Concept to Commercialization: It's in Our Wheelhouse.
Medical Device Project Management and Engineering Consulting Firm
A Trusted Partner for Medical Device Design & Management
Driving success for startups and established corporations.
Customer-Success Driven & Mission Oriented
Our Capabilities
- Project Development & Assistance
- Device Design & Rapid Prototyping
- Supply Chain & Manufacturing Management
- Commercialization & Fulfillment
- Quality & Regulatory Affairs
At a Glance
30+ issued patents
50,000+ engineering hours
27 satisfied clients
4 years in business
Explore our Services & Capabilities Further
Project Development & Assistance
We take on the responsibility of overseeing and coordinating every aspect of your medical device development process, from concept to launch. Our team will help you develop a comprehensive approach for commercialization, research your requirements, and explore prior art to ensure your product stands out in the market. We have a wealth of experience in R&D, particularly with orthopedic implants and instruments, and will provide you with comprehensive product realization support from concept through commercialization, with a focus on medical device design and development.
Device Design & Rapid Prototyping
Our team of experienced designers and engineers will work with you to create a medical device design that meets your specific needs and requirements. We use the latest CAD development tools including Solidworks & Creo, and employ design for manufacturing techniques as well as FEA analysis to ensure your product is optimized for production. We offer quick in-house prototyping, design for injection molding, extruding, CNC, 3D printing, and more to bring your product to life and test its functionality. We prioritize working closely with clients to ensure that designs meet their needs and requirements and are optimized for production.
Supply Chain & Manufacturing Management
We strive to ensure that your medical device is manufactured to the highest standards and that the cost of goods is kept to a minimum. Our team will work with manufacturers to optimize the design of your product and reduce the cost of goods while ensuring that your device meets the necessary quality standards. We also provide comprehensive supply chain management to ensure your product gets to market on time and on budget. This includes identifying the right manufacturers for your product, managing inventory and supply chain logistics, ensuring products are delivered on time, and managing the process from raw materials to finished goods.
Quality and Regulatory Affairs
Wheelhouse Medical offers comprehensive Quality and Regulatory Affairs services to ensure that your medical device meets all necessary standards. Our team will help you navigate the complex regulatory landscape, including FDA compliance, ISO certification, and other industry-specific requirements. We are registered with the FDA as a medical device establishment, insured, and have a quality system in place that is compliant with the FDA's regulations under CFR 820. We provide guidance and assistance with regulatory packaging and labeling, quality control, receiving and inspections, development of work instructions and trainings, and expiration management to ensure your device is ready for commercialization and fulfillment.
Commercialization & Fulfillment
Wheelhouse Medical offers commercialization and fulfillment services to bring your medical device to market, including market research, product launch, and distribution. We provide fulfillment services such as product inventory tracking and management, purchasing, storage, and shipping. We also manage the inventory of a medical device, including tracking stock levels, reordering supplies, and ensuring that the device is readily available for distribution. Our services also include receiving and inspection, light assembly, storage and shipping, managing supply chain, products, expiration dates, lot number assignments, etc. Our team will assist you every step of the way to ensure your product is high quality, compliant and reaches your target customers.
Wheelhouse Medical Specials Program
Custom Class I Surgical Instruments
At Wheelhouse Medical, we understand that every surgeon's needs are unique, which is why we offer our Specials Program for designing custom surgical instruments tailored to your specific needs. Our program includes a comprehensive design, manufacturing, and regulatory process that ensures your instrument meets all necessary FDA requirements and is fully registered in the GUDID database with full traceability, including all documentation including a DHF, DHR, DMR, etc.
Our Specials Program is designed to provide you with a personalized solution that meets your exact requirements, no matter how complex or unique they may be. Our team of experienced engineers and designers work closely with you to understand your needs and develop a custom solution that is tailored to your exact specifications. We are committed to providing you with the highest level of service and support, from the initial consultation to the final delivery of your custom instrument.
One of the key benefits of our Specials Program is our ability to address needs that larger companies may not be able to fulfill due to the specific and specialized requirements of some surgeons. We are dedicated to providing personalized solutions that meet your exact needs, no matter how simple, complex, or unique they may be. This enables you to have full control over the design of the instrument, from its size and shape to the materials used, ensuring that the final product is perfectly suited to your surgical needs.