Written by: Andrey Grishin, MD, Globiox Consultant
Ensuring Quality of the Final Product. Every Medical device manufacturer must guaranty high product quality to avoid costly product recalls and legal issues which can also pose risk to the public. Product recall negatively impacts its brand reputation and the company’s bottom line. Ensuring required product safety, security and reliability are extremely crucial to survive the tough competition in the emerging markets. Establishing a Quality Management System before you start to design and develop your device is vital for taking full control of the safety and reliability of your product through its entire lifecycle.
Regulatory Compliance. Medical device manufacturers must ensure adherence to the current product safety standards and regulatory compliance, not just local but sometimes global regulations or guidelines (ICH, MDSAP). Medical equipment manufacturing companies must pay attention to compliance and regulatory standards that differ from country to country, region to region, sometimes even state to state. Pro tip: Some regulatory bodies offer discounted fees for small business. Ensure you have all of your documentation submitted to each regulatory body to take advantage of the price reduction.
Localization of Medical Devices. In emerging markets, local medical device manufacturers are often more successful as compared to their international competitors. This is possible because the local players offer tailor-made products aimed at resolving local market/customer needs and constraints. The local medical equipment manufacturers are often involved in market research and have leverage and the benefits of local operations and domestic sales force connections to bridge the gaps in the global market.
Internet Integration and Data Security. Internet-enabled medical devices and surgical instruments that are high on the list of innovations pose a technical challenge for medical device companies. The growing concern of medical equipment manufacturing companies is to collect, secure, and manage vast amounts of sensitive data that is stored in a cloud-based infrastructure to prevent data theft and data breaches.
Cost of Product Development. Development, design, compliance, and manufacturing costs are going up; it is not a secret that entrepreneurs require extensive funding, and, in some cases, it may take them a while before they will see return on investment. It may take a regulatory agency some time to approve the device and allow its sales.
GLOBIOX’S team will be able to help you navigate through the challenges of regulatory and quality, all while working within your budget.
Our team of experts will provide you with an affordable option to establish a fully-functioning, customized to your specific needs QMS, a pathway for fast and efficient regulatory submission, data security management and everything else your medical device may need.