Biggest challenges in medical device manufacturing.

Biggest challenges in medical device manufacturing.

Real planning is the key to success for any business but to an even greater degree in the medical device manufacturing industry.

1. High costs of product design and development The main driver behind the high cost of new product development is the amount of time essential to take an idea from conception to realization. By deciding a solid foundation for a design project with clear and concise necessities specifications, these costs can be condensed, and organizations will understand faster “to-market” times and improved ROI. This is possible by initial expert involvement in design and development.

2. Regulations and government Regulatory and Quality team are essential contributors when it comes to addressing the norms for patient safety offered by the current medical device regulatory atmosphere.

However, it’s important for all members of the team, particularly engineers and project leads to have at least a high-level understanding of the requirements, as you will likely run into problems impacted by the regulations throughout the design process. Discuss thoroughly with all stake holders, come to consensus decision, if any issue, seek help from external expert and finalise approach.

3. Technology and security As the Internet-of-Things (IoT) becomes more and more combined into society and more devices are carrying consumers’ important personal data, privacy and trust is a growing security challenge for medical device companies. Any leakages of personal data can cost company heavily.

4. Product quality and high recall rates Along with regulatory agency implementation actions and data breaches, product recalls are another way in which a company’s brand and bottom-line can be quickly and incredibly affected. More significantly, poor product quality can lead to serious end-user injuries or even death. While even the most basic medical devices face these challenges, newer, more technologically advanced products are at an even higher risk. Risk assessment tool is available to all stake holders. ISO and all other regulatory standard like MDR, FDA also talks of usage of this tool. In-house strong procedure of risk assessment with training to all stakeholder is must. As you are aware that even products are also categorised in risk category like 1 which is less risky and 3 which is most risky. This also brings applicable controls in that order, so patient gets most safe product.