Contract Manufacturers Free Up Energy and Capital
17 September 2009
Among the driving forces of medical device companies is the growing demand for quality of life and the desire to live longer. As a result, new analytical and treatment methods are being pursued while some aspects of treatment are moving from expensive institutions to health centers and the home.
PartnerTech's medical equipment business area specializes in the development and manufacture of medical device products and analytical instruments in the life sciences.
Carl Lidén, corporate sales manager for medical equipment, says, "We free up the time, energy and capital of our customers so that they can concentrate on their core operations. When we handle their production, they don't have to tie up capital unnecessarily or deal with the problems that volume fluctuations can cause. We develop and manufacture both modules and complete systems, as well as taking care of the storage, distribution and servicing of products, accessories and spare parts."
New customers are often recommended to us by the ones that we have worked with earlier. Some of our customers are Biotage, Gambro, Getinge, Gyros, Jolife, Phadia, Perten Instruments, Thermo Fisher Scientific, PerkinElmer and Finnzymes Instruments.
As a contract manufacturer, PartnerTech often gets involved at an early stage of product development, but may begin later in the lifecycle as well. When we start participating during the product development phase, the foundation is laid for cost-effective production and the time from concept to market launch is shortened. PartnerTech's project organization – which consists of development and production engineers, as well as assembly personnel – is structured with medical device and biotechnology customers in mind. To ensure superior quality, we use certified production processes and specific areas for the assembly of individual products. Our quality system meets customer requirements for global delivery.
"Most of our units are ISO 13485 certified," says Lidén, "which is a pre-requisite in this industry."
PartnerTech's customer centers and plants in Sweden, Norway, Finland, Poland, the UK, the United States and China can adapt production to the specific requirements of each customer and product. The plants in Ǻtvidaberg and Vellinge, Sweden – as well as Moss, Norway, and Vantaa, Finland – have special medical device skills. The first three are also centers of excellence with expertise in system integration, electronic components and enclosures.
"Our organization is set up so that our customers have a local connection at the same time as the structure and supply chain is global," says Lidén. "Ǻtvidaberg focuses on systems that are subject to strict regulatory requirements, Vellinge on electronic components and point-of- care instruments, Moss on design and Vantaa on systems and point-of-care instruments. PartnerTech's units in Poland are often devoted to large-scale production of mature medical device products."
The assignments we receive from our customers are often comprehensive. Lidén gives an example: "We handle both production and integrated assignments. When it comes to integrated assignments, we often get involved at the product development or new product introduction phase. If a customer has developed a prototype, we frequently streamline production on the basis of cost-effectiveness studies. Storage, logistics and spare parts management are often part of our integrated assignments. A third type of assignment is outsourcing, which involves reaching agreement with our customers on ways for us to take over all or part of their production. We have a well-established transfer process to make that transition as smooth as possible."
Because new medical technology products and instruments tend to be technically sophisticated, they are associated with high development costs. Most companies focus on a launch in the United States, the single biggest market for many products, in order to recoup such investments. But due to the strict FDA approval process, it may be difficult to enter the US market. Both the company that applies and its suppliers are subject to complex, extensive regulations.
"PartnerTech has passed several FDA inspections and meets QSR, 21 CFR Part 820 for medical device products," says Carl Lidén. "The purpose of the inspections is to ensure compliance with the law."
He adds that PartnerTech conducts regular trainings, preferably with customers, to maintain superior skills and expertise. Providing the same training to both employees and customers makes the work process much easier.
