Does Your Products Require a More-Flexible Sterilization Cycle?

Drug-coated products along with other novel materials are presenting some unique challenges for EtO sterilization. “These products require more versatility than the usual traditional cycle can offer,Inches Peter Veselovsky, president of Konnexis, told MD+DI. Sterilization of those newer products frequently requires “precisely controlled low-temperature, low-humidity environments.”

Different techniques may be used to extract EtO, Veselovsky explains, but since there are different acceptable residual levels, “flexible sterilization cycle designs are necessary to meet stringent needs,” he described. “And innovative cycles are necessary to deliver EtO in faster ways.”

Veselovsky continues to be helping medical device manufacturers develop and control such flexible EtO cycles through Konnexis’s AccuSolo sterilization process control system. Launched in 2014, the program may be used to control any EtO chamber created by manufacturer one validated form of software. “We can control the most complex chambers,” he stated.

Using Konnexis’s system, “medical device manufacturers can be cultivated and validate an EtO process on their own in-house chamber after which export the recipe to the contract sterilizer (that utilizes AccuSOLO),” he added. “Many top-ten medical device companies also do that to assist their very own internal processes in situation they exhaust capacity.”

Companies can run their cycles on all chambers across all global locations, and new versions from the upgradable and scalable software does apply to some site when requested. “If any risk was discovered between any user, we are able to make certain it’s remedied and enhancements are distributed. So that as additional features are added, they become open to the installed base,” he stated.

In case of a catastrophic PLC CPU failure, Konnexis’s system enables restoration to begin failure with no redundant PLC system, the organization reported.

Such abilities are “not simple for a custom SCADA solution, and altering all chambers to function in the same manner isn’t economical,” he stated.

Konnexis presently serves about 60 installed EtO chambers globally, “all running near to the same version,” he stated.

In 2015, the organization started supplying a located service simulator that enables people to design cycles and run them on the virtual chamber. “The solution enables users to check these cycles within the cloud,” Veselovsky stated. “Operators could be trained while using simulator rather with an actual chamber.”

To assist manufacturers get the cycles required for novel materials, AccuSolo continues to be “augmented having a peristaltic pump to provide precise humidity levels inside a unique way apart from pressure,” he described.

Recipes may also be built around “families of merchandise,Inches he stated. “This might help save your time, rather of running everything at worst situation.” Because AccuSolo can interface with corporate ERP systems, barcode scanners may be used to identify recipes for product families to guarantee the right cycles are selected.

And also to assist in preventing accidents, Konnexis has additionally built-in a flammability analysis tool, which offer predictive research into the gas composition. “Mixtures can have up graphically on charts,” he explains. “If there’s an excessive amount of EtO within the chamber, air valves won’t have the ability to open. Safety interlocks are made to prevent accidents. We’ve eliminated what caused accidents—phase advance. Rather, the cycle aborts securely utilizing an instantly determined sequence.” The machine may also warn users about an excessive amount of humidity at certain temperatures.

Veselovsky stated configuring AccuSolo takes only a couple of hrs, in contrast to per month or even more needed to build up software customized to particular chamber.

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For that latest insights on medical product, R&D, user-centered design, and much more, attend the conference at MD&M Minneapolis November 8-9, 2017.

A Unique Business Design

Within the wide field of incubators, accelerators, co-working and wet lab spaces, and investment capital, Naglreiter Medical Device Development Organization (NMDDO) occupies a distinctive niche.

The organization, located in Miramar, FL, was began with the aim of lowering the some time and sources which go into creating a new medical device company or developing a cutting-edge medical technology.

Days or several weeks, in addition to huge amount of money will go into finding or creating a facility, crafting an excellent system, and hiring talent. NMDDO offers entrepreneurs an opportunity to skip towards the fun stuff—developing we’ve got the technology or product. Their business design is different from outsourced development and talking to plans by continuing to keep control over the work in one place with aligned timelines.

“We give a full business manual, we offer all of the quality systems, and we’re the folks, the gear, and also the quality system backbone that then adopts that company,” stated NMDDO President Brett Naglreiter.

NMDDO uses customized service contracts to begin a customer relationship. Including a quote encapsulating the whole cost for which the entrepreneur really wants to achieve. However, a person doesn’t need to use NMDDO for each a part of that plan—“We’ll be just as much or very little of this budget,” Naglreiter stated. The client can figure out what sources she or he wants use of, including facility space, equipment, sterilization service, a piece of equipment shop, human sources and accounting systems, NMDDO associates, along with a quality system. As this contract covers the client using their beginning indicate their finish goal, it eliminates the requirement for additional transactions.

Naglreiter described, “We’re not carrying out a project for you, we’re not manufacturing it for you, we’re manufacturing it, getting regulatory clearance, with you.”

NMDDO could work with as many as five mid-sized or 10 small early-phase companies and projects previously, and it is presently at two-thirds capacity, Naglreiter noted. To date, NMDDO finds new clients by person to person and it has developed knowledge of the vascular, GI, ophthalmic, and spine fields, amongst others. Most of the company’s past and current customers are well-known, including Exceed Medical/Stryker Neurovascular, Edwards Lifesciences, Syntheon LLC, and Guaranteed Medical Corporation.

Clients choose the services and systems that actually work perfect for their demands. For example, one client could use NMDDO’s people and facility space, but continue using its very own quality system. Another would bring their very own employees but use NMDDO’s facility space and quality system. A serial entrepreneur who comes in having a novel technology might want the whole package, because she or he doesn’t wish to have to employ anybody or develop a facility. This versatility attracts prospects, Naglreiter stated. “It’s such new . . . it requires some time to allow them to realize that that’s what’s on offer.Inches

This versatility and combination of client needs means NMDDO must conserve a detailed arrange for its very own staffing and repair needs. The organization applies its plans because of its people to an exclusive staffing model that will help determine when you should hire new associates. You will find approximately 50 associates at NMDDO at this time.

“The model itself wouldn’t just inherently cause success. It really may be the people,” Naglreiter described. “I’m very proud of those that actually work here and just how lucky I’m [in] how gifted they’re. It’s the power and also the people with the proper atmosphere and also the right model making it all work.”

Eventually, NMDDO clients leave the firm. Potential occasions that may trigger this have an acquisition or perhaps a commercial milestone. Naglreiter emphasizes that departing the business isn’t a hassle for that departing company, because everything they produced while at NMDDO remains their very own. “That’s where the special moment is available in in the model, since it is being developed in your system and we’re working in your body,Inches Naglreiter stated. “The IP is yours . . . The term transfer isn’t even needed . . .” The ip, the standard management system, the physical assets, plus much more remains with the organization because it moves to the next phase.

Naglreiter sees lots of future possibility of his company’s business design. “I believe that it’s a great model that people could replicate at key locations as with the San Francisco Bay Area or Boston or Minnesota,” he stated. “I often see this as increasing numbers of of the franchise concept that we’re able to model in various locations and individuals will begin to appreciate the length of time and cash they’re saving when they begin with this at first to de-risk their programs.”

Guest Commentary: Healthcare marketing should concentrate on the individual

Notwithstanding the continuing debate on how to finance healthcare within this country, we all know the healthcare sector is experiencing an impressive transformation, with consumerism in the centre.

Digitally driven consumers have inspired all healthcare organizations—including providers, payers and retailers—to alter how they market, communicate and, most significantly, deliver care.

Consumers are in possession of immediate access to details about their choices, that has increased expectations by what a seamless, finish-to-finish healthcare experience feels and looks like. And contains intensified the requirement for true direct-to-consumer marketing to win these consumers at each reason for engagement.

Place in its basic form, healthcare marketing today is about delivering the best message, right person, in the right time—and then calculating it. The days are gone when brand awareness alone—through broadcast, billboards, sponsorships—is enough to influence consumers around the best choices for their healthcare needs.

Healthcare marketing is not about qualitative awareness, but instead it comes down to quantitative, targeted tactics and prescriptive modeling. For big, integrated systems for example Ascension, this means doing grass-roots research and consumer behavior and language testing to ensure that we are able to completely understand the populations we serve and anticipate their demands before they can enter our doorways. Additionally, it means getting a powerful, accessible brand that customers trust and discover convenient and connected.

It takes searching beyond audience segmentation and comprehending the individual–a segment of 1. Carrying this out correctly necessitates understanding search trends, consumer behavior, media consumption, clinical and nonclinical health risks factors, along with other data to really understand the easiest method to achieve individuals.

These changes also push us to consider larger than billboard and newspaper ads. We must be visible and open to our patients both before and as soon as they require us.

We have to be also dedicated to more-accessible, more-convenient and much more-seamless care delivery. We have to allow it to be simpler for customers to navigate our sites of care, both physically an internet-based, with cellular devices. This is not a pleasant to-do it is a must-do.

Situation in point: Nearly 80% of healthcare engagements now start with some form of online search, and most individuals searches begin on the small device. That to be the situation, healthcare marketing must be aimed toward winning at the purpose of engagement. Translation: less qualitative awareness, more quantitative marketing, and ensuring the knowledge is mobile-friendly.

After I talk to different organizations or groups about healthcare marketing, or perhaps internally after i talk to leadership at Ascension, I start by flipping that old marketing model on its mind. Healthcare marketing was once referred to as an upside-lower pyramid, using the base on the top representing awareness and also the tip at the end representing consumer engagement, and a lot of other activities happening among.

In the current consumer-centric landscape, we’ve moved our marketing closer to begin conversion.

The top pyramid now represents access points, mostly online, through mobile-friendly physician scheduling tools and urgent-care appointments. The center area of the pyramid has become a global-class website design that’s mobile-friendly and connected straight to sites of care. And also the is made of now sophisticated, analytics-driven consumer relationship management.

With this new quantitative, data-driven method of work, healthcare providers must realize the requirements of consumers better. Being an organization, we have started to readjust our marketing and clinical focus to determine our hospitals with the consumer lens. Consumers aren’t peripheral towards the equation those are the equation. Consumers have started taking their encounters in other industries and applying these to healthcare. This can be a new approach that people wouldn’t have thought about a couple of years back, but we are evolving as a result of the dynamic requirements of consumers today.

The way forward for healthcare marketing

Join thought leaders, hospital CEOs and senior marketing executives from top healthcare organizations across the nation at Modern Healthcare’s annual Proper Marketing Conference November. 7 in Chicago. Find out more and register at ModernHealthcare.com/StrategicMarketing

Q&ampA: How you can Pinch Pennies Without Stifling Innovation

Nowadays, it doesn’t appear to appear how big your R&D finances are, it never feels large enough. Frequently the greatest challenge when assembling an expense-effective finances are finding ways to save cash without having to sacrifice on innovation.

Nikhil Murdeshwar may be the principal research engineer at Olympus Surgical and formerly offered inside a similar role at Medtronic. Murdeshwar has spent years working in the area of research and medical device design and it has received several patents and awards for his contributions towards the field.

Murdeshwar lately chatted with MD+DI Qmed about methods to identify and eliminate waste inside your R&D budget, in addition to a couple of ideas to help researchers obtain the greatest bang for his or her buck — all without having to sacrifice on innovation.

Editor’s Note: The statements and opinions expressed fit in with Nikhil Murdeshwar and don’t represent Olympus.

MD+DI Qmed: To begin with, what is your opinion are the most significant aspects to think about when searching in an R&D budget to judge whether you’re getting the most from your spending?

Murdeshwar: I detest metrics clutter. Therefore, I seek indications in the budget that represent past and future, and gratifaction and revenue expectations. Such things as:

  1. Client satisfaction or quantity of innovations that return price of capital inside a reasonable time.
  2. Number of the portfolio motivated through customer needs.
  3. Revenue generated through product innovations.
  4. Development in internet present value across new items.

MD+DI Qmed: What exactly are some methods an organization can speak to eliminate waste within their R&D budget, and just how would they start identifying a number of individuals areas?

Murdeshwar: First of all, there’s no silver bullet for this complicated question. Next, waste is really a purpose of poor planning and communication. There are various methods to eliminate waste within the R&D budget, however i like visiting a firm foundation which includes:

  1. A powerful organization
  2. A structure
  3. A method aligned with sales
  4. Project groups
  5. An R&D procedure that is disciplined
  6. Warning signs of wise spending
  7. Metrics identifying value and waste

MD+DI Qmed: Inside a similar vein, the amount of challenging could it be to trim an R&D budget without always sacrificing on innovation? What advice have you got for individuals searching to trim waste without stifling innovation?

Murdeshwar: Scientific studies are dangerous, and predicting effective outcomes is extremely difficult. Striking balance between pushing the condition-of-the-art, whilst dealing with risk is really a daunting challenge. Changes towards the R&D budget begins with a smart strategy, which influences the different sorts of merchandise needed, which controls the amount of fully-supported projects within the pipeline.

Therefore, once the R&D finances are trimmed, the contact with bad outcomes increases unless of course that technique is either modified to take into account less products, or even the project plans are revised to take into account the greater risk.

Ultimately, the easiest method to trim R&D budgets without stifling innovation would be to have less, fully supported projects which are stocked with appropriate expertise.

MD+DI Qmed: What is your opinion is a very common mistake or misconception that frequently results in a bloated R&D budget, and just how can research groups save money and time on individuals areas?

Murdeshwar: A couple of common errors that cause bloated budgets are:

  1. Budget inputs from non-technical those who are centered on minimizing spending.
  2. Rushed R&D budgets which use estimates from previous years.
  3. Parallel path investigations that are utilized to meet on-time deliverables.

R&D groups can save money and time on these mistakes by:

  1. Seeking direct input from project teams.
  2. Identifying a necessity and preparing a company situation to warrant value.
  3. Revisiting budgets, value, and purpose in the exit of every project stage.

MD+DI Qmed: What exactly are some cost-efficient tools that will help R&D departments enhance innovation without considerably setting their budget back?

Murdeshwar: Some cost-efficient tools that will help R&D departments are:

  1. Voice of customer
  2. Constructing need statements
  3. Recognizing innovation outcomes that appear simple

MD+DI Qmed: What are the trends on the increase in the R&D field that researchers should think about when assembling an expense-effective budget?

Murdeshwar: A few of the latest trends in formulating cost-effective R&D budgets are:

  1. Transporting safe into PDP projects
  2. Challenging parallel path investigations
  3. Questioning market dynamics and customer interest
  4. Getting the courage to cancel active projects
  5. Placing greater importance on user inputs
  6. Emphasizing record relevant quantities
  7. Thinking about make and purchase decisions

MD+DI Qmed: Finally, you’ve labored extensively within the R&D field for any couple of different titans from the medtech industry. What is an essential lesson you’ve learned you could spread to other people within the field to assist promote low-cost, high-impact research programs?

Murdeshwar: [The significance of an R&D friendly atmosphere with the proper leadership, built around reliable and experienced people.

This Product Has Existed for 25 Years

It’s available in various sizes and configurations now, however the Gore Excluder AAA Endoprosthesis, which seals off abdominal aneurysms from the aorta, hasn’t altered significantly because it was brought to the ecu market in 1997.

The endovascular aneurysm repair (EVAR) device continues to be implanted in additional than 300,000 patients identified as having a stomach aortic aneurysm (AAA), based on its manufacturer, W.L. Gore & Associates. Before EVAR, patients with AAA had two options: major surgery to correct the aneurysm or entered fingers.

“The quantity of patients who weren’t candidates for surgery really drove the first experience with EVAR,” Eric Zacharias, vascular business leader for Gore, told MD+DI Qmed. “And now it’s actually a method that, especially in the U.S., it’s the main selection of patients if they’re given a choice of getting their aneurysm treated.”

The aorta comes from the center in to the abdomen, splitting in 2 to provide bloodstream towards the legs. AAA’s typically develop underneath the kidneys, nearer to that split. Gore’s EVAR device consists of two components: a corner section that anchors in the proximal finish from the aneurysm and descends into among the aortic branches within the leg and also the contralateral leg segment that matches within the trunk and descends in to the other leg. To put the unit, choices makes a person small cut on each side from the groin and uses catheters to thread the unit in to the anatomy.

The greatest switch to Gore’s EVAR device happened in early 2000s after physicians learned that some bloodstream serum components were dripping through its walls. The organization added an impermeable layer of film inside the Gore-Tex layers from the stent graft to prevent the leaks.

“That was the only real (major) change we’ve designed to the implant within the last twenty years,Inches Zacharias stated.

Furthermore, some early devices were built with a mismatch between your nitinol frame and also the graft, or problems in the manner the graft connected to the frame. The devices developed holes, resulting in “some pretty catastrophic put on occasions,” Zacharias stated.

The organization also found that many patients’ aortas were degenerating within the seal zones within the proximal and distal ends from the stent. Because AAA is another progressive disease, patients’ aortas have a tendency to continue weakening and alter shape with time, prompting the organization to build up different shapes and conformable devices.

Physicians advised Gore on changes that must be produced in how you can affix, anchor, and seal the unit inside the aorta. Gore added an anchoring system around the proximal finish from the EVAR to carry it in position and let it react to physiological changes. The organization has additionally made strides in the catheter-based EVAR delivery, making the aneurysm simpler to gain access to and enabling better device positioning.

“The whole goal would be to bypass the aneurysm,” Zacharias stated. “When you set individuals devices, they have to serve that very same function inside a reliable and sturdy way.”

The alterations have led to better outcomes, based on company data. Gore established the worldwide Registry for Endovascular Aortic Therapy this year, closing enrollment just over 5000 patients in 2016. The most recent data generated with a three-year postprocedural follow-from 3273 patients demonstrated a 98.5% rate of survival, freedom from reintervention at 93.4% and freedom from aneurysm enlargement more than 5 mm at 92%, the organization noted. The speed of conversion from EVAR to spread out surgical repair was .4%, and incidence of Type 3 endoleak (holes, defects or separations within the graft fabric) was .2%.

Repairs to individuals kinds of endoleaks as much as 5 years publish-implant push the expense of EVAR near to individuals of open AAA surgery however the lengthy-term outcomes remain similar, with less morbidity risk from EVAR, based on Zacharias.

Gore is constantly on the get the Excluder line. Its Conformable AAA Endoprosthesis delivery system gives physicians angulation charge of the proximal endograft and also the choice to bend the unit to higher fit complex anatomies. The organization also launched an iliac branch Excluder in Japan last summer time, following Food and drug administration approval in 2016.

EVAR prices remain stable, and the organization is focusing on producing them to a lesser extent. Future bundled payment initiatives can create “an interesting balance” within the ongoing evolution of AAA treatments, based on Zacharias.

“We do things inside our product cycles to organize us for devices that perform towards the CLSI clinical standards, which are cheaper for all of us to create and therefore are therefore cheaper for that patients and also the healthcare systems,” he stated.

Swallowable Flexible Sensor to Identify Stomach Movements

Scientists at Durch allow us an adaptable sensor that patients can swallow. The sensor stays with the stomach wall and may relay details about stomach peristalsis. This might help doctors to identify disorders that slow lower the movement of food with the gastrointestinal tract, or monitor intake of food in obese patients.

The study team wanted a non-invasive solution for monitoring stomach movements. To do this, they produced an adaptable device for elevated safety. Due to the sensor’s versatility, it may be folded up and squeezed right into a small capsule, which patients can swallow easily. The capsule breaks lower within the stomach and also the sensor adheres towards the stomach wall right after it’s liberated.

“Having versatility can impart considerably improved safety, the way it causes it to be simpler to transit with the GI tract,” states Giovanni Traverso, an investigation affiliate at MIT’s Koch Institute for Integrative Cancer Research.

The sensor includes electrical circuits printed on the flexible polymer. The fabric is piezoelectric, meaning that it may generate an electric current and current when it’s robotically deformed. It’s so sensitive that movements from the stomach wall are sufficient to create electricity within the material, which informs the sensor the stomach is moving.

When testing the machine in pigs, they discovered that the sensor can certainly keep to the stomach wall. Their prototype relayed details about stomach motility, and may tell once the pigs ate food or drank water. The present form of the unit transmits information through wires, however the researchers aspire to design a more elaborate wireless version soon.

The sensor may help doctors to identify digestive complaints that reduce stomach motility. Another application involves monitoring the meals consumption of obese patients. “Having a window into how much of an person is really ingesting in your own home is useful, because sometimes it’s hard for patients to actually benchmark themselves and understand how expensive is being consumed,” states Traverso.

Study in Nature Biomedical Engineering: Flexible piezoelectric devices for gastrointestinal motility sensing…

Via: MIT…

New Connected Devices Aim to Tackle Drug Noncompliance

Noncompliance with drug regimens remains a substantial healthcare concern. “Today, 60% of patients neglect to adhere to their medication regimen,” Sai Shankar, director business development – connected devices for Aptar Pharma, informs MD+DI.

Aptar Pharma believes that turning metered-dose inhalers (MDIs) and dry-powder inhalers (DPIs) into connected devices could have an effect. “This can improve patient engagement and considerably increase dose adherence and improve patient health outcomes, as patients manage their treatments better,Inches states Shankar. “Connected devices provide objective monitoring and real-time data with digital solutions. This improves patient adherence, which reduces hospitalization occasions in chronic illnesses. Hospitalization reduction decreases costs to payers, creating value in healthcare system.”

Aptar Pharma is partnering having a digital health solution provider to build up a portfolio of connected devices for example MDIs and DPIs. “Aptar Pharma offers drug-delivery devices that literally brings within the full connected functionality and integrate all of them with software programs which are available to patients/consumers,” he states.

“For respiratory system, we are featuring our c-Devices portfolio at CPhI, including our connected pMDI, connected BAI Platform, and Connected Prohaler devices,” Shankar states. “We’re also partnering with KaliCare on connected solutions for EyeCare, and will also be featuring individuals connected devices too.Inch

Shankar along with other people in the Aptar Pharma team is going to be talking about drug-delivery devices at CPhI:

Tuesday, October 24 at 10.30: Guenter Nadler, Director Business Development – “Innovative respiratory system solutions for expanding your products portfolio

Tuesday, October 24 at 15.50: Sai Shankar, Business Development Director for Connected Devices – “Driving better patient outcomes with connectivity

Wednesday, October 25 at 10.30: Arnaud Fournier, Business Support Manager Injectables – “Setting new standards for coated stoppers

For more information, visit Aptar Pharma at CPhI stand 42F10.

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And make certain to look at these educational possibilities at MD&M Minneapolis in November:
  • Workshop: Transforming Healthcare with Augmented & Virtual Reality” by
    Brandon Bogdalek, business development manager, Worrell
  • Deep Design: Using Technology to enhance Clinical Work Processes” by Kathleen Harder, PhD Director, Center for Design in Health, College of Minnesota
  • How Usability Research & Engineering Are Altering Medical Device Development” by Sean Hagen (BlackHagen Design) and Michael Lynch (Intertek)
  • Situation Study: How Human-Centered Design Disrupted Cancer Treatment,” by Mu Youthful Lee (Varian Medical Systems)
  • Top 6 IoT Design Techniques for Success” by Gianfranco Bonanome, director of IoT Solutions, Intelligent Product Solutions

Stop Carrying This Out to enhance Your Device Manufacturing Process: Part 1

Editor’s note: This is a component 1 of the two-part series. 

The manufacturing world is filled with practices to follow along with to enhance manufacturing processes and lower connected costs. These practices include, but aren’t restricted to: minimizing the eight wastes of Lean, recognizing and eliminating non-useful work, applying the perception of manufacturing and set up, and taking advantage of record process control (SPC). Regrettably, once we constantly add practices to the tool package we forget the larger picture. This happens personally and organizationally, driven through the daily crush of having stuff done. We don’t even think holistically concerning the organization, and finish up losing concentrate on the essential things because we attempt to complete an excessive amount of. 

This enhances the question: what don’t let stop doing to enhance our manufacturing processes?

Stop Separating Development from Manufacturing

The majority of the problematic problems that arise in manufacturing (very high cost goods, high scrap rate, slow manufacturing throughput, high training costs, expense of inspection, etc.) are produced throughout the design process. It’s, unsurprisingly, throughout the design procedure that important design decisions are created. These decisions include: the product’s general design complexity and manufacturability, specifications on components and subassemblies as well as their sourcing options, and also the specifications and tolerances around the manufactured product.

Complex designs boost the costs of products, making set up harder with less tolerance to variation. The second slows manufacturing throughput, increases training costs, boosts the costs of inspection, and increases scrap rate. People familiar with manufacturing know this. However, too frequently the look group accepts design decisions it shouldn’t. This happens simply because they operate under schedule and budget pressure with incentives that aren’t linked strongly to manufacturing costs.

So stop separating manufacturing from development and design.

Give both groups a unified incentive structure that’s strongly associated with current and downstream manufacturing costs. An additional step may be to want rotation of employees between manufacturing and style. Taken even further, nobody ought to be permitted on the design team whatsoever until they’ve spent significant amount of time in manufacturing.

Stop Arbitrarily Defining Needs and Specifications

After you have eliminated the separation between development and manufacturing, you are prepared with this step, that is thoroughly connected using the design controls of 21 CFR 820.30 and ISO 13485.2016 §7.3. Firstly you have to . . . stop following a rules so adamantly. It’s frequently stated the rules constitute the absolute minimum expectation—but frequently we forget what this admonition really means.

The word what of design controls within the rules and standards was attracted from well-known and recognized engineering practices (i.e. Six Sigma, The perception of Six Sigma, systems engineering, and project management software). Many of these practices, roughly speaking, define quality as satisfying the customers’ needs and expectations. To achieve this, the practices would really have you ever first document individuals customer needs you want to satisfy (i.e. product needs) after which validate the resulting pertinent design outputs as satisfying individuals needs.

Six Sigma defines “Important to Quality” (CTQ) outputs as individuals that should be identified and verified/validated since they’re associated with satisfying customer needs. Systems engineering requires verification/validation of design output according to “established and tracked needs.” Likewise, Part 820.30(f) mandates that “verification shall make sure the look output meets the look input needs.” This really is totally different from stating that all design output should be verified/validated.

Our prime-level perspective, attracted in the engineering practices that gave rise towards the Food and drug administration and ISO documents, is the fact that only design output that’s Important to Quality within the customer’s eye needs the rigor of verification/validation. Likewise, only individuals CTQ design outputs require the connected and continuing manufacturing controls, that are costly! It could be contended, from concern some auditor asks why some part of the design wasn’t validated, that it is simpler to simply over-specify needs and validate everything. 

This “audit-friendly” approach has a minimum of three significant problems. First, the validation process is costly, and doing the work for everything adds significant cost. Second, after you have unconditionally defined this design output requirement, you are obligated to watch and manage it. If you don’t achieve this that omission is definitely an audit risk. Third, the rules require that verified/validated design output should be traceable to input needs. In the event that trace doesn’t exist, that insufficient traceability is yet another audit risk.

Remember, auditors aren’t empowered to produce new regulatory needs. If you’re obvious and assured both in your design inputs as well as their traces to verified/validated design output—then you’ve every to fully stand up and argue your situation. Doing this with full confidence and knowledge to assist the argument will win your day.

Whenever you get rid of the artificial limitations between design and manufacturing you are able to better see, trace, and document the connection between design input (needs) and CTQ design outputs. Focus your manufacturing sources on individuals CTQ outputs. Just since you can call a design output essential does not necessarily mean you need to. Most significantly, stop confusing “what you are able to buy” having a CTQ design output. First understand your CTQ outputs as well as their acceptable variation. If widget XYZ model 123 from vendor ABC satisfies the CTQ needs, then go on and source it and document it’s satisfying the necessity. Too frequently we define widget XYZ model 123 from vendor ABC as the necessity itself. Whenever we do this, then one changes (e.g. vendor changes model # or we would like another source), then there’s an costly condition in both quality and regulatory realms. The authors have seen this misstep occur, with connected great expense, on products as minor as: AA batteries, adhesive tape, Ziploc bags, printed labels, solvents, as well as custom manufactured components. In none of those cases were facets of these products CTQ.

Design output that isn’t CTQ can and really should be defined a lot more loosely—with less rigorous manufacturing controls. The best interpretation of the would be to not specify a design output on the drawing employed for inspection whatsoever. For example, a drawing is necessary to fabricate a component or set up, however that drawing doesn’t embody the CTQ design outputs which are pertinent to create validation testing (DVT). Another drawing employed for DVT and incoming inspection could be produced that just includes the CTQ design outputs. Alternatively, the CTQ design outputs could be clearly indicated and therefore distinguished around the manufacturing drawing. Either approach should work.

Whenever you truly know how your design input needs trace for your CTQ design outputs, you are able to focus your sources on tightly monitoring and controlling them. Whenever you do, you will get the next benefits:

  • Your resource needs go lower because you do less monitoring and control overall, and you’re concentrating on the best things!
  • Scrap goes lower because individuals non-CTQ products you formerly rejected are actually acceptable.
  • Incoming inspection costs go lower because you do a smaller amount of it (focusing only around the CTQ products).
  • Inspection costs generally go lower since you are centered on the CTQ inspection points.

Stop Testing Everything and style for which You Need To Do Test

Through the word “testing” here, we’re talking about both acceptance (pass/fail) testing in addition to ongoing monitoring for example SPC. Whenever you effectively eliminate artificial limitations between design and manufacturing, and employ this continuity of tactic to precisely link CTQ design outputs to input needs, you’ve got a option to make in manufacturing: exactly what do you make sure monitor in incoming inspection, set up process monitoring, and manufactured components and assemblies?

The apparent, but possibly and not the best, answer would be to only make sure monitor individuals facets of parts, processes, and assemblies that represent CTQ design output. Regrettably, very frequently we all do way over that.

It’s quite common that whenever SPC first will get brought to a company, control charts are utilized excessively. You will find three unfortunate implications of the approach. It adds expense and sources to gather and process everything data. It makes visual and intellectual clutter that dilutes focus from the truly CTQ parameters that needs to be monitored. Lastly, that diluted focus makes it simple to mis-apply SPC, resulting in incorrect interpretations from the results. All this can certainly result in the conclusion that SPC doesn’t work and isn’t worthwhile, that is a regrettable and incorrect conclusion.

It’s also present with collect inspection/test data much more frequently as well as on more test points than we ought to. You will find important implications to collecting an excessive amount of data: we incur additional expenses and sources we dilute the main focus of individuals sources from CTQ activities and when we don’t act upon the information, we create downstream regulatory and liability risk.

By doing an excessive amount of, we cannot possibly satisfy our definitions of the items we will do, that is a regulatory risk. We simply throw away cash. So, whenever a disagreement is built to collect data because it might be nice to possess or it may be needed later, that proposal ought to always be held to the question—“What will you use the information?Inches If there’s not really a obvious and actionable reaction to this, then your data shouldn’t be collected.

Coming back towards the question of the items design outputs to check or monitor—certainly any test point that’s CTQ, or functions like a surrogate, should be either tested or monitored via SPC. If monitoring can be used, a suitable process/design capacity ought to be defined together with action limits and activities. Specifically for design output that’s problematic when it comes to rework, setting an expectation of the high process capacity is one thing to think about. For those who have effectively and rigorously tracked input needs to CTQ design outputs, the amount of monitoring and testing points will probably be surprisingly small in number.

Getting done the above mentioned, there will always be of design output that isn’t CTQ however that must exist just so that you can manufacture a component or set up. We ought to have a risk-based method of deciding the way we manage that design output. Carrying this out accords with good engineering practice and up to date regulatory trends. For individuals design outputs that aren’t CTQ, but that you possess some need to suspect you will see problematic variation, monitor or test, but achieve this in a reduced frequency in accordance with that which you practice for that CTQ outputs. For individuals in which you haven’t much need to suspect variation or where significant variation doesn’t present any concern, test yearly, or consider not testing whatsoever. Specifically for commercial off-the-shelf (OTS) components, especially where you can find industry standards used by the manufacturers—for example, AA batteries—consider not testing whatsoever.

The perception of that which you do test

It doesn’t seem sensible, when it comes to either cost or quality, to define a CTQ design output that’s difficult or impossible to check or monitor. 21 CFR Part 820 does define procedures to follow along with for “special processes,” but validation of these processes is costly, the information used is frequently problematic, which validation frequently becomes invalid with time when confronted with significant variation of incoming components and assemblies.

The answer would be to the perception of that which you do test. Throughout the design process, identify your CTQ design outputs, and make the ultimate CTQ design outputs in a way that they’re available to and permit non-destructive testing/calculating. Individuals CTQ design outputs ought to be defined so they are robust to variation. Remember, there are a large number of design options which will fulfill the design inputs. Don’t lock to the first identified, and reject individuals that don’t fulfill the above criteria.

Keep in mind the criteria in the last paragraph apply broadly. Robotically you have to design to permit physical access towards the CTQ calculating points. You should also avoid stack-up problems that lead to very tight tolerances. For electrical circuits, you need to create and offer access points for probes in appropriate locations. For printed circuit boards, design inside a sufficient quantity of probe suggests test a higher number of the circuit. Achieve for any mid-to-high 90% testing coverage which means you have high confidence inside a truly functional circuit that passes testing. That top coverage also enables you to definitely trobleshoot and fix component failures, which reduces rework that creates thermal excursions, which reduces reliability within the field. In software, attempt to add functionality that’s strictly gift for testing purposes.

Should you browse the above paragraph carefully, a style ought to be apparent. It’s fine, even advantageous, to include happy to the look output that’s strictly meant for testing purposes, as lengthy because it is associated with or perhaps is a stand it for CTQ design output.

Preventing Battery Disasters

Battery technologies have enabled an unparalleled degree of mobility and freedom to users of medical systems all over the world. Battery technologies have redefined the ability cord from as being a mobility obstacle which regulates patient movement to some maximum distance in the nearest power outlet, to merely existing simply like a nuisance or perhaps a chore, as users of battery-powered medical systems can savor the freedom of portable power but nonetheless must remain vigilant to charge the battery again using a cord once the battery is empty.

This remaining nuisance has sent device manufacturers on the quest to improve the individual experience by finding methods to extend the portability of the battery-power solution. Many manufacturers are evaluating convenience technologies for example wireless charging or energy harvesting to increase time span between corded-recharges, and many are emphasizing reducing the general power needs of the systems, therefore achieving an extended runtime through lower rate use of battery energy. A concerning trend has emerged, however, where device manufacturers are achieving greater runtime for his or her systems simply by utilizing a bigger and much more energy-dense battery, as empowered by continuous developments in battery technology.

Lithium-ion technology is broadly adopted into medical devices because of their best-in-class energy density (250-700 Wh/L) and particular power (250-330 W/kg). The opportunity to fit substantial levels of energy right into a small volume, and getting the power storage mechanism weigh relatively little, is very compelling for medical systems which enable patient mobility. Lithium-ion cell manufacturers, battery power integrators, and medical systems designers work very difficult to increase the utility of those lithium-ion technologies. Cell manufacturers develop and launch greater-capacity and greater-power cells each year. Battery integrators leverage the cell technology enhancements to build up solutions for brand new markets or improve existing solutions in mature markets. Systems designers select and incorporate battery technologies to their platforms according to specifications and abilities.

Each link within this value chain is connected but independent. Design decisions produced by all parties might not be conveyed to any or all people from the chain, and also have the possibility to result in misaligned expectations using the other people of the chain. As medical device applications demand bigger batteries, it is essential for those people from the chain to know the elevated risks that can come out of this development in energy density in the cell, battery, and system levels. All people of the chain must stick to design concepts to make sure that all battery disasters are mitigated before they occur.

Lithium-ion technologies are a secure technology when it’s correctly used inside a controlled window of operation. Every person in the worth chain (cell manufacturer, battery integrator, systems designer) is very conscious of this controlled window and should clearly demonstrate the capability to manage & keep up with the lithium-ion technology in this particular window, even under extensive abuse and fault modes, to earn regulatory approval and demonstrate compliance essential to bring the lithium-ion powered means to fix market (examples: Cell Level UL1642, Battery Level UL2054, Cell/Battery level IEC62133, system level IEC60601).

The greatest risk in lithium-ion technologies are when out of control occasions transpire which trigger an electro-chemical phenomenon known as “thermal runaway.” Thermal runaway is really a catastrophic self-faster degradation of the lithium-ion cell, typically the result of a thermal energy absorption from the electro-chemistry triggering a series of exothermic reactions internal towards the cell. These exothermic reactions result in more thermal energy generation and absorption, further speeding up the response kinetics. A thermal runaway event can result in extreme hazards including fire, gas venting, and perhaps even explosion.

The motive force of thermal runaway is the development of thermal energy towards the electrochemistry from the lithium-ion cell, in a trigger point approximated as roughly 500 kJ of warmth. This thermal energy may come from exterior sources (extreme heating of nearby components, or closeness of open flame), from internal sources (introduction to separator within the cell resulting in anode-cathode short circuit, or undesirable debris introduced during cell manufacturing), or from extreme occasions (lighting strikes, or metallic punctures of cells for example driven nails or staples). It’s very hard to de-energize a thermal runaway once it begins. However, it is extremely achievable to create a cell, battery power, and system solution containing a thermal runaway event and prevents battery power disaster that could harm someone or even the surrounding atmosphere.

Despite the fact that battery power must demonstrate the capability to safeguard itself, there’ll always be scenarios that are past the cell manufacturers’, battery integrators’, or system designers’ control. As energy density and cell counts rise in the batteries utilized in medical systems, it might be more and more imperative that design engineers whatsoever quantity of a value chain start to design hoping that the thermal runaway event can happen.

The next design concepts can be found as guidance toward correctly that contains a thermal runaway event and mitigating disaster:

  1. Realize that utilizing a battery solution with multiple cells, or using cells rich in energy density, and particularly using multiple cells rich in energy density, will raise the potential hazard resulting from a thermal runaway event. Once the battery grows which hazard potential increases, so should design diligence in making certain potential catastrophes are mitigated through proper material selection and thoughtful cell, battery power, and system-level design choices.
  2. Predictive accounting in design phase ought to be conducted to calculate where energy from the thermal event would spread. Just one-cell thermal runaway event can generate roughly 3 MJ of thermal energy. This energy will exit the cell by means of light, flame, and heated gas.
  3. Find out the critical regions of battery and system construction which may maintain the direct road to energy release inside a thermal event (solids, fluids, and gases is going to be ejected). Battery and system designers will include pyro-phobic material between your cells and elements that won’t survive contact with this degree of thermal energy. In instances where the thermal energy is redirected toward a surface, thoughtful consideration should be given to make sure that surface isn’t directly accessible with a patient (who could suffer burns upon touch). Information on an immediate thermal path between cells with no other heat dissipation path will usually lead to propagation.
  4. Vent pathways ought to be identified to make sure increases in internal pressure from the battery or system don’t lead to further issues (just one cell thermal runaway event can generate ~.5 mol of gas release).
  5. In multi-cell battery power, design the cell-stack configuration and orientation to limit the potential of a thermal event in a single cell from propagating with other cells. When utilizing round form factors, don’t position cells mind-to-foot without significant separation distance or even the inclusion of pyro-phobic material. Most thermal runaway powers will exit straight from the finish from the cylinder. Sufficient cell spacing and heat dissipation is easily the most effective way of stopping propagation.
  6. Side-wall ruptures can and do from time to time occur during thermal runaway occasions. The chance of a side-wall rupture could be reduced by including structural support round the cell. An easy carrier is extremely good at stopping along side it-wall rupture and making certain thermal powers are directly out the top cylinder.
  7. Include flame arresting screens to avoid flames and sparks from exiting battery.

A Simple Cable Modification to Reduce Cost

Ultrasound medical devices typically employ multiple fine wire gauge cables. There are many aspects to a cable design that can impact cost, but one in particular—color—can have a significant effect on the overall budget.

To begin an examination of such economic considerations, I share an actual email I recently received below:

Hey Mike,

At some point it would be helpful to go through the cable design from a cost point of view. If we want to do a round of cost cutting, we’d like to know what constraints that we put in place are the biggest cost contributors.

Thanks!

The interesting aspect of this request is that the initial prototype has not yet even been manufactured. However, the process, from the customer’s perspective, has already moved on to cost reduction requirements without even testing the performance of this new assembly from both a physical and electrical perspective. Often this is already well known, but the point is still relevant. Being proactively cost sensitive is crucial to customer satisfaction.

As with most new products, in addition to functionality, there is a strong emphasis on cost, both the initial product cost and, in some cases, a future schedule of cost reductions. When the topic of cost is considered, the conversation typically centers on material choices and mechanical details that serve to address a design problem or a product performance issue. It is understood that as the product moves from development to manufacturing, volume will increase and fixed costs will become a smaller part of each unit’s cost calculation, thereby resulting in a lower per-piece price. Further, as a vendor becomes more familiar with the product from a manufacturing perspective, additional efficiencies will provide cost-saving opportunities.

However, there are often opportunities to reduce cost that revolve around simply doing things differently. One such opportunity to “design-in” cost savings revolves around an often overlooked cable characteristic: the color code.

While the end use may be very different depending upon the application, the process still remains the same. For example, a hospital operating room at Massachusetts General as opposed to with an oil pipeline in a large Texas refinery obviously will have very different end requirements, yet the basic cable constructions used for these ultrasound applications are very similar. In the example provided below, we will compare various structures using 38 AWG (gauge) high-capacitance micro-coax with the finished cable consisting of 68 coaxes with an overall braid and protected under a ruggedized jacket. (See Table 1.) This cable is then terminated to a series of interposers that contain connectors for mounting to the OEM’s final NDT probe product.

 

 

Table 1

 

 

 

Coax Count

68

 

 

Conductor AWG

38

 

 

Material

Silver Plated Alloy

 

 

Stranding

Solid

 

 

Insulation

PFA

 

 

Shield

Tin Copper

 

 

Jacket

PFA

 

 

 

 

 

 

Table 1: The goal—a finished cable consisting of 68 coaxes with an overall braid and protected under a medical-grade jacket.

Generally, in a construction of this type, the coaxes would be combined into groups of 16-core bundles (4×16 coax bundles) (Figure 1 at left below) with two additional pairs in the center. Each coax bundle of 16 would consist of a single-color group of coaxes. From a cost perspective, as it relates to the cable only, this approach makes sense in that it minimizes color changes during manufacturing, since each color change requires a material, line, and reel change out, which increases the cost due to the manufacturing overhead.

Figures 1 and 2: Consider which of the two options for an ultrasound cable consisting of 68 coaxes makes the most economic sense: Figure 1 (at left), which combines the 68 coaxes into groups of 4 16-core bundles (4×16 coax bundles), or Figure 2 (at right) which organizes the core bundles into 8 groups (8×8 coax bundles), with each core bundle carrying 8 discrete colored coaxes.

The simple counter approach taken by Hitachi to lower the cost was to restructure the 16-core bundles into 8 groups (8×8 coax bundles) (Figure 2 above at right), with each core bundle carrying 8 discrete colored coaxes. In other words, the new design uses 8 colors per core for the 8-core bundles versus 1 color per core for the 16-core bundles. In this approach, every one of the 8 bundles is identical and the bundles are then further distinguished during the final cabling process by helically wrapped colored threads. From a high-level design perspective, this approach would seem to add cost rather than reduce it—and that would be a correct assumption. However, the goal is to reduce the cost of the final product, even if that means increasing the cost of an individual component or process.

As Table 2 demonstrates, the degree of the increase could be classified as insignificant. Using a cost of $250 per additional color change, the total increase that this discrete color code adds to the overall cost calculates to less than $0.01 per foot.

 

Table 2

 

 

 

 

Construction:

68 coaxes/16 coax bundles plus 4

 

 

 

Quantity:

1,640 feet / 500 meters

 

 

 

Color Changes:

4

 

 

 

 

 

 

 

 

Discrete Bundle Colors:

Total Footage per Conductor

Total Meters per Conductor

 

 

Black

29,520

9,000

 

 

Brown

29,520

9,000

 

 

White

26,240

8,000

 

 

Blue

26,240

8,000

 

 

Total

111,520

34,000

 

 

 

 

 

 

 

 

 

 

 

 

Construction:

68 coaxes/8 coax bundles plus 4

 

 

 

Quantity:

1,640 feet / 500 meters

 

 

 

Color Changes:

8

 

 

 

 

 

 

 

 

Common Bundle Colors:

Total Footage per Conductor

Total Meters per Conductor

 

 

Black

16,400

5,000

 

 

Brown

16,400

5,000

 

 

White

13,120

4,000

 

 

Blue

13,120

4,000

 

 

Orange

13,120

4,000

 

 

Yellow

13,120

4,000

 

 

Green

13,120

4,000

 

 

Red

13,120

4,000

 

 

Total

111,520

34,000

 

 

 

 

 

 

 

Color Change Cost

$250

 

 

 

Total Cost Adder

$1,000

 

 

 

     

 

 

Cost increase

$0.009 per foot

$0.029 per meter

 

 

 

 

 

 

Table 2: In the 4×16 coax bundles approach, each of the 4 bundles of 16 is colored Black, Brown, White, and Blue. Operators need the raw inner materials (conductor, insulator, shield) that are then made into 16 reels of each color. In this example, enough quantity of inner conductor would be extruded using a natural pfa color and the lot would be shielded. Then the material would be jacketed for the 4 different colors. Black would be made first, then the machine would be purged of that color and restarted for the Brown insulation. The color change process would be done four times, resulting in four batches of 16 reels. The cable must then be cabled per the 16-core bundle diagram. This means that a machine is loaded with 16 reels of Brown. The coaxes are then wound together and wrapped with a tape to secure them. An outer jacket is then extruded and this is repeated for the other 3 color bundles. Finally, all four 16-core reels are loaded onto the machine and they are again twisted, tape wrapped, and a final jacket is applied.

In the 8×8 approach, 8 initial colors are produced on large reels. The reels are then loaded onto the machine, and the cores are twisted, taped and then jacketed. When a reel is full, the operator swaps out the reel for an empty one and they continue until the entire batch is complete. Once all the material is made, the 8 color core bundles are then loaded onto the machine, they are again twisted, taped, and jacketed. This requires much less setup and ease of change over after the color operations are completed because it is a common element (i.e., 8 cores with 8 colors per core).

 

While a modern extruder payoff can be programmed to create reels of any quantity, one might argue that increased set up time at the pre-cabling operation would be required in order to handle the additional four reels added as a result of the smaller coax bundles. We need to consider that the 4×16 core coax bundles would require 4 set ups each with 16 reels—one for each colored bundle—while the discrete code in essence uses one 1 set up for 8 reels from which 8 bundles of the same construction are created. While there will be an additional 4 reels at the final cable set up for the discrete option, at worst the cabling setup cost is offset.

From a final cable run-time perspective, clearly the set-up time to cable these 8 bundles is greater than that required to cable only 4×16 coax bundles. However, in the run quantities generally associated with micro-coax multi-conductor constructions, the impact on cost, much like that associated with color changes, is minimal when considered as part of the total cable cost.

From the assembly perspective, when processing cable bundles in which all the coaxes are of the same color, tools that identify the proper electrical connection are required. This process is often referred to as “buzzing out.” Even with a discrete code and multiple smaller bundles, the sheer number of conductors on the higher conductor count products, such as a 128-coax construction, often requires these same tools to be used. For lower-count products, such as those using the 64-coax product discussed here, or those products with even smaller coax counts, the discrete color code allows the operator to visually identify and place the coax conductors without the use of an electrical test unit, thereby saving immense labor and time in termination.

This advantage alone can translate into significant cost savings when compared with a similar assembly made using the 4×16 coax bundle construction. (See Table 3 below.) The discrete color code, with all other things being equal, reduces the final product cost by 4%. Regardless of the margin used to set the commercial price, by using the discrete color code there is a significant cost advantage.

 

Table 3

 

Assembly Length

3 meters

 

Interposers

8

 

 

 

 

Labor Savings 8 Bundles Discrete vs. 4 Bundles Uni-Colored

10%

 

 

 

 

Product Cost – 16 Coax Bundles

$155.25

 

Product Cost – 8 Coax Bundles

$149.04

 

         

Table 3: The cost represents a finished assembly with connecting boards (interposers) soldered onto the wires. The devices are typically shipped as sub-assemblies so that the OEMs or their assembly partners can complete the probe attachment and system connectorization.

An argument could also be made that the additional bundles might subtract from the product’s flexibility. In considering that position, we need to take into account the ‘rope’ construction used in uninsulated copper stranding products. (See Figure 3 below.) A rope construction—similar to that created when the 4×16 coax bundles are reconfigured into 8×8 coax bundles—is chosen by copper fabricators when flexibility and the ability to maintain its shape during bending are required by their customers for high strand count conductors. This being said, any difference in flexibility, with all other things equal, would be indistinguishable for most constructions.

 

Figure 3: An example of a common cable configuration called a “rope construction.” When the wires are twisted in this manner, they provide the benefit of strength, diameter control, and the ability to yield highly flexible cables. Figure 2, in this example, when completed, results in a cable that is closer to a rope construction than the example in Figure 1, so the argument is that it also provides a better end product by nature of the configuration.

 

From an overall OD perspective, the construction of the 8-core product in lieu of the 4-core geometry yields an overall increase of 0.2 mm, or 0.007 in., with all other parameters being equal. The cost impact of this minor difference would be measured in pennies, similar to the cost impact of the color changes outlined earlier. However, this larger OD could be addressed by reducing the jacket thickness as well. Depending on the thickness, reducing it by 0.0035 mils would provide an additional cost savings while not negatively impacting the cable’s performance.

Considering both the potential cost savings as well as physical advantages of the smaller discretely colored coax bundles, clearly this is a design avenue worth exploring during the design phase of any cable assembly project that utilizes typical micro-coax constructions. Your cable design partner will be well positioned to examine and quantify the cable dimensions and the potential cost savings with you.

 

Hitachi will be exhibiting at MD&M West, February 6-8, 2018, at the Anaheim Convention Center in Anaheim, CA.