Startups foster innovation for a number of reasons. Not the least of which is that they are often founded in response to a specific problem. The entrepreneurs behind them are driven to answer the tough questions that have plagued their careers. They are motivated, focused, and creative. So it’s no surprise that these startups are often attractive not only to the patent office, but to investors and larger companies, as well.

Working with medical device startups carries myriad benefits. First, you get to contribute to major breakthroughs by providing complementary services. Second, if the startup succeeds, they’ll likely continue using your offering (probably at a greater scale as their business grows). Third, successful startups often find the attention of much larger companies, resulting in occasional acquisitions. This in itself can very quickly expand your network. It also validates that your business is a trusted provider in the industry, since you now work with such high-profile companies.

By contributing to the success of small companies, you provide an avenue for them to contribute to the success of your own company. Consider it an investment of your resources, for an eventual payout of increased business and credibility.

In our globalized world, business is conducted between more countries than most people can name. But perhaps the most infamous business supplier is China. Companies outsource production ranging from simple block toys, to the increasingly complex smartphones taking society by storm. But it’s not just products traveling abroad; there is always potential for contamination during production and shipping.

What precautions can be taken to prevent foreign illnesses from infecting U.S. citizens?

Running imported goods through a sterilization procedure can eliminate biological threats. For example, electron beam irradiation can easily be applied to most packaged goods. First, customers must determine the radiation tolerance of their products and packaging, and then find the appropriate dosage for their materials. This can often be done by the company supplying the irradiation service.

This validation is necessary because certain materials will degrade when exposed to various radiation levels. Having an audit is crucial before beginning any irradiation process.

Of course the best way to neutralize any threat is by preventing it in the first place. For manufacturers, this means maintaining a healthy work environment by setting guidelines for workers, and ensuring these guidelines are met. Have someone at the ground level available to monitor daily operations, and have a plan in place for dealing with potential issues (including sick workers, faulty protective equipment, etc.). Identifying issues before they become problems is the ideal way to minimize risk.

So, how exactly do you choose the sterilization method that will preserve the integrity of your product’s structure and ensure its functionality? After determining with your sterilization provider which procedure, be it gamma ray, EtO, e-beam, gas plasma sterilization, etc., are feasible for your product design, consider the pros and cons of your remaining options in 5 key areas:

1. Efficacy:  As we covered in our discussion of combination devices, planning and testing has to given for the effect of irradiation on dosing, and developments are still underway. By way of further example, this article highlights how standard ethylene oxide (EtO ) can be damaging to the biologic, or active ingredient, contained in a combination device.
2. Environmental Impact:  While we’re not insisting you learn the intricacies of each process (nor assume you have the time), ask the questions that are important to you. Cobalt-60 is used in gamma ray; ethylene oxide is petroleum-based; the chemicals and side effects vary greatly among sterilization techniques.

Whether voicing environmental concerns or physical priorities (as expanded upon below using our past experiences and this Eastman study as a great point of reference), communicating with your sterilization provider at the forefront of the product lifecycle brings you closer to the making fully-informed decisions.

1. Appearance:  Having a sterile appearance is essentially non-negotiable for medical devices. And, the reality is that several processes can result in yellowing or browning effects on certain polymers.
2. Materials: There can be compatibility challenges; e.g. in studies, gas plasma has caused corrosion in certain materials.
3. Residual Matter: One of the main disadvantages of EtO  is the potential for toxic residues to be left in products and materials that have been sterilized. The three most common toxic residues of importance are ethylene oxide and two of its reaction products, ethylene chlorohydrin and ethylene glycol.

These examples, not intended as a comprehensive checklist, demonstrate the complex effects of this key decision. If any of these areas have sparked interest and/or questions, please feel free to contact an expert at Nutek today. Let us help you consider your priorities, explore your options, and integrate this stage as part of your product development processes!

Often times, these obstacles stem from decisions that could have been made early on in the product lifecycle, such as packaging and sterilization. As many of our readers know, delays in this particular industry can be very costly; sometimes a month is enough to cost a company its business regardless of the product’s potential. So how can you avoid this all-too-common mistake and avert business disaster?

Our advice is to move the packaging/sterilization planning to the front-end of your product development lifecycle. Although the actual packaging and sterilization generally occurs at the end of the lifecycle, planning during the pre-clinical stages offers MANY ADVANTAGES:

Don’t be caught waiting for your materials at the end; waiting your vendors’ time; or waiting for a second round of techniques to be developed and implemented because what you had imagined would work, didn’t work in the end. Contact us to integrate our medical device sterilization and packaging expertise into your decision-making to optimize your processes early on.

For example, in a non-combination device, such as a cartridge that delivers a drug, the cartridge would typically be sterilized through radiation, with the drug itself sterilized aseptically.  In a combination device, such as a drug-eluting stent (DES), the drug is integrated into the device itself (in this example, into a stent platform’s polymer coating). Radiation will sterilize the DES, but what effect will that have on the efficacy of the medication?

Given this concern and other complexities, sterilization procedures for these progressive new technologies are still being developed on a trial-and-error basis. Even large corporations have yet to develop a consistently effective combination sterilization methodology. NUTEK offers a variety of solutions to assist in delivering safe, sterilized combination devices.  Our reliable electron beam (e-beam) irradiation processing can determine the effect of irradiation at various dose levels.  It can target a specific area of your device, so that you can examine the effects of a precise dose on that area.  We can even provide a 3D map of the dose received throughout the product or package during the irradiation process.

In the above example, if the dose of radiation required to sterilize a DES (or other combination device) is found to reduce the effectiveness of the device’s drug by 20%, the device can be manufactured to contain precisely the amount of additional medication required to counteract this effect. We look forward to discussing this and other ideas with you at the show. Contact us to arrange a meeting in advance, or stop by Booth #1107.  (Reminder: we are “NUTEK,” with a K!)

In 2007, we moved to our current facility in Hayward, California, experiencing a fourfold increase in capacity. Throughout our growth, we have held to our mission of being flexible and thorough in our services; a philosophy that has made us the go-to service provider for a range of sterilization and sterilization validation needs. By working closely with our clients, as early on in the process as possible, we’re able to help save them time in getting new products to market. Moreover, our experience in these development stages has enhanced our capabilities and expertise. Working on R&D means that we conduct materials testing, materials compatibility and other types of research and exploration related to our e-beam technology. Keep an eye on this NEW space for related research, findings and more on:

• New frontiers and issues in medical device sterilization
• Our cutting-edge electron beam (e-beam) irradiation technology
• A look at our inside operations (For instance, on how we’ve only had 13 hours of downtime in 14 years!)
• Exciting new developments at the company
• And, upcoming events!

Our goal with the redesign of our website was to make the information that we give to you easier to find and more timely. If you have any questions or comments about the site in general, or anything in particular, please let us know by clicking here.

~ The NUTEK Team