By Jay Tourigny

 

These days, savvy medical device engineers, designers, and manufacturers are partnering with suppliers to accelerate new products to market. Whether it’s by providing advanced materials, upgraded solutions, cleaning and regulatory training, or assisting with process validation, a well-chosen supplier assists their customer every step of the way.

 

Advanced cleaning solutions have been developed to help designers speed new product development. There are low-maintenance cleaning fluids available that are safe for, and compatible with, a wide variety of materials. These solvent-based cleaning fluids are hostile to pyrogenic growth, easy to use (and reuse), clean without residue, and eliminate ongoing process and regulatory hassles associated with aqueous cleaners.

 

Efficient lubricant coatings are also available to designers. These medical grade lubricant coatings are ISO 10993 tested and will not creep or otherwise migrate. They provide easy, consistent application, which improves the look and feel of the finished device. The lubricant also works to overcome assembly problems associated with stacked tolerances by significantly reducing actuation forces of a finished device to heighten functionality and usability.

 

At MicroCare Medical, we work with medical device designers and manufacturing engineers to ensure they have an efficient manufacturing process—that they’re using the right cleaning and lubricant solutions in the right way, and that they’re consistently producing a high-quality product. Our in-house R&D laboratory and expert field service technicians allow us to work directly with individual customers to define a cleaning and/or lubrication process that are appropriate for them and specific to their products. Customers can learn step-by-step how to clean or coat their products in a process that is properly scaled to their current and future needs. This process is repeatable, improves productivity and efficiency in the cleanroom, and can help save on labor, carrying, and material costs. In the end, the designer saves time and money in getting his or her product to market and has an established solution to use with future projects.

 

In addition to improving the product development processes, a knowledgeable supplier can also assist early on in compliance with appropriate certification standards. Resolving such details on the front-end saves the designer time on testing procedures on the back-end. Materials testing and certification processes are exhaustive and can take anywhere from months to years to complete. The best supplier knows that testing and certifying their products to industry standards in advance provides the end user with confidence that the product is suitable for their specialized needs.

 

Designers, engineers, and manufacturers are benefiting by partnering with their suppliers. As the trends [highlighted] become increasingly popular, designers will continue to experience time- and cost-efficient solutions that meet their needs.

 

Jay Tourigny is vice president of operations at MicroCare Medical, a supplier of advanced cleaners, carrier additives, coatings, and lubricants for medical device designers and manufacturers throughout North America and Western Europe.

By Stephen J. Swift

 

There is growing need in a wide variety of medical markets to solve difficult system challenges where power, performance, efficiency, security, and reliability are critically important. Microsemi’s recent acquisition of Zarlink brings key capabilities to a portfolio that already include some of the industry’s broadest ranges of products and technologies for implantable devices, diagnostic equipment, portable health monitoring systems, and other medical systems.

 

The acquisition is particularly important for addressing key challenges in the implantable device market, where there is increasing pressure to reduce size, increase functionality, and extend battery life while ensuring safety, reliability, and efficacy. Shrinking device size is one of the most critical challenges, and miniaturization has become the key growth driver for life-critical implantable devices such as cardioverter-defibrillators (IDCs) and cardiac rhythm management (CRM) products as the industry continues to explore new applications in therapies and diagnostics. The smaller the device, the less intimidating and invasive it is to implant. Compact devices also enable faster healing and are significantly less noticeable.

 

Zarlink has made considerable progress in these areas, with highly integrated, medical-grade radios that are used to wirelessly connect implanted medical devices with programming and monitoring equipment, and ultra-low-power radios that can extend battery life for ingested/sensor devices such as wireless endoscopy imaging capsules. Zarlink’s custom RF transceiver for the Given Imaging Pillcam™ capsule offers an ideal example. While conventional wisdom suggests that advanced packaging is the primary driver for shrinking implantable devices, power efficiency is also a huge factor. The less energy consumed by implantable devices, the smaller their batteries, which can represent a significant portion of the device footprint. Zarlink’s RF transceiver enables the Pillcam to operate with only two small batteries during its eight-hour journey through the digestive track as it takes more than 50,000 images and wirelessly transmits them to a portable recorder. The Pillcam can relay up to 14 images per second while consuming less than 7.5 milliwatts of power.

 

The Zarlink acquisition also enables Microsemi to deliver solutions for wireless health monitoring applications, including ultra-low-power wearable devices that are connected within Body Area Networks, or “BodyNets.” These networks will enable users to track, monitor, and collect data about their health, and share this information with healthcare professionals and other third parties over wireless connections that could potentially include mobile handsets on cellular networks. Zarlink is a member of the IEEE802.15.6 standards body that is developing an international standard for this short-range, low-power, and highly reliable wireless communication technology that can be used in close proximity to, or inside, a human body.

 

Zarlink’s products join an already broad Microsemi portfolio that includes high-power FETs, IGBTs, and RF devices for MRI machines, plus power delivery-and-management solutions for implantable devices, and sense-and-control and power-management solutions for oncology-radiation treatment machines and portable patient monitoring systems. Microsemi also offers a family of flash-based field-programmable gate arrays (FPGAs) that squeeze greater functionality into smaller space while providing upgrade flexibility and robust security for portable medical devices. Ultra-low-power FPGAs, such as Microsemi’s flash-based IGLOO® devices, enable the implementation of a variety of storage and I/O functions that minimize power draw down for systems such as automated external defibrillators, which may be left unattended for weeks or months between tests. For equipment used in radiotherapy environments, Microsemi also has a complete portfolio of devices with high single event upset (SEU) immunity to unintended and unexpected configuration changes so that programmable logic can be used reliably. Additionally, the company’s flash-based FPGAs provide a live-at-power-up feature that gives users immediate access to control functions—key considerations for portable medical devices.

 

Microsemi’s acquisition of Zarlink offers a number of immediate benefits to the company. It strengthens Microsemi’s position in high-value medical markets with high barriers to entry, and it expands an already extensive mixed-signal product portfolio and associated design capabilities. It also is expected to drive revenue growth by building on existing product strategies and leveraging strong cross-selling potential across a shared base of overlapping customers. Microsemi also expects customers to realize significant benefits from its acquisition of Zarlink. The combined companies now have the opportunity to deliver additional value through new offerings as the company leverages its expanded portfolio to strengthen and extend its product roadmaps.

 

Stephen J. Swift is the sr. vice president and general manager of Microsemi Corp., Communications and Medical Products Group (CMPG).

By Rick Gallisa

 

 

As a medical device manufacturer, it is no secret that complex regulations continue to be increasingly challenging to meet. But beyond regulations, product quality is paramount for patient safety and brand protection. The other side of the equation is minimizing costs in R&D, manufacturing, the supply chain, and compliance.

 

Further, as technology and product innovation lifecycles continue to compress, more complexity is added to the equation. Together, these industry pressures often lead to conflict, which exacerbates management’s task of providing impactful value to patients while maintaining the financial community’s expectations.

 

If you face these challenges, then I would propose an effective strategy might be to first look at how your production, inventory, and quality management processes are being managed and continuously improved. An approach that yields the highest flexibility and visibility for improvement might just help you to achieve greater process improvement and regulatory compliance for the lowest possible cost structure.

 

In other words, why not take a Lean approach to Quality?

 

For most device makers, manufacturing objectives include improving efficiency, cutting waste, and reducing costs—and doing so while under intense regulatory scrutiny. New processes, products, or demand shifts, however, often require a new approach to doing business. Often times, these changes can result in production delays for a myriad of reasons, such as new process validation, quality planning & testing for production control, or sourcing and vetting of new key component suppliers for new products or expanded geographic markets.

 

These potential disruptions can be significantly diminished.

 

Best-in-class medical device manufacturers are now starting to synchronize their production, warehouse, and quality processes with suppliers, effectively establishing collaboration between their internal production processes and those of their suppliers. During times of economic uncertainty, opportunistic windows can sometimes be opened, helping to negotiate new terms and conditions as a way to ensure future profitability. Now might be an excellent time to consider such a change.

 

Another consideration: instead of doing an inspection at the receiving dock after goods have already been received from your suppliers, what if the delivery didn’t occur until the inspection results had already been performed, having been agreed upon between manufacturers and their suppliers? Not just certificates of acceptance, but data that can be built into electronic Device History Records for more robust genealogy. The results can then be electronically transmitted and verified in a far more efficient manner so that medical device manufacturers can better control their suppliers’ flow of approved subcomponents and raw materials, minimizing inherent organizational inventory buffers.

 

This process improvement could redefine how production processes are executed. Raw materials could be scheduled to arrive as they are used, in exactly the right quantity and with exactly the right quality, resulting in less waste and improved operational throughput.

 

In fact, delivery schedules could be better synchronized, with increased visibility to your supplier’s operations, helping to improve efficiency. By receiving materials not only just in time, but also in sequence, as applicable, production efficiency can be significantly improved. This efficiency, when combined with sufficient flexibility to adjust operations should a supplier disruption occur, can lead to significant process improvement. This practice originated in the automotive industry and its tiered supplier networks—the origins of Lean—many years ago, and is still being refined for optimization as markets shift. This is not unlike the landscape facing medical device manufacturers today.

 

This intelligence could then form a basis for corrective actions with suppliers, helping manufacturers to further engage suppliers in quality improvement processes where real “ownership” can be established, managed, and maintained.

 

To keep up with unique industry challenges and move innovation forward, it is more important than ever to take a Lean approach to quality. Implementing real-time visibility and control across operations and your extended manufacturing supply chain network could result in many benefits. Advantages include reduced time for new product introductions and more standardized, consistent business processes to help address both global regulatory requirements and internal corporate manufacturing goals.

 

Rick Gallisa is a Life Sciences Industry Director at Apriso, a manufacturing operations management software provider that offers global solutions for manufacturing excellence.

Was just reading an article about a lab at Hershey Medical Center that has identified a virus that has killed cancer cells in laboratory tests and human breast cancer tumors in infected mice. Should the accidental discovery pan out to be the long awaited cure for cancer, it would certainly be the most significant medical breakthrough in over a century and some might argue, of all time. However, before anyone gets ahead of themselves (myself included), there is the history of this type of discovering not panning out in the past.

 

According to the article, approximately 20 years ago, there was a discovery made that had the medical community (and much of the public in general) if the common cold could hold the cure to cancer. Unfortunately, once the research moved to human trials, the success of the experiment ended. One can only hope this discovery will not meet the same fate.

 

And there is always the conspiracy theory side of the cancer cure debate that has a cure never being discovered because there is too much money to be made in cancer research. While I won’t engage in a debate over that pessimistic point of view, I will say that when you are talking about the billions of dollars that are involved in this area of research, it is not a theory that can be immediately dismissed. It is my hope, however, that it is one born out of frustration over the lack of a cure and will one day be proven false as a cure comes to light.

 

Whether or not that cure comes from this small virus remains to be seen.

 

Sean Fenske, Editor-in-Chief, MDT

Healthcare reform is needed due to rising costs for stakeholders across the board. After that statement, the water gets murky. Where to begin, how to save money, how to cut costs are all questions that have yet to be answered. However, hearing that Walmart is entering into the healthcare arena comes across to me as more troubling than it does as a potential solution. Is primary care through a retail organization a way to reduce the costs of healthcare?

 

Moreover, what will this mean for the medical device industry. How will selling product to Walmart for their in-store clinics be for medical device manufacturers? Will they use a bulk buying strategy similar to how they buy from product manufacturers? Will they expect such discounts that the margins are razor thin for medical device manufacturers?

 

I'd love to hear from the industry about this. Have you ever sold to a retail store for an in-store clinic? Will this impact the costs of healthcare at all? Please share your comments.

 

Sean Fenske, Editor-in-Chief

I saw in this article that online gamers collaborated to solve a challenge posed to them in the form of a game. The challenge was to create an accurate model of a retrovirus protein that will allow researchers to design drugs targeted at key elements of the protein to help block it. Hopefully, the research will lead to great breakthroughs in AIDS/HIV research and perhaps other diseases as well.

 

Perhaps even more interesting is the use of the program that was used to create the game. Researchers at the University of Washington turned to Foldit, which takes scientific challenges and turns them into games. In this case, that game was then turned over to the online gamers who figured out the correct model in approximately three weeks.

 

Could a variation of this type of collaboration actually result in new technology being developed in the future, even in areas such as medical devices? The idea is pretty incredible and I look forward to hearing of more success stories from this program. No doubt there will be new attention being given to it by science and research communities.

 

Sean Fenske, Editor-in-Chief

A new electronic patch that applies to the skin like a temporary tattoo offers medical monitoring applications such as heart rate, brain waves, or muscle tissue activity. Discovered this tech in this article.

 

When I think of the miniaturization of medical devices for monitoring applications, I think of devices that can be conveniently worn by the patient in their day-to-day activities and remain discrete, resembling a cell phone. I have never thought we'd reach a level of device that resembles this type of technology so quickly that had such capabilities.

 

In terms of what types of advances can be realized from this technology in the future, the article cites that sleep apnea, neonatal care, and electronic bandages are all potential applications. Personally, I look forward to seeing how far the technology can be taken. 

 

Sean Fenske, Editor-in-Chief