Design for manufacturability encompasses many design techniques that ultimately reduce cost and improve quality. It starts with designing individual components with features that reduce setups and runtime in fabrication as well as tolerancing parts for the intended fabrication method. Making intelligent material selections that reduce raw material costs and allow for the tolerances required as well as any functional needs is important. It’s also important to consider how the part will be inspected and ensure consistency between vendors and incoming metrology. The Baymar team understands and applies these principles to everything we design.
Design for assembly involves designing parts that make it easier, faster, and less likely to assemble incorrectly. There is a long list of techniques to accomplish these goals such as using symmetry so it can’t be installed incorrectly or alternatively designing a feature so it only goes together one way (poka-yoke). Reducing the number of fasteners and reducing the number of parts is a way to increase efficiency in assembly.
Cost reduction is important throughout the lifecycle of the device. In development, it’s important to attack cost reduction early and often and ideally before you start verification. Once the product is on market, there are many more constraints that make cost reduction challenging but with a team that pays attention to the details like Baymar, it can be done. We use many cost reduction techniques such as part count reduction, part complexity reduction, tolerance analysis to open tolerances where possible, and conversion to injection mold or other lower cost fabrication techniques to name a few.
Our team can design packaging to ensure your product makes it to it’s destination the same way it left the factory. We also work with your shipper or in some cases, a third party, to do shipping validation.
Labeling is a very important component of the medical device. It’s important to make sure the correct information is on the label, that the label is clear and concise, and that it is visually appealing as well. We work with regulatory and marketing teams to design or update labeling that meets everyone’s requirements.
Injection molded plastics for medical device can be very complex, whether it is design or implementation at the molder. From a design perspective, the Baymar team has experts that understand materials, drafts, textures, and how to reduce cost and complexity in molded part design. When it comes to launching a new tool, whether it is a new design, new supplier, or replacement tool, Baymar can provide technical support through the whole process. Working alongside your procurement and supplier quality teams, we can interface directly with the molder to walk through process optimization and first shots, first article parts and inspection, issue resolution, process/tool qualification, and any PPAP requirements your company may have. We have worked with many tools and many molders, both large and small, and domestic and international, to help companies meet the required CpK’s and other quality objectives.
Our team of engineers can help support your design verification process, whether it is for a new product launch or a design change. We will ensure every requirement is verified and the trace matrix ties it all together. We can support both the writing and execution of design verification for both hardware and software.
Baymar has developed benchtop reliability test fixtures in order to test the life of components such as pumps and valves as well as subsystems like fluidics modules or electromechanical systems. We have also developed protocols to test at the system level. Once we have data we can help mitigate reliability issues through redesign or alternate component selection. As with our all our services, we can manage these changes from concept to implementation including documentation, V&V, and change orders.
If you have a feasibility prototype or development concept, let Baymar optimize your design. We incorporate design methodologies such as design for manufacturability, serviceability, and assembly and cost reduction when we work through the design. We can also perform tolerance analysis to allow maximum tolerance where possible, reducing cost, and ensure tolerances are tight where needed for functionality. Let us help optimize your design and launch your product ready for production.
Our team can help design or identify appropriate techniques to validate testing methods for platforms or subassemblies as part of development or production. Our team has experience designing test method validation experiments, writing test method validation protocols, as well as analyzing test method validation data and writing the corresponding reports.
Whether it’s protocols for design verification, a design change, or an engineering study, we have written and executed those protocols. Well thought out protocols are important for risk mitigation and showing that requirements have been met, but they take time. Our team can take that off of your engineers’ full plates and ensure you have thorough and complete testing documentation.
With many of our customers, we are trained in their quality management system and have the capability of initiating and executing change orders. This takes this time-consuming burden off of your team and moves them to a review role, freeing up their time for more value-added tasks.
Our team can design, plan, execute and report findings of accelerated and real-time stability studies to demonstrate the shelf-life of instrument consumables under intended storage conditions.
Baymar can assess the long term integrity of fluid path materials using accelerated material compatibility testing. We have a calibrated incubator and measurement equipment to analyze valve components, pump components, tubing, fittings, reservoirs, and more. We can also analyze the effect on the reagent using mass spectrometry to ensure nothing is leaching into your reagents and potentially affecting patient outcomes.
We can support your team with EMC/EMI, UL, and Electrical Safety Testing. We will work with the testing service provider of your choice (or we can recommend one) to get this testing performed and also mitigate any failures discovered during testing.
Our team of scientists can design experiments for a variety of applications, including experiments to address questions or test hypothesis as part of early development and feasibility testing for reagents and assays, to establish root cause or provide on-market support, or to verify and validate product requirements. Designing a comprehensive and effective experiment requires expertise to center the testing on the right question(s), addressing all relevant factors, and including appropriate numbers of experimental replicates and controls. Our team has that expertise and knows how to identify the right functions to collaborate with (e.g. biostatistics, analytical chemistry, design transfer) to make sure the experiment is as comprehensive and effective as possible.
Our team can help design or identify appropriate techniques to validate testing methods for assays and reagents. Our team has experience designing test method validation experiments, writing test method validation protocols, as well as analyzing test method validation data and writing the corresponding reports.
As an extension of our study design services, we also write testing plans, study protocols, and study reports, as well as compiling and analyzing the experimental data collected in the studies. We also offer the possibility of executing scientific experiments in house (e.g. verification and material compatibility studies) as long as the equipment and materials needed for the study are accessible to us.
Managing design changes is one of the specialties best established across Baymar’s team, and doing so from the scientific side of an IVD product or system throughout its lifecycle is not the exception. Besides the managing of engineering changes, our team has experience coordinating and managing design changes that pertain to the scientific side of IVD products, such as: replacement of reagent raw materials, changes to reagents or formulation processes to improve the performance or stability of IVD bulk reagents and assays, among others.
Our team can design, plan, execute and report findings of accelerated and real-time stability studies to demonstrate the stability of preserved bulk or ancillary reagents and IVD assay reagents under intended storage conditions. These studies can also include comparison of preservation methods, guard-banding of raw material concentrations, stability under shipping conditions, and stability under in-use or open-bottle conditions.
Our team of scientists has the experience and expertise to assist on all aspects of the development process of an IVD assay, from conceptualization and early development, to feasibility testing and design lock, and to verification and validation of the selected design.
Our team of scientists has the experience and expertise to assist on all aspect of the development process of ancillary or bulk reagents used to supplement core IVD assays or the function of an IVD system, from conceptualization and early development, to feasibility testing and design lock, and to verification and validation of the selected design. We can assist with reagent development-associated activities such as material compatibility testing, antimicrobial resistance or bioburden testing, testing of formulation process, and concentration guard-banding testing.
We can help create and edit technical and clinical literature regarding scientific aspects of IVD products for internal and field use (non-customer-facing).
We collaborate with Development, Design Transfer, and Manufacturing to help develop standard operating procedures for use in scientific applications in development, manufacturing and QC/QA laboratories. This includes Final Acceptance Tests, Manufacturing Formulas, Standard Control Procedures, Handling of Raw Materials, etc.
The Baymar team has designed and built hundreds of assembly and test fixtures. We design holding fixtures with smart features such as poka-yoke and symmetry, ensuring your assemblies go together right the first time. Our test fixtures are designed to test subassemblies prior to moving on to the next step, preventing costly rework. We can also ensure you have the necessary documentation to support your master process validation, saving you time in your launch cycle.
If you are in need of inspection fixtures or go/no-go gauges for complex parts or custom assemblies, Baymar can apply our expertise in GD&T, inspection, and sub-assembly testing to deliver high quality inspection fixtures.
Our team of engineers have deep experience in design transfer and manufacturing line setup. We can help develop your process so it flows smoothly, allows for in-process testing, and accounts for field service sub-assemblies. We can also help develop assembly and test fixturing, tooling requirements, part presentation, and more. Assembly line design is a complex process with many factors to consider and we can help you work through them with ease.
Many times the field service team is not a priority in the development process but it’s important to have at least a preliminary set of service parts and subassemblies established at launch. The risk assessment is typically used to help determine what these should be. Baymar can guide you through this process and create custom subassemblies where required as well as determine tool requirements, in-field testing, and more.
In addition to helping identify and create service parts and assemblies, the Baymar team can help with field service procedures, custom assembly and inspection tools, testing procedures and a lot more to help create your service manual. If you’re developing new assemblies for field replacement, we can help develop service bulletins that define the procedure for proper field replacement.
It is important to inspect or test at each significant assembly step to ensure that bad product is not being passed down the line. If this isn’t done, it can result in expensive rework and delays in production. We have extensive experience developing in-process inspection and test fixtures to mitigate this risk and ensure that only good product is moving down the line.
Our team of manufacturing engineers have deep experience in equipment validation. We can both write and execute IQ, OQ, PQ and PPQ documentation for your production line, anything from basic fixtures and tools, to complex automation.
We have developed unique, model based work instructions for our clients that allow for better configuration control in development, faster time to market, and clearer procedures for your operators. By utilizing the 3D model, we eliminate the need for photographs which requires that you have physical parts on hand to even start your documentation. It also allows for exploded views, cross sections, and detailed shading to making things much more clear. We also utilize symbols whenever possible to reduce the amount of reading, allowing the operator to quickly determine what needs to be done.
The Design History File is a critical component of your device documentation. It can be a daunting task to put this together and ensure it is complete. We can help guide you through this process and support you with the technical documentation required to make this complete.
The Baymar team understands the hazard analysis, design FMEA, process FMEA, and service FMEA and can lead or participate in these important risk analysis meetings as contributors or independent reviewers.
For global companies, RoHS and REACH compliance are important steps in the development process. Baymar has supported our customers by analyzing thousands of BOM items and ensuring they meet these requirements and assembling the supporting documentation to file. If we discover that a component or material does not meet the requirements, our design team can help mitigate the problem by selecting a compliant material or component, performing the necessary verification testing, and implementing the change.
The Device Master Record generally consists of all the drawings and specifications for the finished product. We can help by creating these drawings and specifications or ensuring they are complete and all accounted for.
The DHR or traveler consists of the data related to the build. This records information like who built and inspected the product, who tested the product, what calibrated tools were used, expiration dates of materials and so on. This allows for traceability if any issues occur with the product. Baymar has extensive experience in creating the travelers that make up the DHR and can optimize these documents to give you adequate information but not be to burdensome.
The traceability matrix is what ties the requirements to design verification. This ensures that every single design requirement has been met and verified. The Baymar team has helped clean up requirements documentation and populate the trace matrix, keeping everything clear and organized to clearly show evidence that all requirements have been met.
Our team of engineers can help ensure your final bill of materials is complete and correct in your ERP. With large assemblies it’s easy to have incorrect data on the BOM which can result in variances and potentially delays in manufacturing. We can check the BOM between the assembly drawings, work instructions, and your ERP, ensuring everything is matching.
With unique or complex components, it is highly recommended that you develop inspection procedures to define exactly how the part is to be inspected. This ensures consistency between the vendor and the customer resulting in less discrepancy and potentially failed components on the dock. If you have subassemblies made elsewhere, it’s important to have testing or inspection of that assembly which may require special equipment or procedures. Baymar can develop all of this for you, resulting in a smooth inspection process.
In addition to developing the tooling and fixtures, Baymar can develop the procedures for in process inspection and testing. It’s important that these procedures are unambiguous and well defined to ensure that bad product does not pass down the line. These procedures can also be used for testing service assemblies.
Final acceptance testing is one of the most critical pieces of the assembly process. This ensures that the product is built correctly and ready to meet the patient. Baymar will use inputs from design verification and the risk assessment to determine a comprehensive final test that ensures the product meets the requirements and is ready to help patients.
Baymar has a long list of engineers that are trained in geometric dimensioning and tolerancing (GD&T). Our team is obsessive over the details which ensures that parts are clearly defined and toleranced to allow for proper fit as well as toleranced appropriately for the manufacturing method of the part. We do drawings all day and every day and we can be a huge help to your team, whether it is revising drawings for creating them from scratch.
Our project management team can help track the configuration of builds during prototype, verification, and validation builds. This is important to have in the DHF and is very useful when trying to track down issues. This is time consuming detail work but important to the process.
All projects at Baymar are managed using the Agile methodology. With an Agile team mentality, Baymar can adapt to project changes in a quick, effective manner. We do this by emphasizing stakeholder involvement and communication.
Our project managers work with your vendors to ensure they are meeting expectations and work through any non-conformances or design issues with them. This includes everything from machined parts to sheet metal to injection molded parts.