Driven by a combination of robust R&D infrastructure, a strong regulatory framework, and significant investment from both private and public sectors, the US stands at the crossroads of healthcare innovation with a booming medical device sector that is poised for growth.

According to a report by Business Fortune Insights, the country’s medical devices market is anticipated to grow to $291 billion by 2030. This marks a CAGR of 6.1 per cent, up from $192.78 billion in 2023 during the forecast period. A key driver of the industry's growth is the continuous demand for improved healthcare solutions due to an ageing population and the prevalence of chronic diseases.

Companies in this field are heavily investing in developing cutting-edge technologies such as wearable health monitors, minimally invasive surgical devices, and AI-driven diagnostic tools. This phenomenon also plays a role in creating high-quality opportunities, which support nearly two million jobs, directly and indirectly.

The Food and Drug Administration (FDA) also plays an essential part in ensuring the safety and efficacy of these devices through rigorous approval processes. The US' emphasis on innovation, paired with a strong regulatory environment, ensures that the medical device industry will continue to thrive and advance healthcare outcomes domestically and globally.

To honor its continuous achievements and showcase the region’s prowess to the rest of the world, Florida International Medical Expo (FIME) returns for another edition between June 19 and 21, welcoming leaders from across the globe to exchange ideas to pave the way for sustainable businesses, share knowledge and solutions to some of the pressing topics that concern the healthcare industry.

This year is packed with a host of exciting conferences under the Business and Innovation Health Hub umbrella, with engaging sessions led by the healthcare’s cream of the crop. With a carefully curated selection of topics, professionals take away strategies to drive collaborations with start-ups and medtech organizations, understand global business practices and tap into markets in other parts of the world, learn about the main regulatory issues in Latin America and insights into the ever-evolving world of healthcare and industry potential, to name a few. These will provide an intimate look at enhancing entrepreneurship, improving the supply chain and enabling digital transformation in a dynamic healthcare landscape

Small ventures carry huge potential and FIME understands the importance of having a healthy environment for concepts to develop and flourish. The Innov8 Start-Up Competition is one such opportunity that gives 20 of the most promising ventures a platform to present their ideas and innovations to a panel of esteemed judges for a chance to nurture and continue their revolutionary initiatives.

Product launches are also in store to give visitors a first look at the latest innovations and explore various partnership opportunities. While each organisation brings unique solutions to the forefront, Vision AI is among the most awaited. The web-based platform is expected to revolutionize the detection of retinal diseases, creating an environment for efficient referrals and enabling the timely management of eye conditions triggered by diabetes. Vision AI will also showcase retinal imaging technology to detect Alzheimer’s and heart diseases. Adding to the list of breakthroughs in medical imaging, StriXion™ by JPI Healthcare Solutions will present its multi-modal system that covers various needs in X-ray, fluoroscopy, and tomosynthesis.

The three-day show is packed with much to discover and explore. With an area of 150,000 square feet and 1,300 exhibitors from 55 countries, visitors can indulge in a variety of categories inclusive of orthopedic devices, laboratory, pharma and nutrition, physiotherapy and rehabilitation, imaging, healthcare and general services, medical equipment, infrastructure, as well as IT systems, solutions and digital health.

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 2023, Chilean services exports registered US$2 billion, 55.5 per cent more than in 2022, according to the Department of Market Intelligence of ProChile, with figures from the National Customs Service. These figures are record-breaking in the sector of non-traditional Chilean exports. Additionally, exports in the medical category alone reached US$248 million globally.

This year, ProChile, the Chilean Government Export Promotion Bureau, an agency within the Ministry of Foreign Affairs that promotes Chile’s exports of goods and services worldwide, will visit FIME in Miami, Florida, with eight companies prospecting business opportunities.

Jaime Silva, Trade Manager for the sector at ProChile's Miami office, will be a speaker at the trade show to shed light on the advancements the country has made in the global medical device and equipment market, as well as discuss the institutions that support procurement in Chile.

The innovative Chilean companies below will showcase advanced cutting-edge devices, sophisticated medical solutions, and the latest technology in the healthcare sector.

• Plan 3D: Supports teachers and students in the health sector with scientifically and commercially validated clinical simulators that reduce medical errors due to their level of realism and novelty.
• Candel Medical Company: Provides neuro-rehabilitation from home through transcranial direct current stimulation for stroke and brain trauma treatments complemented with digital therapy through the mobile application.
• Biomedical Devices: Healthtech startup that supports patients with neurological damage to walk again with more than 50 medical centers, a resourceful customer network in the USA preparing for commercial launch at the end of this year.
• MedETechni: A leading medical technology company specializing in the development of innovative wound care devices, with a focus on the treatment of the diabetic foot.
• Eniax: Pioneering health company that created the first virtual assistant, Patricia who accompanies health users in a personalized, decisive and omnichannel way, providing a better care experience.
• Pegasi de Chile: Accelerates the diagnosis and treatment of cancer patients through the intelligent use of data.
• Salud Moderna de Chile: Pioneering company in digital health for Spanish speakers offering cutting-edge technology integrated into networks of doctors that provide remote medical care of the highest quality.
• Switch Comunicaciones: Provider of technological solutions that maximize the use of surgical wards with patient tracking systems that indicate the status of patient journey without human intervention by utilizing BLE (Bluetooth Low Energy) technology.

Chilean exports of Research and Development (R&D) services have experienced notable growth, accumulating US$135.7 million in 2023. These exports have diversified into multiple subsectors, excelling in areas of advanced research.

Notably, R&D services in medical and pharmaceutical sciences stand out due to their economic value and potential impact on global health and well-being. The emphasis on pharmaceutical research and development is particularly relevant today, as innovation in medicine and the search for new treatments are more critical than ever.

Chile, through its R&D exports, is contributing significantly to this field, establishing itself as a key player in the development of advanced medical and therapeutic solutions with international implications.

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

Brazil represents the largest medical device (MD) market in South America and thus, it is a much sought-after destination for several manufacturers around the world, with commercial interest in launching their products.

According to the Brazilian Alliance of Innovative Health Industry (ABIIS), edition 45 of the Economic Bulletin, in the accumulated period from January to December 2023, the US was the main country of origin of Brazilian imports of MDs, of which Brazil purchased $879 million — or 17.2 per cent of the 5,101 billion in MD imports. Countries like Germany (15.8 per cent) and China (11.4 per cent) were also important product suppliers for Brazil.

The Bulletin also states that the US was the main supplier of MDs for Brazil in 11 market segments. In another five segments, China is the main supplier. In the IVD reagents segment, Germany appears as a relevant player.

The Brazilian National Health Surveillance Agency (ANVISA) regulates all health-related products. It is mandatory to have a local legal representative for product liability, and the local legislation classifies the MDs depending on the nature of the application or operation and the intrinsic risk they pose to the health of the patient, operator or third parties involved. The definition of the need for safety and efficacy documents is entirely related to the classification of the product, depending on its nature and risk class.

MDs are classified into four risk classes (RDC 751/2022 DMs; RDC 830/2023 IVDs) that differ in classification rules considering whether the product is active in terms of action or energy conversion; whether it is invasive or non-invasive in terms of applicability; and in relation to the length of stay with the patient, whether it is transient, short or long-term. For higher-risk MD (classes III/IV), the presentation of clinical studies to prove efficacy and safety is mandatory.

On the other hand, products that fall into risk classes I/II undergo a simplified notification process, and the presentation of clinical studies, in this case, is only required when the product is considered innovative in design, raw material or indication for use. In the current days, there are still challenges for foreign manufacturers to enter the Brazilian market, and this includes local-specific certifications such as INMETRO (National Institute of Metrology, Quality and Technology); integration of Brazil’s local requirements into the R&D stages and Clinical Evaluation for innovative and risk class III/IV products.

Another challenge is to face the long line for license approval. For implantable and orthopedics products, for example, the timeline for approval can take around 12 months. For other products (equipment and IVD) the scenario is more favorable, with shorter timelines (around three to six months).

Globalization and the fast advancement of new technologies have presented a major challenge to all regulators around the world. According to ANVISA, the volume of submissions along with the complexity of documentation (complex and diverse studies) for analysis, as well as an increase in external demands, and the shortage of human resources has been a constant challenge faced by the General Management of Technology and Health Products (GGTPS), prolonging the estimated time to complete the submissions’ analyses.

In the last two decades, Brazil gained international visibility in the health control of MD, developing governance practices and promoting arrangements in the regulatory model to align with the global convergence scenario. To support this mindset, ANVISA’s Strategic Plan developed for the period from 2024 to 2027 has priorities related to the Agency's essential responsibilities and to face the challenges and needs of a future that is already present in Brazil's health regulation.

As defined within the Strategic Objectives, obtaining recognition as an international reference health authority is one of the agencies’ priorities. The Strategic Plan also mentions that, in an era of global healthcare public partnerships, regulatory agencies have sought the alignment with global dynamics of interdependence and regulatory trust practices (reliance) for products and health services, facilitating the approval of medicines, vaccines and MDs.

Several actions are already implemented and in force, facilitating the approval processes for the registration of MDs imported into Brazil. Regarding Good Manufacturing Practices Certification, ANVISA has already implemented two initiatives:

1. Brazil is part of the Medical Device Single Audit Program (MDSAP) that allows manufacturers of MDs to hire an Auditing Body, authorized within the scope of MDSAP, and carry out a single audit that will cover the relevant requirements of Participating Regulatory Authorities. It replaces the necessity of an audit performed by ANVISA in manufacturing units of MDs.

2. The validity of the Certificate of Good Manufacturing Practices issued by ANVISA for MD manufacturers granted through MDSAP was extended from two to four years, through the publication of the RDC 850/2024.

With regards to the MDs submissions, ANVISA published the IN 290/2024, which establishes the process to leverage authorization from an Equivalent Foreign Regulatory Authority (AREE). It applies only to Class III/IV MDs and IVDs, which are subject to a more complex regulatory process in Brazil. The AREEs include the following — Australia Therapeutic Goods Administration (TGA), Health Canada, FDA and Japan Ministry of Health, Labor and Welfare (MHLW) — bringing many expectations of positive impacts as it establishes the optimized procedure for the review and decision of submissions for registration of MDs.

With this approach, ANVISA expects to have a simplification of submission analysis and better use of the workforce. These improvements are already adding value to the MDs area and the expectation is to have a 30 per cent decrease in the timeline for the risk class III/IV license approvals.

In conclusion, it is quite clear that ANVISA is aware of the existing challenges. On the other hand, their improvements show that the Agency will not spare efforts to be an innovative and reliable health authority to the whole world. Stepping into Brazil’s market has its complexities, it can be challenging, however, Brazil is the largest MD market in Latin America, therefore, persistence will prove itself to be worth all the effort.

Laura Baroni is the Regulatory Affairs Analyst at Vera Rosas Group in Brazil. She will be speaking at the “Main Regulatory Issues for LATAM — How to Surf LATAM's Regulatory Issues” session on June 20 at 11am.

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

While medical device startups may have innovative ideas and technologies, they face significant hurdles in obtaining regulatory approval compared to well-established corporations.  Some of these challenges are due to the complex and stringent nature of the regulatory environment, resource constraints, and regulatory inexperience. Throughout my 30-year career in the device space, I’ve worked with hundreds of startups and have compiled a few costly mistakes companies should avoid making.

Not involving a regulatory affairs professional in the early development stages

Developing a medical device without regulatory affairs input often leads to delayed launch and increased costs. The complexity of the US FDA and EU regulations and standards can be confusing for startup companies. Regulatory affairs professionals can guide you on the eventual classification of your device, which defines the level of documentation required to obtain approval.

Identifying and mitigating risks early in the development process is also essential for ensuring the safety and efficacy of the medical device. Regulatory affairs professionals can help assess regulatory risks associated with the device’s design, intended use, manufacturing processes, and clinical data requirements. We advise clients to check in with regulatory professionals early and often when designing a new medical device.

Underestimating the cost of bringing a medical device to market

The costs associated with bringing a medical device to market are substantial. Depending on the device’s risk classification, companies can expect to spend hundreds of thousands, if not millions, of dollars as they take their device from concept to clearance. Understanding the costs associated with regulatory compliance, product development, manufacturing, clinical trials, and marketing allows manufacturers to create realistic budgets and secure adequate funding.

Companies risk underestimating their financial needs without a clear understanding of these expenses, leading to funding shortages and delays in product development or market entry. Cost estimation provides insight into potential financial risks associated with the development and commercialization process.

Manufacturers can identify areas where costs may exceed projections and develop contingency plans to mitigate financial risks. Additionally, understanding the cost implications of regulatory requirements helps companies assess the feasibility of bringing their device to market within budgetary constraints.

Overly broad or unsubstantiated claims

The US FDA and EU regulatory bodies require medical devices to undergo rigorous testing and evaluation to ensure their safety and effectiveness. The Indication for Use for the device must be focused and accurate. Making your Indication for Use overly broad risks rejection from your approval authority. We often advise clients to apply for a narrow indication on their first submission and then expand that indication on subsequent submissions.

Making exaggerated or unsupported claims about a medical device's capabilities raises concerns. Marketing material must balance a fine line between “fluff” and unsubstantiated claims. Off-label usage does occur, but device manufacturers are prohibited from marketing a device for any use other than the approved Indication for Use. Engaging in misleading marketing practices undermines the ethical responsibility healthcare providers uphold and can harm patients by promoting ineffective or unsafe treatments.

Making multiple unsubstantiated claims about a medical device can have severe consequences for startup companies, including regulatory sanctions, legal liabilities, damage to reputation, market rejection, loss of investor confidence, and ethical concerns. Startups must prioritize transparency, integrity, and evidence-based communication when promoting their products in the healthcare industry.

Weak document control and quality management system

The US FDA and the EU regulatory body require medical device manufacturers to establish and maintain robust quality management systems (QMS) to ensure the safety and effectiveness of their products. A weak QMS can lead to non-compliance with regulatory requirements, potentially resulting in delays in product approval or market withdrawal. Document control and QMS are essential for maintaining the integrity of critical documents, such as design specifications, manufacturing procedures, and quality records. Without effective document control, companies risk using outdated or incorrect documents, which can compromise the safety and efficacy of the medical device. 

A weak QMS may also lead to inconsistencies in product quality and performance. Document control and QMS are crucial in identifying, assessing, and mitigating risks associated with developing, manufacturing, and distributing medical devices. Inadequate document control makes it difficult to track changes and updates, increasing the likelihood of errors or deviations that could pose risks to patient safety. A weak QMS may also result in inadequate risk management practices, leaving the startup vulnerable to potential hazards and liabilities.

Traceability is essential in the medical device industry to ensure accountability and facilitate recalls or corrective actions when necessary. A robust document control system enables the startup to track the history and status of documents throughout their lifecycle, including revisions, approvals, and distribution.

Without proper document control, tracing the origin and handling of critical documents becomes challenging, impeding the ability to effectively address quality issues or regulatory inquiries.

Tracy Eberly is the Founder and CEO of Fang Consulting. His session, ‘We Put the No in Innovation’ will take place at FIME 2024 on June 19.

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 the realm of healthcare economics, the United States stands as a pivotal case study, juxtaposed between soaring expenditures and fluctuating outcomes. As we delve into the labyrinth of statistics, policies, and partnerships, a nuanced understanding of the American healthcare landscape emerges.

The US allocates a staggering chunk of its GDP to healthcare spending, far outstripping its global counterparts. Roughly 17.7 per cent of the nation’s GDP is funneled into healthcare, as per the latest data. This figure, while emblematic of the country’s commitment to healthcare, places it at the zenith of global healthcare expenditures. Comparatively, countries like Switzerland and Germany trail behind, dedicating around 12 per cent and 11 per cent of their GDP, respectively, to healthcare.

Yet, juxtaposed against this colossal spending, the question arises: Are Americans reaping commensurate benefits in terms of health outcomes? Regrettably, the answer is a resounding NO. Despite its lavish investment, the US lags behind its peers in several key health metrics. Life expectancy, infant mortality rates, and preventable mortality rates all paint a sobering picture of subpar health outcomes.

A deeper dive into the American healthcare infrastructure reveals a labyrinth of hospitals and healthcare systems. The US boasts over 6,200 hospitals, ranging from small community clinics to sprawling medical centers. These institutions wield significant purchasing power, collectively spending billions annually on supplies directly tied to patient care. Major manufacturers and suppliers such as Johnson & Johnson, Medtronic, Medline, Cardinal Health, and GE Healthcare dominate this intricate supply chain, supplying everything from MRI machines to sutures to disposable syringes.

However, amidst this bustling marketplace, a paradigm shift is underway. Innovations geared towards monitoring hospital spending and clinical outcomes are gaining traction. Advanced analytics platforms and AI-powered solutions offer tantalizing prospects for optimizing resource allocation and enhancing patient care. By scrutinizing expenditure patterns and clinical data, healthcare providers can pinpoint inefficiencies and drive tangible improvements in patient outcomes.

But how does the US government ensure accountability and quality amidst this complex web of transactions? Enter core measures — a set of standardized metrics designed to evaluate clinical performance across various domains. These measures, endorsed by organizations like the Centers for Medicare & Medicaid Services (CMS), serve as yardsticks for assessing the quality of care delivered by hospitals. From mortality rates to readmission rates, these metrics offer invaluable insights into the efficacy of healthcare delivery.

Yet, for suppliers and manufacturers navigating the intricate landscape of US hospitals, challenges abound. Stringent regulations, fierce competition, trade wars, and reimbursement uncertainties pose formidable barriers to entry. The selling process itself is often protracted and multifaceted, involving intricate negotiations and rigorous product evaluations. Success hinges not only on the quality and efficacy of the product but also on forging robust partnerships with healthcare providers.

Amidst these challenges, however, glimmers of hope emerge in the form of exemplary partnerships between hospitals and vendors. Collaborative ventures aimed at streamlining procurement processes, optimizing resource utilization, and driving innovation have yielded tangible dividends. From implementing just-in-time inventory systems to co-developing cutting-edge medical technologies, these symbiotic relationships underscore the transformative potential of strategic collaboration.

The evaluation and adoption of medical supplies and services for hospitals involve a diverse array of stakeholders, each playing a crucial role in the decision-making process. Here are the key stakeholders typically involved:

Hospital Administrators and Executives: Hospital administrators and executives hold ultimate responsibility for the procurement decisions within the hospital. They oversee the strategic direction of the institution, including budget allocation and resource management. Their input and approval are essential for the adoption of new medical supplies and services.

Clinical Staff and Physicians: Clinical staff, including physicians, nurses, and other healthcare professionals, play a vital role in evaluating the efficacy and usability of medical supplies and services. Their firsthand experience with patient care informs their feedback on the suitability of different products and their impact on clinical outcomes.

Supply Chain, Materials Management, and Procurement Teams: Supply chain, materials management and procurement teams are responsible for sourcing, purchasing, and managing inventory of medical supplies and services within the hospital. They collaborate closely with clinical staff to assess needs, evaluate vendors, negotiate contracts, and ensure timely delivery of supplies.

Quality Improvement and Patient Safety Teams: Quality improvement and patient safety teams focus on ensuring that medical supplies and services meet established quality standards and contribute to positive patient outcomes. They may conduct evaluations, audits, and assessments to monitor the performance and safety of products and services.

Finance and Budgeting Departments: Finance and budgeting departments play a critical role in evaluating the cost-effectiveness of medical supplies and services. They analyze budgetary constraints, conduct financial assessments, and provide input on the affordability and long-term sustainability of procurement decisions.

Regulatory and Compliance Officers: Regulatory and compliance officers ensure that medical supplies and services comply with applicable laws, regulations, and industry standards. They assess the regulatory landscape, review vendor qualifications, and verify product certifications to mitigate legal and compliance risks.

Vendor Representatives and Suppliers: Vendor representatives and suppliers offer products and services to hospitals and actively engage with stakeholders throughout the evaluation and adoption process. They provide product demonstrations, offer technical support, address concerns, and negotiate contracts to secure sales.

Patient Advocates and Advisory Groups: Patient advocates and advisory groups represent the interests of patients and advocate for products and services that prioritize patient safety, comfort, and satisfaction. They may participate in product evaluations, offer feedback from a patient perspective, and advocate for patient-centered care.

Technology and Innovation Teams: Technology and innovation teams explore emerging trends, research new technologies, and assess innovative solutions that have the potential to improve patient care and operational efficiency within the hospital. They may pilot test new products and services and facilitate knowledge transfer to clinical staff.

External Consultants and Subject Matter Experts: Hospitals may engage external consultants and subject matter experts to provide specialized expertise, conduct assessments, and offer recommendations on the selection and adoption of medical supplies and services. These consultants bring industry insights, best practices, and impartial perspectives to the decision-making process.

By involving these diverse stakeholders and fostering collaboration, hospitals can make informed decisions about the evaluation and adoption of medical supplies and services that best meet the needs of patients, clinicians, and the organization as a whole.

In conclusion, the American healthcare landscape is a tapestry of paradoxes — a juxtaposition of lavish spending and lackluster outcomes, of innovation and inertia, of challenges and opportunities. As we navigate this complex terrain, one thing remains abundantly clear: the imperative of forging synergistic partnerships, driving innovation, and fostering a culture of cost-conscious clinical accountability to usher in a new era of healthcare excellence.

If you would like to learn more, please join me and an expert panel on June 19 at 2pm as we discuss how to navigate the US health system sales cycle.

Kenneth C. Wong, FACHE, CEO, Consultant, Adjunct Professor, Past President and board member of the American College of Healthcare Executives of South Florida.

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

When designed for humans, AI and technology have the power to change lives. Digireha Inc., a digital health company headquartered in Tokyo, Japan, is proving this by challenging innovation in rehabilitation through the use of gamification-based applications, sensors, and databases.

It all started when Yuki Oka, Founder and CEO of Digireha, came across a young girl Mako, who was diagnosed with Fukuyama-type congenital muscular dystrophy and suffering from unmotivating rehabilitation. Upon hearing her story, Oka developed the Digireha app to make rehabilitation more enjoyable. 

In the early days, the tool focused on improving rehabilitation for children with special needs. Since then, it expanded its reach to serve the 2.4 billion patients around the world who need rehabilitation. The system has already been introduced in 80 hospitals and facilities in Japan alone. Furthermore, academic research is being conducted in cooperation with hospitals followed by the publication of academic papers.

From a startup company's perspective, partnerships between hospitals and medical device companies and startups can foster innovation and promote transformative progress in healthcare. There are three reasons for this:

First, through partnerships, we can bring innovation to the healthcare industry more quickly than ever before. Today's technology landscape continues to evolve at a dizzying pace, and digital transformation professionals will work together to open new possibilities.

The Digireha system, for example, quantifies a variety of pre- and post-rehabilitation information on a patient's rehabilitation and compares the patient's progress. These figures can be viewed on a dashboard in an easy-to-understand manner not only by medical professionals but also by patients' families and caregivers. This fosters an environment of better care for patients not only in the hospital but also in the community.

As part of its future vision, the application — based on patient big data — will have a real-time response function based on patient motivation and skills. Thereby we expect patient success stories and high self-esteem. We will motivate people who find it reluctant to come to the hospital and aim to create a positive environment to do their best through the power of digital technology.

Secondly, a new market can be expanded based on credibility, the network of the hospital and the startup's idea and ability to execute. Through the value of Digireha's services and its educational benefits, it can not only become indispensable to the market and its stakeholders but also create solid social value to facilitate the resolution of new issues.

The elderly, the sick, and children with special needs often feel socially isolated, which is why we must foster a sense of social solidarity and provide new social systems through digital technology. If people can manage their own digital health data and share it with those who need it, they can establish sustainable and extended support throughout their lives.

This is especially beneficial for parents of those with special needs, who are often concerned about who will take care of their children in the future when they are long gone. Such anxieties could be alleviated by the accumulation of data over the years, which could also increase the number of people who have a deep understanding of their children. Such an event can be considered not only for disabled children but also for elderly caregivers, and data can serve as a voice for them to deepen communication.

Finally, the most important objective is to increase people's well-being through the power of digital transformation. Digireha will expand overseas, starting with Delhi, India this year, and the United States in 2025. Based on the knowledge accumulated at hospitals and daycare facilities in Japan, Digireha's products will be delivered to the world.

Digireha currently conducts academic research through joint trial programs with research institutions and hospitals in the US, which makes it a reputable organisation to partner with and fosters a level of safety and security when localizing this product for people in the country.

We understand the challenges of the global healthtech market in the US and India, and growing from there, we aim to build on health to improve the well-being of many people and create a world where no one is left behind, especially the elderly, the sick, and children with special needs.

Technology can make our lives unhappy or happier, depending on how it is used. We at Digireha aim to be a health platform that supports all people around the world, fostering health and self-determination for all, including those with special needs, through technology. We believe that by partnering with hospitals and healthcare organizations, we can share our vision and create a better world.

Moeko Takagi is the Global Partnerships Division Manager at Digireha, Japan. She will be speaking as part of the panel, ‘Driving Hospital Innovation: Collaborating with Startups & Med-Tech Companies’ at FIME 2024 on June 19.

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 Technology

Biopharmaceutical leaders Pfizer mapped out an exciting journey in AI and gene therapy in the Middle East, Russia and Africa (MERA), as its regional headquarters in Dubai marked their 175th anniversary on Tuesday.

Patrick van der Loo, Regional President, and Yasser El Dershaby, MD., who is the Vice-President — Medical Affairs Lead in the Middle East, Africa, Russia, Belarus and CauCAR, said that the next decade is expected to see scientific breakthroughs as Pfizer places a stronger focus on natural language processing, big data and integrated technology to gather medical insights, analyse healthcare data, and improve patient outcomes.

“We are also using different integrated technologies to reach patients in their own language, regardless of where they are, and customising the healthcare approach and patient-related medical strategies. Just as we have omnichannel retail, we now have similar omnichannel strategies to customise our approach for healthcare professionals as well as for patients. I think Pfizer is one of the few organisations that is maximising the use of artificial intelligence in everything we do, even in our internal operations,” El Dershaby said.

van Der Loo highlighted Pfizer’s atrial fibrillation programme as a recent example of its AI prowess.

“Here, a programme was developed to manage the atrial fibrillation of a patient and through the use of AI, we could automatically adapt the video to every language in the world, while keeping in mind the specific restrictions that a label may have in one country versus another. This way we can have patient information and applications delivered faster than before,” he explained.

To date, Pfizer is active in 75 countries within the MERA region, and patient-centricity and accessibility remain its key focus areas. Loo revealed that in 2023, its medicines reached over 45 million patients in MERA and these numbers exclude the COVID-19 vaccine and related treatments. Additionally, 30 of its access programmes — dedicated to oncology, inflammatory and rare diseases, among others — reached over 15,000 patients in 11 countries in the region, arming them with the knowledge to understand their condition and make informed decisions for treatment.

In the same year, Pfizer also launched a mobile app, IUdo, in Egypt, Qatar and Lebanon to enhance the patient experience for those accessing their medicines through their affordability programmes.

El Dershaby also highlighted recent investments and new partnerships with four different biotech companies to develop mRNA vaccines to combat various cancers. Among these is Pfizer’s recent acquisition of Seagen, which will further expand its research and development around oncology solutions.

Other promising news involves the results of a recent CROWN study that evaluated a lung cancer treatment in people with previously untreated, anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). Lorlatinib showed that it could comfortably extend the lives of patients by an additional five years.

Pfizer is also prioritising rare diseases that are prominent in the Middle East region, including Sickle Cell Disease (SCD) and thalassemia. The biopharmaceutical company signed an MOU with the Department of Health — Abu Dhabi (DoH) earlier this year to advance research in SCD, which involves observing real-world data with the aid of AI.

From oncology and internal medicine to vaccines and immunology, Pfizer continues to actively work with governments, regulatory authorities and local communities to advance research and ensure their discoveries and portfolio reach those in need.

Milestones

Pfizer’s achievements are aplenty but below are a few notable milestones that revolutionised healthcare and its delivery:

1849: Founded by German cousins — Charles Pfizer and Charles Erhart
1944: Became the world’s largest producer of penicillin
1950~: Established their first International Division in the US in 1950, followed by an entry into other markets — South Africa in 1951, Kenya and Nigeria in 1957, Morocco, Algeria and Tunisia in 1960s, and so on. Its first Middle East headquarters was set up in Dubai, UAE in 1997.
1967: Released their first broad-spectrum antibiotic
2003: Started delivering skills-based services to health organisations through the Global Health Fellows Program
2004: The Infectious Disease Institute was established in Uganda to train professionals and offer related treatments
2010: Pfizer-DSV distribution hub launched in Dubai to cater to the UAE, Kuwait and Bahrain. Also launched the vaccine to prevent invasive pneumococcal disease in children aged six to 17 years.
2016: Pfizer’s Ibrance receives approval to treat metastatic breast cancer
2020: Manufactured with BioNTech, Pfizer created and distributed the vaccine against COVID-19 at lightning speed to control the epidemic
2023: Pfizer acquires Seagon to accelerate the next generation of cancer treatments

Back to Technology

The United States medical market stands as a significant opportunity for international companies, given its immense size and profitability. With healthcare expenditures reaching $3.8 trillion in 2019, representing nearly half of global healthcare spending, the US market is indeed alluring. However, despite this substantial investment, the US healthcare system faces challenges in delivering quality care, with health outcomes often lagging behind those of other industrialized nations. This dynamic underscores both the promise and the complexity of entering the US market. This disparity drives the average margin for healthcare sales to over twice that of Germany – to over 70 per cent.

Entering the US medical market poses significant challenges, particularly in establishing the right sales organization. Estimates suggest that small foreign manufacturers should anticipate expenditures ranging from $2 million to $5 million over the first 36 months, highlighting the financial risks involved. Moreover, data indicates that over 80 per cent of international companies attempting to enter the US market fail to achieve profitability, emphasizing the importance of a well-thought-out strategy.

Often people consider the US regulatory landscape as the primary obstacle. While challenging, the regulatory process is predictable and not wildly different from other processes. There are thousands of very competent consultants who can achieve regulatory approval for you in a predictable timeframe and cost.

The primary hurdle, and one that is almost universally unexpected for international companies, lies in understanding the nuances of the US sales landscape. Unlike in many international markets where distributors actively sell and create demand, US distributors typically focus on order fulfillment, expecting others to generate demand. This fundamental difference can leave foreign companies perplexed, as they grapple with the need to build demand while navigating the intricacies of the market.

However, amidst these challenges lies a potential solution: the two-tiered approach to sales organization. By leveraging independent representatives for demand creation and distributors for logistics, companies can navigate the complexities of the US market more effectively.

Independent sales representatives, often referred to as reps, play a crucial role in the success of companies entering the US market. These professionals operate as contractors rather than employees, leveraging their extensive networks and industry expertise to promote and sell products on behalf of manufacturers. With established relationships across various market segments, independent reps possess invaluable insights into customer needs and preferences, enabling them to effectively communicate the value proposition of products to potential buyers. Their autonomy allows them to focus on specific territories or market segments, tailoring their sales approach to suit local preferences and market dynamics. By partnering with independent reps, companies gain access to a cost-effective and scalable sales force without the overhead costs associated with hiring and managing a direct sales team. Additionally, independent reps often bring years of experience and industry knowledge to the table, further enhancing their effectiveness in driving sales and market penetration.

In conclusion, while the US medical market presents its share of obstacles, it also offers significant potential for growth and profitability. The key to success lies in building a sales organization that can sell to the various government entities, the GPOs (that represent over 15 per cent of total buying power) as well as all the other potential customers that you face in this giant and profitable market. With careful planning and the right partners, international companies can seize the opportunities available in this dynamic market.

Zach Selch is an international sales growth leader, the Principal at Global Sales Mentor, and a trusted partner in navigating the complexities of the US medical market and achieving success in this lucrative arena. He will speak at FIME 2024 on June 20 about building a US sales organization for rapid profitable commercialization.

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

Healthcare systems worldwide have increasingly turned to digital solutions to bolster clinical quality and cost-efficiency. The rapid adoption of technologies like electronic health records (EHRs), telemedicine, and Internet of Things (IoT) devices has streamlined operations, yet it has also expanded the attack surface for cybercriminals. With sensitive patient information at stake and security measures often inadequate, healthcare infrastructure has become a prime target for cyber threats.