Healthy Growth – Industry Outlook on Medical Device Manufacturing

  • 21 November 2018
  • cre8


The healthcare industry is completely reliant on the manufacturing of Medical Devices. Being slightly more vulnerable to economic fluctuations, the Medical Device industry is largely protected by revenue unpredictability due to its expensive nature. The Medical Device industry has been in decline since 2013. In the time span of 2013-2018 the industry suffered a -1.3% decline. In despite its downward trend the Medical Device industry is forecasting a +3.0% slope in the upcoming years ranging from 2018-2023. Factors that have contributed to this upward growth is attributed to technological advances, increased healthcare spending, improving economy and the increased need of medical devices by the elderly.

Basis of competition in this industry is high and the trend is increasing. Due to the significance of the product manufactured, device performance and quality are vital. The Medical Device industry is facing new and impeding trends that have arisen due to technological advances, demanding consumer base, changing demographics and tougher regulations. Significant trends include…

3D Printing: The Medical Device industry is remarkably dynamic so it’s no surprise that it has adopted the practice of implementing 3D printing technology. By procuring and understanding the possibilities that 3D printing can offer the industry will transform the way Medical Devices are manufactured.

Cyber Security: Medical Devices are being designed to be implemented alongside the internet, smart phones, facility networks and electronic health data. As these advancements make healthcare professional’s job more streamline, it poses a serious threat to the privacy of patient’s information. New regulations and requirements are being introduced to the market by the FDA’s Regulatory Science Priorities to counteract any potential threat of loss of personal information.

Pricing Transparency: The Medical Device industry is facing the issue of how medical devices are valued, priced, and purchased. This makes things such as substantial price increases for some medical devices a pressing issue. By initiating transparent pricing policies, the correlation between manufacturers of Medical Devices and health care providers will change.

Audits and Compliance: Document management is extremely vital due to the importance it plays in compliance. Key compliance issues that the industry faces are namely FDA 21CFR Part 11 compliance, ISO 13485, and cGMP.

By keeping up with pertinent trends and paying close attention to innovations and advancing technology Medical Device manufacturers will be able to enjoy the +3.0% upward growth over the next anticipated 5 years. Medical Device manufacturers will have to face heavy regulation and specification as technology progresses and other adverse opportunities present themselves. By adhering to compliance standards and producing leading technological advances in their industry, Medical Device manufacturers will establish a profitable market.

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