Herndon, Virginia – Registration is open for the Industrial Designers Society of America (IDSA)'s Medical Design Conference 2016: From Volume to Value, which will be held Nov. 11–12, 2016, at the University of California-San Francisco (UCSF) Medical Center's Mission Bay Conference Center, based in a new 43-acre life sciences campus for teaching and research.
The IDSA conference will be chaired by Bill Evans, IDSA, senior vice president of innovation at Bridge Design, a Ximedica company.
“It's an exciting time to be a designer in healthcare," Evans says. "Our profession has a pivotal role – using design to help improve outcomes in a more cost effective way made possible by the digital revolution sweeping through our industry."
The conference is co-sponsored by UCSF, with Aenor Sawyer, MD, from the Department of Orthopaedic Surgery taking the leadership role for UCSF. She is very involved in the UCSF Center for Digital Health Innovation and is the director of UCSF Skeletal Health Service. Dr. Sawyer will draw the participation of clinicians, researchers and others in her wide network, into our Medical Design Conference program.
Evans adds that this year’s conference will take place in one of the most dynamic innovation hubs in the United States – and take up one of the most pertinent conversations today – the creation of meaningful value to truly transform the healthcare system. “Recognizing that no one entity – patient, provider, payer or innovator – can address the complete value loop, this conference will draw representatives from the entire ecosystem to foster relevant dialogue and shared learnings.”
At IDSA's 2015 International Conference in Seattle, Evans spoke on The Next Wave of Healthcare Innovation.
IDSA Medical Design Conference 2016 speakers and sessions will focus on the practice and current methodologies in the design and development of medical technologies.
IDSA Executive Director Daniel Martinage, CAE, says advancing the conference to the U.S. West Coast will enable the premier event to reach an even wider audience. "Our partnership with Bill and the top-notch Bridge/Ximedica team will result in a best-in-class event,” Martinage says.
The IDSA Medical Design Conference is expected to draw designers, medical professionals, and other experts in related fields to keynote sessions, panels, and hands-on workshops. Attendees will network, exchange ideas, and engage in thought-provoking – often one-on-one – conversations in a dynamic environment.
In 2015, Bridge Design joined forces with Ximedica to create a full-service, ISO13485 certified and FDA-registered, medtech development firm. IDSA is one of the oldest and largest membership organizations for industrial design professionals with dozens of communities, including the Medical Special Interest Section led by Sean Hägen, IDSA, who chaired the first IDSA Medical Design Conference in 2014 at the Center for Advanced Medical Learning and Simulation (CAMLS) in Tampa, FL. He also spoke at the second IDSA Medical Design Conference also held at CAMLS in 2015.
McLean, Virginia – Manufacturing technology orders made a 17.5% gain in June compared to May according to the latest U.S. Manufacturing Technology Orders report from AMT – The Association For Manufacturing Technology. At the end of the first half of 2016, orders are down 15.8% compared to the midpoint of 2015.
Current market forecasts indicate 2016 orders will finish lower than 2015, though announcements for new manufacturing facilities and factory expansions give optimism for an upturn in capital investment in the second half of 2017. Additionally, orders are expected to see a boost following IMTS – The International Manufacturing Technology Show in September.
“There are many mixed indicators in manufacturing right now, a reflection of its creeping growth rate overall. There has not been enough expansion activity to truly impact capital investment in new equipment,” said AMT President Douglas K. Woods. “The historical average pickup in orders for the months that immediately follow IMTS is 32%, which we expect to see again this year. But beyond that our industry is not likely to see sustained growth in order activity until the broader manufacturing economy accelerates.”
Economic analysts have characterized U.S. manufacturing as stabilized with the dollar moderating in value. Manufacturing technology providers report inventories of machines are much lower and the order mix for machines is shifting to more complex and sophisticated products.
June 2016 manufacturing technology orders were valued at $323.74 million, compared to $275.47 million in May. For the first half of 2016, orders totaled $1,833.93 million, vs. $2,177.64 million for the first half of 2015. USMTO data is a reliable leading economic indicator as manufacturing companies invest in capital metalworking equipment to increase capacity and improve productivity.
Source: AMT – The Association For Manufacturing Technology
The Inaugural Integrated Industries Conference on Tuesday, September 13, 2016 will bring together industry experts with the goal of addressing solutions to current manufacturing concerns, sharing new trends & best practices, and ultimately helping companies thrive in today’s dynamic manufacturing environment.
Chicago, Illinois - The manufacturing automation industry is a large, complex, multi-billion-dollar entity. It features multiple layers of suppliers, researchers, developers, providers, and customers. Likewise, the range of problem types and possible solutions is wide and vast and often confusing to navigate. Many things contribute to the complexity of manufacturing automation and there is no “one size fits all” solution when analyzing a problem. Much like approaching your personal health, whether it’s proactively establishing a healthy lifestyle or diagnosing a chronic problem, there are thousands of providers with thousands of solutions and it can be hard to know what is right for your situation. When considering automation, approach it as carefully and inquisitively as though you’re addressing your personal health. The path is revealing and can help keep you out of trouble. For example:
Am I in a position to be proactive and establish a healthy lifestyle or am I sick and need to figure out what’s wrong?
Are you setting up a greenfield facility for a new production line or trying to fix a problem within an established manufacturing process? The nature of your starting point makes a big difference.
Do you have time to carefully plan a strategic path forward or do you need to stop the bleeding before a crisis occurs?
Do I need a general practitioner or a specialist?
Will any general purpose machine builder do or do you need a company that specializes in dispensing or high-speed, small part assembly?
How complex is your problem? Many integrators can handle a wide range of straight forward applications but many integrators have evolved into specialists in specific applications such as welding, dispensing, packaging, etc.
Where does your application fall on that spectrum?
Should I really ask my doctor if I need the purple pill because I saw a commercial on TV? Should you consider buying one of those friendly, inexpensive robots because you saw one at a tradeshow? There are many suppliers advertising their products as the solution to your problem.
Has your problem been diagnosed to the point where a specific solution can even be defined? Don’t let the tail wag the dog.
Am I hoping to find a quick-fix remedy and neglecting to look at the real underlying causes of my poor health? Are we looking to automate something because it seems easier than fixing our current bad practices?
A diet pill won’t make you lose weight if you refuse to eat healthy and exercise just like an automated vision inspection repair loop won’t improve product quality if you don’t trace back to determine and fix the root cause errors. This presentation digs into a variety of diagnosing questions and illustrates specific examples of good and bad automation initiatives and outcomes.
About the speaker Jordan leads AMT’s effort to introduce automation into new markets. He is a 30 year veteran in the industrial automation world with a background in industrial robotics, machine vision, and electronics assembly. Jordan has managed in several international companies and holds a Bachelor of Arts in Communications from the State University of New York, Binghamton.
In Part 2 of this 3-part series on the changes between ISO 13845:2003 and ISO 13485:2016, P&Y Management Resources’ founder discusses how to quantify the cost of quality.
ISO 13485:2016, when implemented by industry-specific specialists, provides for continued improvement, emphasizing defect prevention, and the reduction of variation and waste in the total supply chain while improving the financials. That is why generic ISO 13485:2003 is hurting your business, prescribing an overabundance of lengthy generic procedures and generic auditors; hence, the new industry-specific ISO 13485:2016.
One of the most notable benefits original equipment manufacturers (OEMs), plastics processors, and precision tool makers offer is that they start and lead the product manufacturing process, showing the biggest trends in the industry. They offer a glimpse into what companies, big and small, are investing in, and more importantly, what they consider to be the top needs of manufactures – from the CEO to the workers on the plant floor and everyone in between. High performance and clarity of operations strategy are a common pairing because it is operational processes and functions that OEMs, plastics, and precision tooling companies deliver to customers.
In the past, organizations implemented management systems to meet the requirements of applicable international standards due to customer or marketplace pressures. They were viewed as an additional cost to the business rather than actually providing a platform for finding opportunities for process, product, and service improvements.
With the issuance of the 2016 revisions to ISO 13485 and ISO 14001:2015, organizations are required to demonstrate measurable performance improvement. By proper use of the management system requirements, organizations can achieve sustainable business success. The sustained success of an organization is the result of its ability to achieve and maintain its objectives in the long term. The achievement of sustained success for OEMs, plastics processors, and precision tooling companies is a complex and demanding challenge as they operate in an ever-changing environment.
This series of articles, ISO 13485, is a guide for how companies have used the management system requirements of ISO 13485 and ISO 14001 to realize cost savings.
ISO 13485:2016 improves the financials by asking: How much does quality cost? Most companies would be hard-pressed to translate quality into real dollars and cents. What they do realize, however, is that a lack of quality could cost millions of dollars in rework, scrap, recall, or even liability lawsuits.
We need to understand OEMs, plastics processors, and precision tooling organizational elements are aligned, or else different parts of our operation will head in different directions. Fundamentally speaking organizational elements are:
Processes
Sourcing approach
Infrastructure
People
However, processes come first because the purpose of operations is to deliver a service or product to customers, which requires the right processes. If we don’t understand the processes we want, then it’s hard to choose suppliers, build infrastructure, or select people that consistently deliver. The highest level of a process is a value stream. We need to know our value streams as they are today, what we want them to look like in the future, and the gaps we need to fill – a value steam map for each department.
Measure current processes
Unavoidably, value stream clarity means we need to have competencies in measurement. Simply put, without measurement we are in the dark, and few operational leaders really enjoy that experience. This means that the first step after mapping your current processes is to measure them. This is often the starting point for a genuinely advanced operation. The measures must address effectiveness (or the extent we are meeting customer needs to a defined level of quality), efficiency (how much it is costing us to do so), and sustainability (the extent to which we are burning out our people or infrastructure). No assessment of today is complete without at least a point-in-time assessment of performance; later we will want to try to make that continuous and in real-time.
If we know our current processes and our quantified performance, we can now be clear on what our future processes will look like and targets for how they will perform. The next step is to decide the core: what we will do ourselves as opposed to outsource. In these decisions we are first assessing what we can do better than anyone else at a given level of cost, or what gives us a unique competitive advantage.
When we know what our future processes look like, what our measurable targets are, and which pieces we will do ourselves (as opposed to outsource), then we have real clarity of operations strategy. Now we have a platform on which to make decisions about people and systems because we understand what we want to do, and which pieces we will be delivering ourselves. Only at this point can we feel confident about all the workforce is on the same page.
Waste elimination
The fastest way to improve performance is waste elimination, but first you have to find the waste and prioritize. I recommend that organizations do two important things:
Collect data on specific value streams in order to reduce waste
Develop the infrastructure and means to measure on an ongoing basis.
It is important to focus on the first of these two imperatives.
A value stream is the high level of activities that are conducted, generally sequentially, to provide a customer with an outcome. For example, product research, design, marketing, sales, fulfillment/installation, and servicing. Processes tend to be practically defined as specific parts of a value stream, for example the product development process or the sales process.
CEO/owners needs to know in detail when to use data collection methods. And, they should assure themselves that they have access to competent personnel who can use the right approach. These days, the journey need not be a long one (given the development of modern tools and techniques), but there is still no alternative to good information being the basis of good decision making. That goes as much for waste elimination as any other leadership consideration. Otherwise, it is exceptionally difficult to emerge from the fog of loose information and hearsay.
About the author: Lewis Yasenchak is the founder/owner of P&Y Management Resources, specializing in ISO compliance/certification, quality training, and related management issues for the plastics industry. He can be reached at 706.694.2977 or lewis.yasenchak@windstream.net .
Helping robots to communicate more effectively with machines
First international interface standard launched for automated manufacture of workpieces.
Frankfurt am Main, Germany – Industry 4.0 is on everyone’s lips, but practical implementation is still rather tentative. This is due not least to the lack of standards for linking the digital machines to each other. The VDW (German Machine Tool Builders’ Association) in Frankfurt am Main is now engaged in changing this. It has for the first time formulated a comprehensive and nonetheless flexibly applicable standard with which robots or other workpiece carrier systems can be integrated more simply into a production system. This standard is scheduled for submission to the responsible technical committee of the International Organization of Standardization (ISO) in the upcoming weeks. “We are thus launching a first globally valid standard for interfaces in automated production systems,” says a gratified Dr. Hartmuth Müller, Chairman of the VDW’s “Machine Tool – Automation Interface” Working Group, which has drawn up the standard.
Boost for automation It was only recently that the WGP (German Academic Society for Production Engineering) – a grouping of front-ranking German professors in this field – warned the small and mid-tier companies not to miss out on the revolution involved in digitized value creation chains made possible by Industry 4.0. The lack of standards for networking production lines, let alone entire production chains, is deplored not only by academics. “The firms often have to endure protracted struggles before their machines are able to communicate with each other in an automated production chain,” concurs Ralf Reines, a technical consultant at the VDW. The problem is this: “Machines are not going to understand each other if the interfaces concerned are not compatible because they have not been standardized, just as people cannot talk to each other if they don’t speak the same language.” Depending on the manufacturer concerned, signals like “Release the workpiece” and “Place the workpiece in the loading station” have different names, and the meanings behind them are not uniformly defined. This is why, for example, a robot cannot necessarily “agree” with the processing machine involved on how to load and then process the workpieces.
Costly and elaborate reprogramming not required Sizeable production lines are in most cases installed without being able to test beforehand whether the machines are actually able to communicate with each other via the various interfaces provided. The individual machines involved are frequently too large and complex to be transported into a test environment. For this reason, the individual interfaces (i.e. the connections via which the data from the various machines are exchanged with each other) are discussed and coordinated beforehand by system integrators on the basis of numerous documents. Then comes the great moment when the line is switched on – and only too often nothing works. The amount of time and money expended on reprogramming the interfaces can be avoided – if all interfaces conform to a standard right from the start – as laid down in the new standard. “This will impart significant momentum to digitization of production operations, and is an important step forward on the path to Industry 4.0,” says Hartmuth Müller confidently.
New standard is flexibly applicable The newly created standard can be applied on a modularized basis, in order to meet a huge spectrum of disparate requirements – wherever particular workpieces have to be moved from transporting machines to processing machines. This may involve simple removal of a product’s parts or complete complex production lines, e.g. in an automotive production facility, where the workpieces are processed at different machines. In all, users can choose between three stages and different options for interpreting the standards to suit the specific project involved. Certain control system signals can be added or omitted, e.g. depending on whether the processing machine possesses a loading door guarding the machining area or not. The most important safety-engineering-related aspects are also laid down in a special safety interface.
In order to guarantee simplicity in actual use, the experts at the VDW have described the standard in an Excel file, with which the signals can be easily filtered for the various stages and options involved.
The formal procedure at the ISO begins with a survey on whether the standardization project is of international importance. For this to apply, at least four countries have to regard the project as deserving of standardization. Should this be the case, the work involved in international standardization will be commenced. The experts are in no doubt that this will happen before the end of this year.
