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Healthcare Business Review Weekly Brief
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Bringing a medical device to market is not a straight path from innovation to approval. It’s shaped by shifting global frameworks, compressed timelines and exacting regulatory demands. For most companies, this creates familiar tension; internal teams drive for speed while regulators urge caution. In that push-and-pull, progress is often at risk. That’s where Sobel Consultancy comes in—not just as a regulatory expert, but as a true strategic partner, helping companies stay focused, aligned and on course when the stakes are highest. Clients turn to Sobel for direction that helps them know when to press ahead, when to pause and how to make those decisions in line with the bigger business picture. Turning every regulatory complexity into progress and pressure into purpose has enabled Sobel to earn its place in the niche. “We’re constantly balancing two forces,” says Maik Endler, founder and CEO. “Clients want efficiency, speed and clarity. Regulators require precision, process and accountability. Our job is to reconcile both without compromise.” Sobel weaves compliance into the core of the business. Whether a device needs to hit an aggressive market window, a submission faces shifting EU MDR expectations or a global launch strategy outpaces internal regulatory capacity, it creates the infrastructure needed for sustainable, scalable growth. That can never happen by relying on standardized checklists. Sobel contextualizes. It analyzes each guidance document in technical depth and applies it in ways specific to the product, the market and the stages of development. Sobel works directly with regulators as collaborators, not gatekeepers, and builds strategies that meet regulatory expectations and business objectives. With a combination of deep industry knowledge and an agile, case-by-case mindset, Sobel helps clients move forward with clarity. And where intelligent automation or AI-based tools can reduce errors and improve speed, Sobel integrates them, delivering compliance operations that are both rigorous and efficient. For instance, leveraging proprietary processes and technology has dramatically accelerated complex tasks. Clinical evaluation reports that once took over a month can often be completed in one to two weeks.
Dental Marketing Services 2025
For dental professionals looking to thrive in a competitive industry, effective marketing isn’t just an advantage—it’s essential. Yet, many dental professionals don’t fully understand the power of traditional or digital marketing, causing them to miss valuable opportunities to attract new patients and enhance their practice. On the flip side, some practices have tried marketing before, only to be disappointed by partnerships that overpromised and underdelivered, leading to frustration and hesitation. That’s where Medical Marketing Guru comes in. More than just a marketing agency, they are educators and trusted partners, equipping seasoned dental professionals and dental startups with the knowledge and strategies needed to build a strong digital presence and achieve lasting success. “We combine innovative digital marketing tactics, customized campaigns and personalized client education to empower medical and dental professionals and establish a strong market presence while achieving consistent growth,” says David H., owner of Medical Marketing Guru. The company guarantees that every service is custom-designed to match each practice’s goals and budget. A strong digital foundation is always the starting point, beginning with website development and SEO to enhance online visibility. This foundation is then reinforced with targeted advertising and reputation management, helping new practices build credibility and connect with their local communities. While online marketing is critical, Medical Marketing Guru also recognizes the power of traditional outreach. Direct mail campaigns remain a key tool for reaching potential patients in the surrounding area. With years of experience executing successful mail campaigns, the company provides expert recommendations to target specific geographic areas and maximize impact. For startups looking to build a strong and recognizable brand, Medical Marketing Guru also offers logo design, branding, and rebranding services to help create a cohesive identity that resonates with patients. By integrating branding with digital and traditional marketing efforts, new practices can establish a compelling presence from day one. A PERSONALIZED ONBOARDING PROCESS Medical Marketing Guru believes that an effective marketing strategy starts with understanding the unique vision of each practice. Before onboarding, clients complete a detailed questionnaire that captures their goals, challenges, and expectations. During the initial consultation, the team reviews these responses and aligns proposed marketing strategies with the practice’s objectives. From there, the process moves into production, where the team collaborates with clients to refine website designs, marketing materials, and campaign strategies. Whether through email or video conferencing, ongoing communication ensures that every campaign accurately reflects the client’s brand and values.
CXO INSIGHTS
Contribution of Nursing in Patient Care
Sandra Marcela Cortés Gómez, Chief Nursing Officer, Fundacion Santa Fe de Bogotá – Colombia
Navigating Healthcare Consulting: A Fusion of Innovation, Leadership, and Human-Centric Approaches
Claudio Soto Angelo, Chief Medical Officer, Clínica Los Coihues
Revolutionizing Healthcare through Innovative Precision Solutions
Roberto Caldeira Cury, Vice President of Customer Service and Experience Units, Dasa
The Growing Concern of Cyber security in Healthcare
Dino Scanio, MPH, Doctoral Candidate, Multiservice Hospital Director of Clinics, Driscoll Children’s Hospital
Detective: Finding out who is truly in the interview chair
Dan Mather, MSN, RN, Director of Clinic Operations, Salina Regional Health Center
Collaborative Regulatory Approaches: Strengthening the Relationship Between Manufacturers and Regulators
Anthony Piotrkowski, Director of Regulatory Affairs, STERIS
Navigating The Future Of Pharmacy
Amos Chery, Director, Pharmacy Operations and Regulatory Compliance, MedStar Health
IN FOCUS
EDITORIAL
The Future of Medical Device Regulation
As the medical device industry advances across diagnostics, wearables, implants and digital health, Latin America is emerging as a region of growing strategic importance. This rise is fueled by expanding healthcare infrastructure, increasing demand for advanced medical technologies and ongoing regulatory modernization that enables faster and more efficient market entry. A new generation of regulatory consultants is facilitating this growth and providing critical guidance to navigate diverse approval pathways, local representation requirements and evolving compliance standards across the region. Reflecting this trend, Latin America’s medical device regulatory affairs market is projected to reach approximately $446.2 million by 2030, growing at a CAGR of 9.4 percent from 2025 to 2030. A slew of technological trends is driving the industry forward. Regulatory intelligence platforms automate the monitoring of regional policy updates, helping consultants stay ahead of changes and ensure clients remain compliant in real time. Cloud-based document management systems streamline the submission and tracking of regulatory dossiers, reducing delays and improving stakeholder transparency. AI-driven data analytics enhance risk assessments and market entry strategies by providing predictive insights based on historical approvals and regional trends. This edition of Healthcare Business Review Latin America spotlights the region’s leading medical device regulatory consultants who are setting a new standard for what it means to be regulatory-ready in Latin America. It features insights from Dr. Amos Chery, director of pharmacy operations and regulatory compliance at MedStar Health, who discusses how pharmacy operations must balance innovation with compliance. He emphasizes the role of training, technology and proactive strategies to navigate automation, outsourcing and evolving regulations in healthcare. Roberto Caldeira Cury, executive medical director at Dasa, discusses how the organization is transforming healthcare in Latin America by embracing precision medicine and data-driven diagnostics. The magazine also features Sobel Consultancy, a strategic regulatory partner known for turning complex compliance demands into clear, actionable strategies. Through scalable infrastructure and expert guidance, it helps medical device companies align fast-paced innovation with evolving global regulations. We hope this edition helps your organization build the partnerships it needs to sharpen its competitive edge in the medical regulatory space.
