Elizabeth Norwood, Senior Chemist at MicroCare, LLC05.23.24
In medical device manufacturing, cleanliness is essential for patient safety and product integrity. Even small traces of contamination on parts can have significant consequences, such as device malfunctions, compliance breaches, or health risks. This emphasis on rigorous cleaning can be challenging for manufacturers, who must adhere to strict standards set by regulatory agencies like the Food and Drug Administration (FDA) and the International Standards Organization (ISO). Meeting these high cleanliness benchmarks in-house can put a strain on resources, requiring specialized equipment, skilled personnel, and rigorous quality controls. As a result, many manufacturers opt to outsource various aspects of production, allowing them to focus on their core competencies while gaining efficiencies and flexibility.
The strategic importance of outsourcing in the medical device industry is reflected in market trends. The global medical device outsourcing market was estimated at USD 128.8 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 12.8% from 2024 to 2030[1]. This growth trend underscores the growing reliance on outsourcing for various manufacturing processes, not just for supporting cleanliness but also for streamlining operations and reducing costs.
Medical device cleaning must remove production debris, such as machining and stamping oils, dust, metal filings, marking inks, and even fingerprints. This must be completed before the devices undergo assembly, coating, sterilization, or packaging. As medical devices continue to shrink with tighter gaps, deep blind holes, and complex geometries, cleaning and drying these parts is more challenging.
![](https://images.rodpub.com/images/307/196_main.jpg)
Medical devices are constructed from a variety of materials, including metals, ceramics, polycarbonate, and acrylic.
Another crucial factor to consider is material compatibility. Medical devices are constructed from a variety of materials, including metals, ceramics, polycarbonate, and acrylic. The cleaning process must be robust enough to remove contaminants, yet gentle enough to avoid damaging delicate surfaces or components. Striking this balance requires expertise and a careful approach.
Beyond defining cleanliness levels, sharing device design, material makeup and typical types of contaminants present with potential outsourcing partners is essential. This information helps them understand the scope of work and tailor their cleaning processes to meet your specific needs.
Next, assess the partner's specialized expertise, advanced cleaning technologies, and quality systems. A reputable partner should have access to innovative cleaning methods that are both effective and environmentally friendly. Vapor degreasing, for example, uses sustainable cleaning fluids to remove contaminants without resorting to harsh chemicals, offering a balance between efficacy and environmental responsibility. This process is ideal for cleaning complex medical devices, where precision and compliance are critical.
Before making a final decision, ensure the partner offers demonstration testing on actual production items. This step is crucial for confirming their cleaning capabilities and ensuring they meet your cleanliness requirements. This testing also allows for the identification of any issues before committing to a long-term outsourcing partnership.
Leverage your partner's oversight on compliance requirements. A dependable outsourcing partner will have robust quality systems in place, including process validation, documentation, and regular audits. These systems ensure that cleaning operations meet standards and reduce the risk of compliance issues. Periodic re-testing and re-validation are also essential to support the effectiveness of cleaning processes.
Providing new product samples for test cleaning runs helps find potential issues early. Adequate notice of adjustments allows the outsourcing partner to plan and distribute resources efficiently, reducing the risk of misunderstandings, delays, and production disruptions.
A key aspect of effective communication is aligning on sustainability goals. Discussing the desired cleaning fluids and processes in first discussions ensures both parties are on the same page about environmental sustainability.
![](https://images.rodpub.com/images/307/197_main.jpg)
Vapor Degreasing Overview: uses sustainable cleaning fluids to remove contaminants without resorting to harsh chemicals, offering a balance between efficacy and environmental responsibility.
It's important to stipulate the use of sustainable cleaning fluids, such as modern cleaning fluids used for vapor degreasing, which is an effective cleaning method in medical device manufacturing. These fluids are designed to meet stringent regulatory standards while supporting eco-friendly practices. Unlike older cleaning solvents like Trichloroethylene (TCE), Perchloroethylene (Perc), and n-Propyl bromide (nPB), which pose potential environmental and health risks, these fluids are more environmentally conscious. Based on newer chemical technology, many have low Volatile Organic Compound (VOC) content, low Global Warming Potential (GWP), and are not classified as hazardous air pollutants (HAP), minimizing their environmental impact.
Medical device manufacturers can meet regulatory requirements while reducing their environmental impact by choosing a partner who prioritizes sustainability and uses modern, eco-friendly cleaning fluids. This helps support compliance with environmental regulations and shows a commitment to corporate social responsibility.
Develop a clear process for transitioning from in-house to outsourced cleaning operations. This process should include steps for a controlled shift of operations, training for new procedures, and quality control measures. Building flexibility into the plan allows for rebalancing and optimization as needed, ensuring that the transition doesn't affect production timelines or quality standards.
Key to successful outsourcing is selecting partners with proven ability in medical device cleaning, robust quality systems, and an ability to adapt to evolving industry demands. Effective communication throughout the partnership ensures that the outsourcing process meets current and future needs.
Additionally, integrating sustainability into these outsourcing decisions provides a long-term advantage. As environmental regulations tighten, choosing partners that use modern, eco-friendly cleaning fluids helps support compliance while showing a commitment to corporate social responsibility.
Outsourcing offers a balanced approach to efficiency, reliability, and sustainability. By carefully selecting partners, keeping open communication, and planning transitions thoughtfully, manufacturers can achieve the precision and compliance needed in medical device cleaning, contributing to safer and more reliable products.
Elizabeth Norwood is a Senior Chemist at MicroCare, LLC, which offers precision cleaning solutions. She has been in the industry more than 25 years and holds a BS in Chemistry from the University of St. Joseph. Norwood researches, develops, and evaluates cleaning-related products. She currently has one patent issued and two pending for her work. For more information, visit www.microcare.com.
The strategic importance of outsourcing in the medical device industry is reflected in market trends. The global medical device outsourcing market was estimated at USD 128.8 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 12.8% from 2024 to 2030[1]. This growth trend underscores the growing reliance on outsourcing for various manufacturing processes, not just for supporting cleanliness but also for streamlining operations and reducing costs.
Defining Your Unique Precision Cleaning Needs
The first step to effectively outsource cleaning operations is clearly defining your unique precision cleaning needs. This involves understanding the specific contaminants to be removed and the cleanliness levels needed for your medical devices, considering their intended use and relevant regulations. Medical devices can be intricate assemblies with complex shapes and delicate materials, making thorough cleaning a challenge. Yet, the requirement for perfect cleanliness is crucial.Medical device cleaning must remove production debris, such as machining and stamping oils, dust, metal filings, marking inks, and even fingerprints. This must be completed before the devices undergo assembly, coating, sterilization, or packaging. As medical devices continue to shrink with tighter gaps, deep blind holes, and complex geometries, cleaning and drying these parts is more challenging.
![](https://images.rodpub.com/images/307/196_main.jpg)
Medical devices are constructed from a variety of materials, including metals, ceramics, polycarbonate, and acrylic.
Beyond defining cleanliness levels, sharing device design, material makeup and typical types of contaminants present with potential outsourcing partners is essential. This information helps them understand the scope of work and tailor their cleaning processes to meet your specific needs.
Selecting Aligned Outsourcing Partners
Selecting the right outsourcing partner is critical to ensure successful precision cleaning operations. Start by evaluating the partner's experience in the medical device industry, focusing on their familiarity with industry-specific regulations. The ideal partner should have a proven history of compliance and quality assurance. Quality certifications, such as ISO 13485, show that the partner adheres to strict standards and understands the requirements of medical device cleaning.Next, assess the partner's specialized expertise, advanced cleaning technologies, and quality systems. A reputable partner should have access to innovative cleaning methods that are both effective and environmentally friendly. Vapor degreasing, for example, uses sustainable cleaning fluids to remove contaminants without resorting to harsh chemicals, offering a balance between efficacy and environmental responsibility. This process is ideal for cleaning complex medical devices, where precision and compliance are critical.
Before making a final decision, ensure the partner offers demonstration testing on actual production items. This step is crucial for confirming their cleaning capabilities and ensuring they meet your cleanliness requirements. This testing also allows for the identification of any issues before committing to a long-term outsourcing partnership.
Maintaining Regulatory Standards and Validation
Regulatory compliance is central to medical device cleaning. Given the strict requirements set by agencies like the FDA, ensuring that your outsourcing partner keeps high regulatory standards is critical. This includes staying updated on changes to medical device regulations and adapting cleaning processes to meet these evolving standards.Leverage your partner's oversight on compliance requirements. A dependable outsourcing partner will have robust quality systems in place, including process validation, documentation, and regular audits. These systems ensure that cleaning operations meet standards and reduce the risk of compliance issues. Periodic re-testing and re-validation are also essential to support the effectiveness of cleaning processes.
Effective Communication
Effective communication with your outsourcing partner is crucial for a successful partnership in medical device cleaning. Manufacturers should inform their partners about changes in production volumes, product mix, or cleaning needs. This ongoing dialogue ensures the partner can adjust cleaning processes, resources, and capacity to meet evolving production requirements seamlessly.Providing new product samples for test cleaning runs helps find potential issues early. Adequate notice of adjustments allows the outsourcing partner to plan and distribute resources efficiently, reducing the risk of misunderstandings, delays, and production disruptions.
A key aspect of effective communication is aligning on sustainability goals. Discussing the desired cleaning fluids and processes in first discussions ensures both parties are on the same page about environmental sustainability.
![](https://images.rodpub.com/images/307/197_main.jpg)
Vapor Degreasing Overview: uses sustainable cleaning fluids to remove contaminants without resorting to harsh chemicals, offering a balance between efficacy and environmental responsibility.
Medical device manufacturers can meet regulatory requirements while reducing their environmental impact by choosing a partner who prioritizes sustainability and uses modern, eco-friendly cleaning fluids. This helps support compliance with environmental regulations and shows a commitment to corporate social responsibility.
Planning a Phased Transition
Transitioning to an outsourced cleaning partner requires careful planning to avoid disruptions to production. A phased approach can ensure a smooth transition and allow for adjustments. Start by setting a realistic timeline aligned with your internal capabilities, considering the time required for testing, validation, and quality assurance.Develop a clear process for transitioning from in-house to outsourced cleaning operations. This process should include steps for a controlled shift of operations, training for new procedures, and quality control measures. Building flexibility into the plan allows for rebalancing and optimization as needed, ensuring that the transition doesn't affect production timelines or quality standards.
Realizing the Strategic Potential of Outsourcing
Outsourcing cleaning operations in the medical device industry offers manufacturers a strategic edge, enabling them to focus on their core business while ensuring compliance with rigorous regulatory standards. By partnering with specialized cleaning experts, companies can achieve the elevated levels of cleanliness needed, minimize risks, and streamline production processes.Key to successful outsourcing is selecting partners with proven ability in medical device cleaning, robust quality systems, and an ability to adapt to evolving industry demands. Effective communication throughout the partnership ensures that the outsourcing process meets current and future needs.
Additionally, integrating sustainability into these outsourcing decisions provides a long-term advantage. As environmental regulations tighten, choosing partners that use modern, eco-friendly cleaning fluids helps support compliance while showing a commitment to corporate social responsibility.
Outsourcing offers a balanced approach to efficiency, reliability, and sustainability. By carefully selecting partners, keeping open communication, and planning transitions thoughtfully, manufacturers can achieve the precision and compliance needed in medical device cleaning, contributing to safer and more reliable products.
Elizabeth Norwood is a Senior Chemist at MicroCare, LLC, which offers precision cleaning solutions. She has been in the industry more than 25 years and holds a BS in Chemistry from the University of St. Joseph. Norwood researches, develops, and evaluates cleaning-related products. She currently has one patent issued and two pending for her work. For more information, visit www.microcare.com.