5 Misconceptions About Medical Device Contract Manufacturing The medical device industry is a fast-paced and ever-changing field. As medical device companies work to bring new medical technologies to the market, they face many challenges. One of these challenges is that medical device companies often have limited in-house manufacturing capacity. In this situation, medical device contract manufacturing can provide a solution that helps medical device manufacturers gain access to medical devices without adding significant overhead or taking up valuable resources. The medical device industry has many misconceptions about medical device contract manufacturing, and it is important for companies to know the truth behind these myths in order to make an educated decision when choosing a partner. MISCONCEPTION #1: THE COSTS INVOLVED IN SWITCHING PRODUCTION TO A CONTRACT MANUFACTURER ARE PROHIBITIVE It’s true that there are costs involved in switching medical device production to a contract manufacturer, but the benefits of outsourcing far outweigh the costs. Capital expenditure associated with the purchase and maintenance of the necessary machinery and skilled staff to facilitate in-house production is significant. When you choose to outsource, the costs are drastically reduced and medical devices can be made more efficiently and quickly. Contract manufacturers are adept at reducing cost and maximizing efficiency, providing medical technologies that meet the highest quality standards at a cost that is typically lower than many expect. MISCONCEPTION #2: WHEN OUTSOURCING, IT IS IMPOSSIBLE TO MAINTAIN CONTROL OVER THE PRODUCT With in-house production, you have full control over every aspect of the production process and while this may sound like the most sensible plan, if you choose the right contract manufacturing partner, any concerns around losing control over your product can be laid to rest. Naturally, with the outsourcing of any product, you may lose a measure of control around the processes. However, this should not dissuade you from exploring contract manufacturing options. When working with an experienced medical device contract manufacturer, you will normally be assigned a dedicated project manager providing full transparency in the production process, and enabling you to be fully involved at every stage if desired. MISCONCEPTION #3: OUTSOURCING WILL DECREASE QUALITY OF THE PRODUCT While medical device manufacturing is a complex process, when working with an experienced medical device contract manufacturer that you are confident in, outsourcing can actually help to improve quality control processes. Quality control and regulatory compliance is a critical part of medical device manufacturing and your chosen medical device contract manufacturer should be well-versed in all current regulations. Always check that they have departments or staff dedicated to quality assurance! Working with an experienced medical device contract manufacturer can help to ensure that your product meets quality standards while also saving you time, money, and resources on any additional compliance work needed for regulatory agencies. MISCONCEPTION #4: IT TAKES TOO LONG TO TRAIN PEOPLE ON SPECIFIC PROCESSES WHEN OUTSOURCING When it comes to training, not all medical device contract manufacturers are created equal. When you opt to outsource your medical device manufacturing, make sure your chosen partner is experienced in the medical device industry and has a good track record of producing medical devices to high standards. Hiring and training in-house employees can be extremely time-consuming, however by working with an experienced medical device contract manufacturer, there will likely be skilled workers who are already fully trained and equipped to operate the necessary equipment and carry out industry-specific processes. MISCONCEPTION #5: MEDICAL DEVICE CONTRACT MANUFACTURING IS ONLY FOR SMALL COMPANIES Outsourcing medical device manufacturing is not just beneficial to small companies. Many medical technology companies and medical device manufacturers find great value in outsourcing their medical device production or assembly and rely on experienced medical device contract manufacturers who can meet the needs of large-scale projects while still maintaining high-quality control standards that will meet the medical device regulatory requirements. By outsourcing medical device manufacturing, large companies can still work flexibly, maintain a lean workforce and keep costs low. As you can see, there are lots of misconceptions about medical device contract manufacturing, from how it works, what people should expect when they work with an outsourced manufacturer to produce their product, and the time and costs associated with doing so. Now that we’ve outlined the main misconceptions and addressed common concerns, we hope you better understand the process and are able to make a more informed decision when it comes to contracting out medical device production for your company. WHAT MISCONCEPTIONS HAVE YOU HEARD ABOUT MEDICAL DEVICE CONTRACT MANUFACTURING? There are many benefits of outsourcing medical device manufacturing, but medical device contract manufacturers should be chosen carefully. Do your research, ask the right questions, and find a medical device contract manufacturer that is experienced, highly skilled, and provides the resources required to meet all of your medical device needs from start to finish. If you're looking for a dedicated medical device manufacturing partner feel free to contact us! We provide medical device contract manufacturing for a variety of medical devices and we look forward to discussing the possibility of partnering with you on your next project. Please contact sales at sales@appliedengneering.com Applied Engineering October 7, 2021 How to Grow Your Business with Contract Manufacturing Services Every business wants to grow, but with business growth and expansion comes a multitude of new challenges. While it may seem simpler to outsource many of these new challenges, there are some aspects that business owners are reluctant to contract out. One of the most complex challenges for many growing businesses is volume production. Production takes up considerable time and resources; it requires the need for more space, more skilled labor, production capabilities, and more. As companies grow, it’s common to find themselves spending less time on revenue-generating activities like marketing or product development as they struggle to keep up with demand. Production, however, is also one of the areas that many are reluctant to outsource. This reluctance often stems from a fear of losing control over the quality and operations of their product or service, but contract manufacturing services can provide this reassurance while also allowing for business growth. If you are a growing company looking for new ways to scale operations, contract manufacturing services offer an easy and cost-effective solution that can increase production capacity while creating more time for focus on your core competencies. You can dedicate more time to research and development, and revenue-generating activities such as sales and marketing and securing new client accounts. Reports show that many companies across the globe are still not using contract manufacturing to its fullest potential in gaining the competitive advantages it can provide. The reality is that using contract manufacturing services is a great way to grow your business while minimizing the risks! Let’s take a closer look at some of the benefits and provide insight on how it can help you grow your business... BENEFITS SPACE & SKILLED LABOR A contract manufacturer offers more than just the physical space and equipment needed to produce your product. They will also provide skilled labor that is trained in your specific process requirements. This ensures consistency in your products and also saves you time. Contract manufacturing solutions give businesses access to much-needed production capacity that would otherwise be out of reach due to lack of space, labor, or expertise without increasing capital expenditures or permanent staff requirements. CONSISTENT QUALITY Contract manufacturers ensure quality control through stringent auditing processes that verify the production process is being followed correctly on all levels of production to meet your specifications. MAXIMUM EFFICIENCY A contract manufacturer can help small businesses maximize production, reduce overhead expenses, and increase cash flow by using their expertise to ensure a streamlined and efficient manufacturing process. They can be responsible for overseeing all of the steps involved in creating an individual product - from design to raw material acquisition to the final product assembly. ABILITY TO COMPETE WITH LARGE ENTERPRISES Contracts manufacturers have access to advanced machinery and technologies that make them world leaders in their field. These resources allow manufacturers of all sizes an opportunity to compete with large enterprises. QUICKER TURNAROUND SPEEDS - COST SAVINGS - IMPROVED MARGINS Put simply, more products are marketed faster, at competitive prices. With greater efficiency comes faster time-frames; you can meet deadlines more quickly and see improved margins on per-unit costs. LOWER INVESTMENT Contract manufacturing services are a low-cost investment, with turnkey solutions available at all price points. For those looking to scale their production volume for the first time or grow an existing product line, contract manufacturers provide access to much-needed capacity that can be scaled up and down as your business needs change; they don't require the high fixed costs of owning a production facility. Contract manufacturers can provide solutions for a variety of industries, such as aerospace, automotive, semiconductor, and medical devices. Whatever your industry, it’s worth doing some research to see whether contract manufacturing might be the right move for your business. HOW TO CHOOSE THE RIGHT CONTRACT MANUFACTURER? The process of selecting a contract manufacturer can seem daunting, but there are some things you can do to ensure you find one that will fit your needs and grow your business. Before you start looking, take some time to think about what is important to you in a manufacturing partner. Is location an issue? Do you need them to have experience working with other companies like yours? Once you’ve identified these criteria, it will make the process easier. Obviously, not all contract manufacturers are the same and your decision will need to consider what services they offer, their capacity for production as well as a variety of other factors. Contract manufacturers have different areas of expertise, so you need to make sure you do your research to find a contract manufacturer who can meet all of your needs. Please consider the following when choosing your contract manufacturing company: Do they have experience working in your industry? Do they have a strong supply chain team with a global footprint? Are they utilizing a rigorous inventory management process? Does the company have a dedicated Quality team and Program in place? How does their capacity compare with your current needs or desired growth plans? Are they reliable enough to meet your deadlines, quality standards, and target costs? Do they provide dedicated resources to your program? Are they ISO certified and/or registered to manufacture to your industry standards? What is the process of placing an order with them, from concept to delivery? Contract manufacturing, when done correctly, is an easy and cost-effective way to grow your business. It minimizes risk and provides consistent quality while maximizing your own internal resources to focus on other key areas of your business. It enhances your ability to compete with larger enterprises, generates quicker turnaround speeds, and improves cost savings. When you're ready to take your business to the next level, it's important that you have a trusted partner in manufacturing. There are many benefits of partnering with a contract manufacturer and we hope this blog post has helped you understand some of the advantages of utilizing contract manufacturing solutions and how they can help grow your company. At Applied Engineering we can work with you to provide a cost-effective solution to meet your production needs. We're always happy to answer your questions about contract manufacturing services and discuss how we can help you grow your business. Contact Applied Engineering today for more information on our offerings and solutions. We'd love to hear from you! Applied Engineering September 3, 2021 6 Reasons Supply Chain Outsourcing Is Right for Your Business As a fundamental building block in all businesses, supply chains have been undergoing dramatic changes over the past few decades as a result of globalization and advances in technology. Effective supply chain management has increased in importance for this reason and is crucial to business success whatever the industry. Supply chains have now become a complex and integrated system of processes and resources for: Sourcing Producing Delivering Satisfying customer expectations They can be expensive to manage in-house and often companies are better off outsourcing these responsibilities. For most organizations outsourcing their supply chains is fast becoming a necessity. Not only do these companies have to deal with ever-evolving business models but also numerous constraints such as stringent government regulations, limited financial resources, and changing consumer preferences. This alone may be enough for an organization to explore strategies that can provide access to flexible solutions that help them offer the best products and services to their customers. Businesses today need a mechanism that can help them thrive under all these pressures and improve operational efficiency. One such approach is outsourcing your supply chain. Outsourcing supply chains can help businesses: Reduce operating costs Improve resource allocation Increase efficiency of supply system management Simplify logistics operations across the supply chain network And more ... It is an extremely common practice for businesses today to outsource one or more aspects of their supply chain. A solution that has been growing rapidly over recent years is for businesses to opt for Total Supply Chain Outsourcing (TSCO) which encompasses many different supply chain-related services within one package. For businesses who want to quickly improve their supply chain management, this can be a great beneficial option. By combining all aspects of the supply chain into an outsourced solution, a business can save time and money, as well as ensure seamless communication between internal departments and external partners. The global supply chain management market is on track to grow at a CAGR of 11.2% from 2020 to 2027 with the market reaching $37.41 billion in 2020 according to Businesswire. It's not surprising then that the outsourcing of supply chain functions has gained so much traction in recent times. Companies worldwide are constantly looking at new and improved ways of reducing costs and speeding up their time to market while scaling up/down as needed with procurement capabilities. But is it right for your organization? Whether you are considering outsourcing just one aspect, or your entire supply chain management, here are six reasons why supply chain outsourcing is the right move for your business. REDUCES COSTS Outsourcing supply chains can help you optimize costs by streamlining processes. This means that you will have fewer employees on staff and spend less on in-house services. By improving an inefficient supply chain, companies can reduce their overhead expenses, producing significant cost savings while still maintaining product quality levels or even increasing them. EFFICIENT LOGISTICS MANAGEMENT When it comes to managing suppliers, distributors, and customers across long distances; supply chain management becomes more difficult with each added mile of distance. As such, logistics management has become a major challenge for supply chain managers. Outsourcing supply chains can be a cost-effective way to manage logistics and improve supplier relationships, all while ensuring that your customers are satisfied with the products they receive from you. MITIGATES RISK Outsourcing reduces problems associated with each individual aspect of the supply chain. Specialist companies who are more knowledgeable about your market and better equipped to handle manufacturing/assembly, inventory and distribution will work together with you to provide a unified view of the supply chain, allowing you to better fulfill orders while mitigating risk. Outsourcing can also serve to reduce the financial risks of large capital equipment investments, extra manufacturing space, transportation, and of course labor. INCREASES PRODUCTION CAPACITY AND EFFICIENCY Supply chain outsourcing can help you reduce lead times by replacing in-house production with external suppliers or contract manufacturers. This will allow you to focus on your core competencies in order to compete more effectively and achieve faster production cycles. This in turn results in improved levels of customer service and assists in ensuring you can consistently meet customer demands. INCREASES GLOBAL REACH AND ACCESS TO NEW MARKETS In the global environment, reacting to a changing economy and tightening competition from business rivals of a similar product line is difficult without proper planning. Outsourcing provides an opportunity for such companies to have a stronger position by expanding their operations globally. This can provide them with access to new markets utilizing supply chain expertise in other countries or regions of the world while maintaining a streamlined and efficient supply chain. MITIGATES ENVIRONMENTAL IMPACTS Outsourcing can also help companies meet sustainability goals within the supply chain. By implementing supply chain strategies that cut down on the use of fossil fuels and increase energy efficiency, companies can reduce their environmental footprint and create a more sustainable supply chain from development and contract manufacturing right through to product distribution. Applied Engineering August 23, 2021 6 Benefits of Robotic Systems Integration Industrial robots were first invented in the 1960s, and the company General Motors used the first one. According to Mike Wilson, author of Implementation of Robot Systems, there were over 2 million robots installed in different industrial sectors in 2015. This number has increased as more and more manufacturers introduce robotic systems integration into their production lines. It’s one of the latest technologies, dubbed the future of manufacturing. Despite an increase in popularity over time, there are still some misconceptions when it comes to robotic systems. Some assume that with robot integrators, it is too expensive and only suitable for mass producers such as large automotive manufacturers. This is not the case. Automation solutions like robotic systems integration are quite accessible and have a number of benefits for both low and high-volume production. There are robotic systems options available that will fit the budget, needs, and space of any production line. Robotic integration uses robotic systems to provide automated solutions. It’s the process of programming these systems to complete specific automated manufacturing tasks. A crucial part of robotics systems integration is the integrator. A robotic systems integrator will analyze manufacturing needs, provide custom solutions, design, and then support the robotic system. Robotics system integration is an adaptable technology used in many industries, including medical and industrial. Many common industrial uses include assembly, painting, dispensing, palletizing, production inspection, material handling, welding, and production testing. Robotic systems integration is very flexible, scalable, and accurate, providing a significant return on investment. BENEFITS OF ROBOTIC SYSTEMS INTEGRATION There are plenty of benefits to introducing robotic systems integration into your manufacturing process. As you will find in the following list, benefits are relational, meaning that when you utilize industrial robots you will receive all of the benefits listed rather than one or two. Robotic systems integration: Improves accuracy and precision: Industrial robots achieve an exceptional level of precision. Increases consistency: Tasks are always completed with the exact specifications needed, every time. With better consistency and quality, there is also a reduction in production costs. Boosts speed: Industrial robots complete automated tasks at a much faster rate. The timing to complete a task is predictable and can positively affect the production line. Saves on labor costs and better utilizes employees’ skills: When an industrial robot is completing routine tasks, you can either reduce labor or assign employees to other jobs where their skill sets are better utilized. Improves floor utilization: Industrial robots take up less space than employees as they don’t need aisleways to walk to and from machinery. Fosters a safer workplace: Complete high-risk tasks completed by industrial robots keep employees out of danger and reduce occupational hazards. As experts in manufacturing engineering and robotics integration, Applied Engineering has worked with manufacturers from prototype to high volume production. Bringing their passion and expertise, the team can work with you to design solutions that will help you achieve the six benefits of robotics system integration listed above. For more information, contact sales@appliedengineering.com. Applied Engineering August 3, 2021 5 Compelling Reasons to Outsource Electro-Mechanical Assembly Without question, a primary factor for any equipment manufacturer in today’s competitive market is its ability to create and maintain innovative products that align with what clients need while keeping an eye on the future of their industry. In a bid to remain competitive and maximize profits, many manufacturers choose to outsource their non-core areas. This of course can greatly increase efficiency by freeing up time and resources to perform core functions so that other aspects of the operation succeed at an optimal level. When an OEM insists on keeping all aspects of production in-house, overheads are generally higher due to the requirements of specialist equipment, additional skilled labor, and of course additional facility space. By strategically outsourcing some of the high-cost, low-margin aspects of production, companies can improve their bottom line and maintain a competitive edge. For many original equipment manufacturers, electro-mechanical assembly is often a critical component of the production process, but is this a task that should be outsourced? From printed circuit boards to complex box builds, many manufacturers consider the production of their electromechanical assemblies to be a function that has to remain in-house. However, there are many reasons why electromechanical assemblies should be outsourced to a factory that specializes in their production. Here are just a few of the most compelling: REDUCTION OF OVERHEADS Electro-mechanical assembly is an expensive process to invest in, requiring specialized machinery, a highly skilled and trained labor force, and additional space dedicated to assembly. Cost savings of outsourcing electro-mechanical assembly can be significant and are often a key reason behind many manufacturers' decisions to outsource. INCREASED DEVELOPMENT SPEED Typically, work gets done much faster when outsourced to a partner with a dedicated workforce specializing in electro-mechanical builds. This contributes to faster development and completion of the finished product. RELEASE RESOURCES When electro-mechanical assembly is outsourced to a specialist contract manufacturing partner, a company's resources can be focused on core competencies and high-margin activities. This should also result in increased production without risking quality or safety. REDUCE THE NEED FOR SPECIALIST EQUIPMENT AND THE RISK OF OBSOLETE TECHNOLOGY Electro-mechanical assembly processes typically require that companies invest in the latest technology to ensure both speed and efficiency. This is both expensive and time-consuming. By outsourcing to a contract manufacturer who already has all the specialist hand tools and fully automated machinery, and is constantly researching and utilizing the latest technologies, companies can reduce the need for investment in new equipment and the associated time and capital expenses. IMPROVED QUALITY CONTROL Quality control over electro-mechanical assembly work is critical to success. Electromechanical assemblies require precision and close tolerances for proper function. Specialist contract companies provide highly skilled assembly technicians in addition to expert testing procedures to ensure each individual component and the completed assembly component functions as intended. Outsourcing electro-mechanical assembly is undoubtedly a smart decision with many advantages and a great way to reduce the need for in-house expertise and equipment, while still maintaining quality production. To learn about our services and how we can help meet your complex manufacturing needs, reach out to our sales team. Applied Engineering July 21, 2021 7 Interview Questions to Ask a Medical Device Contract Manufacturer Countless industries are turning to contract manufacturing, including medical device companies. A medical device contract manufacturer can make the entire medical product or a component of the medical device through injection molding. This may include life sciences products, medical circuit board assembly, and items used in medical research. A medical device manufacturer has a unique set of development and manufacturing capabilities conducted in a specialized facility, as the FDA regulates all medical devices that are sold in the United States. Whether you are interviewing medical component manufacturers or device contract manufacturers, you need to ask the right questions. You want to ensure they can provide the manufacturing services you need and meet all of your requirements, from consultation to design to product development. Bottom line, you need to find a reputable medical device contract manufacturer you can trust because your business and reputation depends on it. To help you do this we have compiled a list of the top seven interview questions to ask a medical device contract manufacturer. 1. ARE YOU FDA REGISTERED? DO YOU MEET ISO STANDARDS? A robust quality management system is important. Even the slightest deviation from medical device regulations set by the FDA would have dire consequences for your business. The medical device manufacturing process is highly regulated, and you need to trust that your medical device contract manufacturer can assure quality and follow processes. This is the first question in this list for a reason. Even after a positive response, do your due diligence. Look to see if the medical device contract manufacturer previously received any violation letters from the FDA or if the FDA has ever withheld products because the manufacturer didn’t comply. Having your production lot discarded because it didn’t meet standards is costly and must be avoided. A medical device contract manufacturer should also meet other regulatory standards such as ISO 13485 for the quality management of medical devices. 2. ARE YOU CAPABLE OF MANUFACTURING A HIGH VOLUME? You need your medical device contract manufacturer to meet your business needs. Many contract manufacturers maintain line utilization at a high level. Generally, this is done by balancing current operational demands with new business expectations, and while they are looking after their business, you need to look after yours and make sure you are both aligned. Ask if they have the human resources and space for a new line, and if so, when will a new line be produced (time to market). And in the event that you need more volume than initially forecasted, can they increase production quickly? 3. DO YOU HAVE SUPPLY CHAIN EXPERIENCE? Effective supply chain management will ensure everything from production to delivery is completed on time. Does this medical device contract manufacturer have experience in planning, forecasting, assembly, quality assurance, storage, and shipping? Let’s say you use different vendors and suppliers for your raw materials. Are they experienced and equipped to change the vendor without disruption? How would they handle long lead items so that production wouldn’t be stopped? Do they visit suppliers, use quality materials and stand behind them? It is best to get the answers out on the table early and use a written contract to clearly outline who is responsible for any failure. 4. ARE YOU EXPERIENCED IN YOUR MARKET? If you were interviewing a person for a role in your company, you would ask for their previous employment experience. The same idea applies when interviewing a contract manufacturer. Ask if they have experience working with products of components in your market. An experienced contract manufacturer will better understand required filings, regulatory standards, and raw materials. Further, they will be better equipped to handle growth and a high volume. Ask for examples of products similar to your product, and ensure those whom you are working with are the same individuals who have the experience. 5. HOW WILL YOU MANAGE OUR PRODUCTION PLAN? During the interview/consultation stage, the medical device contract manufacturer will come up with a plan that will outline how they will meet your production needs. This plan should lay out exactly how they will meet your timeline and expectations. At this time, you will also finalize scheduling which will be included in the contract. In this contract, ensure dates are outlined for installation, inspection, and production. 6. ARE YOU FINANCIALLY STABLE? This isn’t necessarily a question you can ask outright and expect to receive the most transparent answer to. If finances are rocky, they aren’t likely to tell you. Instead, you’ll need to do a little digging. Ask about their suppliers and then follow up with them. Do they pay suppliers on time? You’ll also need to do some credit checks of your own. This is critical. If the medical device contract manufacturer failed to pay a supplier for an essential raw material or piece of equipment, it could cause costly delays or entirely shut down the production line. 7. WILL YOUR FACILITIES MEET OUR NEEDS? The facility where medical devices are produced must meet regulations, deliver a quality product and meet demand. Ask for the specifics of the exact location and the layout of the facility your device will be manufactured. Ask for verification that the facility has the necessary classification (e.g., ISO Class 7, ISO Class 8), is environmentally controlled, and has state-of-the-art technology. Additionally, ensure the storage facilities meet standards as well. You must also inquire about their contingency plans. For example, if a large storm took out power lines, could they continue production? Do they have emergency power generators? If operations needed to be performed at another facility, would they take the same precautions and abide by the same standards? You will get a solid understanding of their ability to deal with unprecedented events by asking if they have dealt with any unexpected issues in the past and how they handled them. The medical device contract manufacturer you use will ultimately determine the quality of your product. You must do your research and ask the right questions before signing a contract. In addition to these questions here, ask for documentation like training logs or references. By doing your due diligence in the beginning, you can establish a solid relationship that will allow you to grow your business. Applied Engineering June 22, 2021 AE Facility Tour Join us on a tour of our 45,000 square foot facility located in San Jose, California. Applied Engineering is a Silicon Valley-based contract manufacturer, specializing in electro-mechanical builds. If you have questions regarding any of our areas (or if you’d like to know more about how Applied Engineering can meet your manufacturing needs), we welcome you to reach out to our sales team. sales@appliedengineering.com Liana Slater June 16, 2021 Who We Are Spend a few minutes with our CEO Jack Yao and learn about how Applied Engineering can help meet your complex manufacturing needs. To learn more about our services, reach out to our sales team at sales@appliedengineering.com Liana Slater June 2, 2021 8 Ways Program Management Streamlines Contract Manufacturing Contract manufacturing, when you outsource manufacturing of your product line, enables you to have your products manufactured without the resources and capital needed to have your own factory. When looking for contract manufacturing services, your requirements will depend on your product manufacturing needs. For example, you may or may not require a company that offers CNC machining capabilities and complete assembly. Contract manufacturing reduces labor costs, helps you meet demand fluctuations, and ultimately provides you with cost savings. Economies of scale, both internal and external, occur when your manufacturing capabilities are increased. When a large portion of your business is outsourced, you can focus on growth and customer relations. These benefits are enhanced with program management. Program management streamlines contract manufacturing, provides greater quality control, and reduces lead times, ultimately providing better customer service. As Jeffrey M. O’Brien wrote in Wired, “The future of gadget-making is not about making gadgets; it’s about imagining them. Someone else makes the imaginary real.” You have come up with the gadget and need someone to help you make it. Contract manufacturing will do that, but program management will ensure it’s done right and streamline the entire process. Here are eight ways program management streamlines contract manufacturing: 1. INCREASES THE FLOW OF COMMUNICATION With contract manufacturing (without program management), you may not have a point of contact to reach out to for questions or issues. This dramatically complicates the flow of communication. When you are working with a program manager, they are dedicated to your goals, needs, and issues and serve as your dedicated point of contact. They will help walk you through the entire manufacturing process, beginning to end. They’ll answer any questions you have, from protecting intellectual property to acquiring raw materials to production through to delivery. Program management will streamline the entire communication process, which will, in turn, eliminate miscommunication, errors and save you time and money. 2. CREATES A SUPERIOR SUCCESS PLAN Program management is a highly effective way to develop your success plan. Program managers understand the ins and outs of contract manufacturing and will help you design a robust plan to meet your goals. With an understanding of the machinery, they are able to optimize the process to stay within your budget and timeline. Further, not only will program management help you plan for success, but it will help you achieve it. 3. PROVIDES QUALITY CONTROL Program management ensures your products meet any required standards. Your design, process, and product development are reviewed, assembled, tested, and shipped while maintaining standards and quality. Your program manager understands your operation and processes, which are both critical components of your manufacturing process. 4. MANAGES AND RESOLVES UNEXPECTED ISSUES Along the way, you may run into issues. Resolving these issues might be costly and timely, but with superior program management, you will be better equipped to handle any unexpected problems that arise. Program management will troubleshoot any unforeseen circumstances and work with you to create a solution. According to Electronic Products & Technology, you should have a plan in place with your New Product Introduction (NPI) that will come up with ways to address unforeseen challenges or obstacles. 5. ENSURES CONTINUOUS IMPROVEMENT You likely want your business to grow, and program management will help you accomplish this goal. With status reviews and continuous improvement, your organization is in a better position to expand. Program management of your contract manufacturing will take inventory management, volume forecasting, and business objectives into consideration while working with you to improve further. 6. UTILIZES THE EXPERTISE AND KNOWLEDGE OF OTHERS Managing your manufacturing can be costly. Time is money, and one of the most rewarding savings will come from outsourcing contract manufacturing and acquiring program management. The processes involved in contract management can be challenging, tedious, and inefficient if you are not familiar with or experienced in it. As a result, this can result in inefficiencies, mistakes, and ultimately, unhappy customers. Program management streamlines contract manufacturing by utilizing the expertise and knowledge of others. 7. USES PROVEN, EFFECTIVE CHECKLISTS For each product you manufacture, there is a learning curve. Whether it is developing new processes, checklists, or training, it can take time and money until you’re running like a “well-oiled machine.” Program management reduces this by using proven, effective checklists. A checklist will detail the procedures step-by-step to ensure nothing is missed and everyone is on the same page. 8. CERTIFICATION When you opt for program management, you are also benefiting from the experience and certification held by the program manager and organization. The program manager may have plenty of experience in design, engineering, and procurement, as well as contract manufacturing. The certificates they hold are also advantageous to you, further ensuring quality. They have a solid grasp of your requirements, as well as their own knowledge and expertise. When combined, they’ll interpret your specs and effectively manage your manufacturing process to ensure accuracy. Program management is an essential piece of the contract manufacturing puzzle. The relationship with your program manager will help you reach your business goals and prevent costly errors. Mid-size to large scale international brands use program management to streamline their contract manufacturing. There are options for how this will look for your organization as well. You can choose to have the entire production managed, managed with your team, or managed with an additional third party. You can use a hiring firm or look for a contract manufacturing partner yourself. Either way, you must look for a highly reputable contract manufacturer. Applied Engineering, for example, is exceptionally reputable with over 40 years of experience in offering hi-tech electromechanical contract manufacturing services. Applied Engineering’s key differentiators are our advanced new product introduction processes coupled with experienced personnel which includes a seasoned, dedicated group of Project Managers. Applied Engineering also has the registration and certification to back up this long-lasting reputation. Lastly, when looking for a contract manufacturer, ensure their core competencies align with your business so the outsourcing transition is smooth and communications are crisply channeled through a seasoned project manager. Applied Engineering May 27, 2021 Conformance vs. Compliance: What's the Difference? Many companies, regardless of industry, operate under guidelines, standards, or regulations. A governing body or authority may establish these regulations, and the company may be legally required to follow them or voluntarily agree to meet these standards. When considering the regulations or standards your company must meet, you may have wondered—conformance vs. compliance: what’s the difference? Occasionally these words are used interchangeably, and some believe they are synonymous; this, however, is not true, and there are some important distinctions to note. Generally speaking, compliance refers to the mandatory requirements a company must meet that are established by an external organization, authority, or governing jurisdiction. While compliance is more formal and a legal requirement, conformance is voluntary. Conformance refers to the norms, expectations, standards, and policies that a company abides by. These may be established by the company itself or by another organization. If we look at conformance vs. compliance through the lens of a manufacturing company like Applied Engineering (AE), we can better understand the difference. Depending on your jurisdiction and the items you manufacture, you may be required by various parties to have specific qualifications, certifications, and validations. This is an integral part of the manufacturing process, and you must ensure you are meeting all legal or standardized requirements. As your manufacturing service provider, AE will supply your manufacturing project with the various certifications and validations you must comply with, such as laboratory equipment qualification, cleaning validation, or computer system validations. When manufacturing medical devices, safety and quality are not voluntary. Therefore, manufacturers must comply with several authorities. For example, in the USA, the FDA’s Centre for Devices and Radiological Health (CDRH) regulates medical device manufacturing. This includes the classification of devices, Quality System regulation, medical device listing, labeling requirements, and establishment registration. Here is where the conformance vs. compliance confusion comes in. A third party may establish recommendations, standards, and regulations that you as an organization can volunteer to conform to. This could then become a matter of compliance if you choose to seek certification. For example, the International Organization for Standardization ISO 9001 outlines the requirements for a quality management system. To conform, manufacturing plants must have a quality management system that can then be certified and audited by an independent certification body. Although it is not required, it is recommended that manufacturers choose to abide, just as AE has. That said, if you opt to receive certification, you must then continue to comply with the set guidelines to remain certified. The consequences of noncompliance can be dire as it could ruin your reputation or prevent you from operating. It can also have extreme financial repercussions or worse. Regulatory pressure is at an all-time high, so your manufacturing firm must be just as committed to compliance as you are. Bottom line, to ensure quality manufacturing and that you are meeting all legal requirements, use a manufacturer who will ensure compliance and conformance with the necessary industry standards. Applied Engineering April 9, 2021 What Is Clean Room Assembly? Clean rooms are used in industries where particles or contaminants can affect the manufacturing process. It’s a room that can vary in size and complexity, that provides a controlled environment free of pollutants like airborne microbes, dust, chemical vapors, and aerosol particles. A clean number controls the number of particles per cubic meter. Physicist Willis Whitfield invented the clean room in 1962. His design featured a highly filtered airflow to flush out air contaminants and was being used in manufacturing facilities around the world within just a few years. These rooms use HEPA filtration to remove particles from the air to get a specific level of sterility. In addition to HEPA filtration and fans, clean rooms also have specific flooring, wall systems, hardware, and ceilings that keep particles down and meet different clean room classes' criteria. WHAT IS CLEAN ROOM ASSEMBLY? Simply put, clean room assembly is the manufacturing that occurs within a clean room. Clean rooms are often required for pharmaceutical and medical device manufacturing. It’s also used for E-beam column assembly, optics assembly, and metrology tool integration and build. Contamination during assembly could adversely affect the final product. For example, when manufacturing medical devices, they must be in a sterile environment to ensure they don’t become contaminated. The ISO 13485 regulates contamination control in medical device manufacturing, requiring the use of a clean room There are different classifications of clean rooms. This classification is based on the number of particles per cubic foot. For example, a certified class 10,000 environment will have 10,000 particles per cubic foot, and a class 100 environment will have 100 particles per cubic foot. A light-scattering particle counter determines the concentration of particles in the air. Your typical office has between 500,000 to 1 million particles per cubic feet and your average urban outdoor space has 35 million per cubic meter. A clean room significantly reduces the number of particles in the air. The HEPA filter units must stay on at all times. Once you turn them off, particles per cubic foot will quickly increase, and it can take several hours to clean the room again. In addition to having a HEPA filtration system in place, contamination prevention processes must be in place for your clean room to remain clean. This involves wiping down surfaces regularly, making sure doors remain closed, prohibiting eating or drinking, wearing clean room suits over street clothes, and wiping down any equipment or material brought into the clean room. Items with uncontrolled microbes like paper, fabric, and pencils are often not used in a clean room and would be replaced with an alternative. REACH OUT FOR CLEAN ROOM ASSEMBLY If you are looking for a clean room, Applied Engineering has over 1500 square feet of clean room manufacturing floor space that can be expanded to accommodate any manufacturing build plan. We offer clean room assembly between class 10,000 to class 100 environments. Reach out for more information on Applied Engineering’s clean room assembly services. Email sales@appliedengineering.com for more information. Applied Engineering March 19, 2021 Build to Print vs. Design and Spec: Fabrication Quick Guide When it comes to fabrication, you have options, and the option that will work for you depends on your current needs and long-term goals. Build to print and design and spec are two different types of contract manufacturing. To help you understand the differences, similarities, and benefits of these two processes, we have put together the following quick guide. WHAT IS BUILD TO PRINT? Build to print is a type of contract manufacturing that refers to the process of building products to client work instructions. This is commonly used to manufacture components or pieces of equipment. In the build-to-print process, a client will provide a product drawing that has been created by an engineer and contain exact specifications down to the millimeter. The design will also outline the necessary materials needed to create the product, and then the product is created. The manufacturer is then responsible for producing the product according to those drawings. WHAT IS DESIGN AND SPEC? Design and spec refers to the process of building products from scratch, according to a client's need, function, or size requirements. Design and spec can help clients develop solutions for the problems they have. After discussing the problem and coming up with a solution, the manufacturer will assist in designing and creating a product. In the design and spec process, manufacturers help clients see a project through from beginning to end. WHAT ARE THE SIMILARITIES/DIFFERENCES BETWEEN BUILT TO PRINT AND DESIGN AND SPEC? The key difference between build to print and design and spec is that you already have your design with build to print, and with design and spec, you do not. When you require design and spec services, you’re asking that a manufacturer assists with the creation of engineering drawings and plans. WHAT ARE THE BENEFITS OF EACH? The main benefits of build to print are accuracy and efficiency. Once a client has their built to print designs, it will allow them to make repair pieces and build to specification quickly. For example, if they have an assembly line and a piece is broken, a replica piece can be quickly produced in order to prevent delays. The benefit to design and spec is when the specifics, measurements, and materials remain unknown, and a client needs assistance in determining what the most cost-effective options are. WHY IS APPLIED ENGINEERING THE RIGHT CHOICE FOR EITHER PROCESS? Whether you are looking for built to print services or design and spec, you want to choose an experienced engineering team you can trust. At Applied Engineering, we work with you to ensure you get exactly what you are looking for. We are a contract manufacturing services company with over 30 years’ experience in providing total manufacturing solutions for our clients, including built to print and design and spec. As you can see, there are benefits to both processes. If you are looking to learn more about build to print and design and spec services, or need help determining which is best for you, reach out to Applied Engineering for more information. Applied Engineering February 28, 2021 7 Types of Additive Manufacturing If you are familiar with 3D printing, then you have a general idea of what additive manufacturing is. As inexpensive devices have become increasingly more accessible, you have likely seen 3D printing referenced in the news, TV shows or movies. This mainstream status is what the Harvard Business Review has called “the 3-D Printing Revolution.” It’s important to note, these depictions of 3D printing are oversimplified and too general. Although 3D printing and additive manufacturing are often used interchangeably, they are not synonymous. additive manufacturing is a broader term used to describe manufacturing techniques made in a similar layering fashion. These manufacturing techniques are used to create everything from toys to shoes to the parts on a jet engine. WHAT IS ADDITIVE MANUFACTURING? Additive manufacturing is the process of building physical objects by layering materials like metal, plastic, or concrete. It is a process that uses special software and equipment. The software will first create a design known as a Computer-Aided Design (CAD). The equipment will then take this CAD file and strategically layer material, creating a physical representation of the CAD. There are seven types of additive manufacturing, each with its own processes, methods of layering, and equipment. WHAT ARE THE SEVEN TYPES OF ADDITIVE MANUFACTURING? To clear up confusion on the different types of additive manufacturing, a set of standards were created that categorize the different processes. These categories were created by the International Organization for Standardization in 2010 and provided clear definitions for additive manufacturing processes. These definitions helped improve global communication between those who work in the industry. 1. VAT PHOTOPOLYMERISATION VAT Photopolymerisation is also known as stereolithography. This type of additive manufacturing uses a vat of liquid photopolymer resin—which is how VAT photopolymerization received its name. A build platform is lowered from the resin’s top, moving downward, and a laser beam draws a shape in the resin, creating a layer. The average thickness of one layer is between 0.025 and 0.5mm. After each layer of resin, it must then be cured using ultraviolet (UV) light. This process of photopolymerization uses motor controlled mirrors to direct the UV across the resin surface, causing it to harden. These steps are repeated to add layers. For increased accuracy and finish, most equipment uses blades that go over each layer to remove defects before applying and curing the next layer. Using a liquid creates a great deal of accuracy and detail in the finished project; however, it lacks the structural support provided by other types of additive manufacturing. This is corrected by adding support structures. Although the VAT photopolymerization process is quick to complete, the clean-up and post-processing time is lengthy. VAT Photopolymerisation is used in several industries to create parts and products ranging from hearing aids to Nike shoes. 2. MATERIAL JETTING With material jetting, the print head is above the platform, and material is deposited onto the surface in the form of droplets. Hundreds of micro-droplets are positioned with charged deflection plates, providing increased control and accuracy. These droplets then solidify, creating a layer. This is repeated, building up layers. The droplets may be distributed continuously or individually using the Drop-on-Demand (DOD) method. This method is similar to an inkjet printer. Material jetting can be done with various materials, including polymers and waxes. This type of additive manufacturing is precise, and you can use multiple materials for one project. Although accurate, it is not the most efficient method as time is spent re-filling the reservoir that depletes quickly. Material jetting is often used to create realistic models or prototypes. 3. BINDER JETTING This type of additive manufacturing uses a binder and a powder-based material. This powder-based material is applied to the build platform with a roller, and then the print head deposits the binder on top. The binder adheres the layers together and is usually in liquid form. Following a layer, the product is lowered on the platform. This is repeated to create more layers until the product is finished. When using this process, you can use different materials, including polymers, ceramics, and metals. Binder jetting is considered one of the speediest additive manufacturing methods and allows for customization. For example, if you require material of a specific quality, you can change the binder-powder ratio, or if you want to create a product that has color variation, you can do so. One of the drawbacks of binder jetting is the increase in post-processing time, and it may not be the best choice for creating structural parts. Binder jetting is used in industrial applications, dental and medical devices, aerospace components, part casting, luxury applications, and more. 4. MATERIAL EXTRUSION Material extrusion is a type of additive manufacturing process often used in inexpensive at-home 3D printers where the material is drawn through a nozzle, heated, and then deposited in a continuous stream. This nozzle moves along horizontally and the platform moves up, down, and vertically. This is how the layers are created. Because the material is heated (melted) when it is applied, it fuses to the previous layer. The bonding between layers can also be controlled through temperature and chemical agents. Although material extrusion is often seen in inexpensive models, it has many capabilities. Polymers and plastics can be used, which provide strong structural support. However, there are also limitations to this additive manufacturing process. Accuracy is reduced because of the nozzle thickness. Material extrusion is also one of the slower types of additive manufacturing. Many automotive companies use material jetting to create manufacturing devices used in assembly lines. 5. POWDER BED FUSION For powder bed fusion additive manufacturing, a layer of powder is applied to the platform. A thermal energy source like an electron beam or laser fuses the powder before a second layer is applied with a roller or blade. This layering process is then repeated. There are slight variations within powder bed fusion, including: Selective Laser Melting (SLM) Selective Laser Sintering (SLS) Electron Beam Melting (EBM) Direct Metal Laser Sintering (DMLS) Despite the differences between these variants, all powder bed fusion manufacturing occurs in a near-vacuum, pre-heated chamber with inert gas. Metals and polymer powder materials can be used, which act as a support structure, making it a suitable type for prototypes and visual models. There are some disadvantages to the powder bed fusion method as it requires more time to complete projects; however, this additive manufacturing process is still used in various industries, including aviation, to create parts of a jet engine. 6. SHEET LAMINATION Sheet lamination is a process that binds layers using ultrasonic welding or an adhesive. There are two variations of sheet lamination; ultrasonic additive manufacturing (UAM) and laminated object manufacturing (LOM). The difference between the two is found in the material used and the bonding process. UAM uses metal that is bound together with ultrasonic welding. LOM uses paper that is bound together using an adhesive. Sheet lamination is done by placing the material on a cutting bed. Layers are applied and bonded to that material. and the shape is cut with a knife or laser. This process can bind different materials and is relatively low cost and speedy. Accuracy is sometimes lacking in sheet lamination and may projects that utilize this additive manufacturing process may require post-processing. Sheet lamination is often used for prototypes. 7. DIRECTED ENERGY DEPOSITION Directed Energy Deposition (DED) is one of the most complex types of additive manufacturing. A four- or five-axis arm will move around, depositing melted material around a fixed object. The material is melted by an electron beam or laser and will then solidify. Metal powder or wires are the most common material used with DED, but ceramics and polymers may also be used. You can achieve a high degree of accuracy due to the ability to repair and control grain structure in DED. The finish varies based on the material used. In the case of metal, a powder will provide a much better finish than wire; however, you can achieve your desired effect with wire through post-processing. Direct Energy Disposition is often used to repair or fabricate parts. In summary, additive manufacturing is much more complex than the term “3D printing” suggests. Although these 7 types of additive manufacturing differ in many ways, they all play a vital role in countless manufacturing processes and have the revolutionary potential for future uses. To learn more about processes supported at Applied Engineering contact sales@appliedengineering.com Applied Engineering January 22, 2021 Bringing 2020 Business Lessons Learned into 2021 No doubt that 2020 has been a challenging year for most of us. In addition to battling the global pandemic, we have encountered event cancellations, unemployment, business shutdowns, wildfires, stock market volatility or heaven forbid, the loss of a friend or family member. I, for one, was done with 2020 since September, and was looking to embrace the unknowns of 2021. But as we roll towards the beginning of 2021, I realized that there are key business practices learned (or made apparent) in 2020 that should be carried forward to 2021 to build a stronger organization. KEY BUSINESS PRACTICE #1: SELECTING SUPPLIER/PARTNERS WITH STRONG BUSINESS RESUMPTION PLANS Most of us do not examine business resumption plans when we choose a supplier. Generally, when a request for quote (RFQ) is issued, often, the key selection criteria are based on cost and lead-time. Of course, there are other factors involved in choosing a good supplier, however, having a strong business resumption policy is often not taken into consideration in choosing a supplier. At the onset of the shelter-in-place this year, we all witnessed companies struggle to ramp back up due to a lack of a business resumption plan. At Applied Engineering, not only do we have a business resumption plan in place, but we also review and update our policy routinely, which helped us to ramp back our business seamlessly once we received our essential business status. This is not just an opinion; it is a fact. AE is on track to financially outperform 2019 despite of the pandemic impact and shutdown. Putting our resumption plan in action allowed AE to react, respond, and restart without losing much momentum. KEY BUSINESS PRACTICE #2: LEARNING TO WORK TOGETHER, APART Yes, in business, face-to-face interactions are priceless. The handshakes and eye contact builds trust and a personal connection. At the onset of the shelter-in-place, we quickly realized that working from home will be the new normal for many of us. Online meeting platforms made this transition as smooth as possible given the abrupt announcement of the edict. However, just having the online software to conduct meetings does not displace the need to build trust… at least not initially. Fortunately, at AE, we have a ritual of reviewing our core fundamentals for the week during the first 3 to 5 minutes of our weekly meetings. We took these opportunities to share our thoughts on key fundamentals that will not only help AE survive the pandemic but help us thrive during these difficult times. Some examples of key fundamentals are: Listen to others with the intent to understand; challenge the mindset of “we’ve always done it this way”; keep workspace and personal space clean and organized; and practice blameless troubleshooting. There are many other AE fundamentals. I would be happy to share them in future blogs. KEY BUSINESS PRACTICE #3: WITHOUT HEALTH, NOTHING ELSE MATTERS How many times have we all realize we take our health for granted when we are ill? At AE, staying healthy is not just wishful thinking, it is another one of our core fundamentals. Prior to shelter-in-place was instated, we had anointed a COVID czar and brainstormed safe practices at work to allow everyone to continue to function without jeopardizing their personal health and safety. It was a priority! Policies to wipe down public areas, mask, gloves, social distance, and temperature measurements were put in place swiftly. As an employee-owned company, employee-owners started walking groups and push up challenges to remind and encourage each other to not only preserve health but to stay mentally and physically healthy during this challenging time. I look forward to shedding my mask at work, but why wouldn’t we continue this practice of staying healthy post-pandemic? For those of you interested, hit me up for a mountain bike ride or a hike. I would be glad to join you on a bike or on foot for a jaunt around the trails of the Santa Cruz mountains. Reflecting on 2020, what are some of the learnings you would carry forward to 2021 with you? Please share your thoughts with me and others who can benefit from your insight. Jack Yao December 21, 2020 Key Criteria for a CM Supply Chain Organization A CM’s (Contract Manufacturer’s) Supplier Selection is critical to the success of any given project. It is worth your time to find out more about the CM’s Supply Chain Team and capabilities. Supplier selection has increased dramatically in the last decades due to the advent of a truly global economy, and choices are many and varied. Having an experienced Supply Chain Team that can make smart choices is even more important in ensuring you are partnering with the right CM. Ideally, you are looking for a partner, not just a vendor, for a long-term partnership. Things to look for in an effective supply chain organization: Does the CM’s Supply Chain Team think globally, yet act locally? A CM’s (Contract Manufacturer’s) Supplier Selection is critical to the success of any given project for both quality, schedule, and cost reasons. Does the Supply Chain Team have a Global presence and understanding when required? Are they able to personalize their interactions by having a local presence on a global scale? This ensures the relationships are conducted in a “local” fashion independent of whether it is an offshore partner or a local partner. What is the size and experience level of the CM? Does the CM invest in an experienced, multiple person staff? Is the respective Manager a seasoned veteran? Where in the organization does this Team report? It should be a key team and highly visible within the executive group. They are one of the most important elements the CM has in developing and maintaining long term partnerships with customers. Is the Supply Chain Group capable of adjusting their suppliers at each phase of a customer’s “ramp”? Seeking a CM partner that can support you through your production ramp by adjusting their supplier selections as required, is critical to your seamless transition from prototype to high volume production. Knowing when and how to efficiently switch suppliers, based on their respective skill sets, is core to your CM’s capabilities as they support your ramp. This allows you to focus on other elements of your growing business and places the burden on your CM partner to effectively manage the dynamic supply chain. How do they vary their selections and practices to support their certification requirements? Dependent upon what certifications and procedures may be required for your product manufacturing it is important to understand the Supply Chain Team’s experience and breadth in selecting the correct suppliers specific to your needs; Medical Device- 13485 criteria or Defense & Aerospace- AS9100 and/or ITAR criteria or Semiconductor and/or Consumer Electronics- SEMI S2, S9 compliances and/or UL508A registered or CE certification etc. Do they have a full understanding of the respective certifications and compliances as they relate to supplier selections? What documentation can they show you as examples of their selections? How do they develop and strengthen their supplier relationships? Do the CM Supply Chain Team and the Quality Team routinely visit and audit their suppliers? It is good to understand how interactive they are with their supplier network. Performing routine audits and engaging in face to face visits is an important aspect of maintaining quality products and relationships with their suppliers. Does the CM award or recognize their high performing suppliers? This can be reflected in many ways but is a good indicator of the strength of their relationships with their suppliers. Does the CM Supply Chain Team have an AVL (Approved Vendors) list? It is worthwhile to understand if they do and how do they establish and maintain that list over time. It is also beneficial to ask if and how the CM Supply Chain Team measures its suppliers. Once a supplier has been chosen and qualified, metrics and measurements are incredibly important. Most systems can track on-time delivery and rejection rates and these should be used at a minimum to track supplier performance. This information should be documented and fed back to the supplier at regular intervals. These metrics are good to use as a basis for Quarterly Business Reviews (QBRS) with the supplier. If it is apparent that supplier performance is declining, the root cause needs to be determined, so the issues can be addressed. Feedback, both negative and positive is fundamental to improving performance for all parties. How do the Quality and Engineering Teams work with the Supply Chain Team? Typically, in well-organized CM’s the Quality and Supply Chain teams work in concert with each other to ensure their AVL suppliers are performing to expectations and following all required procedures. It is worth checking. Does the CM have documented processes and procedures which are used between the Quality Team and the Supply Chain Team? Are the Quality and Supply Chain Teams interacting at a high frequency- daily interactions etc.? What procedures and policies are routinely reviewed between the groups? Are there feedback processes in place? Risk Mitigation How effective have you managed risk to your supply chain? If Supplier A is unable to deliver, do you have a backup or plan in place to bridge any disruption? Given the unpredictability, of this current year, this has become key. It is always good practice to rate suppliers in terms of risk and have a back plan in place. Can additional safety stock inventory be held to mitigate any supply chain disruption? In Summary The Supply Chain Team is critically important to a CM’s success, growth and maintaining their long-term relationships with both their customers and their suppliers. If they have the attributes discussed above and can demonstrate those to you during your investigations, then you are well on your way to have made the right selection in your CM evaluations. Murray Wicks October 15, 2020 The Added Benefits of Partnering with an ESOP Contract Manufacturer What is the real “value-add” of a contract manufacturer to its customers? It is their people. How best to cultivate a winning team year over year? It could be… by empowering them through ownership of their company! The basic ESOP structure that converts employees into part owners of the company creates unique benefits that help the company raise its quality and increase customer satisfaction to a higher level. Some of these benefits include: • Motivation- Shared ownership motivates people at all levels within a company to take the extra step, to make the extra effort to achieve cross-functional objectives. As owners of the company, employees are empowered to take ownership of their performance and quality of work and take pride in their company’s brand and success. It truly is a team effort which translates to consistently providing a quality product to customers year after year. • Retention- Retaining experienced, highly productive people is the key to maintaining long term customer relationships. The ESOP Contract Manufacturer typically has very little employee turnover. This results in a familiarity with the products, processes, and personnel of their respective customers which in turn strengthens the trust between both companies. ESOP benefits are structured to incentivize employees to stay for the long term which helps the company retain valuable knowledge. The company’s customers, in turn, benefit by having a consistent team of knowledgeable experts who are committed to their continued success through years of cooperation. • Training- is especially productive and effective if the personnel are motivated and plan to stay with the company. The training programs develop strong in-house expertise and challenge the respective employees to learn new skills and hone the ones they have. • Equal voices for change/improvements- ESOP Contract Manufacturers typically enjoy a diverse, open forum in terms of driving improvements in processes, procedures, and products. These improvements are a direct benefit to their customers. • Fun place to work- Life is short. ESOP Contract Manufacturers recognize the importance of looking forward to helping their fellow “owners” and the customers who depend on them …it is fun and rewarding, it’s not just going to work to pick up a paycheck. You will likely see the difference when you take a tour through an ESOP Contract Manufacturer’s facility. Enthusiasm and collaborative atmospheres are pervasive. • Communications- Typical ESOP companies excel at communications as they understand the importance of working together to solve customer’s challenges. You will usually find a collaborative solution seeking vs. finger-pointing. The ESOP culture facilitates an outward-looking view in support of its customers. It creates faster, focused, quality solutions. In summary, ESOP Contract Manufacturers understand their “value-add” to their customers. The “employee-owners” are the key to maintaining and growing long-term customer relationships. Their enthusiasm, pride of ownership, and experience have a profound impact on ensuring quality products and services are provided consistently to their customer requirements. For these reasons, the ESOP Contract Manufacturer should be uniquely positioned to support your outsourcing requirements Viet Pham September 8, 2020 5 Behaviors that Build Quality from the Inside-Out A famous sage once said; “it’s good to look at the forest before staring at the bark of a tree”. A company’s culture is often an overlooked, important, aspect of improving product quality. So, before you dive into a specific quality problem, look at the “forest” – the Company Culture. In addition to Pareto charts and root cause analysis, improvements in behavior can have a tremendous impact on resultant quality. The recommended behaviors highlighted below should help you and your team on the path to building a Quality-driven company culture. 1. Strive to Cultivate a Process-Driven Environment. Promote development and implementation of processes through all departments thereby minimizing reliance on tribal knowledge and unwritten interpretations. Companies who live by their processes typically have better control over effective corrective actions by tracing the flow to the area where there was a process break-down. Training plans can be established by simply following the documented procedures. A process-driven culture is key to producing consistent, efficient, and high-quality products. 2. Always Good to Know the Difference Between Facts and Assumptions. A recommended good practice prior to making technical and business decisions is to research and gather data from reliable sources. This is particularly important when putting together a proposal, designing a process, or performing root cause failure analysis for a customer. Avoiding assumptions and developing a focus on the facts will typically minimize “opinion-based” control decisions. Once the team appreciates a “fact-based” decision-making methodology, “opinion-based” frustrations and apathy in the workspace will be eased. Data-driven organizations enable teams to efficiently identify and solve the correct problems, naturally promoting quality. 3. Please Practice Blameless Troubleshooting. We have all seen how blaming each other can tear an organization’s culture apart. When staff has the habit of fixing processes through root cause analysis, there is no fear in saying “my mistake and I’ll fix it”. All the wasted time pointing fingers evaporates and creative solutions come to the forefront. When failure occurs, analyze the alternative solutions, implement the best solution, and track results in the event additional adjustments are needed. In the manufacturing of complex capital equipment, root cause failure analysis almost always leads to something missing in a process, not someone. Please practice blameless troubleshooting and watch how quickly quality improves! 4. Mistakes Happen, but Not Learning from the Mistake is the Only Mistake. Albert Einstein is widely credited with saying, "The definition of insanity is doing the same thing over and over again but expecting different results." How often do we accept the status quo with the belief the issue will go away? Organizations that embrace change and push for continuous improvement find rapid progress. Develop a culture where making the same mistake twice is unacceptable. 5. Think Ahead. Anticipate and Plan for the Unexpected. We live in a dynamic world with plenty of surprises waiting around the corner. COVID-19’s massive disruption shows this is truer than ever. Gather your team and review potential scenarios for the future. How should your department respond should these events occur? Find experts and gather their input. If you have your rainy-day plan developed, the team will not panic. Energy will go into execution. Customers, Suppliers, and Teammates will see you not as a victim of unforeseen circumstances, but as leaders prepared for change. So, think ahead and develop your plans for what may be. Protect that quality-focused culture you’ve so diligently nurtured. In conclusion, organic quality improvements can occur when companies adopt the following essential behaviors: Insist on documented processes; follow facts and leave opinions behind; apply blameless troubleshooting; implement corrective actions such that mistakes are not repeated, and develop a plan B for the unexpected. Building Quality from the-inside-out is easier than you think! Colleen Sweeney August 6, 2020 Always Look Behind the "Certified Curtain" of Contract Manufacturers Your company is now ready to begin the investigation of outsourcing your new product and there are many “certified” Contract Manufacturers (CM) to choose from. Many of these Contract Manufacturers advertise a list of certifications. We recommend that you peel back the “Certification Curtain” in your investigations. Here are some things to look for as you are weighing your CM options: DO THEY HAVE A DEDICATED QUALITY STAFF? Please take the time to meet the Quality staff. This key role in some companies is, unfortunately, a “shared” responsibility”, meaning they have an employee that is, in fact, wearing a quality hat only when audited or externally required. Quality is too many times considered “window-dressing”. To truly adopt and continually execute a Quality Management System companywide takes a lot of time and energy. This time and energy deservedly require a dedicated Quality team. HOW EXPERIENCED IS THEIR QUALITY STAFF? In your meeting with the Quality Manager please ask about their Quality experience and background. This pivotal role in a CM is not for a junior staff member, as the responsibilities are large and hopefully Company-wide. How do they interact with Operations, Supply Chain Management, and the other internal factions within the company? How do they guide and oversee the adherence to their certifications? We would recommend taking a factory tour with them…do the assemblers and technicians on the manufacturing floor know them well? Can they show you some of the daily quality trackers/reports as they move from station to station? Does it look like they are “active” and aware of the projects on the manufacturing floor? The Quality team at a CM should be a “roll-up-the-sleeves”, highly visible group amongst the manufacturing staff. Fully engaged in projects as they come in the door… all the way to packaging and shipment. DO THEY HAVE A QUALITY MANAGEMENT SYSTEM (QMS)? One of the most important aspects of a QMS is using it as a corrective action system. If a company is practicing true continuous improvement, their corrective action log will have activity with root cause analysis that goes beyond operator error. True improvement comes from process change, instruction development, and custom tooling It is worthwhile to ask to go through their documented, company-wide Quality Management System with them. Hopefully, the processes and procedures are easily accessible, and the respective Quality Manager can walk you through the process in a very straight forward, familiar fashion. As they are doing this, it is beneficial to understand how the other groups within operations are continually supporting the system and what their level of ownership entails. Successful Quality Programs rely on communication routines across the organization…periodic cross-functional meetings, reviews, banners, data sharing etc. Is that visible during your investigations? IS THERE A QUALITY TRAINING PROGRAM IN PLACE? The manufacturing of quality products is based on the continual training of the people building and inspecting the products. Does the Quality staff have a training program in place? Can you see the documents? Does it encompass the executive, middle management, and all levels within the organization? A top-notch Quality Team has a vested interest in their training processes to ensure your product line is matched to the proper skill level. WHO DOES THE QUALITY TEAM REPORT TO WITHIN THE CM? Who does the Quality Manager and team report to in the organization? What level of the organization do they reside in? Are they empowered to affect change at the management levels within the company? This is often where internalizing the respective certification processes and procedures fall short. The Quality Manager is typically much more successful in evangelizing company-wide “change-initiatives” if they have the buy-in and active support of the management levels of the given CM. Their processes and procedures need to become embedded in the very fabric of the company. Then the certifications are real. DO THEY HAVE A DEDICATED INSPECTION LAB? When investigating the CM, it is beneficial to understand where the Quality Team performs their adherence to ISO-9001, AS9100, and 13485 as an example. Do they have a Quality Inspection Lab at their facility? If so, then a walk-through to see what inspection/metrology equipment they have is worthwhile. In addition, do they have a dedicated Quality person who runs the lab and maintains hard copy and soft copy records? Do they routinely calibrate the equipment with dated labels to indicate the last check/audit? When the Quality team is truly engaged in projects then it is usually apparent with parts in various stages of being inspected, kitted, labeled, and stored for the manufacturing phase. This can be seen while taking the tour in and around the respective inspection lab. In summary, selecting your long-term CM partner is extremely important to the success of your product launch. As you go through your selection process, you will note that many CM’s advertise their respective Certifications. Given the importance of your selecting the right CM please take the extra time and energy to look behind the “Certification Curtain”. It will be a worthwhile step in ensuring you have made the right selection and that you will be delivering a quality product to your clients for many years. Brian Conway July 15, 2020 New Product Introduction (NPI) Best Practices You just came up with your latest prototype design idea. To reduce your fixed cost your company has decided on an outsourcing model. How do you aim your efforts towards a successful path? First, you will want to know: • What is important to you for your New Product Introduction? • What gets you to market, and staying on top of your market? • What is important to you for your product’s lifecycle? Obviously, time to market is a key objective. And, your design needs to be accepted into the market at the right price, with unwavering customer confidence. This requires manufacturing repeatability, reliability, and supplier ownership in your success. Supplier ownership that parallels the life cycles of your product and service. This requires the selection of the right Contract Manufacturer to partner with who has a proven track record of delivering a high standard of manufacturing and service quality, customer dedication, superior communication, flexibility, and patience. Qualities to look for in an NPI partner: • Effective Communication through a partnership relationship: Dedicated Program Management and Manufacture Engineering who know and understand your product requirements through the life cycles of your product(s). • Solid understanding of your requirements and expectations; including product requirements, timeline, and cost expectations. Transforming your requirements into an alignment of what Applied Engineering will deliver. • Manufacturing efficiency (DFM): BOM structure analysis and implementation for maximized assembly throughput. • Material Management: Strategic Supply Chain and Inventory Management to reduce liability exposure and reduce lead-times. • Effective Change Management through your product life-cycles, including product enhancements and (EOL) end of life issues. • Copy Exact Principles: Technical specification and build documentation management to assure that your products are manufactured the same way every time. In essence, a partner who will fully buy into your vision and help drive you to success. Steve Hockemeyer June 23, 2020 Top 7 Criteria to Consider when Picking a Contract Manufacturer Your company has just developed a prototype system and you have been given the task to select a Contract Manufacturer (CM) to help ramp manufacturing. Where do you start? There are a large number of CM’s out there and each with their own expertise. How do you select the right one? Here is a list of key criteria that will help you make the right selection. Key Criteria #1 - Attitude: The most important overall criterion is the CM’s Attitude. Is this contract manufacturer willing to be a key partner to you and your company? Are they flexible and willing to move and change direction when you need it the most? Will the contract manufacture go the extra mile to ensure your successful launch of this new product? Key Criteria #2 - NPI: Does this CM have a documented New Product Introduction (NPI) Process and the infrastructure to support this essential productization step. You need to make sure that this CM has the expertise and capability to move your product from the prototype stage to volume manufacturing. Key Criteria #3 - Technical Expertise: It is very important that the CM has the technical expertise to support the build and test process. You do not want to select a PCB board level CM to build a large scale OEM process tool where a strong level of electromechanical expertise is needed. To validate technical expertise, make sure the contract manufacturer can show you examples of past build projects that demonstrate the needed technical capability Key Criteria #4 - Size: Biggest is not always better. If you are a small to mid-size company, going with a large contact manufacturer might not be the right choice. In most cases, you are not going to get the attention you need or the resources from the large CM. Also, you most likely will not get the CM’s A-players on your small to medium size project, where is you went with a smaller CM, you would. Key Criteria #5 - Location: It is always better to pick a CM that is in your general area. Communication will be a lot better with face to face meetings and you can also personally validate your build more frequently by directly visiting the CM’s factory. Key Criteria #6 - Quality: Does the contract manufacturer have documented Quality (QMS) process. Are they certified, such as ISO9001, ISO13485, or AS9100? Are they audited on a yearly basis? Does the CM have a true quality department staffed by real people? Key Criteria #7 - Price: This criterion is one of the hardest to qualify upfront. Price is much more than a dollar value on the contact. It has to do with the overall value that the CM brings as your partner and how they can ensure your success. Make sure you understand what value the contract manufacture is bringing to the table. Is it their NPI process, is it their Supply Chain, or their technical expertise? Going for the lowest price does not mean that you are getting the best value. In conclusion, using these 7 criteria can help you select the right CM to ensure a successful launch of your new product. You will need to understand which criteria are most important and weight them accordingly. TO GET IN CONTACT WITH AE SALES YOU CAN REACH US AT SALES@APPLIEDENGINEERING.COM. Mark Danna April 30, 2020 OLDER SERVICES CONTRACT MANUFACTURING CLEAN ROOM ASSEMBLY PRECISION COILS PDU’S & CONTROL PANELS MACHINE SHOP MARKETS SEMICONDUCTOR & CAPITAL EQUIPMENT LIFE SCIENCE INDUSTRIAL AUTOMATION DEFENSE & AEROSPACE EMERGING TECHNOLOGY ABOUT OUR COMPANY CAREER OPPORTUNITIES OUR TEAM CERTIFICATIONS PRIVACY POLICY SUPPLY CHAIN CODE OF CONDUCT Copyright 2020, Applied Engineering, Inc. All Rights Reserved. Website by Wei-Haas Creative. 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