2 reasons why medical device outsourcing is poised for growth
According to a recent report by Grand View Research Inc., the global medical device outsourcing market is expected to reach USD 292.93 billion by 2030, registering a compound annual growth rate (CAGR) of 12.1% during the forecast period. Reasons for the expected growth include compliance with regulatory standards as well as increasing demand for sterilization services as a result of the pandemic.
Other research reports predict similarly healthy growth for the medical device outsourcing market: Allied Market Researchfor example, predicts a huge increase in outsourcing services over the next decade, as medical device manufacturers pursue cost-cutting measures and accelerate time-to-market while ensuring they meet industry regulations.
The rise in outsourcing is also attributed to the aging of the world’s population, which is accelerating the demand for medical devices and supplies. Furthermore, industry analysts predict that an increasing number of medical device companies will turn to outsourcing so that they can focus on core competencies, such as marketing.
Kim Trautman, General Manager and Vice President MEDIceptconveys his views with Packaging Digest about how some of these changes – particularly the more stringent regulatory requirements – will affect the contract packaging industry and the medical device companies it serves.
What are the main challenges for medical device contract packers and how do you address them?
Trautman: Like the FDA [Food and Drug Administration] returns to performing medical device inspections following the COVID restrictions, a number of manufacturers and contract service providers recently issued an FDA Form 483 Process Validation. In fact, MEDIcept is currently helping several clients respond to FDA Form 483 as well as Notified Body noncompliance related to packaging, controlled environment, and sterilization.
As part of supplier controls in accordance with FDA Quality System Regulation 21 CFR part 820.50 and ISO 13485:2016 clauses 4.1.5 and 7.4, finished device manufacturers are responsible for process validations related to contracted services, such as packaging and sterilization processes . The finished device manufacturer is required to review and “approve” objective evidence of process validation even if it is performed by packaging contractors and sterilizers as part of their supplier controls.
So even if a contract packager is not a finished device manufacturer and is not typically inspected by the FDA, global regulators have increased pressure to have compliant objective evidence of process validation, including environmental controls. The off-the-shelf manufacturers are now cascading that pressure onto their suppliers of these outsourced processes.
Why and how do changes in medical device regulations and standards affect the need for outsourcing?
Trautman: The biggest changes in medical device regulations and outsourcing standards come from two key sources:
1. European Union Medical Device Regulation (EU MDR) and the EU in vitro diagnostic regulation (EU IVDR).
The EU MDR and IVDR requirements are driving the increased use of external services related to many things, including authorized contract representatives, biocompatibility testing and materials testing, clinical evaluation report (CER) services, internal audit services and post-market data analysis services. with all other typical outsourced manufacturing services. Manufacturers still have so many gaps to fill the increased EU requirements that internal resources are stretched and/or the necessary competencies/equipment needed to meet these requirements are not within the company.
“Manufacturers still have so many gaps to fill the increased EU requirements that internal resources are stretched and/or the necessary competencies/equipment needed to meet these requirements are not in-house.”
2. New US Environmental Protection Agency (EPA) proposed rule regarding ethylene oxide (EO) emissions for EO sterilizers.
The new rule proposed by the EPA is likely to have a profound effect on all medical device manufacturers that require sterilization services. Many turnkey firms will likely have to determine whether the new EPA requirements are worth the capital expenditure on equipment versus switching to contract sterilizers. And in order for contract sterilizers to recoup the costs of these new emission reduction requirements, they will have to determine how to meet these new stricter EO emissions requirements, which will ultimately affect the prices of EO sterilization as well as other sterilization methods. The effects of this new proposed rulemaking will need to be watched carefully over the next five to 10 years.
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