HDA is a full-service medical device prototyping and contract manufacturing company. Our team boasts decades of experience providing top-grade services to medical startups, mid-size companies, and multinational corporations. We provide development and manufacturing services at any point in your product’s life cycle — including prototyping and compliant pilot production.
We have the technical and practical experience to get your low-volume orders out on time with consistent, high-quality craftsmanship. Our FDA-registered facility is capable of producing medical devices of every classification; Class I, Class II, and Class III. In addition, if you need help proving the critical functions of your innovative medical device concept, HDA can develop and manufacture industry-standard prototypes to your exact specifications.
Because medical device prototyping is a multilevel process, our work is all about consistent quality checks and due diligence. Utilizing the prototype model allows HDA and our clients to work with physical devices as opposed to virtual designs. Feasibility can be more directly assessed and the cost savings are significantly reduced as a result.
Partner with HDA for Your Medical Device Prototyping
Our full-service medical device manufacturing team is led by expert engineers, technicians, and seasoned regulatory specialists. We can get your product ready as quickly and safely as possible. If you’ve identified a need for your medical device in the healthcare industry, we can help bring your product into reality. Our refined development and manufacturing process is ready to meet your unique production goals and efficiently produce working prototypes.
Designing a groundbreaking medical device concept and getting it to market is filled with complex and intricate processes. These can often be daunting for many companies. HDA is ready to help you to navigate the prototype production phase and handle any necessary regulatory certifications during the process. In addition, our time-proven development and evaluation procedures allow you to test your product and confirm its primary functions.
Medical device prototyping with HDA can benefit your product development in several ways:
- Accelerate Development. HDA’s ability to manage full-service prototyping under one roof offers more control and efficiency over the development process. In addition, we will implement proven strategies and procedures to quickly and effectively develop your product the right way.
- Test and Evaluate. Medical device prototyping allows for the testing and evaluating of your product’s design and functions. HDA will help develop and improve your concept to ensure its critical role.
- Ease Regulatory Process. HDA will ensure the design process supports your product’s intended function. In addition, we test and document development methodology.
- Documented Designs. We document the design and development of your medical device with an industry-standard design history file (DHF). The DHF records all changes to your concept during the product and production process. In addition, regulatory certification necessitates instruments to document development histories.
- Minimized Costs. We lower future high-volume production costs through the medical device prototyping process. Our optimized production methods inform the full-scale production methods required for your market-ready product. This cost-effective manufacturing benefit saves money and time.
- Improve Safety. More than 1.7 million injuries from medical devices have been recorded over the last decade. HDA mitigates patient and consumer injuries with thorough prototyping development, evaluating and improving product safety. We refine your product’s design at every stage of development to create a better, safer medical device.
HDA’s approach to medical device prototyping provides your product with a clearly defined development plan to make sure there are no surprises along the way. We have industry-best personnel and development processes to get you through product design, manufacturing, and successful regulatory compliance. In addition, we consider the entire life cycle of your product from inception to market.
Ready for Your Medical Device with Compliant Pilot Production
Do you want to begin clinical testing on your newest medical device product? Are you ready to file a 510(k) premarket submission with the FDA?
HDA offers compliant pilot production to fulfill low-volume, audit-ready products orders. Our FDA-registered facility is capable of producing completely compliant medical devices to meet your needs. Leverage our facility, experienced engineers and technicians and regulatory specialists to create fully compliant, high-quality products.
We look at compliant pilot production as a crucial step toward full-volume manufacturing for your medical device. Our processes are refined and ready to be implemented in full-volume production after successfully moving your product into clinical trials or a pilot market. Additionally, compliant pilot production also allows us to uncover any issues that may impact the manufacturing process. HDA uses this stage to refine production processes and help you refine your product design as well.
At HDA, we utilize scalable and replicable processes to guarantee your products’ long-term success and quality. We test your device’s design and manufacturing process to ensure it consistently produces functional, safe products without significant or costly issues.
Combining engineering-based transfer to manufacturing and procedure-based assembly ensures that each device meets its critical function and design before leaving the manufacturing facility. In addition, we prioritize testing and evaluation processes dedicated to optimizing quality and efficiency during medical equipment contract manufacturing and production.
HDA’s compliant pilot production services include several benefits:
- Design Verification. Throughout the development process, HDA actively verifies your product to ensure it fulfills predetermined functions and safety requirements. In addition, we can mitigate functional and safety issues before the product reaches the manufacturing stage by aligning our design output with the design input.
- Design Validation. HDA implements stringent design controls that inform our development process through development and manufacturing. Our comprehensive validation process confirms the product’s usability, critical function, and safety before it reaches manufacturing.
- Low-Volume Manufacturing. Our manufacturing team and facility can easily scale to manage low-volume and clinical orders efficiently. We utilize a lean manufacturing process to reduce lead time and mitigate wasted cycles during production, saving customers time and money while providing expertly-crafted results.
- Optimized Development Process. HDA jump-starts the planning and optimizing of your product’s development life cycle. Implementing crucial processes to streamline development — including testing and evaluation — allows us to do so. We eliminate costly mistakes and delays by adhering to time-tested procedures.
HDA upholds specific and stringent standards throughout the development process to make sure your 510(k) filing or clinical trials move forward successfully and on time. In addition, our low-volume manufacturing methods are proven to save time and reduce production mistakes that lead to costly delays.
Develop your next prototype or low-volume pilot with HDA, and you’ll receive expert engineering, optimized development, and advanced manufacturing to ensure the long-term success of your next innovative medical device.
As a full-service medical device manufacturing company, HDA offers many different manufacturing services to fulfill the needs of our customers. We’re ready to leverage our decades of knowledge and experience to help you create the following big product. So reach out to us today and tell us all about your new idea!
