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.
NCR and CAPA resolution is critical to any medical device company. This is one of the key areas the FDA looks at when they perform an audit. It’s important to be both thorough in the investigation and timely in corrective and preventive actions. Baymar can support entire NCR and CAPA projects from root cause investigation to designing both a short term immediate fix to a long term preventive fix. Our team can write and execute the necessary verification and validation protocols and update the risk documentation as well. We are experts at working within the restrictive on-market redesign constraints. If field replacement is required, we help ensure it can be done in the field by your service team or the customer as required. We also ensure they have the instructional materials and tools necessary to get the job done. We also make sure the production team has the updated documentation, training, and tools they need to implement the change. Baymar handles every detail to make NCR and CAPA resolution as painless as possible.
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.
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.
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.
Our team has developed significant expertise with the requirements covered by Europe’s new and complex IVD regulation (IVDR), performing a variety of activities meant to make all future and existing products fully compliant with the regulation. Our experience includes conducting gap analysis to determine what’s required to make an existing product fully compliant with IVDR requirements, designing and writing regulatory documentation included in IVDR (e.g. Performance Evaluation Plans, Analytical Performance Reports, Performance Evaluation Reports), assisting with other IVDR documentation requirements (e.g. Intended Use Statements, Scientific Validity Reports, Comprehensive Literature Reviews, Clinical Performance Reports), and updating regulatory risk management documentation to comply with IVDR (e.g. FMEAs, Risk Management Reports), among others.
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 has the experience and expertise to develop and validate effective system decontamination processes, as well as improving existing ones to address chemical and microbial contamination issues.
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.
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.
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.
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.
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.
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.