Over the past number of years, there has been an increase in the number of medical device companies looking to outsource their manufacturing activities. With technologies such as 3D printing advancing at a phenomenal rate, the whole industry’s landscape is changing as a result. What once was just an idea for an innovative device can now be brought to reality in next to no time. This has created a space where virtual companies can blossom and focus their resources on value-added activities outside of manufacturing.
This industry shift has created opportunities for a contract manufacturer to become an extension or a manufacturing arm of these companies. But for this partnership to truly support medical device companies, contract manufacturers must provide the following:
A medical device company’s needs and wants should not be restricted by a contract manufacturer’s limitations. It is essential that a contract manufacturer have a flexible team and a robust quality assurance system that will satisfy a wide scope of customer desires and expectations. These can be related to unique inspection/cleaning requirements, label sizes, rapid prototyping, UDI bar codes, or environmental conditions. To meet these needs and overcome these challenges, it’s very important that your contract manufacturer has the ability to explore and invest in new technologies as and when they become available.
2) Market access
A contract manufacturer with a global presence can provide growing companies access to multiple markets. In many instances, our team at SteriPack USA will act as conduit between our U.S.-based customer and our other manufacturing sites in Europe and Asia. Having this global presence allows SteriPack customers to reduce the impact of language barriers and time zones as well as gain invaluable guidance to help circumnavigate through different license and regulation requirements abroad. If a U.S.-based customer is utilizing SteriPack Malaysia for their production, we believe it is essential that they have a domestic U.S.-based point of contact through which to work. A fluid flow of communication between the customer and their contract manufacturer is critical to manage expectations and resolve any issues should they arise.
As a contract manufacturer, we serve a customer base ranging from small start-up companies to very large multinationals. With this comes the need to cater to labor-intensive, low-volume projects for the likes of clinical trials as well as to fully automated, extremely high-volume projects when transferring existing business to SteriPack. Such a range creates a strong need for adequate resource planning to ensure sufficient capacity is always in place on our machines. At SteriPack we believe capacity should never be an issue. If a machine is nearing full capacity, a new machine will be purchased and made available.
4) Diverse technology offering
OEMs today can have a wide range of products across many market segments. In many instances this can include both the drug and the device being packaged as one. Ideally, their contract manufacturer should be able to support each of these product portfolios. To do this successfully, a contract manufacturer needs to have a broad depth of knowledge as well as technologies at their disposal. These may include powder filling, liquid filling, drug encapsulation, injection molding, and blister packaging services, to name a few. It’s also important to have the necessary registrations and licenses in place to be able to offer these services. Within the SteriPack Group, our customers have the ability to leverage our knowledge base of these technologies and make informed decisions for the best path to market. This diverse product offering and knowledge base allow us to further enhance our relationship with OEMs and add as much value as possible.
5) Business Contingency Planning
In the event of an unforeseen circumstance that may affect your supply of product, it is essential that your contract manufacturer has a contingency plan in place. Continuity of supply is a critical element for any OEM and something that should be considered when selecting a contract manufacturing partner. At SteriPack we plan for this by utilizing the same equipment as best as we can across each of our sites in Europe, Asia, and North America. This uniformity of equipment alongside one global quality assurance system allows us to adequately plan for an interruption in supply. For example, if our ability to supply out of our Lakeland, FL, facility is in some way jeopardized, we have the ability to switch this supply to one of our other sites while the issue is resolved. This not only gives our customers the peace of mind that we can deal with and resolve an issue that could affect their continuity of supply, but that we also have the ability to essentially copy and paste our manufacturing processes from our U.S. site to our European or Asian facilities should they ever wish to explore other markets outside of the United States.
SteriPack was originally set up in 1994 to serve the medical packaging market by converting pouches, bags, and lid stock for OEMs. However, year after year the company’s added value services of contract packaging, assembly, and injection molding began to account for more and more of the group’s overall revenue. By March 2016, it was clear where the future growth of the company would come from, and so it was decided to divest the converting side of the business and focus exclusively on contract manufacturing. Today SteriPack has ISO 13485 certified manufacturing facilities located in Ireland, Poland, Malaysia, and the United States (Lakeland, FL). In March 2017 SteriPack also acquired a new 110,000 sq.ft facility located in Mullingar, Ireland.
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