7 Factors to Consider in Selecting a Medical Device Sterilization Contractor

Medical device companies benefit by evaluating additional services, scalability, green operations

For medical devices, sterility is one of the most important steps in development and production. In today’s world, sterilization and the decision on selecting a sterilization contractor may be more critical than ever.

How fast companies can get their products to market can mean success or failure of the product, the company and, in many cases, the end user. Most companies have no time to waste, yet many sterilization companies are at maximum capacity dealing with suppliers and prioritizing the highest volume most lucrative customers leaving limited supply for other companies and customers. Current market dynamics require careful attention to identifying, evaluating, and choosing a quality, reliable contract sterilization vendor. To assist in that process, Boulder Sterilization Services (BSS) offers the following seven factors to consider:

  1. Turnaround time – The time to sterilize and validate products and get them to market quickly is of utmost concern. However, you must be able to balance this with reliability, process integrity, cost and the availability of other services to integrate that may speed market introduction.
  2. Scalability – Small device companies often focus, understandably, on immediate needs, but it’s important to also look at the ability of the sterilization contractor to scale for future business. That scalability may come in the form of sterilization capacity as well as abilities of the company to handle other services that will accelerate time to market.
  3. Cost – As with many products and services, it’s usually neither the least expensive nor most expensive vendor that is the best. Look for a sterilization vendor that meets your needs, is reliable, and whose staff is professional, sharp and easy to work with.
  4. Process controls – How the vendor handles segregation of processed and unprocessed product is critical for quality control. Make sure you understand how the sterilization contractor confirms that its process provides clear segregation.
  5. Green operations – Evaluate the process the sterilization contractor uses. Over 50% of medical devices are sterilized using Ethylene Oxide (EO) to reduce disease transmission. With the proper infrastructure, EO can be a great, safe, and effective low-temperature sterilization method. Search out companies that use an abator (catalytic converter) system to mitigate release of specific gases into the atmosphere.
  6. Customer service – Finding a vendor that will communicate and work with you is very important. As sterilization is a critical step in the development and manufacturing processes, find a vendor that will serve your needs, maintain compliance with your regulatory bodies including allowing audits, answer questions, and ensure their services are a good fit.
  7. Additional services – For many medical device companies, working with a vendor that it is a “one-stop shop” makes all the difference in getting products to market. “Often, medical device companies will work with separate design, manufacturing and compliance consultants,” explains Jim Kasic, Founder and Chairman of Boulder Sterilization. “They end up losing valuable time, energy and resources coordinating between them.” Instead, he says, the right contract firm may be able to offer all services under a single roof, drastically reducing the amount of effort and time a client must otherwise expend to coordinate between the different functions.


Because the choice of a sterilization contractor impacts cost, efficiency, convenience and ultimate time to market, it is a critically important step for medical device manufacturers. Companies that take a little time up front to consider these factors will reap the rewards for years to come.

Peggy Fasano, former Chief Operating Officer, Boulder iQ