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Clinical Research: Phase 1 - Phase 4

Best Practices for Interventional Cardiovascular Medical Device Trials in Asia

The emerging markets of the APAC region offer tremendous potential for clinical research. Best practices for cardiovascular medical device development in Asian countries can offer insights on navigating the regulatory and clinical landscape of this region. Widely recognized as one of the most important growth frontiers for medical devices, the Asia Pacific (APAC) region comprises...

Contract Pharma – Realizing the Full Potential of Precision Medicine in Oncology

Innovation in oncology drug development is being driven by “precision medicine.” Precision medicine promises a new paradigm in oncology where every patient receives truly personalized treatment. This approach to disease diagnosis, treatment and prevention utilizes a holistic view of the patient—from their genes and their environment to their lifestyle—to make more accurate decisions. Growing at...

Reimbursement Rules & Considerations for Medical Device Development in Asia

For medical device developers seeking to enter the diverse, complex Asia-Pacific (APAC) market, having a well-planned reimbursement strategy is critical for commercial success. Thoughtful consideration of coverage, coding, and payment should be factored into the product development cycle at its earliest stages, and understanding the reimbursement landscape in all the countries in which you intend...

Unlocking the Full Potential of Precision Medicine in Oncology

Precision oncology promises a new standard of care where therapies are tailored to the molecular profile of a specific tumor. For the full potential of precision medicine to be realized, regulatory, technical, clinical, and economic frameworks will need to evolve to the nuances of these novel treatments. In recent years, innovation in oncology drug development...

IEEE Spectrum: Cyber attacks on Medical Devices Are on the Rise—and Manufacturers Must Respond

Cyberattacks are increasingly common in the health care industry. As the number of networked medical devices increases, so does the urgency for makers of these devices to understand and mitigate threats to device security. In an increasingly interconnected and digital world, more and more medical devices contain embedded computer systems, which can be vulnerable to...

4 APAC Countries With Shifting Medical Device Regulations: What You Need to Know

The upcoming compliance deadlines for the European Union Medical Device Regulation (EU MDR) have dominated conversations about the increasingly complex regulatory landscape device manufacturers are facing. But it’s important for device manufacturers to remember that regulations are shifting elsewhere in the world as well, including in the Asia-Pacific (APAC) region. In this post, we explore...

The Challenges in Fulfilling the Promise of Personalized Oncology

Personalized oncology promises a new model of cancer care where medical decisions are based on a holistic view of the patient, including their genes, environment, and lifestyle, and tailored to the molecular profile of their tumor. To date, great strides toward the paradigm of personalized oncology have been made in the area of cancer immunotherapy,...

Understanding Recent Regulatory Changes for Pediatric Oncology Trials

Of the 1.7 million new cases of cancer in the U.S. in 2018, 10,590 involved children aged 14 or younger.[1] While children typically have a better cure rate for cancer, biopharma companies have traditionally shied away from pediatric oncology trials, resulting in fewer treatment options. However, the regulatory landscape is evolving, and the demand for...

Applied Clinical Trials – 3 Critical Challenges: Fulfilling the Promise of Precision Oncology

Precision oncology promises a new model of cancer care where medical decisions are based on a holistic view of the patient, including their genes, environment, and lifestyle, and tailored to the molecular profile of their tumor. To date, great strides toward the paradigm of precision oncology have been made in the area of cancer immunotherapy,...

Strategic Planning for Compliance with the EU Medical Device Regulation

The changes are significant. Here’s what you must know. The EU Medical Device Regulation sets the stage for an arena where transparency, quality, and patient safety are paramount. Manufacturers must prepare and build compliance into their product development strategy to ensure a successful transition to this new regulatory environment. Medical devices play an increasingly critical...