Discover a strategic approach for selecting the ideal manufacturing partner to develop your sophisticated robotic surgical system and understand the key criteria you need to consider.
The Integration of Robotic Surgical Systems in Modern Medicine
It's no secret that robotic surgical systems have revolutionized the medical field by providing unprecedented precision, control, and minimally invasive options for complex procedures. These systems enhance the capabilities of surgeons, reduce patient recovery times, and improve overall surgical outcomes.
The integration of robotics in surgery represents a significant advancement in medical technology, leading to improved patient care and new possibilities for clinical applications.
The effects of surgical robotics have not only transformed the landscape of modern medicine but have also sparked a surge in demand for advanced medical devices. As the capabilities of robotic systems continue to expand, medical equipment manufacturers have been presented with a wide spectrum of opportunity to innovate and develop cutting-edge technologies.
The Growing Demand for Robotic Systems
The growing demand for robotic surgical systems has created a development frontier for medical device manufacturers to explore - and the products they are creating come in a wide variety of shapes and sizes. According to Global Market Insights Market Reports, the surgical robot market is expected to reach $26.4BN and an estimated compound annual growth rate (CAGR) of 16.1%. In the last year, robotic surgical systems made up about 20% of the project proposals at HUI - an exponential increase from the prior year.
Source: Surgical Robots Market Size. Data published by Global Market Insights on 07/2024. Accessed 08/19/2024.
This new frontier has developed a need for strategic partnerships with experienced and technically proficient manufacturing partners. By collaborating with manufacturing partners who possess a strong track record in the industry, have the necessary technical expertise, and prioritize compliance and quality assurance, medical device companies can ensure the successful development of their robotic surgical system.
Key Factors to Consider When Choosing a Manufacturing Partner
Choosing the right manufacturing partner for your robotic surgical system involves evaluating several critical factors. These include the partner's experience in the medical device industry, their track record with similar projects, and their ability to meet your specific technical requirements - including their manufacturing capabilities.
Medical Device Industry Experience
Talk to your potential partner about their experience. Think beyond tenure and ask about some of their experience in product development, engineering, prototyping, and compliance - specific to the medical device industry. Beyond experience, be sure to check for ISO 13485 certification and their ability to help you meet compliance standards such as IEC 60601-1.
Sample Questions About Experience:
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- Does your organization have experience manufacturing for the medical device industry?
- Is the organization ISO 13485 certified and experienced with IEC 60601 standards?
- How much experience do each of your team members have?
Track Record for Similar Projects
While all manufacturers have the capability to produce parts, it is crucial to capitalize on their past achievements throughout the product development journey. The selection of the right partner for your project can make or break its success - finding a manufacturer with a proven track record is essential to instill confidence and assurance within your team.
Sample Questions About Similar Projects:
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- Has your organization ever developed or manufactured a robotic surgical system?
- Does your organization offer end-to-end manufacturing or would you work with an integrator?
- Do you have experience developing or manufacturing a similar product? If so, what were the challenges?
- What kind of tolerances are you capable of manufacturing? (robotic systems require precision).
Technical Requirements & Capabilities
Now that you've gauged the basics and established whether the manufacturer is a fit based on their historical work - it is important to qualify them on your technical requirements and capabilities. Your goal is receive a consistent delivery of high quality parts.
Sample Questions About Track Record or Capabilities:
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- What kind of in-house capabilities or services do you provide?
- What is your organizations annual external PPM score? How do you remediate issues?
- Does your organization have clean room capabilities or work with an integrator who does?
Evaluating Technical Expertise and Manufacturing Capabilities
Technical expertise is paramount when selecting a manufacturing partner for your robotic surgical system. This includes their proficiency in advanced manufacturing techniques, robotics engineering, and their familiarity with the stringent requirements of medical device production.
Advanced Manufacturing & Robotics Capabilities
Advanced manufacturing is typically sorted into three core categories: efficient production, intelligent production, and effective organization. Advanced manufacturing technologies commonly used with medical carts and mobile robotic system chassis include automation, laser machining or welding, and cell-based manufacturing.
Sample Questions About Advanced Manufacturing & Robotics:
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- Does your organization have an in-house engineering team? Do they design parts for manufacturing?
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- Does your product development team have experience developing robotic systems?
- What type of advanced manufacturing technologies do you have or typically use?
Assessing the partner's manufacturing capabilities involves looking at their production facilities, technological infrastructure, and their ability to deliver high-quality products consistently and efficiently. Be sure to ask your potential partner about their external quality (PPM) and their schedule attainment or ability to be on-time.
The Role of Compliance and Quality Assurance in Robotic System Production
Safety of the care provider and patient is at the core of every medical device. Compliance with regulatory standards and rigorous quality assurance processes are crucial in the production of robotic surgical systems because they help ensure safety and reduce your company liability.
During the development phase of your project you may choose to work with an industrial design firm or an integrator in conjunction with your manufacturing partner. Either way, be sure to utilize a manufacturing partner that is well versed in IEC 60601-1 standards - this will typically speed up the development process and help you avoid costly revisions. Give the manufacturing partner extra points if they administer internal tests such as the videos below.
View More Videos on IEC 60601-1 Here: Or View Our Online Guide
Your manufacturing partner must also adhere to international medical device regulations, such as ISO 13485, FDA requirements, and understand the proper labelling or packaging requirements.
Quality assurance ensures that every component of the robotic system meets the highest standards of safety and performance, minimizing risks and ensuring patient safety.
Building a Long-Term Relationship with Your Manufacturing Partner
The internet age has left us to believe that all solutions exist online. That we can conduct a quick Google search and find a solution for almost anything. Although this may feel true due to the sheer accessibility of information at our fingertips, there is really just a lot more noise. The reality is there are truly only a handful manufacturers for robotic systems, so establishing a great relationship with the right partner is important.
Establishing a long-term relationship with your manufacturing partner can lead to sustainable success and innovation. This involves clear communication, mutual trust, and a shared vision for future developments.
A reliable partner will not only help you navigate the complexities of manufacturing but also support you in scaling your operations, addressing challenges, and exploring new opportunities in the evolving field of robotic surgery.
Key Takeaways from Robotic System Development
As we had stated previously, finding a manufacturing partner with experience developing robotic surgical systems is critical. Robotic systems are intricate and successful delivery of a production order requires a perfectly conducted orchestra of competencies throughout the process. Below, you will find a handful of key development takeaways ,specific to robotic systems, from the product development experts at HUI.
Key Development Takeaways | Robotic Systems:
- Always be thinking about the manufacturability of your system and components.
- Maintain good project management - it's absolutely critical based on the sheer number of components
- Standardize your components wherever possible - it's an instant efficiency for supply chain and subassembly
- Utilize off-the-shelf components wherever possible and try not to reinvent the wheel when unnecessary
- Assemble the prototype early in the design phase to jumpstart any manufacturing efficiencies
- Consider logistics variables - robotic systems weigh more than standard carts
- Seek smaller production orders - Robotic systems are not mass manufactured due to their complexity
