When developing a medical device, a company may not always be considering the long term “what if” questions if the product is a success. But planning for the growth of the product early can be just as crucial as a successful product design. If scaling the manufacturing of the device is not possible, the consequences can be just as fatal for the product as failures during product development.
As such, it’s critical for companies to partner with service provider that can scale in the areas required to ensure a successful product launch and expansion. For startups, this can mean access to capabilities they may otherwise not have inhouse, such as prototyping and regulatory expertise. For established manufacturers, a service partner can provide a secondary source for manufacturing, helping to ensure a resilient supply chain.
To share additional insights on the role a service partner can provide to both startups and established manufacturers, Andrew Gladd, director of sales for Life Science Outsourcing Inc., responded to a number of questions. In the following Q&A, he speaks to the importance of scalability, gaining access to additional capabilities, and important criteria during the selection process.
Sean Fenske: When it comes to a contract manufacturer supporting the medical device manufacturing industry, why is scalability important?
Andrew Gladd: Scalability is of paramount importance in contract manufacturing for the medical device sector because it directly correlates with a company's ability to meet increasing market demand. As medical device companies grow, the volume of product needed rises. Without the ability to scale up production in a sustainable manner, these companies risk not meeting demand, causing potential loss of market share, revenue, and credibility. Scalability ensures the ability to produce consistent quality, maintain efficient lead times, and navigate supply chain complexities, all of which are crucial for long-term success.
For any company, achieving scalability is likely the ultimate objective as it is crucial for long-term profitability and success. In our observations over the years of working with medical device manufacturers, many of them fail to adequately prepare for the demands of increased production volume. Being able to manufacture a few thousand units annually does not automatically translate to being able to sustain that level of performance when required to produce thousands of units per month. This oversight can disrupt supply chains and elevate risks that could have been mitigated through proper planning. Ultimately, the issue of scalability impacts not just the manufacturer but also the end users of the medical device.
Fenske: For start-up medtech firms, how often do they have an adequate QMS in place? Is this something they need to identify in a contract manufacturing partner?
Gladd: Startup medtech firms often don't have a fully developed quality management system (QMS) in place at their inception, as they are primarily focused on product development and market entry. A robust QMS is vital for regulatory compliance, product quality, and traceability. This is where a contract manufacturing partner with a strong QMS can add immense value, helping startups ensure their products meet FDA and ISO 13485 requirements right from the start.
Countless promising medical device ideas receive funding almost daily, with the potential to revolutionize the healthcare industry. However, many of these startups lack the expertise to navigate the complexity of the regulatory requirements necessary for that device to achieve market entry. The right manufacturing partner should have years of experience in dealing with regulatory agencies like the FDA. They can assist in setting up the appropriate documentation and reporting mechanisms required for audits and submissions. This expertise can be a critical asset in expediting the regulatory approval process, thereby accelerating your device's journey from concept to market.
Fenske: During the development phase, rapid iteration can be valuable in determining what features or capabilities to include in a device. How important is it to work with a manufacturing partner who can facilitate R&D and prototyping at this stage?
Gladd: During the development phase, having a manufacturing partner who can facilitate rapid R&D and prototyping is crucial. This capability allows for swift iterations, enabling companies to refine product features, troubleshoot issues, and optimize designs in real-time. This agility not only accelerates time-to-market but also ensures the final product is of the highest quality and functionality.
A seasoned manufacturing partner likely has experience in handling devices similar to yours and can provide invaluable feedback and guidance during the research and development (R&D) phase. This expertise can lead to significant time and cost savings in the long run. Such a partner can offer well-informed recommendations that extend beyond just manufacturing and assembly, advising on optimal packaging solutions and sterilization methods just to name a few. The wealth of knowledge they bring to the table is invaluable and can be your pivotal factor in effectively planning for scalability in the years ahead.
Fenske: What about having access to cleanroom space? Since a startup company may not be able to afford this for their location, how valuable is a manufacturing partner who can permit use of this area to them?
Gladd: For startups, having access to cleanroom space via a manufacturing partner is invaluable. Setting up and maintaining a cleanroom is both costly and complex. By leveraging a manufacturing partner's cleanroom facilities, startups can ensure product sterility, maintain high-quality production environments, and save significant costs and time. This is especially crucial for products that require stringent contamination control.
Managing a cleanroom is a complex task that requires years of experience in proper maintenance and decontamination procedures, which must be performed daily to maintain an extremely low concentration of airborne particles. By leveraging your partner's cleanroom and facilities, you can bypass the ongoing costs and labor associated with maintaining such a controlled environment. This enables you to concentrate solely on your medical device's development. The same logic extends to the calibration and upkeep of the various tools and resources available in a cleanroom. Utilizing a partner's established facilities and expertise not only alleviates these burdens but also adds an additional layer of reliability and quality to your manufacturing process.
Fenske: Shifting to the other end of the spectrum, as established medical device manufacturers seek to establish a more robust supply chain, how important is it for them to identify second sources for manufacturing?
Gladd: As established medical device manufacturers seek to fortify their supply chain, identifying second sources for manufacturing becomes essential. Second sources can provide backup during disruptions, ensure continuous supply, and even offer competitive pricing options. They can also facilitate entry into new markets by meeting region-specific regulatory and production requirements.
The COVID-19 pandemic exposed the risks of over-reliance on a limited number of supply chains. When these primary channels were disrupted, the industry faced considerable challenges in sourcing raw materials, as well as in securing uninterrupted logistical transport to move these scarce resources across closed borders. Contract manufacturing organizations (CMOs) have that expertise in sourcing a variety of services and materials from multiple vendors. This experience equips them with the know-how to swiftly transition to secondary sources when primary ones are compromised. Medical device manufacturers can benefit substantially from this expertise by partnering with seasoned outsourcing manufacturing organizations. This collaboration not only enhances supply chain resilience but also better prepares them for unforeseen disruptions.
Fenske: What have you found to be the most important factors or considerations for these companies in identifying additional or new manufacturing partners?
Gladd: The most important factors for companies when identifying additional or new manufacturing partners include:
- Track Record: A history of success in handling high volumes and helping similar companies scale up.
- Quality Assurance: Robust QMS in place, adherence to FDA and ISO 13485 standards, and consistent high-quality production.
- Scalability: The ability to adjust production levels according to demand without compromising quality or lead times.
- Facilities: Access to specialized facilities like cleanrooms and laboratories.
- Regulatory Knowledge: In-depth understanding of the regulatory landscape to navigate complexities and ensure compliance.
- Transparent Communication: Open channels of communication and proactive problem-solving approaches.
When considering a new manufacturing partner, it's crucial to evaluate the additional tools and resources they bring to the table to help mitigate risks. A partner offering more than just assembly and manufacturing—such as in-house sterilization and packaging—can significantly reduce various risks. Having a dependable solution for these additional services means you don't have to rely on multiple vendors and supply chains, thereby streamlining your operations even more. The versatility of your chosen manufacturing partner will ultimately enhance your own capabilities as an original equipment manufacturer (OEM), making your operations more resilient and agile.
Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell medical device manufacturers?
Gladd: As most OEMs and startups know, medical device manufacturing is a complex and highly regulated industry. Companies, whether startups or established entities, need to recognize the value of partnering with experienced contract manufacturers. Such partnerships not only alleviate production burdens but also bring industry expertise, resources, and regulatory knowledge to the table. Your partner should also demonstrate commitment to quality, continuous improvement, and dedication to strong outcomes. This collaboration is crucial in accelerating innovation, ensuring product quality, and achieving long-term success. To all medical device manufacturers: Choose your partners wisely, as they play a pivotal role in your product's journey from conception to market and beyond.
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