Technical Feasibility

Creating engineering solutions for technically difficult designs and products.

Conducting a Technical Feasibility study is part of our process for creating engineering solutions for technically difficult designs and products. Proaug prides itself on being able to provide innovative solutions to our customer’s needs and it is important to take into consideration production methods, production techniques, overall project requirements and project location and/or application when determining the best overall methods for your product design and development needs.

By systematically going through various aspects of the project, a detailed understanding of its feasibility can be established, and a conclusion reached, on how a project should be developed. Proaug prides itself on being able to provide innovative solutions to our customer’s needs while also making sure the results are viable. Concepts are generated based on the industrial design, evaluated against project requirements and refined to achieve a feasible design approach while also taking into consideration that developing today’s technologies requires an understanding of the human mind and body more than ever.

The objective of the technical feasibility step is to confirm that the product will perform and to verify that there are no production barriers. Commitment to cutting-edge technology and thoughtful problem solving result in knowledge about the product or process design, performance, production requirements, and keeping production costs reasonable. Here at Proaug, we strive to save you time and money through concept generation, concept refinement, prototyping, and testing. Our experience, mechanical expertise, and persistence help us focus in on the necessary modifications to produce a better performing product for our customers.

At Proaug, we ask questions that lead to big picture thinking, ie we are constantly considering technical feasibility aspects for our projects with the end result being solutions that exceeds your expectations. Our results speak for themselves; we have a history of delivering designs that meet our stringent performance requirements and also the goals and timetables of our clients, which include some of the most recognized companies in the world.

Product Developement

Developing new products with creative design solutions, expert mechanical engineering techniques, and patented new technologies and strategies.

Proaug is a full-service product design and development firm with a passion for developing new products with creative design solutions, expert mechanical engineering techniques, and patented new technologies and strategies. Although product development is creative, it also requires a disciplined, systematic approach to guide the processes that are required to get a new product from an idea to a marketable product.

At Proaug we specialize in designing medical, consumer electronic, military, energy and industrial electronic products with an emphasis on innovative, small, rugged and cost-effective designs which means our engineers have extensive experience in designing products for some of the most demanding environments. We have a strong track record and experience in delivering quality mechanical solutions for high-tech products.

Identifying design criteria, analyzing potential solutions, generating concepts and prototyping are all integral parts of our product development process. Through this methodology, we ensure our designs and concepts have passed muster, made business sense and have offered excellent value. Industrial design surfaces and conceptual layouts are used as the basis for the creation of detailed parametric 3D solid models (NX, CREO or Solidworks). Design for Manufacturing (DFM) and Design for Assembly (DFA) input is incorporated to ensure that the models are inclusive of manufacturing features and can be manufactured.

Proaug engineers have undergraduate and advanced degrees in physics, mechanical, aerospace and quality engineering; including registered professional engineers and a six sigma black belt. With these capabilities in-house, our clients save time and money in getting to market. You won’t waste valuable time interfacing between a design house, engineering company, prototype shop and factory. Our expert project managers take the hassle and confusion out of product development with our integrated approach. With design and engineering expertise in a variety of industries, we approach all projects from a functionality, cost/manufacturability and consumer appeal standpoint.

Engineering Analysis

Effective use of simulation reduces development costs and time to market.

Engineering analysis distinguishes true engineering design from “tinkering”. Once you’ve conceived alternative solutions to your design problem, you need to analyze those solutions and then decide which solution is best suited for implementation. Analysis is the evaluation of the proposed designs. At Proaug, effective use of simulation reduces development costs and time to market. After analyzing your alternative solutions, you need to decide and document which design solution is the best.

Computer models and prototypes yield valuable information to assist in the decision phase. Proaug will conduct dynamic, static, and/or thermal analysis using the Solidworks Simulation FEA software package. Solidworks is a solid modeling computer-aided design (CAD) and computer-aided engineering (CAE) computer program that allows us to raise the quality of your products while reducing costs for prototypes and testing by easily subjecting our designs to real world conditions.

Since every design problem is unique and requires different types of analysis, we utilize a variety of methods to assess viability. Tolerance analysis will be conducted on interfaces that are identified as critical for function using a Proaug’ proprietary software application. We believe that a thorough understanding of variation in part dimensions and assembly constraints propagate across parts and assemblies, and how that total variation affects the capability of a design to achieve its design requirements within the process capabilities of manufacturing organizations and supply chains.

Our next level engineering analysis methods provide us with the ability to exceed expectations while sill maintaining our commitment to providing innovative solutions to our customers needs. Our tag line says it all: “Product Designed for the Way We’re Designed”. For us, it’s more than a slogan—it’s a mission to look at technology from the perspective of the person who will be using it. Proaug will continue working with great partners who are humanizing the technology that we create through our collaborations.

Supplier Support

Proaug is capable of establishing the entire supply chain to meet prototype or production volumes.

Suppliers are an integral part of our success. Our supply management system helps to reduce the complexity of the manufacturing process for our customers. By partnering with our suppliers, we go far beyond simply filling orders. Through ongoing communication and support we have forged strong supplier relationships that offer significant advantages to our customers. Proaug is capable of establishing the entire sequence of processes involved in the production and distribution to meet prototype or production volumes that meet the needs of our customers.

The value Proaug brings to our customer extends beyond mechanical product design. An efficient supplier support system must be reliable and result in a quality product that meets the manufacturer’s needs while assuring that the product is delivered on time. Proaug can provide complete design solutions by leveraging our network of supply partners who specialize in hardware, software, prototyping and manufacturing in order to provide the best solutions to our customers. Proaug works our clients to develop a custom solution to meet and exceed their expectations We maintain our supplier relationships by focusing on earning trust, maintaining alignment of our customers goals with our deliverables, maintaining transparency throughout the process, staying abreast of current trends in technology and maintaining resiliency of our supply chains, all while maintaining our high standards of excellence.

Since our inception in 2003, Proaug has built a reputation as a trusted partner for some of the most recognized companies in the world. We work with our extensive group of partners to provide prototyping and production solutions to our customers. Prototype processes include stereo-lithography (SLA), selective laser sintering (SLS), direct metal laser sintering (DMLS), 3D printed parts, urethane molds, computer numerical control (CNC) machining, sheet metal laser cutting and forming, etc. Production process include injection molding, die casting, progressive stamping, weldments, contract manufacturing, etc. Proaug’ optimized system of supplier support lowers your costs while accelerating the production cycle.

Verification

The design is evaluated for compliancy to the product requirements specification.

At Proaug, we strive to ensure that we meet or exceed the requirements for our designs. Carefully evaluating designs for compliancy to the design specifications and correctness, completeness, and consistency throughout the process are the keys to meeting and exceeding project goals while keeping overall costs reasonable.

As our customers projects move from concept to production, our verification processes track the project activities against the plans and ensure that requirements for design, implementation, and testing are being met consistently. If the project is deviating from the plans, then a course correction is required. Either the plans need to be changed to reflect reality (while still embodying a quality process), or the project needs to refocus on the defined processes. It’s very easy to throw processes out the window when schedules get tight, but experience has shown that doing so only makes it more likely that additional problems will be created. Planning and implementing a quality process help projects avoid costly missteps.

Simulation is one of the primary ways that the design synthesis process is verified. At Proaug, our engineers generate the test benchmarks, define the simulation runs, and perform simulations based on project requirements. Testing is performed in-house or at local accredited agencies capable of exposing and certifying the product against standards such as MIL810, ISO 60601, UL or CE.

Identifying design problems, and solving them as early in the design cycle as possible, is the key to keeping projects on time and within budget. By conducting thorough verification and validation, we can assure our customers that our deliverables have been stringently evaluated and meets the needs of the customer while complying with regulations, requirements, specifications, or imposed conditions to ensure that they perform to design goals and specifications. Proaug’ product verification and validation provides timely data during all phases of the product development cycle which is critical in making decisions about the products being released to the marketplace.

Industrialization

Turning good ideas into great products.

The transition from the design phase to the mass production phase is critical and requires the consideration of various constraints: technical, organizational, economic and human. The industrialization engineer plays a key role in this complex process. To meet the needs of our customers Proaug engineers have undergraduate and advanced degrees in physics, mechanical, aerospace and quality engineering; including registered professional engineers and a six sigma black belt. The value Proaug brings to our customer extends beyond mechanical product design. Proaug can provide manufacturing support, conduct supplier audits, and handle all part approval activities.

A management process with well-defined milestones and targets guarantees the achievement of high-level quality and production targets at lowest production costs. Proaug prides itself on being able to provide innovative solutions to our customer’s needs. By consistently performing manufacturing process analysis we maintain and grow our knowledge of the newest manufacturing methods and utilize them in our industrialization analysis. We strive to provide technical leadership and guidance to our customers throughout the design, development and production process.

Proaug is focused on providing engineering services in five major markets: industrial, military, consumer, energy, and medical. This diversification promotes “cross pollination” of ideas and technologies that ultimately bring value to all of the products we develop. Proaug engineers are experienced designing products that meet stringent safety ratings, are durable and ergonomic while maintaining cosmetic sensibility. Proaug has extensive experience integrating hardware, acoustics, antennas, displays and other electromechanical components into a package that can withstand consumer abuse.

At Proaug, our engineers work diligently to eliminate waste of time, money, materials, man-hours, machine time, energy and other resources. We accomplish this by investing in product knowledge and production activities, by analyzing the goals of production tasks, focusing on part standardization, preparing assembly and other technical work instructions, leading prototyping activities and working to resolve and provide guidance on technical issues for our deliverables.

Production/Quality Support

The Proaug team includes Six-Sigma Black Belts capable of auditing supplier quality processes and procedures.

Once designs have been thoroughly vetted, they must be produced at volumes to meet the needs of our customers, bringing another level of quality control to the process. When managing a mass production line, our primary goal is to ensure the highest quality in manufacturing and that when our products are shipped to customers we are not only meeting timeline projections but also exceeding customer expectations. At Proaug, the importance of monitoring production quality and efficiency is paramount. Our team includes Six-Sigma Black Belts capable of auditing supplier quality processes and procedures which enables us to better identifying and removing the causes of defects and minimizing variability in manufacturing and business processes.

Each discrete stage of the production flow should be tested before your product can move on to the next. Proaug works with the manufacturers to understand their process capabilities and to create designs capable of achieving the desired product quality. This includes conducting Design for Manufacturing (DFM) and Design for Assembly (DFA) reviews with the manufacturers during the design process and conducting gap analysis using a Proaug internal tolerance analysis tool to establish proper dimensional tolerances. This data provides invaluable information. It allows us to conduct root cause analysis of quality issues, and improve production quality.

Manufacturing and business processes have characteristics that can be defined, measured, analyzed, improved, and controlled. At Proaug, product development engineering and manufacturing engineering translate design requirements into manufacturing requirements to ensure device master record is complete and provide guidance to design engineering, manufacturing and product quality engineering for development of manufacturing test/evaluation methods and process validation.

Our continuous efforts to achieve stable and predictable process results result in sustained quality improvement. Our commitment to “Product design for the way we’re designed” has resulted in our engineers being named over from mechanical devices to software and extending across a wide range of products and Proaug receiving awards from both the Department of Energy and Department of Homeland Security.

Regulatory Affairs

The Proaug team includes Six-Sigma Black Belts capable of auditing supplier quality processes and procedures.

Proaug provides comprehensive Regulatory services of global product development, registration and commercialization. We deliver informed advice and pragmatic services and solutions for new product and market authorizations, Health Authority submissions, post approvals, CMC and lifecycle management to help companies maximize their product’s commercial potential and market success. Proaug’s global Regulatory affairs expertise enables Life Sciences and Bio-Med companies understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in order to successfully launch their products in new markets and maximize the value of their assets.

Medical Devices Europe Market

Any medical devices that you need to sell in Europe you must first obtain CE Marking certification, more commonly referred to as the CE Mark. The path to CE Marking approval involves compliance with the current Medical Devices Directive (MDD) or the new European Medical Device Regulation (MDR), which takes effect on May 26, 2020. Whether you are introducing an entirely new device into the EU market or you need assistance transitioning an existing medical device with CE Marking certification,

Gap assessment examines your existing documentation to determine your readiness for CE Marking submission under the EU MDR

If you currently have FDA 510(k) clearance and want to pursue European CE Marking certification, we can examine your current technical documentation to determine what is needed before pursuing CE Marking certification for your device. Our comprehensive audit will look at your device history file, risk procedures, clinical data, testing reports, post market surveillance (PMS), labeling, and much more, providing you with a clear picture of what needs to be done. Proaug can then help you fill the missing gaps in your existing documentation as needed to support CE Marking submission.

Transitioning existing medical devices with CE Marking under the MDD to the EU MDR

The new EU MDR will impose new requirements on manufacturers to demonstrate the safety and efficacy of their devices. Most of the devices that currently have CE Marking certification under the Medical Devices Directive (MDD) do not have adequate supporting documentation to meet the requirements of the EU MDR. Proaug can examine your existing Technical File or Design Dossier and prepare a comprehensive report of shortfalls. Common areas we address for clients include clinical literature reviews, risk procedures, post market surveillance, Economic Operator agreements, and product life-cycle management.

Our CE Marking certification support for medical devices includes:

• Determining the classification and regulatory pathway for your device.
• Performing a gap assessment of your existing technical documentation.
• Compiling your documentation – including your Clinical Evaluation Report and risk assessment – in support of a new CE Marking certification.
• Assisting with MDD to EU MDR CE Marking transition strategy for existing device portfolios.
• Evaluating or implementing an ISO 13485-compliant quality management system.
• Preparing for the Notified Body inspection of your quality system.

Pharmaceuticals Support: (API/Formulations)

• Global Regulatory filings to US (ANDA/NDA/USDMF), Europe (MAA/MAV/ASMF), Canada and Row market
• Dossier preparation for different countries: Dossier preparation and compilation as per Common technical dossier (CTD format/ Asian Common Technical Dossier (ACTD) Guidelines.
• Preparation of DMF/ASMF/ADMF/ CEP or (CoS): Drug Master File (DMF) compilation for open and closed parts.
• Critical Review of Dossier and Preparation of GAP Analysis Report.
• Handling health authority queries / requests for additional information and post approval change management.
• Handling of customer queries / requests for additional information.
• Technical Support in CMC-Writing, SOP Writing, Protocol Writing, Expert report (QOS) preparation.