5 challenges for medical device manufacturers
11 February 2022
Medical device manufacturers face a number of challenges. From problems with quality and product recalls to navigating a stringent regulatory landscape, medical device companies have a lot to consider in order to keep consumers safe and stakeholders satisfied.
If that wasn’t enough, there’s also medical device supply chain challenges to contend with, cyber security threats looming on the horizon, and the age-old challenge of ensuring collaborative processes are productive and efficient.
To delve deeper into these issues, we outline 5 challenges facing medical device manufacturers and the industry more widely.
1. Quality concerns
It goes without saying that medical device manufacturers work within 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 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 companies. Poor quality and product recalls cost the medical device industry billions each year, while lawsuits also damage company reputation – a risk you may struggle to recover from.
2. Medical device supply chain challenges
From extensive delays to hiked prices, Covid-19 had a disruptive impact on supply chains for many industries, including medical device manufacturing. With a myriad of regulatory requirements and a high demand, the industry is facing continued pressure. While a robust supply chain is therefore essential, achieving this proves a difficult challenge.
What are these medical device supply chain challenges? For one, each and every part of a medical device must adhere to regulatory demands, which can make it tricky to change suppliers. Relying on suppliers in different countries, as many global medical device companies do, also has its risks. If one of those countries experiences some kind of disaster, this has a disruptive knock-on effect, as we saw with Covid-19.
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.
3. Medical device regulatory challenges
There are a number of different regulations that medical device companies need to consider. The fact that many of these differ around the world can be a challenge for medical device manufacturers. Some of the main regulations 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 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 evidence your compliance, such as with compliance reports. However, these can be time-consuming to produce and add to the pressures faced by medical device companies.
4. Outdated processes and ensuring successful collaboration
Developing medical devices is a lengthy and costly process. Review cycles, for example, 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 working practices, the need to achieve quality standards and adhere to regulatory requirements remains as pressing as ever. Ensuring that remote teams are working efficiently therefore also 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 do not gel well with remote working. They can also stall innovation and increase development time, which does not help when it comes to productivity and meeting important deadlines.
What’s more, failing to embrace digital tools can hinder 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, centralised location can also make it difficult to hold people accountable and can consequently increase risk.
5. Cyber security
This brings us to the fifth challenge facing medical device companies. While digital processes undoubtedly improve processes, some new technological developments can put security at risk.
The Internet of Things, for example, allows devices to communicate so that they can send, receive and generate valuable data over the internet. As the medical device industry is responsible for protecting sensitive data, they must prioritise cyber security and have plans in place in case a data breach occurs. As this takes time, it can slow down development and increase production costs. It can also impact getting regulatory approval.
However, as society becomes increasingly digital, managing the risks that accompany technology must be addressed.
How can Ideagen support the medical device industry?
We provide software for highly regulated industries, including medical device companies and medical device manufacturers. Our web-based tool for document collaboration, can improve how you work with colleagues both remotely and in the workplace.
Let’s take medical device reports as an example. You can work together with colleagues on the same file, document each step of the process, review the work, and track progress with full visibility of all the changes that have been made. Cancer Research UK are just one of our customers who use our solution to help their medical writing and technology teams to collaborate and review technical documents, ultimately reducing time spent on reviews.
Our document collaboration solution also makes your processes traceable, auditable and transparent so that you can meet your regulatory challenges head on. Lexicon Pharmaceuticals, for instance, benefit from a visible audit trail to demonstrate accountability and ownership.
Now that you understand some of the main challenges for medical device manufacturers, 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.
Customer success stories
Designed to assist with writing complex medical device reports and regulatory documents, our solution enables companies like yours to seamlessly work with colleagues on shared documents.Find out more