Crucial challenges that Medical Device Companies face
The medical device companies are going through a series of specific challenges by providing medical equipment. But it’s not just medical equipment, they need to make equipment that is cost-efficient and innovative, and it must have a certain value for providers, practitioners, investors, and of course patients.
The MedDev industry is expected to rise together with the rising aging population and increased health concerns.
Medical device companies have to deal with a huge level of complexity throughout the product development process. Resources, consultation from qualified experts, and financial investment are all necessary bits and pieces for successful clearance, approval, or entering the market.
Product Development
Medical device manufacturers must warrant product quality to avoid product complaints. Such a thing negatively impacts their reputation and company integrity.
Also, there are other various issues for concern: is medical device company building something completely innovative or may be disruptive, how well it stands up to competition, what steps have been taken for preclinical data and usability to confirm if
end-users can actually use the device.
Identification of whether the used literature and risk-benefit profile demonstrate the indications for use, then if the product needs to be protected from malicious software and cybersecurity attacks.
Thus, ensuring satisfactory product safety, security and reliability are extremely critical to surviving the competition in the emerging markets.
QMS
QMS implementation is another level of challenge. There are many barriers to conquer that can be tricky, but it’s not an impossible task. It’s not the rare case that manufacturers haste through the QMS implementation, which surely leads to a poorly implemented and deployed system that can guide to inefficiency. To evade any possible mistakes, it’s important to create a QMS implementation plan that covers all key elements.
The QMS is here to guide the company to analyze the needs of customers, motivate and better-prepare staff, define the processes for the production and provision of services, and to keep them under control.
An effective system means competitive advantage and demonstrates that the medical device company meets the requirements and is able to consistently achieve its policy and objectives.
Regulatory journey
Navigating through the various regulatory pathways to obtain market clearance or approval process can be challenging for many medical device manufacturers.
A 510(k) is a premarket submission made to FDA to demonstrates that the device that will enter a market is at least as safe and effective, substantially equivalent, to a legally marketed device that is not subject to Premarket Approval.
In the EU, MDR assures high standards of quality and safety of medical devices being produced in or supplied into Europe. Similarly to FDA, EU MDR will establish a robust, transparent, predictable, and sustainable regulatory framework for medical devices to assure a high standard of health and safety.
Every major market for medical devices has its own specific regulatory framework. If the company plans to launch the device besides the USA or EU, it needs to understand the requirements in those regions.
The regulatory strategy is one of the most, if not the single most, challenging aspects of launching a medical device.
Conclusion
These three elements can potentially extend the time of bringing devices to market:
· an inefficient product development,
· the absence of an organized QMS implementation and
· regulatory approvals strategy.
It’s not easy to bring a medical device to market. The process can be quite complex for new manufacturers of medical devices. But, employing a strategic plan from the start, a lot of stress can be reduced during the process, while increasing the chances for success in bringing the medical device to market.
