MEDICAL DEVICE

It goes without saying that medical device manufacturing is a high-stakes industry. End-users rely on safe and effective medical devices, and the cost of poor quality (COPQ) can be severe. Across the industry, quality concerns arise in design, software, and in non-conforming materials and components. Problems can also occur if a medical device is manufactured and later needs to be recalled.

If things go wrong, entire operations can temporarily be shut down until quality issues are identified and resolved. As you might expect, this leads to costly delays. What’s more, product recalls run the risk of end-user grievances, and potentially even injury or death. Not only is this dangerous to the customer, but it also spells trouble for the manufacturer. Poor quality and product recalls cost the medical device industry billions each year, while lawsuits also damage company reputation – a risk many struggle to recover from.

Medical device manufacturing companies must consider many different regulations. The fact that many of these differ around the world can be a challenge. Some of the main regulations are:

ISO 13485 – Compliance with ISO 13485 requires implementation of a quality management system, which demonstrates commitment to producing high quality products.
ISO 14971 – This standard refers to the application of risk management to medical devices.
21 CFR 820 – This regulation ensures medical devices are safe and that appropriate quality processes are used throughout development. Compliance is essential for the US market.
MDR – To meet the requirements of the EU Medical Device Regulation, medical device manufacturers will need to have a comprehensive risk-based QMS in place. It is important that all staff understand the different regulatory requirements that are applicable to your company, so that they can be properly implemented at each stage. It is also important to produce an auditable record of compliance, such as compliance reports. However, these can be time-consuming to manually produce and add to the pressures faced by medical device companies.

Developing medical devices is a lengthy and costly process. Review cycles can take months. Added to this, the shift to remote working at the start of the Covid-19 lockdown made it difficult for medical device companies to collaborate successfully. While most have now settled into their remote work, achieving quality standards and adhering to regulatory requirements remains as pressing as ever. Ensuring that remote teams are working efficiently continues to be a concern. Although technologies exist to help with collaboration, many medical device companies have delayed digital adoption, thus leaving them at a disadvantage.

This hesitancy to update ways of working creates further challenges. Manual, document-based processes make remote working difficult. They can also stall innovation and increase development time, which limits productivity and meeting important deadlines. What’s more, failing to embrace digital tools hinders how well medical device companies manage their compliance obligations. Gathering disparate documents for audits can be complex and time-consuming. Not having regulatory documents in an accessible, centralized location makes it difficult to hold people accountable and can consequently increase risk.

Since 2002, 3 HTi has worked with medical device manufacturers to overcome these challenges. Our solutions help integrate product delivery; manage risk, audit, and compliance; and promote agility in your product lifecycle. Contact us today for any of your technology or professional services needs.