Choosing the right partner for medical device manufacturing is crucial to ensure high quality products, regulatory compliance and prompt delivery. With the high precision and accuracy required in the healthcare industry, it’s essential to navigate the selection process wisely.
Considerations for Medical Manufacturing Partners
Years of Experience & Industry Expertise
Look for a partner with a proven track record and extensive experience in medical device manufacturing. Assess their expertise in the specific area you require, such as wearables, woundcare, medicated dressings or diagnostics. An experienced partner will be well-versed in industry regulations, quality control systems, and technological advancements, ensuring compliance, optimal product development and validation.
BDK have been converting and combining materials into shapes since the 1970’s. Although we work within a number of industries, we are adhesive specialists in the medical industry and partner with some of the leading healthcare organisations.
Consistently Meeting Regulatory Compliance
Ensure that the potential partner adheres to the necessary regulatory standards, such as Medicines and Healthcare Products Regulatory Agency (MHRA). Verify their certifications, licenses, and quality management systems to guarantee compliance with the required guidelines and minimise the risk of regulatory issues.
BDK operates several class 7 (class 10,000) cleanroom manufacturing facilities which are bio-burden controlled and monitored to guarantee compliance with BS EN ISO 14644. We also hold ISO 13485:2016 for the production of medical devices, ISO 9001 accreditations and are FDA registered.
Wide Range of Manufacturing Capabilities
Evaluate the partner’s manufacturing capabilities and infrastructure. Consider factors like production capacity, facilities, equipment, and scalability. A capable partner should have state-of-the-art facilities, advanced technologies, and a robust supply chain to meet your manufacturing requirements effectively.
From rotary die cutting to perforation and multi-layer lamination, island or component placement to dosing of active ingredients, our capabilities are diverse and encompassing. This is to make sure we can develop a bespoke adhesive solution for every project and meet your specific requirements.
Stringent Quality Control Measures
Quality is of utmost importance in the medical manufacturing industry. Look for a partner with stringent quality control measures in place, including thorough inspections and testing protocols. Ask for their quality control certifications, such as ISO 13485, to ensure consistent production of safe and reliable medical products.
Our robust quality management system has resulted in BDK earning a reputation for outstanding quality. Our team uses CPK studies, Failure Mode Effects Analysis (FMEA), Statistical Process Control (SPC) and process validation to prove consistency of manufacturing processes.
Strong Collaboration & Communication
Effective collaboration and communication are essential for a successful partnership. Assess the partner’s ability to understand your specific needs, provide regular updates, and maintain clear lines of communication throughout the manufacturing process. A responsive and transparent partner will address any concerns promptly, allowing for effective problem-solving and timely decision-making.
BDK take pride in our comprehensive project management. We use our extensive experience to guide and advise on the right materials for your product development and undertake multiple testing processes to make sure it fits your specification. Our team are always on-hand to answer any questions and to keep you updated with your project’s progress.
BDK: The Best Partner for Medical Manufacturing
Selecting the right partner for medical manufacturing requires all of the factors above. A well-chosen partner will contribute to the success of your medical manufacturing endeavours by providing high-quality products, adhering to regulatory standards, and maintaining effective communication throughout the process.
By following these guidelines, you can confidently choose the best partner to meet your medical manufacturing needs and contribute to the advancement of healthcare.
Contact us today to find out more information and to discuss your project with us.