Choosing a Sterilization Contractor for Your Med Device: 7 Key Questions to Ask

Choosing the right contact sterilization provider can be a challenging undertaking for any medical device developer at any time. But today, dealing with economic uncertainties and supply-chain issues, that challenge can become formidable…with good cause.
 
It’s not unusual for a company to make it through every step of the development process, and then find progress stymied because they can’t get their product sterilized. The resulting delays in getting the product to market can easily amount to thousands of dollars in revenue lost every month and can even mean full market failure if the delays cost the company its competitive edge.
 
To avoid problems, developers need to ask the right questions of prospective contract sterilization companies and understand the responses they receive.

1. What kind of sterilization do you need – or think you’ll need?

As basic as this question may sound, it’s surprising how often it does not get asked. The choice of sterilization methods is broad, with popular options including ethylene oxide (EO), chlorine dioxide (CD), electronic beam, gamma irradiation, hydrogen peroxide and steam. Not all vendors offer multiple options. While that may be fine if you know exactly what you need (now and in the future), it can be beneficial to work with a contractor that offers some choices. And, no matter what they offer, working with a contractor with deep knowledge of all types of sterilization is a smart decision.

2. Is the type of sterilization the contractor offers compatible with your materials?

The materials in your device may dictate your choice of sterilization method, which may in turn narrow your choice of sterilization contractor.
 
While about 50% of medical devices are sterilized with EO, it’s not the right choice for all materials. Although it runs at a relatively low temperature (60°C), it still could affect certain fragile materials. Chlorine dioxide, working at room temperature, is compatible with nearly all materials, including plastic components and electronics. In addition, residuals can be problematic with some absorbable materials when undergoing EO sterilization. CD sterilization, on the other hand, leaves no post-treatment residuals with any materials.
 
In addition, certain types of sterilization are not compatible with batteries. The gamma process is not used with electronics because it can damage the computer chips. Gamma and electronic beam processes can discolor certain plastics.
 
The bottom line: Talk with the contractor about your specific device and its materials. Be certain that the contractor offers what you really need, not just what they have.

3. What size is the chamber?

In sterilization, size really does matter. If a contractor’s chamber is very small, it could be prohibitively expensive to run the volume of product you need. If you have a large product, basic fit may be an issue. If you have a product that needs particular positioning in a chamber, a small chamber may not work – even if the product itself is small. This is often the case for catheters. Although they’re small devices, they frequently must be sterilized straight, so end up needing more room in a chamber.
 
On the other hand, if the chamber is too large for your needs, you may not be able to get enough product in to take advantage of economies of scale. It’s also possible the vendor could add in other products to optimize use of its large chamber. That can work, but it can also cause issues; your product may need to wait in order to fit into the vendor’s sterilization cycle schedule.

4. What is the contractor’s capacity? How close are they to filling that capacity?

Asking this question in conjunction with questions on turnaround can provide clearer insight. If the vendor has capacity for, say, 24 pallets a week, and is running at 150%, there’s a good chance of a backlog. If they are running at 50% capacity, chances are you’ll get good turnaround.

5. What will the turnaround time be?

With clear focus on speeding your product to market, make sure that the contractor can actually meet your needs. Consider the capacity question as explained above, along with the knowledge, experience and advice of the contractor in getting medical devices to market. Look carefully at routine sterilization time as well as validation time. If the former is quick, but validation takes 8-10 weeks, will that meet your needs? You may be better off finding a contractor that can conduct multiple cycles simultaneously, at different set points.

6. Who will write the protocol?

Some contract sterilization companies will ask the customer to write the protocol, while others will write it themselves. Technically, the client is responsible for the protocol, but an experienced sterilizer can often provide a solid draft using a template they have developed. Reviewing and approving will be much more efficient than creating it from scratch.

7. How much does it cost?

Everyone knows to ask the cost. But when you do, make sure you know what it includes. Most device developers will want service not only for routine sterilization, but also for validation – which is sometimes costed as a separate item.
 
When designing a new product, a key piece of the go-to-market strategy is sterilization. It may not be difficult to find a contractor that can do the job. The bigger challenge may be in finding the right contractor for your needs. Asking the right questions, and carefully considering the responses, can set you up for market success.
 

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Jim Kasic is the president, CEO and founder Boulder iQ. With more than 30 years of experience in the Class I, II, and III medical device industry, he holds more than 40 U.S. and international patents. His career includes experience with companies ranging from large multinational corporations to startups with a national and international scope. Kasic has served as president and CEO of Sophono Inc., a multinational manufacturer and distributor of implantable hearing devices, which was acquired by Medtronic. He also was the president of OrthoWin, acquired by Zimmer-BioMed. He received a Bachelor of Science degree in physics and a Master of Science degree in chemical/biological engineering from the University of Colorado, and a Master of Business Administration degree from the University of Phoenix. He can be reached at jim.kasic@boulderiq.com or on LinkedIn.