and advancement of telehealth technologies. By allowing hospitals and medical centers to expand the scope of the services they provide outside of hospital and medical facility walls and into the communities they serve, our aging population will have direct access to comprehensive and preventative care.

Treatment will be more convenient, more comfortable, and, through these efforts, patients will be healthier. This will help to prevent many of the conditions that would have otherwise led seniors to suffer through lengthy hospitalizations and even rehospitalizations for the continued effects of chronic illnesses that then put undue and avoidable stress on our hospitals. This will allow these facilities to effectively allocate their time and resources to patients who require a hospital setting for care.

As seniors represent a higher and higher proportion of our country’s population, an already overburdened healthcare system will have to become more agile and more flexible. By employing these virtual and mobile strategies, our doctors and nurses will be able to see more patients and do so more regularly, keeping patients healthier and happier well into their golden years.

Through the adoption of digital health technologies, it is possible to revolutionize the way in which healthcare is delivered and meet the demands of shifting demographics in not only the United States but all around the world. As our population grows older and wiser, our healthcare system and payor sources must similarly become smarter and more efficient.

Jackleen Samuel is the Founder and CEO of Resilient Healthcare.

Back to Technology

The Food and Drug Administration (FDA), Office of Import Operation’s mission is to protect consumers and enhance public health by ensuring timely access to safe, effective, and quality FDA-regulated products of foreign origin. An integral part of this mission is ensuring that medical devices offered for important into the US meet regulatory requirements and requirements found in the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA conducts regulatory review of imported medical devices with the support of US Customs and Border Protection authorities and resilient collaboration with other partner government agencies and import community.

For medical device importers seeking the most efficient processing of their import entries, preparation and understanding are key. To process the volume of imports into the US, FDA systems interface with CBP system to allow for the FDA electronic admissibility reviews of FDA-regulated entries. FDA-regulated products imported into the US must comply with FDA's laws and regulations. The importer is responsible for making sure these products comply with all US requirements. Therefore, being proactive in understanding the nuances of regulations, required affirmations of compliance, useful documentation, and expectations to import is critical for preventing potential delays (or worse, refusal of goods).  Products which do not comply with US requirements at the time of importation are subject to refusal of admission.

To help comply with CBP requirements, most importers hire a Customs Broker to act on their behalf to facilitate the importation process. By preparing the required information and accurate documentation to provide to a broker, a medical device importer can increase the likelihood of a smooth and timely importation process. This includes details such as product descriptions, product codes, intended use in the US, pertinent addresses of manufacturers, shippers, and importers, and the required affirmations of compliance (i.e., registration, listing, premarket notification/approval numbers, etc.).

The FDA Supplemental Guide outlines all data elements required to be provided in the transmission of an entry. Lastly, importers should be familiar with FDA’s Import Alerts. Products and firms subject to Detention without Physical Examination (DWPE) will be detained and refused entry unless the importer can demonstrate that known violation(s) are not present in their product and/or that the root cause of the violation has been addressed to ensure a safe and effective product.

For an overview of medical devices and the requirements that FDA verifies and enforces at the time they are imported or offered for import into the US, visit the official Importing Medical Devices FDA website. Being proactive in understanding if your product is a medical device and identifying what are the applicable affirmations of compliance, requirements and regulations associated to the medical device and firm(s) is essential in facilitating the importation of the medical device.

An effective way to follow-up on an entry with FDA is to use the FDA’s Import Trade Auxiliary Communication System (ITACS) as it allows the import trade community to upload entry documentation and any additional information requested by the FDA entry reviewer. You may check on the status of an entry via (ITACS) by using the US Customs and Border Protection (CBP) entry number. Additionally, ITACS allows trade to provide the location of goods for lines selected for examination and to view the expected lab completion date for those lines which have been sampled. Furthermore, when there are medical emergency situations associated to an entry, we encourage immediate communication to FDA as sometimes entry information transmitted do not capture the urgency.

In conclusion, navigating the import process for medical devices requires an understanding of the product you wish to import, verifying the product and related firms meet regulatory requirements, and preparing the proper information for importation. By following these guidelines and leveraging available resources, importers can increase their chances of successful importation.

Ruth Dixon is the Program Division Director, Division of Southeast Imports, Office of Regulatory Affairs, US Food and Drug Administration.

Back to Management

Zebra Technologies Corporation, a leading digital solution provider enabling businesses to intelligently connect data, assets, and people, recently announced findings of its latest hospital vision study titled, Critical Supplies, Critical Outcomes: The Quest for Excellence in Materials Management. The study confirmed most (84 per cent) US and UK non-clinical hospital leaders believe integrating automated and digitised inventory tracking systems of anything used or administered at patients’ bedsides is a priority for their organisations.

Hospital asset inventories must be managed precisely to ensure clinicians have the essential supplies, equipment, and medications readily available to provide the best patient care. Yet materials management is an ongoing challenge for hospitals which can impede positive outcomes. A McKinsey report indicates nurses expressed the desire to reduce time spent searching for medical assets by half during shifts to increase their ability to focus on patient care.

Seven in 10 (74 per cent) hospital leaders surveyed acknowledge procedures or surgeries canceled due to out-of-stock, low-stock, or lost supplies is a significant problem for their organisations. Additionally, over three-fourths (77 per cent) of them agree clinical staff spend too much time searching for medical equipment, materials, or supplies when needed, and 75 per cent say it’s a challenge to recover all recalled or expired items.

There is also a lack of faith in clinicians' reporting systems to track adverse events resulting from inventory issues. Seven in 10 (76 per cent) hospital leaders agree their organisations need to improve systems for clinicians to report problems relating to out-of-stock, low-stock, or lost inventory, equipment, or supplies to improve patient safety. Technology and digital solutions can help reduce inventory and reporting issues by providing enhanced tracking, visibility, and forecasting capabilities.

“Hospital staff must be able to identify, track, and capture the location and status of critical resources in real-time,” said Rikki Jennings, Vertical Industry Principal Lead, Zebra Technologies. “That's why we see rapid investment in location and automation solutions. Non-clinical hospital leaders working in new ways with technology behind the scenes can help improve the workflows of front-line clinicians and enhance the patient experience.”

Supplied

Digitisation of inventory management helps boost efficiency and patient care

Hospital leaders have a significant impact on clinical staff and the delivery of patient care. They must ensure medical supplies, equipment, and medication are visible and accessible. Most (84 per cent) hospital leaders acknowledge their role and responsibility in tracking and managing hospital inventory directly impacts patient safety.

A substantial nine in 10 hospital leaders agree it’s vital to track inventory in real-time across categories including pharmaceuticals, consumable/medical supplies, sterile instruments, and implants. Over half of those surveyed believe real-time location systems (RTLS) and radio frequency identification (RFID) will improve inventory management. Nearly seven in 10 hospital leaders indicate they plan to deploy RFID (68 per cent) and RTLS (69 per cent) solutions within the next five years.

The Zebra study also confirmed that outdated or disparate inventory systems get in the way of accurately managing inventory. Four in 10 hospital leaders agree the most challenging workflows are manual cycle counting in clinical storerooms/wards, lack of real-time recording of supply use in surgical spaces, and order fulfillment or replenishment of items in central storerooms.

Hospitals leveraging technology and digitization can strengthen hospital workflows, benefiting physicians, nurses, support staff, and patients alike. Eight in 10 hospital leaders believe real-time location tracking is essential to optimal patient care. They also agree the combined use of RFID and barcode scanners to track and manage inventory would significantly help prevent and reduce medical errors.

Artificial Intelligence (AI) adds more inventory visibility and accuracy

Hospital leaders believe in the power of AI and analytics. In fact, eight in 10 say AI would improve inventory accuracy and visibility in their organisations. About seven in 10 agree predictive analytics (73 per cent) and prescriptive analytics (65 per cent) would also improve inventory management. AI analytics solutions can help forecast inventory needs using historical data to help make more informed and accurate decisions. Hospital leaders are expanding their implementation of AI solutions: three in 10 say they currently deploy AI, and six in 10 say they expect to deploy it over the next five years.

Nearly eight in 10 (78 per cent) hospital leaders also say it’s a priority to use data and analytics to improve materials management. They agree using AI would advance their ability to monitor and predict demand, resulting in increased patient safety. While only 14 per cent say they are currently using advanced analytics and demand forecasting to predict inventory needs, 82 per cent expect to deploy it within the next one to five years.

Survey background and methodology

Zebra commissioned Azure Knowledge Corporation to conduct an online survey among 280 non-clinical decision-makers in large hospitals (1,000+ beds) in the United States and the United Kingdom. These respondents are responsible for overseeing one or more of the following inventory categories: medical devices, durable medical equipment, implants, consumables, medical supplies pharmaceuticals, or sterile instruments.

References available on request.

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Located in Boca Raton, Florida, 45 minutes north of Miami, the Research Park at Florida Atlantic and its Global Ventures program are places where entrepreneurial med tech companies and academia collide.

Spanning 70 acres, the Research Park is widely regarded as South Florida’s premier hub for new pioneering research initiatives and technologies. The Research Park is proudly partnered with Palm Beach and Broward Counties, along with the City of Boca Raton, to drive regional innovation and growth.

Instrumentum, an offsite surgical instrument sterilization company, is one of the latest to join the Park. With a focus on delivering high-quality instruments to laboratories, academic institutions, and industry professionals, Instrumentum serves as a trusted partner in advancing scientific discovery and technological innovation.

Daniel Johnson, CEO of Instrumentum recently reflected on his experience of  joining the Park and how it has propelled his business.

“From the first meeting with Andrew Duffell and the Research Park’s leadership, we have experienced the tangible and consequential assistance that this association with FAU affords,” said Johnson.

“Warm hospitality, community introductions, development guidance, FAU integration, referrals to subject matter experts, access to staffing channels, and networking opportunities with other innovative companies are just some of the compelling advantages of being located in the Research Park at Florida Atlantic.”

Global Ventures, located in the park, is an incubator for tech companies who have already established a presence within their industry and ready for their next level of growth. It was also one of the first international soft landings programs in the country, welcoming foreign tech firms expanding to the US.

Global Ventures has many benefits for its tenants including, shared conference and break rooms, game areas, central mail facilities, flexible terms on office and lab space, and access to FAU resources and benefits.

Currently hosting 28 companies from over 10 countries, Global Ventures serves a number of tech verticals, with a key focus on medical innovation. One of these companies is Triangulate Labs, a total body photography company working to end skin cancer mortality through their Skinmap platform.

“Triangulate Labs is a company with expertise in computer vision and AI. We created it to help solve skin cancer after my sister was diagnosed with terminal cancer”, said Bill Hall CEO and CO-Founder of Triangulate Labs. “Triangulate makes Skinmap, a patented Total Body Photography (TBP) system designed to give dermatologists better information so that they can catch skin cancers earlier and more easily.”

Skinmap is a rapid and efficient system that helps dermatologists track changes in patients’ skin, a crucial indicator for cancer prognosis. It allows for quick digitization of skin in less than 60 seconds, aiding in early detection and providing patients with peace of mind, all while generating new revenue for dermatologists.

To help grow this innovative and necessary medical detection product, Hall decided the Research Park at Florida Atlantic was the place to do it.

“The Research Park has enhanced our company's visibility and reach,” said Hall.  “Regular seminars provide information on useful topics ranging from crowdfunding to immigration. The Park's networking opportunities have proven incredibly valuable to us and have led to opportunities and business connections. Hearing other companies' experiences with vendors, government proposals, funding opportunities, and area trade shows has helped us make the right call a number of times.”

Aside from the testimonials and firsthand accounts of success from companies like Instrumentum and Triangulate Labs, the numbers paint an equally compelling picture of the Research Park’s impact.

In 2023, the Park supported 971 jobs and saw an average of 15 per cent growth in revenues over 2022. Four of these companies ranked on INC 5000 list of the fastest-growing companies in the country.

From job creation to economic growth, the data reinforces the idea that this hub of innovation is making waves in the South Florida community and beyond.

With an impressive track record of job creation, revenue growth and more, the Research Park and Global Ventures is more than ready to propel additional companies to success in the years to come.

“We are incredibly proud of the innovative med tech companies within our Global Ventures program and at the Research Park," said Ryan Lilly, Global Ventures Program Manager. "Their groundbreaking work is not only advancing medical technology but also significantly improving patient outcomes. These companies exemplify the spirit of innovation and excellence that we strive to cultivate here.”

Global Ventures

• Triangulate Labs
• DNA Labs
• HelixVM
• Ultimaxx Health
• Accenius
• Hawkeye MedTech

Research Park companies

• Thema Brain Health
• Instrumentum
• Flospine
• Aventusoft
• Pur Form
• Diowave
• Genesis Care
• Glades Medical
• MPLT
• PBISM
• University MRI

Sign up here to register for FIME 2024, the largest medical trade show in the US, and learn more about the latest trends disrupting the industry.

Back to Management

The Latin American region comprises 20 countries (depending on classification/sources), many of which are categorized as emerging countries with a population that is estimated to have reached 657 million people as of 2024 (CEPAL).

The Latin American market, with several local manufacturers, has outstanding world-renowned professionals who are highly trained in using the latest technology, research and development. Therefore, the region shows a strong trend as an import market for high-tech medical equipment and medical devices.

These are some of the reasons why the Latin American market represents a region of strategic interest for building alliances with qualified partners who have experience in such markets. Disregarding the regulatory issues may imply significant risks for companies that wish to enter the Latin American market. Choosing a skilled and suitable regulatory partner plays an important role in this enterprise and selecting the right one is critical.

Regulatory clearance is a prerequisite for manufacturers to get access to new markets. Latin America poses a challenge for medical device registration as each country has its regulatory legislation or its particular way of applying the same legislation, as it happens among different Mercosur countries.

Although there are different regional trade agreements in force — Free Trade Agreements, Trade blocks, Common Markets, etc. like Mercosur, ALCA, and Pacific Alliance (Alianza del Pacífico) — these agreements do not comprise all countries in Latin America nor have a direct correspondence with a single product regulatory clearance as it happens in the European Union and its medical devices regulations applicable throughout the community and the CE marking.

It may also happen that some countries in this region issue legislations, but these are not applied, or are partially applied taking into account the available resources at the moment of application and/or political and economic changes that impact the system.

Besides, sometimes regulations and requirements to access the Latin American markets change and new requirements are gradually incorporated or are based on practical experience acquired by local RA on the go. This situation, combined with the fact that when the government changes there might be turns in high-level public positions, may result in changes in management and implementation of regulations.

Another aspect that should be considered is the different legislation frameworks regarding medical product license ownership. In general, manufacturers are usually concerned about keeping control of their product licenses and it is exactly at this point where good regulatory advice is fundamental to avoid future problems related to product importation and marketing issues.

MMGC SRL offers manufacturers the possibility to address this issue by thinking together about their regional regulatory strategy and supporting them to make the right considerations to choose among the different holding options possible based on each local legislation.

In MMGC SRL, we usually see that clients launching in the region have an in-house regulatory staff strongly oriented to, and highly specialized in, European medical devices regulations (MDR), FDA regulations or others. However, when entering the Latin America region, they are not familiar with the local healthcare regulations.

In such cases, we recommend they seek support by outsourcing their Regulatory Affairs Management in the region, particularly at the beginning. In this way MMGC usually works by centralizing the regional regulatory issues in close cooperation with their in-company staff to define the best regulatory strategy for each country and, as we share the same regulatory language, the communication among the people involved is fluent.

Currently, several Latin American regulatory agencies are gradually migrating from long and heavy paper-based procedures to online submissions for medical device registrations and license renewals. Nevertheless, as mentioned above, the implementation of these updates is usually gradual and highly based on practical experience acquired on the go by the regulatory authority.

To manage medical device registrations efficiently, it is critical to have expertise and knowledge of these local characteristics.

On the other hand, there are some common guidelines that allow to group countries and manage regulatory issues of Latin American countries in a centralized way.

Centralized Regional Management of Regulatory Affairs offers advantages and avoids extra costs and delays in registrations. In addition, manufacturers have the option to start with one Latin American country of interest and to expand the market to other countries afterwards, therefore optimizing the use of documentation.

MMGC SRL is a Consultancy Company that specializes in Medical Device Regulatory Affairs, a company composed of a multidisciplinary team of professionals that combines training and more than 25 years of expertise from the public and private sectors. We have extensive experience working with international medical device companies to gain regulatory access to markets in Latin America. The tailored-service approach we offer enables us to provide solutions to large, medium and small-sized companies, as well as to serve local and international businesses and local direct distributors.

Monica Mabel Guaita is the CEO and Founding Partner of MMGC SRL (a regulatory affairs consulting firm), and Magdalena Ferrari del Sel is a Regulatory Affairs International Senior Consultant. Monica will speak as part of the “Main Regulatory Issues for LATAM — How to Surf LATAM's Regulatory Issues” session on June 20.

Sign up here to register for FIME 2024, the largest medical trade show in the US, and learn more about the latest trends disrupting the industry.

Back to Management

In today's healthcare landscape, the integration of various technological systems is crucial for achieving true digital health transformation. Today, it is essential to understand how integration serves as the cornerstone of modern healthcare innovation, ultimately enhancing patient outcomes and operational efficiency.

Integration in healthcare involves the seamless combination of various information systems and technologies to create a unified platform for data exchange and workflow management.

True digital health transformation requires more than just technological advancements; it necessitates a cultural shift and strong leadership to foster collaboration across different healthcare sectors when approaching this challenge from an integrated care perspective. Success in interoperability depends on three critical aspects: technology, relationships, and an enabling environment. W.N. Leutz’s five laws for integrating medical and social services provide a valuable framework for understanding the complexities of integration and highlight the importance of aligning policies, resources, and stakeholder engagement to drive successful integration initiatives (Leutz, 1999).

Integrated systems provide healthcare providers with immediate access to comprehensive patient records. This access is critical for making informed decisions and reducing medical errors. For instance, when a doctor can review a patient’s history, current medications, and lab results in real time, the care provided is more accurate and timely.

Moreover, integration improves patient engagement. Patients can access their health information through portals, schedule appointments, and communicate with their providers more efficiently, fostering a more patient-centric approach, more on both of these scenarios later.

Operational efficiency

From an operational perspective, integration reduces redundancy and optimises resource use. Administrative tasks such as billing and scheduling, often bogged down by inefficiencies, can be streamlined. Automating these processes and ensuring system interoperability reduces costs and enhances service delivery.

Integration also supports advanced analytics and data-driven decision-making. Aggregating data from multiple sources allows healthcare organisations to gain insights into population health trends, identify areas for improvement, and implement targeted interventions. This capability is especially crucial in public health settings, where resource allocation and policy decisions must be based on accurate and comprehensive data. Whilst these benefits seem clear, the incentives for it to happen vary from one geography to the next and are a key driver as to why some countries have well-utilised HIEs and others have none.

Cultural and organisational integration

True digital health transformation requires more than just technological advancements; it necessitates a cultural shift and strong leadership to foster collaboration across different healthcare sectors when approaching this challenge from an integrated care perspective. Success in interoperability depends on three critical aspects: technology, relationships, and an enabling environment.

Integration in healthcare goes beyond mere technological challenges and encompasses people, processes, and cultural shifts within healthcare settings. C. Auschra's literature review on the barriers to integration highlights that organisational culture and inter-organisational relationships are significant obstacles that need addressing to achieve successful integration (Auschra, 2018).

1. Technology: Systems must communicate and share data effectively. This includes adopting standards for data capture and sharing, addressing technological fragmentation, and simplifying multiple approaches to data sharing.

2. Relationships: Building trust and fostering good working relationships between staff across various organisations is essential. This involves recognising the benefits of interoperability and creating digital 'champions' who lead and promote digital transformation initiatives within their organisations, with a tight grasp on the governance of data.

3. Enabling environment: Aligning funding, capacity, skills, education, and governance supports interoperability efforts. This includes ensuring that staff have the necessary skills and training to use digital tools effectively, that there is sufficient funding for digital transformation projects, and that national policies support interoperability initiatives.

Why integration in healthcare is not quite so easy

While the benefits of integration are clear, achieving it is not without challenges. These include technical barriers, organisational resistance, and data privacy concerns. A strategic approach to integration involves investing in interoperable systems, fostering a culture of innovation, and ensuring compliance with data protection regulations. Collaboration with technology providers, as showcased at FIME, plays a crucial role in overcoming these hurdles. Let's take a brief look at four key hurdles to overcome:

Technical barriers: One primary barrier is the fragmentation of healthcare systems. Many organisations use different EHR systems with varying data standards and protocols, complicating data sharing. Adopting common data standards and ensuring system interoperability can address this issue. Additionally, integrating legacy systems with modern technologies can be complex and costly, but necessary for achieving true interoperability.

Organisational resistance: Resistance to change is another significant challenge. Healthcare providers may be reluctant to adopt new technologies or change workflows, particularly if they are accustomed to existing systems. Engaging staff in the transformation process, providing training and support, and demonstrating the benefits of integration can help overcome this resistance.

Data privacy and security: Data privacy and security are critical concerns. Implementing robust data protection measures, such as encryption, access controls, and regular security audits, is essential for safeguarding patient data. Healthcare organisations must also comply with regulations like the GDPR in the EU and HIPAA in the US, which set stringent requirements for handling patient data.

The role of national policies: National policies play a crucial role in driving interoperability initiatives. For example, the NHS Long Term Plan in the UK aims to improve interoperability by focusing on access to records for patients and clinicians. Similarly, the US Office of the National Coordinator for Health Information Technology (ONC) has established standards and frameworks to facilitate data sharing across healthcare systems.

Transformative Impact: A Holistic View

Improved patient outcomes

• Reduction in medical errors: Integrated systems reduce the risk of errors by providing complete patient information at the point of care.
• Enhanced chronic disease management: Continuous monitoring and data integration enable better management of chronic diseases, leading to improved patient outcomes and quality of life.
• Increased patient satisfaction: Empowering patients with access to their health information and engaging them in their care journey increases satisfaction and adherence to treatment plans.

Enhanced operational efficiency

• Optimised resource utilisation: Streamlined workflows and reduced administrative tasks free up resources for direct patient care.
• Cost savings: Reducing redundant tests, avoiding medical errors, and improving care coordination lead to significant cost savings for healthcare providers.
• Scalable solutions: Integrated systems provide a scalable solution that can adapt to the evolving needs of healthcare organisations.

Technical barriers, such as the fragmentation of healthcare systems and the complexity of integrating legacy systems, are well-documented obstacles. Organisational resistance and data privacy and security are additional challenges that require robust data protection measures and compliance with regulations like GDPR and HIPAA. I truly believe that by embracing integration, we pave the way for a more efficient, patient-centric, and data-driven future in healthcare, ultimately leading to better patient care and sustainable health systems globally.

References available on request.

James Davis is the CEO of Inicio Health, UK, and part of the panel, ‘Driving Hospital Innovation: Collaborating with Startups & Med-Tech Companies’, which takes place on June 19 at 11.20am.

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