Industry executives discuss the advancements, changes, and challenges in the CAD/CAM industry. Participants concur on the importance of having a skilled workforce, and the need to continue educating customers so they move out of their comfort zone to work with the latest releases and advancements.

Four years ago, the staff of Today’s Medical Developments hosted a CAD/CAM roundtable during WESTEC, featuring a group of industry leaders. Today, we ask many of the same participants – together with a few new ones – their perspective on the CAD/CAM industry and their outlook for the coming years.

Concerns at that time rang out that, “The market is already saturated with CAD/CAM, everybody has got one or more systems already.” Alternatively, their concern was, “The problem in the CAD/CAM industry for all of us…is the workforce…I cannot find skilled people…five years ago [2003] 100% of my R&D work was done in the United States…now [2008] 40% is done outside the United States.”

Now, it is time to hear from our roundtable participants.

TMD: Are finding skilled workers a concern for our company regarding R&D, and a concern regarding the pool of skilled workers utilizing your software?

Picklo: Finding skilled workers is not a concern for our company, but we hear from customers that it is a continuing problem in the manufacturing industry.

Mund: As for our own internal R&D needs, we have been fortunate in finding perfect fits when we need them.

We have seen that finding skilled machinists is a concern for shops everywhere. There is a sense that shops are seeing fewer young people enter the industry, even though today’s machine shops can be among the most exciting and creative places to work. This is why we focus on CAD/CAM education so much at CNC Software – it is important to educate students about the benefits of manufacturing and manufacturing jobs.

McMinn: The best new graduates will always be in demand and Delcam runs an internship program that provides them with a good exposure to our company. We have high standards so we interview carefully for these positions so it is quite a competitive process. Most of these interns go on to become full time employees so this program allows us to attract high quality employees in a competitive environment.

Regarding our customers it is true that there is an increase in demand for qualified operators and manufacturing engineers. With in-sourcing increasing we expect this demand to continue. Many of our customers are asking for more consulting and training services and Delcam is continuing to expand its team of qualified application engineers to meet this demand. The sale of our services in the United States nearly doubled last year and we expect similar demand in 2012.

Mathews: Yes, finding skilled workers is a major concern in both arenas. The domestic hiring pool is quite obviously shrinking in terms of technically competent engineers, a trend we saw throughout 2011 as we actively expanded our team and continue to do so in 2012.

In addition, yes, there is definitely concern regarding the pool of skilled workers utilizing CAM software in manufacturing. I think the two go hand-in-hand and there are several reasons for this shortage. Among those reasons are that manufacturing is not generally viewed as being as glamorous as many other jobs and its relative unpopularity is exacerbated by the fact that technical positions are challenging...and workers have been scared away from the field because for years we have heard that all manufacturing is going overseas and is therefore a poor career choice.

Gibbs: Yes, although this is a bigger problem for our customers than for us. Gibbs has a very low turnover rate. Our top R&D people have been here a long time, some more than 20 years.

Machinists and NC programmers are another story. For example, in the late 60s L.A. schools had a very strong Industrial Arts program that I enjoyed myself. This is where my introduction to machine shops was before going on to study Engineering and Computer Science in college. I was unusual in my study mix, as the aim of Industrial Arts was at non-college-bound students. Of course, all that has changed now. Industrial Arts, or shop class, is all but gone in today’s schools. Budget cuts coupled with the philosophy that everyone should go to college have left a hole in the niche that used to be filled with people that enjoyed working with their hands.

Fishman: Finding good people in R&D is always a challenge. Really, there can be no bigger challenge to any organization today than recruiting the right personnel and talent. As our company has grown into a world leader and our development staff is our industry’s largest, attracting talented engineers is perhaps easier than when we were smaller.

For our customers, finding skilled labor is probably much more of a challenge. Simply put, today, parts and machine tools are getting more complicated, yet the people available to manufacture these parts and operate these machines are becoming harder to find. This challenge is probably one of the biggest drivers of our business’ growth. Since our customers are finding it harder to grow their production by adding people, because those people are just nowhere to be found, they are growing by investing in productivity enhancing software like PartMaker to allow their existing staff to be more productive.

Sivitter: I think this varies geographically both for us and our customers – it really depends where you are in the world as to whether you find a pool of skilled people. There is also a difference in their desires/expectations from CAD/CAM and their desire to be adventurous in its use – pushing the envelope or working very conservatively within the capabilities of the software.

CimatronE’s Micro-Milling Solution enables safe and efficient machining with very small tools, and working at very tight tolerances, in order to achieve an extremely high level of accuracy and surface quality. (Photo: Cimatron Technologies)

Rusk: There are a number of ways Siemens PLM Software is looking to address this challenge of ensuring that companies can implement the latest technologies. Our GO PLM program, provides PLM technology to more than one million students yearly at nearly 11,200 global institutions, where its use is at every academic level – from grade schools to graduate engineering research programs. In addition...we have made available Student Editions of our NX and Solid Edge products, making it easy for students to learn our products in their own home.

In addition, we continue to focus our efforts on making our tools easier to use and implement. Developments, such as synchronous technology, allow engineers to develop designs quickly and easily, focusing on the design task rather than the tool. With direct manipulation of geometry and dynamic feedback of the impact of changes to a model, use of CAD is much easier.

Therrien: [This is] not much of an issue for us.
 

TMD: During the roundtable participants noted that users typically become comfortable with the initial version they learn to use, and therefore they do not advance as newer versions come out – not learning to utilize, fully, the software’s capabilities. Is this still true today, and if so, what is or is not being done to address this?

TOP: NX delivers simulation results faster, having a direct impact on product decisions. (Photo: Siemens PLM Software) MIDDLE: Ease of use is a guiding principal in the development of FeatureCAM. (Photo: Delcam) BOTTOM: Dynamic Mill gives the user the ability to utilize the entire flute length of the cutting tool while maintaining more consistent cutting conditions. (Photo: CNC Software)

Picklo: Cimatron works closely with its customers to keep them current on the versions. Because much of the development in new versions is on customer feedback, they are anxious to run the latest version. To keep our customers informed we offer monthly tooling tips newsletters and webinars, and host user group meetings.

Mund: This will always be true with some people, and sometimes that is the right choice for a shop – their software might fit what they need to do. However, for shops that are either expanding or looking to boost efficiency on the jobs they have, it is beneficial to stay up-to-speed with the latest version as technology develops. We make sure that our latest tools help pull more efficiency out of the shopfloor.

McMinn: There may be a few shops working with outdated software but most Delcam customers are competing globally and they cannot afford to lag their global competition. There are so many enhancements in each release, which provide a competitive advantage, they really cannot afford to be working with an old version. Delcam has worked hard to communicate all of the new technology in each release in our learning zones on Delcam.tv so customers can easily see the value they get for the maintenance investment.

Mathews: Yes, it remains true that customers often become familiar with and comfortable with one version of the software and are sometimes unmotivated to learn newer versions that would allow them to take full advantage of some of the best tools available.

In our experience, this tendency – ultimately a tendency of human nature to become comfortable with any particular habit – serves the customer well until they find there is a need to change. We see this quite a bit in manufacturing, a field in which those who succeed remain competitive by utilizing innovation – by embracing innovation and having it excite them. No one wins in manufacturing today by doing it the way it always was.

Manufacturers who thrive not only see excitement by what they do, but they are pioneers who are constantly searching for ways to become faster and better at what they do. We recognize that we need to help our customers succeed, especially when they are taking a leap in adopting new forms of potentially disruptive technology, such as multi-tasking machining, a field in which ESPRIT excels. In recent years, we have added new methods of support that provide an additional safety net for those making the jump from ‘just so-so’ to major success.

Gibbs: The percentage of our customers on maintenance, those receiving all the latest versions and software improvements, is up since 2008. This is after we correct for those customers who are no longer in business. [Although] 2008 and 2009 were tough on manufacturing, the last two years have been good for manufacturing, spurring competition among the survivors, placing a premium on productivity, and opening the door for upgrades to a better CAM product.

TOP: ESPRIT’s full-spectrum functionality includes programming for 2- to 5-axis milling, 2- to 22-axis turning, 2- to 5-axis wire EDM, multi-tasking mill/turn machining, and B-axis machine tools. (Photo: DP Technology) BOTTOM: Vero Software designs, develops, and supplies software enabling mechanical design and manufacturing software specialized for a range of niche sectors. (Photo: Planit CADCAM Software/Vero Software)

Fishman: Sadly, this is still probably true, to a large extent. What Delcam’s PartMaker has done to combat this phenomenon as to more actively engage our customers through a variety of media to keep them abreast of the latest innovations in our product. These efforts include:

• Regular customer newsletters
• On-line Learning Zones with documentation and video about new releases
• Improved documentation, both written and video, of new products features
• Weekly, free technical update webinars, which are also recorded and made available for download
• Extensive use of our user forum and other social media
• Numerous, intimate and in person user conferences around the country

We recognize that when it comes to learning about new technology, one size does not fit all. Some people are auditory, some are visual, and some are tactile. You need to communicate to all three learning styles to have the maximum impact on a diverse customer base.

Sivitter: I think this is still generally true. From a vendor’s perspective, training and tips for greater productivity are more easily available today, via the web, rather than traditional classroom training. However, individuals, managers, and owners have to become better informed of what is possible, as well as more demanding. If the user is becoming comfortable then someone needs to demand some discomfort.

Rusk: This is a challenge that all vendors and customers face – how to introduce new technologies without disrupting current business. At Siemens PLM Software, with our NX product, we have adopted an evolutionary approach to our innovation. We protect our customer’s data and workflows as we move forward and introduce new tools and approaches to design, where users can use the approach they are familiar with until they build confidence in the new tools. We continue to invest in customer communication activities, such as our PLM Connections user events, where we bring together our customers and help them understand not just the new approaches but the value the new approaches can bring. Our field teams, both direct and channel partners, work with our customers to help them understand how new working approaches can bring benefits to their processes.

In addition to this work, our educational services team have been using on-line tools to make it easier for our customers to learn about new releases without the need for traditional classroom training. Services like our Learning Advantage site offer on-demand training for subscribers. We also work with our services partners to help them deliver more training tips via the web for our customers.

Finally, we have leveraged the increase in availability and acceptance of multi-media tools in our technical documentation making our help tools more interactive, such as and including narrated movies that deliver examples of how to use the new capabilities.

All of these approaches can help bridge the learning gap and encourage the use of new technologies as we develop it.

Therrien: This is always a challenge. Our customers are very busy, and it is always difficult for them to find the time to discover what is new. Therefore, the ability to access the key, new capabilities that will help them most is what is important. At SolidWorks, we have developed an extensive What’s New section inside our software that includes categorized listings of important new functionality that can be easily searched. We also include short tutorials that help users get up to speed on the functionality that is of interest to them most.

Additionally, our resellers are trained in all the new functionality and hold local events for users to help them understand the new capabilities that might be most applicable to them. SolidWorks itself also hosts various events and webcasts as another way of engaging users to get them up to speed.

PartMaker’s solids-based surface machining strategies support 3-, 4-, and 5-axis surfacing strategies. (Photo: Partmaker/Delcam)

TMD: What do you see as the biggest enhancements coming in the next five years for the CAD/CAM software industry?

Picklo: [The next five years will see] automation, standardization, and flexibility to meet customer changes/demands.

Mund: The biggest enhancement coming in the next few years is a continued aggressive push for intelligent toolpaths. Intelligent smart toolpaths dynamically adapt to part shapes and cuts, but they also allow for user knowledge when needed. There is flexibility for users to input their own expertise, if wanted.

McMinn: The CAD/CAM industry will continue to see more consolidation as the industry matures. Customers are demanding that their CAM vendor satisfy all of their manufacturing needs and provide a solution globally. Such solutions are typically provided by a larger company.

CAM systems must make less of a distinction between milling and turning. This distinction is certainly becoming less clear for machine tools, but many CAM systems still treat these two disciplines quite differently. Delcam has invested and will continue to invest a lot of development to allow a customer to create turning and milling operations with equal ease, to mix, match, sequence, and synchronize them as needed.

In five years there will most likely be little programming from 2D. It is becoming so affordable to create 3D models that CAM programming will be performed almost exclusively from 3D solid models. Delcam has been a leader in recognizing manufacturable features from solids and we will continue this development.

Mathews: Within the coming five years, the CAM industry will be focused on enhancing ease-of-use, speed, graphics, simulation, and automation. However, the greatest challenge will be capturing the vast amount of machining intelligence and finding an easy and quantifiable way to make it usable, and therefore valuable, to the average programmer. The ultimate goal is to make the CNC programming process completely automated while retaining the control that machinists need. This feat of automation would include speeding up the manufacturing process while making suggestions that ‘assist’ the programmer throughout.

GibbsCAM software delivers precision and high speed capabilities required for complex medical parts. (Photo: Gibbs & Associates)

One of our goals is to achieve unprecedented automation, quality, and consistency in CNC programming with the ESPRIT KnowledgeBase. ESPRIT’s KnowledgeBase gives you the power to leverage your shop’s most important strategic assets – its best machining practices developed during the years – for maximized productivity and a sharpened competitive edge.

It allows manufacturers to accumulate shop-wide machining experiences and refine their best practices by using real-world input that can be applied automatically. This allows manufacturers to free CNC programmers from repetitive parts programming, giving them time to focus on strategic process planning to further best practices improvements. ESPRIT’s KnowledgeBase provides a push-button approach for any programmer or operator to determine the best method to machine a given part or feature by automatically selecting the most appropriate machining cycles, cutting tools, and machining parameters.

Gibbs: [The next five years will see] better software for MTM support, better cutting and tooling technology integrations for faster cutting, and continued growth in 5-axis machining.

Fishman: I would not want to give away all of our secrets! You will have to stay tuned to our releases to get an answer to this one.

Sivitter: I think it is in the areas of further virtual prototyping and manufacturing automation where the biggest strides will be made. For instance, we are not going to have to make one to know it will work in the field. It will have been tested extensively before we ever go to production. As far as automation, toolpath creation will increasingly happen in concert with designing the part; add a feature and the toolpath comes with it.

Freebrey: The future of CAD/CAM will be based on the introduction of design intelligence into the software and maximizing the use of the industry innovations and cutting edge technologies. Advances in PC hardware, design/engineering machining, and cutting tools will result in CAD/CAM suppliers optimizing their offerings. PC hardware technology is vital to CAD/CAM development. Without advancements in hardware, complex full-machine simulations and high tolerance toolpath calculations would not be achievable. The cost of multi-axis machining centers is also reducing and it is becoming easier to purchase higher spec machine tools that, in return, require the need for advanced toolpath strategies.

SolidWorks product development solutions help designers in the medical field reduce design cycle time and costs, while still focusing on quality and reliability to increase patient safety and reduce liability. (Photo: SolidWorks)

Lots of development during the last few years has seen automation of machining at the forefront of development, with automatic recognition and machining of standard feature types including holes, pockets, and bosses, even to the extent of choosing the correct machining methods based on size and type of geometry.

This will only become more advanced in the future where any component will have the machining method chosen not only be simple criteria, but by even more advanced rules defined by the system. The choice of strategies and tools used, based on the component and what tools are available to the user, will allow for the system to choose the best machining methods – including the number of setups to keep machining time and setups down to a minimum.

Although CAD/CAM companies cover most industries, they often have similar strategies and methods for manufacturing in the general engineering sector. We have already started to see companies switch some of their resources to developing niche products, moving into areas where market growth can be predicted to move forward in the future.

Ultimately, the future of CAD/CAM will be driven by market demands, vertical applications with industry intelligence, and software automation.

Rusk: Current CAD solutions only address a small percentage of the overall product development process.

This coverage will grow during the next five years, bringing more of the early design process into the coverage, capturing and sharing design intent from the voice of customer through to the end deliverable.

With the changes our customers are facing in their products, for example the innovations that are occurring in medical equipment with more use of computer technology to monitor and manage patient conditions, we are seeing a demand for even closer integration between multiple disciplines including mechanical, electrical, and software. This will include increased levels of simulation for complex products to validate, truly, that a design meets its original goals.

New material innovations lead to the ability to manufacture more complex shapes, which will lead to the need for enhanced manufacturing tools, not just CAM technology but on the shopfloor. At Siemens PLM Software, we believe that with our knowledge in machine tool controllers and our CAM solutions, we will be able to help companies get more from their investment in manufacturing technologies.

Therrien: Our customers want even tighter integration between design, cost estimation, and manufacturing software – the ability to take advantage of information already contained in the 3D design model to speed up CAM programming and improve downstream collaboration.

 

Our industry experts have many more thoughts on the CAD/CAM market. To read Part Two, please visit OnlineTMD.com/tmd0312-cadcam-roundtable-part2.aspx.

Part 1 of this in-depth look at CAD/CAM from industry experts appeared in the March 2012 issue of Today’s Medical Developments. The experts had so much to say that we are pleased to bring you the rest of their thoughts and insight into the CAD/CAM industry in Part 2.

TMD: Regarding CAD/CAM technology, what was the biggest advancement in the past five years?

Picklo: [The biggest advancement has been] automation and flexibility of software to meet the customers’ process with tools to handle engineering changes and concurrent engineering.

Mund: We have seen a huge advance in smart toolpaths – toolpaths that dynamically adapt to the shape of the part, adapt to what cuts are coming up, and/or adapt to what cuts were already made.

McMinn: A number of advancements to machine tools have affected advancements in CAD/CAM technology during the last five years, in particular 5-axis and multi-tasking machines. However, the biggest technology change in software in general has been the development of multi-threading. This is the ability of an operating system to execute different parts of a program, called threads, simultaneously, which effectively doubles productivity. With some systems, the programmer must carefully design the program in such a way that all the threads can run at the same time without interfering with each other. With our system, you can prepare, calculate, or edit toolpaths in the foreground while calculating other toolpaths in the background, with minimal degradation in processing speed. This is what we term background processing. It works on any hardware system but the benefits are greater on multi-core machines. The unique advantage Delcam has is that parallel processing can be used in both foreground and background calculations simultaneously. This will undoubtedly provide greater performance and greater productivity, and facilitate more experimentation off the shopfloor so that they can get optimal efficiency with their machines.

Mathews: Within the realm of CAD/CAM technology, the most significant advancements within the past five years are the ability to program, much easier, complex multi-tasking machines, and parallel process algorithms that take advantage of multi-core computers. The advancement of programming software not only makes it easy to program sophisticated machine tools, but it inherently allows for the production of more efficient machining strategies.

Today’s more sophisticated post-processing and machine simulation have allowed CNC programmers to keep pace with the increasingly complex and growing numbers of mill/turn, Swiss-turn, and 5-axis machines installed around the world.

Due to the latest generation of multicore computers, the improved calculation speed that has resulted from parallel computing algorithms have delivered significant benefits to CNC programmers in the areas of toolpath calculation for complex 3-axis and 5-axis machining, and in machine simulation verification and collision detection.

In terms of significant developments within Esprit, our multi-threaded stock automation engine benefit users who are now able to start the part-program simulation at any time and at any point in the program. This new feature eliminates the need to simulate all operations from the beginning or to save the results of previous simulations. Now Esprit customers can start a simulation with the stock that results from the completion of all previous operations without first waiting for the simulation of the previous operation. The use of multi-threading technology – where stock calculations occur in the background – will not slow the programmer down.

Gibbs: Healthy growth in the MTM machine market is driving demand for capable software. In addition, market acceptance of high efficiency material-removal technology from specialty products, such as VoluMill, as integrated in CAM products, like GibbsCAM, is another growing market.

Fishman: CAD/CAM is an aftermarket product, serving the downstream programming needs of users of machine tools. Thus, if you want to know what the biggest innovation in CAD/CAM has been in the past five years, look at the biggest innovation in machining. Whatever you think the biggest innovation in machining, be it more advanced 5-axis machining, more robust multi-task machining or ever more sophisticated Swiss-type lathes, the biggest innovation in CAD/CAM has been supporting the latest machine tool technology. What is the biggest advancement in machining in the past five years is obviously a highly debatable point.

Sivitter: I think the whole area of simulation, whether machine tool, flow, or kinematics is the biggest advancement.

Freebrey: The biggest advancement in the past five years has been the introduction of software intelligence, reducing the reliance on CAD/CAM experts. Achieved by a knowledge-based database, this adapts over time and is usable by anyone to achieve the same results, following proven and tested rules and conventions. By establishing plant-wide database defaults that represent company standards, this ensures that from user to user, and job to job, you are producing consistent results and high quality tooling.

OptiRough uses the whole flute length for the first cut then adds smaller cuts to get the part to net shape. (Photo: CNC Software)

Adding intelligence to the software enables the system can automatically select the best strategy or machining parameters based on remaining stock or geometrical attributes. One example of this is the ability to take a standard 3-axis toolpath and convert it for use as a 5-axis toolpath, rather than having to rework it from the beginning. This is particularly useful for dealing with both short reach cutters and deep pockets.

The integration of a CAD/CAM system ensures that data can successfully pass from CAD to CAM. Those same features, diameters, hole depths, etc. can all be read, automatically, by the CAM system – providing the user confidence in programming and automation. Once the machining parameters of a feature are known (i.e. the diameter, length, width, depth, type, size, etc.) this feature can be assigned a machining process (i.e. rough with tool 1, re-machine with tool 2, finish with tool 3) to efficiently cut at the machine.

Rusk: At Siemens PLM Software, we have introduced a number of enhancements that have delivered significant value to our customers over the last five years. Most notable is synchronous technology. Synchronous technology allows engineers to make changes to a design without worrying about how the model was originally built, removing the dependency on the recipe (history) that created the model. This approach allows engineers to do more ‘what if’ studies and to investigate more design alternatives in a shorter space of time, allowing them to make smarter decisions on how to solve their engineering problem, and ultimately delivering better products.

The lack of reliance on a feature history also allows engineers easier tools to modify imported non-NX data, allowing companies easier approaches to working with suppliers and partners.

Delcam's FeatureCAM supports machines with C and Y milling capabilities and sub-spindles, letting users manufacture parts that more complex. (Photo: Delcam)

In addition to this, we have seen significant demand to increase the ability to validate design data before physical test. Considerable enhancements to NX simulation solutions (CAE) enable the analysis of complex multi-disciplinary problems for example structural analysis of flexible bodies under motion. This type of analysis can be critical in products combining mechanical, electrical and software elements for example MRI or X-ray scanning machinery.

The increased levels of regulatory controls and higher levels of awareness of customer requirements have created a need to make engineers more aware of the information that supports the development process. At Siemens PLM Software, our investment in our HD-PLM initiatives have focused on bringing the key information to support the design process to an engineer’s desktop without forcing him to leave his CAD session. Tools such as HD3D make the information instantly available to support product development decisions.

Therrien: Many of the major CAM vendors have decided to develop versions of their products that run directly inside CAD software. Currently there are eight CAM vendors that have applications seamlessly integrated within SolidWorks. In other words, the vendors’ CAM software runs directly inside the program so you do not have to import/export data, and anytime you make a change in your design model, the NC toolpaths can update, automatically. The great thing about this is that companies are more than likely using one of the eight associated CAM programs, so no re-training is required. One of our CAM partners, HSMWorks, is even offering a free copy of their fully integrated, 2-½ axis CAM software to all SolidWorks users.
 

TMD: Another response heard during the WESTEC 2008 Roundtable was that there was market saturation of CAD/CAM systems. Do you still see market saturation or is there a change that has happened, a shift?

Picklo: Although there are still shops out there using generic or no CAD/CAM software, the most successful businesses are those that utilize advanced technology to their advantage and software tailored to their business. Many tool shops continued this practice throughout the economic downturn; one of the reasons they likely are flourishing today.

Esprit's seamless CAD to CAM interface directly imports any native part model from any source, fully intact, with no need for programmers to edit or rebuild geometry. (Photo: DP Technology)

Mund: The CAD/CAM market is definitely mature so we have been focusing more on helping shops use their existing equipment (tools and software) to their best advantage.

McMinn: While it is true that it is hard to find a shop without some CAM system, I would question whether there was saturation in 2008. Certainly, the world of manufacturing has changed so much since then that there is no saturation now. Investment in machine tools has recovered dramatically since the downturn. However, the types of equipment purchased today are generally much more sophisticated. That could simply be companies buying machines that operate at much faster speeds, but is more likely to be that the equipment is more complex, such as 5-axis mills or multi-tasking machining centers. This equipment demands more sophisticated CAD/CAM software to perform at its best. However, one consequence of the downturn was that many CAD/CAM suppliers cut their development staff to try to limit their losses as their sales fell. This has meant that they have not been able to keep up with the recent developments in machine tools and cutting tools. Delcam increased their investments in development in preparation for the recovery. The overall result has been a drop in the number of CAD/CAM suppliers that can support the latest machine-tool technology. Of course, many CAD/CAM suppliers can provide basic 2D machining software, so that could be an area considered saturated. In contrast, there is certainly no saturation in the market for high-end programming systems that can maximize a company’s investment in sophisticated machine tools.

Mathews: The CAM market continues to with saturation, though we do predict a small amount of company growth through product improvements, as well as a rise in consumer demand. As there are just a small percentage of companies not utilizing some type of CAM software, those using software that is outdated, unsupportive, or inadequate due to the rapid advancements of more complicated machine tools, such as multi-tasking and Swiss machines often seek us out for assistance. [Therefore], the market must consolidate a smaller number of suppliers and products to provide an economic balance between the expenses required to fund the R&D with the income that is earnable by a given company and product. Upon close inspection, one will find considerable consolidation is actually already underway in the CAM market. For example, DP Technology, among others in the industry, has made significant international strategic acquisitions during the last several years. In selecting a CAM product, the financial position of the supplier helps the consumer understand that if the company and/or product have the strength and commitment to survive the ups and downs of the current economic reality; it is a strong and viable force.

Multi-task machining and machine simulation modules address the programming needs of CNC multi-task machine tools, which employ multiple tool groups/turrets and multiple spindles. (Photo: Gibbs & Associates)

Gibbs: If anything, the maturation of the CAM market continues. The bulk of CAM sales are existing customers growing, and replacement of other systems. There are fewer first time buyers. [However,] there is plenty of opportunity to provide better solutions and service to people dissatisfied with their current CAM product. One sign of a mature market is consolidation and CAM company consolidation continues, as with the Vero purchase of Planit last year.

Fishman: I do not think the competitive landscape has changed much in CAD/CAM since 2008. There are certain areas of CAD/CAM that are saturated, such as the market for software that performs basic functions like 2D milling, 2-axis turning, or basic wire EDM. At the low end, CAM has certainly commoditized, though not totally. That said, on the niche level, including areas such as Swiss turning, 5-axis milling, and other advanced manufacturing applications, there are still very few companies that do this well, so as a result, these niche market sectors are not saturated and therefore have not yet been commoditized.

Sivitter: I would not call it saturation, but clearly, there is a lot of choice and little apparent differentiation in many cases. However, there are differences so there is still opportunity to sell to new customers, and plenty of opportunities with customers who have outgrown their existing system or made a poor choice the first time around.

Freebrey: While many companies already have CAD/CAM systems installed, the need to adapt to changing markets and economic conditions often force a company to change current practices or industry focus. Many CAD/CAM vendors specialize in specific sectors and offer dedicated functionality. The need to remain competitive drives companies to review their currently installed system and, ultimately, switch to another system that better serves their current requirements.

Rusk: It is clear that there are a number of major players in the CAD/CAM marketplace and that number remains steady – there are no new significant players. However, our customers’ market conditions have led to a number of acquisitions and mergers, which has resulted in corporations having multiple systems (as you also found in your 2008 round table). As a result, of the economic climate we are seeing an increase in the number of companies looking to consolidate to single systems to reduce cost, increase communication between divisions, and leverage joint IP. This consolidation is not a simple task, while design data (model data) can be translated between systems, traditionally there is level of information (meta-data, feature history, drawing associativity) that is lost. At Siemens PLM Software, we have been investing heavily on a suite of migration tools that allow companies to protect the investment in their data and then move it to NX as a single system of choice. Development of these tools has been with customer involvement and a focus on bringing a high level of fidelity to the migration process.

PartMaker’s ConfigPost is a powerful and flexible post configuration tool that is also very easy to learn and use. (Photo: Partmaker/Delcam)

Therrien: For sure, there are many solutions to consider, but there is a lot of opportunity when it comes to seamless, integrated, CAD/CAM. The main shift is that users are demanding a tighter integration between CAD and CAM. To be more precise, the purpose of that integration is so they can eliminate the need to translate and repair data, as well as eliminate the need to have to redo their NC programs every time they get a design change.

Additionally, it has become critical to have the ability to pick any best in class CAD and best in class CAM. Users want to be able to select a best-in-class solution for design, and also be able to select a best-in-class solution for CAM. That means that it is possible these products might not come from the same vendor. In the case of SolidWorks, we have been working to fill this need by collaborating with our CAM partners in developing CAM applications that integrate, seamlessly, into SolidWorks – in other words, your choice of CAM directly inside SolidWorks. Currently eight CAM vendors offer fully integrated offerings inside SolidWorks.

TMD: How has concurrent/collaborative engineering impacted CAD/CAM software use and function?

Picklo: Tools that used to take 12 to 16 weeks now require delivery in six to eight weeks. The only way to accomplish this is to have three or four people working on a project at the same time. Concurrent engineering makes this possible – seamlessly.

McMinn: Clearly working directly with CAD files is essential to avoid translation errors. This facilitates direct communication of native files between the different groups. For SolidWorks users, Delcam now has its embedded gold partner product call Delcam for SolidWorks. This product runs inside SolidWorks and the CAM file is actually a part of the SolidWorks assembly file, which is shareable within the native SolidWorks PLM system.

Gibbs: [The impact of concurrent/collaborative engineering is] not a lot in our primary market, the job shops. Our primary customers are not involved in the engineering process. CAM is still the tail end of the process started in engineering. There is an opportunity for CAM technology to provide design input, or design for manufacturability (DFM), and for CAD systems to provide better focused manufacturing data. However, it has not happened yet.

Vero software incorporates specific process knowledge that enables the designer or machinist to achieve complex and precise components in a fraction of the time it takes when using more CAD/CAM systems that are more generic. (Photo: Planit CADCAM Software/Vero Software)

Rusk: Concurrent/collaborative engineering has increased the need for managed visibility of information throughout the process. Closely integrating solutions like Teamcenter with NX has allowed us to deliver a solution that supports shorter development lifecycles by ensuring everybody has access to the right level of data as they need it, managing revisions, release processes and all of the documentation required to support a product as it moves through its lifecycle.

Developments such as the HD3D suite of tools make it easier to communicate key product information across the organization, giving engineers visibility of important information that can impact product development from multiple sources. For example, the ability to visualize, track, and validate a design against the multitude of product requirements throughout the development cycle increases collaboration between organizations and ultimately leads to better products.

The increased use of open data formats such as JT mean that we can make 3D design information available across the enterprise for development reviews and customer and partner involvement. Recently Siemens PLM Software announced the availability of Teamcenter Mobility, delivering a subset of Teamcenter functionality including model visualization on iPad. This makes model data and key product information more accessible across the enterprise wherever the consumer may be.

Therrien: Customers are seeing big advantages (time reduction, improved quality) of integrated CAD/CAM, as long as they are able to select the solution that fits best. For SolidWorks customers, integrated CAD/CAM equates to timesavings between 25% and 90% of their old non-integrated CAD/CAM process.

TMD: What impact has design for manufacturability (DFM) had on the CAD/CAM industry?

Picklo: [With DFM] the tools added enable shops to design faster and shorten delivery times.

Mund: Any improvement of the manufacturability is a huge boom to software and shops. It makes process much quicker in going from art to part. It also helps shops feel more secure that what they are cutting is what the customer intended.

McMinn: Design for manufacturability has become more important as companies have become better at managing the potential conflicts between the optimum design, for either function or appearance, and the cost of producing that design. One trend that has helped is the introduction of direct modeling. The use of this technology in Delcam’s PowerSHAPE and other CAD systems makes it easier and faster to make changes for manufacturing, such as adding draft to walls to make part removal simpler or modifying fillets to make them easier to machine or to speed material flow. Delcam for SolidWorks also provides toolpath generation techniques directly inside of the CAD environment so engineers can analyze, quickly, the manufacturability of design revisions.

Gibbs: Not much [in regards to DFM]; are parts actually being better designed now? I think DFM for CNC is still largely an opportunity not yet realized.

NX8 provides faster programming, automatic tracking of uncut material across multi-stage machining processes, and programming automation for multi-part setups. (Photo: Siemens PLM Software)

Fishman: Believe it or not, the impact design for manufacturability has had in CAD/CAM is still in its infancy. You will see a lot more impact in the years immediately to come. While solid modeling has proliferated heavily in manufacturing, it still has some pitfalls, which is preventing from taking its place as the sole means of conveying engineering data to manufacturers. That said, one recent innovation, direct modeling, which allows for the manipulation of dumb models, i.e. solid models with no design history of feature tree, has been had a huge impact. For example, the recently introduced PartMaker Modeling makes use of direct modeling tools to allow users to modify dumb models such as Parasolid XT, IGES, and/or STEP models. Dumb model formats are very much the preference of OEMs sending work to job shops and contract manufacturers because using such data helps OEMs protect their IP as well allowing them to have the maximum number of potential vendors because it does not require a vendor to have the same CAD system as them to accept their data.

Sivitter: I am not convinced we are there yet. Do designers really think about the manufacturability of the part? Is the software really restricting their design when it knows you cannot manufacture it?

Freebrey: The rapid development of modern 3D CAD systems have facilitated the evolution of product design, and as a result, ever increasing geometry complexity. However, the manufacturability requirements are often an unknown at the time of design. For this reason, CAD/CAM systems need functionality to recognize potential issues at the design stage, before cutting any steel, at the time when the cost of change is minimal.

For example, in the case of a plastic medical part, engineers make key design decisions, such as part thickness, draft angle, thin walls, etc., without knowing the impact on manufacture. In many cases, the moldmaker is responsible for these corrections, but these issues should have been resolved at the design stage.

Rusk: The increasing awareness of approaches such as design for manufacturability has influenced some significant enhancements in CAD/CAM.

First, design for manufacturability has highlighted the need for easy-to-understand design validation tools that allow designers to identify, quickly, problems with designs that may cause problems in the manufacturing process, for example undercuts in cast, forged, or molded parts, and small transitions in machined components. NX Check-Mate is customizable to allow companies to build in their best practice criteria, and comes with 400 out-of-the-box checks usable to ensure designs meet commonly accepted best practices.

Second, closer links between design and manufacture require increased visibility of design intent for the manufacturing engineer. Approaches such as the use of Product & Manufacturing Information (PMI) adding dimensional, tolerance, surface finish type information directly to the 3D model make transferring this information across the enterprise easier. Once again, validation tools to check tolerance information meets company and industry standards allowing a greater degree of confidence when developing new products. PMI can work directly in CAM to automate the creation of toolpath information, adapting speeds and feeds along with material characteristics to improve product quality.

Therrien: The biggest impact is on the cost of manufacturing products. Generally, products that are easier to manufacture will cost less to manufacture. To this end, with our latest release of SolidWorks, SolidWorks 2012, we have included a real-time manufacturing cost estimation tool that works as you design. SolidWorks, through advanced feature recognition, and the application of an easily customizable database of manufacturing processes, parameters, and material costs, checks the design, automatically, figuring out how to manufacture it and displays the unit cost of the product broken down as material and manufacturing costs. This lets designers design for cost of manufacturing earlier in the design phase, thereby hitting cost targets more consistently and eliminating the need to redesign for cost later after release of the product.

SolidWorks Costing compliments our previously released design for manufacturability tool called DFMXpress included with all SolidWorks licenses. DFMXpress checks parts for manufacturing problems that typically designers often overlook, and usually require correction or modified on the shopfloor.

TMD: In regards to the CAD/CAM market, what role is it seen as playing in regards to the increased precision required in manufacturing of today’s products, looking at general manufacturing, as well as manufacturing in industries such as medical device, aerospace, automotive, and energy?

SolidWorks software packages provide a range of capabilities for a comprehensive design solution. (Photo: SolidWorks)

Picklo: As the market demands for precision and micro-manufacturing have increased, CAD/CAM solutions can deliver results of superior surface quality and tight machining tolerance; quick, safe, and high quality machining of miniature parts and molds; shorter machining time and lower tool wear. The things people are doing today, five years ago were not possible. Today with newer machines, higher quality machining customers are able to produce the smallest of parts.

Mund: As demand for precision increases, CAD/CAM software delivers the most potential benefit by offering toolpaths that match the specific precision needs in a variety of industries such as medical, automotive, aerospace, and energy. These industries all need high accuracy, but cut different materials and in different ways. It is vital that CAD/CAM software produce that precision, but takes into account the needs of the specific industry.

McMinn: Precision effectively comprises two related elements: the ability to achieve a particular tolerance in a sensible amount of time and the ability to maintain that tolerance over a run of parts. CAD/CAM is essential for both elements. It allows machine tools to operate to high levels of accuracy and efficiency, and, even more important, makes it possible to maintain consistency from part to part. Producing high precision parts requires a customer to make the most of his machine tool, tooling, and CAM programming. That is why Delcam works so closely with machine tool companies and high precision tooling manufacturers to ensure that our software products work seamless with those of our partners.

Gibbs: I am not sure any of these industries are crying for increased precision, with the possible exception of medical devices. Most industries are crying for higher productivity and reduced labor as a cost factor, so Asian products do not have a significant cost advantage. With the labor costs minimized by high automation (like MTM machines), and the current weak U.S. dollar, U.S. products can compete with anyone on a cost basis, and we have better quality, engineering, etc.

Fishman: There can be no question that manufacturing is getting more competitive. One aspect of this is that tolerances are becoming tighter, decreasing the margin for error to almost none. When squeezing margins in this way, you can only remain competitive through automation. In this regard, CAD/CAM in fields such as medical device, aerospace, automotive, and energy allows the manufacturer to manufacture to tighter, more precise tolerances with a higher degree of repeatability and measurability.

Sivitter: Very little by way of precision; that is the role of the tooling and machine tools – but in terms of design complexity, virtual prototyping, and productivity, it is significant.

Rusk: The CAD/CAM and CAE market is critical to increasing precision at an affordable cost in today’s products. Simply tightening tolerances and increasing inspection alone will not deliver a cost-effective business.

Utilizing CAD data to increase design accuracy combined with CAE tools to validate critical component and assembly criteria will lead to improved designs. The use of technologies such as PMI and 3D tolerancing will allow companies to employ statistical analysis techniques to analyze tolerance stack-up conditions, once again giving engineers the ability to identify and control key contributors to overall product quality.

At Siemens PLM Software, we believe that a closer integration of our CAM tools with the factory floor can help companies improve product quality and get the maximum return from their investment in machine tool hardware. Closely tying our NX CAM solution to the Siemens Sinumeric controllers allows manufacturing engineers to get the most out of their machine tools, increasing control and delivering more efficient toolpath information.

Therrien: One area that we have seen concern is in the passing of tolerance and other manufacturing information from CAD to CAM. Enhanced capabilities in the area of exporting critical manufacturing information, including the joint development of a new product capable of meeting requirements of the new MIL-STD-3100, are hot topics for us. Of course, the increase in the number of CAM vendors that can seamlessly integrate inside SolidWorks will provide direct access to all modeling information such as tolerances, surface finishes, etc. SolidWorks’ goal is to provide the capabilities necessary to allow our customers to meet their design and manufacturing challenges.

Turning resin into a well-designed medical part requires careful planning throughout each step of the process.

If you talk to anyone who has been in the medical plastics industry long enough, he will have a story about a part that looked great on paper, but created significant problems in production.

Experienced engineers know that it is not enough just to design an aesthetic and functional product. It is equally, if not more important, to ensure part designs are optimized for manufacturability, which often requires the support of a variety of collaborators.

For best results in production, the design must be moldable, the mold must be durable and well planned, and the parts manufactured with precision. Poor designs can create product flaws that present significant safety concerns for doctors and patients. Any weak link in the design and fabrication processes can compromise the integrity of the final part and lead to expensive redesign down the line.

To ensure the best design of a part for manufacturability, designers must rely on the expertise of their moldmaking and molding partners. Production of the best is through a joint effort of a part designer, tool designer, and manufacturer – all in constant communication from the earliest development stages. Through cooperation, a team of designers can avoid many common molding pitfalls and produce better, more efficient, more cost-effective parts.

Let us look at several areas where this collaborative approach can deliver positive results.
 

Choosing the Best
The part design process is the starting point for creating any quality-finished piece. It drives the entire process and sets the course for both mold design and production.

One of the most important part design considerations is maintaining consistent wall thickness. Even thickness makes the part much less likely to contain imperfections.

Sink marks, slight dips in the surface of a part, are a common part imperfection caused by insufficient packing due to inconsistent wall thickness. Generally, gating of a part should be thick to thin so that the last area to pack out is at the gate end of the part. That way, the gate end freezes off last and ensures adequate packing throughout the part.

Similar to sink marks, warp is another type of distortion to a part’s surface. Whereas a sink is typically in one location, warp generally occurs over an entire part. It is also usually the result of inconsistent wall sections, which cause temperature variations during cooling.

Voids are internal imperfections in a part that occur most often in thick-walled areas. They occur when there is a significant difference in cooling rate between skin and core material. These imperfections are not as apparent, physically, as sinks or warp, but are identifiable through X-ray.

In addition to wall thickness, designers must also consider the durability of the part upon ejection from the mold. They should avoid incorporating delicate, fragile features that have a tendency to break during the ejection process.

Early and constant communication among the part designers, tool designers, and molders is critical to the success of a project.

Although gating is more a concern of the mold designer, it is also important for part designers to be aware of gate design. He must determine if the part is able to have gate vestige, and if so, the best placement of the gate. If possible, gates should be located at the thickest area of the part, so that plastic flows from there to the thinner sections. Otherwise, it is difficult to pack out the thick areas.

It is also important to choose the best material for a given application. Certain materials do a better job than others do when it comes to filling out certain wall thicknesses. Many materials have more uniform shrinkage than others do. This also influences the quality of the final part because more uniform shrinkage equals lower warp, often caused by differential shrinkage.

For example, if a customer wants to use Polyvinyl Chloride (PVC), to make a part that is traditionally made of Liquid Crystal Polymer (LCP), he will have trouble filling out the wall. Because the viscosity of PVC is higher than LCP, the resistance of flow will inhibit the material from filling in the thin areas. It is important for designers to rely on recommendations of an expert with knowledge of the properties of various materials for advice on which materials are appropriate for a given application.
 

Design, Fabrication
A good moldmaker will take responsibility for working closely with the part designer and driving the mold design. Based on the part design, he will provide recommendations to the customer on how to create the best mold to produce that part.

Using computer-aided design (CAD) software, mold designers and engineers can create an initial blueprint for the mold. With that as a guide, they can easily react to any changes that may occur on the part design, material selection or cavitation, and adjust the mold accordingly.

To design a good mold, a moldmaker must first ensure that the part design is physically moldable. Occasionally, it is possible to design a part that is not moldable.

Additionally, a moldmaker must be sure that fabrication of steel is possible, according to the mold design. The steel can behave during fabrication differently than assumed during design. Designers must ensure the steel is thick enough to withstand the injection process.

It is also important to make sure that the steel walls have adequate support in relation to the injection pressure. If the walls are too thin, a cavity can deflect under the pressure, causing flash or defects. Designers must ensure there is support to walls in high-pressure areas to prevent this problem.

Alignment is another key to a well-designed tool. When molds close, all components must align properly. Any misalignment will lead to premature wear.

Over time, all molds wear out and need sections replaced. Tool designers must evaluate which parts of the mold will wear out most quickly due to abrasion of the materials. By identifying these sections, they can build replacement inserts. That way, the sections can be replaced, quickly and when necessary, significantly reducing downtime or production interruptions.

Keep Variables in Check
After design of the part and mold, a molder should run samples of a part to be sure everything is functional and molding correctly. Expert molders use scientific molding to evaluate the molding process and make any necessary adjustments. This effort provides for a consistent, repeatable production of the part.

In scientific molding, process engineers determine both the optimal molding conditions and the molding window, or the best speed at which to inject plastic. Using real-time production monitoring systems and advanced quality inspection equipment, they also examine how easily part manufacturing will be and how consistently the mold runs based on several criteria.

Engineers must closely evaluate the manufacturability of a part, considering the process conditions with respect to the limits of the injection-molding machine.

After determining the optimal molding conditions and molding window, moldmakers conduct a first article inspection. They examine all the critical features of a part, and then all the non-critical ones. Often, they will also do a capabilities study, in which they examine critical dimensions over an extended production run. This study enables them to detect any variations over a longer period and adjust the tool or production print accordingly.

Another common monitoring component is a cavity pressure sensor to the mold, especially for higher-volume applications. Installation of the sensor is usually opposite the gate end of the mold and close to the last section to fill. Most sensors have pre-determined levels. Otherwise, the molder can set a threshold on the sensor, generally a low limit for short shot and a high limit for flash.

If the pin and the cavity sensor on the mold do not register the required pressure, the press will automatically divert the part with a chute or conveyor. This lets the molder know whether a part is good or bad before the mold even opens.
 

Cooperation, Collaboration
Plastikos and Micro Mold, sister molding and moldmaking companies based in Erie, PA, specialize in working together to improve part and tool design – reducing cost, improving efficiency, and making products easier to manufacture.

Recently, the designer of a medical valve component came to them for assistance. The customer was producing the valve using an existing mold that was causing internal voids and sinks in the part. Additionally, one of the assembly requirements involved the part pushing onto a metal piece that fit inside it. The force required for this process was causing the product to fail at an unacceptably low force.

Designers at Micro Mold and Plastikos, working closely with each other and the customer, saw opportunities to modify the walls of the part for greater consistency. They cored out the thick-wall sections in a way that did not compromise the overall strength or integrity of the part.

Through modified part and mold designs, they eliminated all the part sinks and voids upon the first shot out of the mold. The tolerance for the force of pushing the part onto the metal component more than doubled.

This case study is a reminder that it is important for designers to find knowledgeable partners and trust their expertise. Through cooperative effort, designers, moldmakers, and molders can produce better parts more cost-effectively and efficiently.

 

About the Authors
Ryan Katen serves as both the engineering manager for Plastikos and the general manager for Micro Mold. He holds both a Bachelor and a Master degree in Industrial Engineering from Purdue University. He has significant tooling and injection molding experience, with a focus on manufacturing process improvement and optimization.

Rob Cooney serves as the manufacturing manager for Plastikos and holds a B.S. in Plastics Engineering Technology from Penn State, Erie, PA. With more than 13 years in the industry, Cooney has considerable expertise in continuous improvement, quality systems, and the scientific molding process to achieve the highest levels of quality and efficiency for customers. Cooney also serves on the SPE (Society of Plastics Engineers) board of directors and is president of the Northwest Pennsylvania chapter of SPE.

Plastikos Inc.
Erie, PA
plastikoserie.com

The treatment of solid tumor skin cancers continues to challenge the medical community, particularly those that have progressed to an advanced metastatic stage of disease. Despite innovations in genomics and proteomics research and drug discovery, development of efficient drug delivery mechanisms that are safe and effective, while achieving the desired treatment benefit, remains a significant unmet medical need. One approach to meeting this challenge involves the use of a process called electroporation. Derived from the words electric and pore, the procedure involves applying a brief electrical pulse to the cancerous cell. The electrical pulse triggers the creation of temporary pores in the cell’s surface – pores that close again once there is discontinuation of the electric field. These transient pores improve the uptake of various drugs more than several thousand-fold. With this technique, it becomes possible to treat cancers locally by targeting the tumor directly without affecting the surrounding healthy tissue.

Developed by OncoSec Medical, for use in two distinct varieties of anticancer therapies – Electrochemotherapy and Electroimmunotherapy – the OncoSec Medical System (OMS) is a technology platform harnessing the power and precision of electroporation. In the former, an anti-cancer drug is injected into the targeted lesion; the tumor is then electroporated and the drug carries out its cytotoxic mechanism of action. As a result, of this targeted approach, the amount of drug needed to induce cell death is substantially lower than the dose required in traditional chemotherapy. The reduced quantity of a locally delivered drug (traditionally, chemotherapeutic agents are delivered systemically) diminishes or eliminates the harmful side effects commonly associated with traditional chemotherapy. In addition to the ElectroChemotherapy approach, the OncoSec ElectroImmunotherapy approach involves the use of a gene coded for a specific protein that regulates the human immune system to recognize cancer cells. While this treatment generates an immune response against the locally treated tumor, it also generates a systemic response against distant, untreated tumors. In this article, we focus on the technology of the electroporation device.
 

Applicator Characteristics Sterile, single use, disposable Plastic handle assembly has six stainless steel needle electrodes on the distal (treatment) end and a transfer cable that securely connects to the front panel of the generator Needle electrodes are assembled specifically in a hexagon configuration capable of treating a 1cm diameter area; treating larger tumors and tumor margins, the applicator is re-applied in a contiguous fashion Needle lengths up to 3cm Applicator heads with straight or adjustable angles in order to address different size tumors and local anatomical requirements A micro-processor embedded in the applicator enables the OMS to configure the correct pulse parameters for each treatment and provide device diagnostics to the base instrument Ethylene oxide (ETO) sterilized applicators are packaged in two Tyvek lidded trays, one within the other to provide for a double sterile barrier

Electroporation Platform
The OMS is a proprietary, reversible electroporation device that has been successfully tested by a third party for electrical safety and EMC standards. As well, a Device Master File (DMF) was submitted to the Food and Drug Administration (FDA) on October 20, 2011 (MAF-1875). The OMS platform consists of four components: the electroporation generator, a reusable handle, a sterile/disposable applicator tip, and companion printer. The OMS electroporation generator incorporates features that ensure the therapy has been properly administered to the patient’s lesion. These features include internal instrument checks of the system parameters before a therapy Ready indication is displayed. In addition, internal instrument tests routinely occur at Power On and during the actual therapy procedure. Following a completed treatment sequence, both audio and visual indicators are provided to the physician user. The audio indication is a series of three short beeps in rapid succession. Visual indications are displayed on the front surface of the OMS generator.

The actual electroporation is applied to the treatment area by means of the OMS applicator handle with attached application-specific OMS applicator tips, which are sterile and disposed of after a single use. The OMS generator automatically sequences the various stainless-steel needle electrodes so that the appropriate engineered electric field is applied during the therapy procedure.

Based on the size and anatomical location of the tumor to be treated, a physician selects the most appropriate electrode applicator. OncoSec has developed a series of ergonomically designed single-use applicators and applicator tips that deliver electrical pulses to opposing electrode pairs of needles to maximize the electrical field strength within the treated tissue.

The OMS applicator handle consists of a cable with a proximal connector that securely attaches to the OMS electroporation generator. The OMS applicators and tips are available in a variety of sizes to suit the appropriate therapeutic application. Several different electrode applicator configurations are available. The OMS system is designed such that the installed base of the generator system allows for a wide variety of new electrode applicator configurations. Typically, the tips are characterized by a 1.0cm diameter six-needle array, 26-gauge needle size, with up to 1.5cm needle length. The applicators are preset at the factory for the delivery of a set number of pulses per patient to prevent their continuous reuse. The generator is capable of supporting several hundred thousand procedures and is completely pre-programmed for ease of use by the treating physician. The treating physician attaches the applicator handle to the sterile/disposable applicator tip. Connection of the OMS applicator handle to the generator automatically configures the treatment session. The OMS applicator sends information for that particular applicator’s size and shape to the pulse generator, which automatically selects the appropriate treatment parameters. Therefore, the user is not required to set any of the parameters for electroporation. The actual delivery of a therapy sequence is controlled by the foot switch activation. If required, the user may interrupt a therapy sequence in process by simply disengaging the foot switch.

Electroporation Micrographs of cells before and after brief electric pulses confirms electroporation causes pores to open/close Researchers discovered that applying a brief electric field to a living cell caused a transient increase in permeability  in the cell’s outer membrane Also observed was that pores would close within minutes of discountinuation of the electric field The phenomenon became known as electroporation By creating these membrane pores, an agent can flow into the targeted cells by an increased factor of 1,000 or more

Upon user activation of the foot switch activator, the OMS electroporation generator delivers a sequence of six pulses of specified voltage and duration in a square wave pulse pattern, which yields the optimal transmembrane potential for reversible electroporation to occur. For each electroporation sequence, the OMS electroporation generator generates six pulses of a specified voltage and duration. After each pulse, the polarity between opposing needle electrode pairs is reversed and the needle pair is pulsed again. After each of these paired pulses, the delivery is rotated to the next opposing needle electrode pair. These parameters and the resultant electric field at the treatment site produce optimized cell membrane permeability. The sequencing of pulses assures complete and uniform coverage of the electric field within the needle array, and consequently, complete and uniform electroporation of the target cells. Meanwhile, the printer provides real-time print documentation during therapy sessions, as well as event log printing, to record previous treatment and system diagnostic information.

In a typical procedure within the operating room, depending on the type of cancer (local or metastatic), the physician injects either a generic chemotherapeutic agent or DNA plasmid encoding for an immunotherapy cytokine directly into the tumor bed. The needle electrodes are then inserted directly into the tumor and pulsed in repeated fashion until the entire mass, including the margins, has been treated. On average, the entire procedure takes 15-30 minutes.

Design, Manufacturing, Testing
The OMS system was developed as a joint project between Johnson & Johnson Ethicon Industries and Genetronics Inc. (now Inovio Pharmaceuticals Inc.). A team of electrical, software, and mechanical engineers developed the OMS electroporation generator and associated applicators throughout a seven-year period. The development was undertaken with strict design controls within an ISO-9000 environment. All the design input and output specifications are documented, verified, and validated per FDA design control requirements.
 

LEFT: The OncoSec Medical System (OMS) is designed to use the power of electroporation to dramatically increase the cellular uptake of OncoSec’s chosen therapeutic agents and enable these agents to provide their cancer-killing benefits. RIGHT: The hand-held applicator has a hexagonal arrangement of three pairs of electrode needles at its distal end. When activated, the generator supplies a series of short duration electrical pulses of specific voltage through the six-needle hexagonal array within the head of the applicator.

 

The OMS system is isolated from the power mains by a rated isolation transformer and further isolated by using opto-isolation throughout the circuit design. The circuit is designed in two main sections: One circuit section supplies the output power for electroporation, while the other, a FPGA-based logic section, controls the user interface and the output waveform. The OncoSec OMS employs redundant safety systems, which are hardware- and software-based to ensure limits on output power and accidental electroporation. Redundancies also include OMS system self-checks that ensure the OMS is ready to output the correct electroporation waveform parameters.

The OMS is thoroughly tested in Onco­Sec’s production and engineering lab, ensuring each unit is ready for clinical operation. Each OMS unit undergoes a series of comprehensive acceptance tests that includes open circuit, high-potential leakage current, ground continuity, and run-in testing. These tests ensure patient and clinician safety while confirming the correct electroporation output.

The OMS system software has been previously fully validated. The design ensures that any micro-controller malfunction will not output any power. Isolating the logic and power sections and system self-checks accomplishes this. There are 98 error codes that clarify the self-checks if any system parameters are not in line with expected values.
 

LEFT: The OncoSec Medical System (OMS) generator is an electronic device that creates a pulsed electric field sufficient to induce a transient increase in the permeability of the cell membranes within the treatment field. RIGHT: OncoSec Medical (OMI) offers applicators with varying needle lengths, electrode needle spacing, tip composition and angles, and handle configurations to allow the treating physician to customize the device for ease of access to a greater range of tumors.

 

In addition, the system incorporates other features to eliminate the possibility of applicator reuse as well as to prevent the use of competitive applicators with the OMS electroporation generator. The current OMS applicators are suitable for treatment of tumors in most solid organs, including skin, breast, and pancreas. OncoSec has several new prototype designs for applicators that access deeper tumors, or tumors in soft tissue (e.g., prostate) or hollow organs (e.g., intestines), that are in development.

OncoSec’s San Diego facility incorporates production and engineering departments for manufacturing, testing, and developing future improvements and the next-generation OMS. The company is able to make future development improvements and subsequent production with minimal assistance from external contract manufacturing organizations. There are a number of near-term possible device improvements being contemplated. For example, some physicians might require different needle lengths for varying tumor sizes, in addition to the 1.5cm needle that is currently available. In addition, the OMS applicator handle and tip are currently configured with six electrode needles; this configuration will support most applications, but future applications may require the development of variants with a different number of needles.
 

The OMS Applicator handle consists of a cable with a proximal connector that securely attaches to the OMS electroporation generator.

 

The technology discussed above might provide a compelling and novel approach to the treatment of both local and metastatic solid tumor cancers.

 

OncoSec Medical Inc.
San Diego, CA
oncosec.com