Five challenges for medical device manufacturers

Developing and manufacturing medical devices that are fit to use in frontline healthcare is a complex venture. Translating concepts for innovative and life-changing devices into finished products is a process that inevitably faces obstacles along the way. These obstacles are often the result of something that is out of any manufacturer’s control.

Following the pandemic many companies shifted their operating model to focus on agility and resilience in order to combat the new remote-working conditions. To do this, organizations had to lean on technology and quickly adopt contactless safety processes. More recently, the war in Ukraine has impacted supply chains and inflation, causing organizations to take another operational transition. Manufacturers now look at geographical diversification in order to reduce their dependency on the world’s most volatile places. However, in doing so, manufacturers are faced with navigating a patchwork of constantly evolving sanctions, trade flows, ecosystem relationships and regulatory requirements across countries.

Manufacturers need to be aware of the challenges facing their organization so they can become prepared, agile and in turn successful. To delve deeper into these issues, we have outlined five challenges facing medical device manufacturers and the industry more widely.

Quality concerns

Medical device manufacturers work in 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 often 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 like this do go wrong, entire operations can be temporarily shut down until quality issues are identified and resolved. As you might expect, this leads to costly delays. What’s more, products that require a recall run the risk of end-user grievances, and potentially even injury or death. Poor quality and product recalls are a risk to a company’s reputation and costs the medical device industry billions each year. These consequences are risks that an organization may struggle to recover from.

Supply chain issues and inflation

The manufacturing industry has been negatively impacted by supply chain issues and inflation following the pandemic. Manufacturing executives who took part in the 2022 Deloitte survey reported that the ongoing supply chain challenges cut profits by as much as 13%. Likewise with inflation, the medical device sector is being hit with inflated and extra costs, causing revenue loss and revaluations of suppliers. Regulatory demands can however make it tricky to change suppliers. Having suppliers in different countries, as many medical device companies do, can leave you exposed to local supply chain disruption risks.

These challenges and issues have followed us into 2023 and continue to be concerns for the future. It is therefore vital that medical device companies have plans in place for disrupted supply chains. If not, companies could land in difficulty and fall behind the competition.

Regulatory challenges

It is essential for stakeholders in projects, especially engineers and project leads, to have a high-level understanding of the regulatory requirements of the device. This is because issues around regulations are often encountered along the manufacturing process.

Organizations should become familiar with international standards and applicable governmental regulations. This familiarity provides a level of understanding and helps them prepare for when related issues potentially arise.

Some of the main regulations to be aware of are:

• ISO 13485 – Compliance with ISO 13485 is about implementing a quality management system, which demonstrates your 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. Relevant for the U.S. market, compliance is essential.
   
• MDR – To meet the requirements of the EU Medical Device Regulation, medical device manufacturers need to have a comprehensive risk-based QMS in place.

It is important to evidence your compliance with detailed and effective reporting. As reports can be time-consuming to produce and add to the pressure faced by medical device companies, an efficient digital process for this is recommended.

Cybersecurity and data risks

Over the past decade, the sophistication and number of cyberthreats targeting the healthcare industry has drastically increased. With every improvement delivered by automation and data analytics, the risk of potential cyberattacks rises. Cyberattacks are of particular concern for the medical manufacturing industry, not only because they can jeopardize the security of systems and information, but because they can also threaten the health and safety of patients.

Nearly every piece of medical equipment is now web-enabled or connected to the organization’s operational network. These connected devices, such as ventilators, crash carts, and patient tracking wristbands can communicate valuable patient information across the hospital network more efficiently and effectively. However, the risk of medical device hijacking, or “medjacking”, is on the rise.

While this digital approach improves efficiencies and care, it also makes the organization more vulnerable to cyberattacks. Manufacturers can adopt a holistic approach towards reducing cybersecurity risks associated with devices by carefully considering and building in cybersecurity during the design and development of medical devices. They should also have a robust post market plan to manage emerging cyber vulnerabilities and any device performance issues when they occur.

Outdated processes and collaboration difficulties

Developing medical devices is a lengthy and costly process. Review cycles, for example can take months and is then extended when collaboration is manual and inefficient.

With the move to hybrid and remote working, the need to achieve quality standards and adhere to regulatory requirements remains as pressing as ever, but companies have had the goal posts moved in terms of regulatory and quality requirements.

Although technologies exist to help with collaboration, many medical device companies have delayed digital adoption and are at a disadvantage. Manual, document-based processes can stall innovation and increase development time, which ultimately hinders productivity and makes it more difficult to meet deadlines.

What’s more, failing to embrace digital tools can impede 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 can also make it difficult to hold people accountable and can consequently increase risk.

How can Ideagen support the medical device industry?

Ideagen PleaseReview is a cloud-based document review solution that is tailored specifically to highly regulated industries. The software enables secure, real-time document reviews and is trusted by 4 out of the top 5 Medical Device Companies.

The platform eliminates the need for risky email chains and attachments and supports teams of two to 200+ people. Cancer Research UK are just one of our customers who use our solution to help their medical writing and technology teams collaborate and review technical documents, and ultimately reduce time spent on reviews.

Ideagen PleaseReview also makes your processes traceable, auditable and transparent so that you can meet your regulatory challenges head on. You have full version control and automatically record all changes and comments in a detailed reconciliation report. Lexicon Pharmaceuticals, for instance, benefit from a visible audit trail to demonstrate accountability and ownership.

Find out more about how companies use our software solutions to reduce document review cycles by 65% and save costs of 35% on average, as well as meet regulatory requirements and collaborate successfully.