7 Factors to Consider in Selecting a Medical Device Sterilization Contractor

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

Peggy Fasano, COO, Boulder iQ

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.

direct diet pills com best exercise to help lose weight can diet pills affect ovulation keto diet basic food list biggest loser who took diet pills keto weight loss pills customer service number best otc weight loss drug how many calories to stay in ketosis best anti anxiety medication for weight loss can you chocolate almond milk on keto diet free trial of garcinia lifestyle changes weight loss should i take phentermine with food keto diet on a small budget how to lose weight by dieting fast diet lose weight quickly pop weight loss cost sources of calcium oxalate in the keto diet running with type 1 diabetes using keto diet best green tea for weight loss 2015 is tazo tea ok for keto diet compare best diet pills 2015 keto diet meal delivery kits how to tell if entered ketosis when starting keto diet can we drink milk in keto diet ways to lose weight healthily keto diet plan and size why am i loosing weight is the keto diet good for people over 60 symptoms of transition to keto diet keto diet daily menu measurements keto diet pumpkin recipes can i have chili beans on a keto diet running with keto diet is the portion of food count on keto diet otc weight loss pills for diabetics type 2 diet sode keto diet are fats important keto diet who is the keto diet designed for metformin and keto diet weight loss is cheese allowed in keto diet how to use herbalife to lose weight fast journal keto diet testing can you have onions on keto diet macro ratio keto diet weight loss keto diet affect breastfeeding alcohol you can drink on the keto diet keto diet health effects are protein shakes good on a keto diet garcinio cambogia vs keto diet pills good fats in keto diet how to get fastest results on a keto diet can we have soth indian cofee with no sugar in keto diet seizure diet for adults what test would indicate a problem with carbohydrate metabolism kidney failure best over the counter diet pills at gnc ketomed reviews apple vinegar pills before and after weight loss caffeine in weight loss pills uti erectile dysfunction effector for sex drive most powerful supplement free trials male enhancement pills does proextender work basic sexual health male porn actor with penis enlargement does traction increase penis size reality if penis enlargement future what is proven to work better and faster that volume pills penis growth browser game trimix gel for erectile dysfunction hand drive sex toy cheap cialis pills for sale extenze 4 day pill penis enlargement flashing word gif can u take extenze with multivitamin sex erection pills that actually work sildenafil citrate 25mg tablet why do antidepressants cause low libido mayo clinic drugs and supplements lipo pills sex drive yohimbe arginine low libido vegan weight loss supplements to help blood circulation erectile dysfunction porn cideos med2005 erectile dysfunction sex change pills 1st month erectile dysfunction butt plug male enhancement sword low estrogen and erectile dysfunction barstool sports jobs androzene complaints viagra effects on male hot mature women what is the maximum dosage of cialis viagra low libido weird growth on the head of my penis breast growth cream 35 year old male with erectile dysfunction health vedios gay penis products in male enhancement sex pills gentlemen does smoking curb your sex drive intercourse positions pre workout boost libido paederia foetida testosterone