End-to-end management, or a boost in one area, we’re ready.
Supporting Your Device at Any Stage
We offer a comprehensive suite of services to support the entire lifecycle of a medical device. Engage us for the full journey from idea to launch, or tap into our expertise wherever you need it most. Our approach is flexible and tailored - think of it as having any department of a medical device company on demand.
Engineering & Design Controls:
Regulatory & Quality Management:
Regulatory & Quality Management:
We turn concepts into reality. Our engineering team uses advanced CAD tools to design and iterate your device, creating prototypes for hands-on evaluation. Crucially, we manage formal design controls – mapping requirements, risks, and specifications – to ensure your device design is robust, safe, and on track for regulatory approval.
Regulatory & Quality Management:
Regulatory & Quality Management:
Regulatory & Quality Management:
Navigating FDA regulations and quality standards is tricky – we’re here to guide you through it. From compiling your Design History File and Device Master Record to implementing a risk management plan, we build the documentation you need for compliance. Already selling a device? We can handle complaint investigations and even FDA adverse event (MAUDE) reporting on your behalf, keeping you compliant post-launch.
Manufacturing & Supply Chain:
Regulatory & Quality Management:
Wheelhouse is an FDA-registered contract manufacturer, ready to produce your device with precision and care. We coordinate vendor sourcing and component procurement, validate manufacturing processes, and oversee assembly. Need sterile packaging for the OR? We’ll manage that too. Our supply chain management ensures that materials and parts flow smoothly, so your product is made on time and on spec.
Operations & Fulfillment:
Operations & Fulfillment:
Beyond making the device, we help get it to your end users efficiently. We offer kitting and assembly services (for instance, putting together surgical instrument sets), warehousing, inventory management, and distribution logistics. Whether you’re shipping to a few hospitals or nationwide, we can serve as your operations backbone – making sure finished devices are packaged, stored, and delivered where they need to go.
Benchtop Testing:
Operations & Fulfillment:
Reprocessing & Cleaning:
Quality assurance is built into everything we do. We perform rigorous incoming inspections of parts and detailed dimensional analysis to confirm components meet design tolerances. Our team can set up custom testing protocols for your device and even provide contract inspection services (using vision systems and other metrology tools) for high-volume quality checks. Nothing leaves our facility without meeting the quality bar.
Reprocessing & Cleaning:
Operations & Fulfillment:
Reprocessing & Cleaning:
For reusable or trial devices, proper reprocessing is vital. We provide biohazard cleaning and re-sterilization preparation services. For example, if you have surgical instruments that come back from evaluations or clinical use, we’ll ensure they’re safely cleaned, disinfected, and packaged for the next use. This helps you manage pilot programs or limited-market releases without worrying about the dirty work (literally).
Receiving and Inspection
Receiving medical devices is a controlled process that is outlined in our Quality system. We cross reference the purchase orders and maintain all the manufacturing documents. Inspection of medical devices requires up to date calibrated instruments and a time intensive process. Occasionally, parts do not meet specifications and we document this on an NCR (non-conforming report) and collaborate with the manufacturer to address those issues.
Light Assembly
Experience with medical device assembly to include inventory tracking, inspection, work instructions, training, quality control, and lot number assignment.
Patent & IP Support:
We’re unique in that we care about your intellectual property as much as you do. We can connect you with specialized patent attorneys who know medical devices, and we assist in providing technical drawings or prior-art research to strengthen your patent applications. And remember, your device and IP stay yours – we’re here to help you protect it, not to claim it.
Inclement Weather Inventory Storage & Fulfillment
Experience with medical device assembly to include inventory tracking, inspection, work instructions, training, quality control, and lot number assignment.
Showcase & Tradeshow Models
Experience with medical device assembly to include inventory tracking, inspection, work instructions, training, quality control, and lot number assignment.
Facilities & Equipment:
Our infrastructure is ready for serious manufacturing. We maintain a climate-controlled warehouse to protect sensitive materials and products. Our facility has industrial 3-phase power for advanced manufacturing equipment and a loading bay for easy shipping and receiving of large freight. In short, we have the space, power, and tech to scale with your project’s needs.
Laser Marking
Project Management
Laser Marking
Project Management
Laser Marking
Project Management
Project Management
Project Management
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.
Available Commercial Space
NEWLY AVALIBLE: Wheelhouse Medical’s XXX sq. ft. bay-access, controlled warehouse is open for new projects. The space features three-phase power capabilities in a temperature- and humidity-controlled environment, providing an ideal setting for our trained staff to support commercial manufacturing, sterile packaging, and fulfillment.
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.