Medical product factories: standards and challenges

Across industries, standards are an important way to safeguard product conformity while simultaneously harmonizing requirements both nationally and internationally. There is probably no other industry in which product conformity is as crucial as in the design and manufacture in medical product factories. Medical product factories are responsible for the design and manufacturing of a wide range of products used to improve human’s health. They can bring in billions of dollars in revenue every year.

Global Standards

Medical supplies are essential tools for healthcare and have direct impacts on public health and quality of life. So, their safety is imperative. To create desirable outcomes for all parties, medical product factories must follow relevant global standards such as FDA, CE,… These standards help ensure that a manufacturing or design process can produce the quality required to serve people. To qualify, FDA will perform a risk-benefit analysis to determine whether authorizing the device is worthwhile. 

Competitor Collaborations

In order to meet requirements, medical product factories need to provide new entrants with information, training before they operate. Design information, machining templates, software, quality assurance for good manufacturing practice in medical supplies industry would all need to be provided in order to boost production quickly. During COVID-19, they should coordinate with other firms to maximize the use of existing facilities to respond to this challenge. Medical product factories should structure their arrangements so that they fall within the boundaries of competition law. 

The Challenges during Covid-19

Medical product factories have not escaped the pandemic’s impact. Similar to pharmaceutical companies, they rely heavily on healthcare facilities for their clinical trial data collection. As the COVID-19 pandemic continues to unfold, medical manufacturers are finding it difficult to make informed decisions about their products, supply chains, and regulatory obligations in the midst of uncertainty. They also try to meet the challenge of supplying sufficient PPE to healthcare providers and people in medical need.

Overall

In closing, this pandemic calls on the medical product factories to work closely with customers, patients, regulators, and public organizations for the sake of public health. They should focus on how they contribute to control the spread of the virus and save lives. Short term, that might mean ramping up production to new levels. In a long term, they need to ensure that speed doesn’t destroy quality. No matter what, medical manufacturers will have an essential role to play in the fight against COVID-19.