Knowledge insights

Top Challenges Medical Device Manufacturers Face


In the medical sector, devices have to work perfectly from the first moment of use to the last one. There’s no room for errors and failures because they can cause serious harm or even death to patients. Under these circumstances, medical device manufacturing is one of the most challenging industries to activate in.

Medical devices at the highest possible quality, increased competition around the globe, and a complex regulatory environment make manufacturers wander how to maintain both quality and profitability. There are three big challenges that most medical device manufacturers face – compliance, quality, and continuous evolution. In fact, these are also the secret ingredients of a successful medical device manufacturer.

In a recent study conducted by the global medical device consulting firm Emergo Group, respondents cited the “changing regulatory environment” as their greatest challenge in 2014.

Regulatory Compliance

Regulatory agencies across the globe have very high requirements for documentation of medical devices; plus, requirements differ from one country to another and medical device manufacturers have to comply sometimes with multiple laws and regulations. Especially in the case of multinational companies, tracking all the necessary regulations and meeting the requirements of each country is an incredible challenge.

Product Inovation

Any medical devices manufacturer struggles and should embrace change in its way to the top. Changes due to new regulations or changes needed for new device features can cause quality problems and reduce productivity. Complete documentation and outsourcing partners are a good way to accelerate product development and bring products faster to the market, with minimal disruption to manufacturing operations.

Maintain Quality

Even though all medical device manufacturers aim and should produce high-quality products, ensuring quality best practices does present some challenges. Quality concerns everyone, from manufacturers and regulators to doctors and patients. Best practices in quality assurance can increase a manufacturer’s earnings, lower costs and risks, and allow them to bring better products to the market.

A close relationship with key partners is essential to meet these challenges. Strategic partnerships allow medical device manufacturers to bring external specialists alongside to work together and reduce the impact of changes, speed innovation, and meet compliance requirements.

The selection of partners who are accustomed to working with medical equipment manufacturers has an extremely important role in reducing quality issues; they have the necessary systems in place to provide proper documentation, testing, verification and validation. To read more on how the right partner for your next embedded software development project can help you meet your business objectives, visit Enea website.

By Enea Services

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