Unsurprisingly, the industry is heavily regulated, and the list of considerations that medical device manufacturers face is lengthy and expensive to overcome.
However, for those that get over the hurdles, there is a huge financial reward for developing a product that can improve lives. Here are five of the top modern-day considerations.
1. Regulatory Compliance
Compliance will be with bodies like the US Food and Drug Administration (FDA) or national Governments throughout Europe, where the European Medical Association also takes a regulatory interest. In Europe, companies can place a CE (Conformite Europeene) mark on devices once they have passed assessments. The FDA has stated it will start rejecting medical devices over cyber soon1.
To reach that point, manufacturers must submit documentation to demonstrate product safety and efficacy via preclinical and clinical trials. The process will likely include device classification, risk analysis, technical file sharing, and any other required information to explain the design and manufacturing process.
Without compliance, manufacturers – and any healthcare facility using their devices – will open themselves up to potential legal and financial risks.
2. Design and Development
The process will involve more parties than many other industrial sectors must include. There will be a collaboration with internal departments, including design, developers, and engineers. Plus, external clinicians, doctors, and even patient groups.
This collaboration helps the medical device manufacturer identify real needs, establish design specs, and develop prototypes. Next, they must go through iterative design cycles, plus comprehensive testing for things like usability, biocompatibility, failure mode and effects analyses.
Only then can the teams refine medical devices to optimize functionality and user experience and minimize potential risks to patients and healthcare professionals.
You may not be aware that healthcare facilities are a primary target for cybersecurity attacks. With medical devices now interconnected, they have become a valuable target for hackers who can use devices to access central healthcare facility networks. Smart pumps on IV drops have been exposed as at-risk.
This exposes the facility and the manufacturer to considerable financial risk. Each attack is reckoned to cost, on average, $10.1 million2.
The FDA and European agencies both recommend medical device manufacturers build robust cybersecurity checks into the build process.
A platform like IriusRisk provides real-time threat modeling analysis to multiple teams at once and highlights potential cyber loopholes throughout the development and coding process. This allows teams to plug potential cyber risks fast, at the start of a project, rather than when it’s more expensive later.
You can download the IriusRisk eBook, Protecting the IoMT and Your Business, for more info.
4. Quality Management Systems (QMS)
Aside from cyber threat assessments, there are broader Quality Management Systems (QMS) to consider. This should integrate every stage of the medical device manufacturing process, from design to distribution.
QMS will include standard operating procedures, work instructions, and process control to maintain product quality and traceability. There should be internal and external audits, management reviews, and corrective and preventative actions (CAPA) to find and resolve problems.
A robust QMS ensures regulatory compliance and fosters a continuous improvement business culture, enhancing overall product quality and customer satisfaction.
5. Material Selection
Medical device materials are key considerations for evaluating mechanical properties and biocompatibility. Factors like tensile strength, flexibility, and resistance to wear and tear should be assessed alongside potential toxicological effects, tissue reactions, and immunological responses.
Further, teams will consider material compatibility with various manufacturing processes like injection molding or 3D printing to ensure consistent and cost-effective production of high-quality devices.
And Then, There is Post Market Surveillance
No medical device will ever be a fire-and-forget exercise; selling it to the market and moving on. After all the above considerations have gone into development and production, the devices must be monitored in the market.
Manufacturers must monitor and assess performance and safety by collecting and analyzing user data, reporting adverse events, and taking corrective action. This allows for continuous improvement, informs device updates or recalls, and ultimately contributes to enhanced patient safety and care.