7 Steps to Successful Healthcare Logistics in Germany
Launching operations in Germany and Europe for your medical device or pharmaceutical company can be a daunting task. It can be difficult to navigate the process without expert knowledge of the system and the necessary steps to take. With this list of 7 steps from Kalms Operations, your company can start establishing successful operations in Germany and Europe.
Step 1: Fulfill necessary pre-requirements before entering Europe
Before beginning the process of establishing your operational business in Germany, there are several conditions you must fulfill. First, you must obtain a CE mark for any product you wish to sell and distribute in Germany and Europe. This step is of the utmost importance since no product can be sold in the EU without a CE mark, with only a few exceptions, e.g. for research. In many cases, you will also need to register your company at the DIMDI, the German Institute for Medical Documentation and Information. Additionally, all pertinent documents to your operational business in Germany must be translated into German.
Meanwhile, the process to begin operations in Germany can be lengthy. There are many steps you must take within your company and with the German authorities. Therefore, all necessary forms should be prepared ahead of time to help ensure the process is as efficient as possible. Similar regulations apply in all other European countries with some small and bigger variations between those regulations.
To help companies expedite and simplify the process, Kalms Operations has created a thorough pre-requirement checklist of forms to complete. You can use this checklist to ensure your company and products are ready to begin operations in Germany and Europe. Kalms Operations is here to ensure the process is as quick and straightforward as possible.
Step 2: Ensure the warehouse you use meets all your quality standards
Warehousing in Europe helps you offer shorter delivery times, which is essential in the healthcare industry. You can save time and money as well because the processing of shipments and customs can be handled locally.
Opening an overseas division can be an expensive option for small and mid-size companies; therefore, a third-party warehousing provider can be the solution. Providing warehousing is not only about offering storage in Europe, but also entails upholding strict quality standards.
To sell your medical devices and pharma in Europe, you need a warehouse that upholds Quality Management standards. The warehouse should be ISO 13485:2016 certified and be able to meet all your fulfillment needs. Additional key attributes to look for in a warehouse include proper and secure storing measures, management of expiration dates, warehousing software with LOT-Management, worldwide shipping of goods, invoicing of goods and customs regulations and applications for shipments around the world.
Along with a warehouse that is ISO 13485:2016 compliant, the warehouse should uphold your SOP (Standard Operating Procedure). This includes a warehouse that will quickly report all feedback, especially any feedback from customers. Moreover, in the case of a product recall, your warehouse must support you with communication and return shipping and strictly follow your instructions and SOP.
Kalms Operations’ Berlin-based warehouse meets all quality standards and as a Third Party Logistics (3PL) provider can reliably fulfill your requirements from a single delivery of goods to frequent shipments. We follow your SOP and quality requirements regarding service, warehousing, risk analysis, product handling and compliance/code of conduct (regulatory).
Step 3: Find a Third party logistics partner with flexible services to fit your fulfillment needs
As your operational business in Europe expands, you need a Third Party Logistics (3PL) partner with extensive healthcare logistics experience. Your 3PL partner should increase your competitiveness and tailor their services to you as you continue to grow. When choosing your fulfillment provider, things to look for include a flexible fee structure and fulfillment costs that mainly depend on the product shipping volume, as well as replenishment of consignment stock at clinical sites (if applicable), support with product recalls and customer mailings (marketing, customer information), invoicing including VAT handling and collection of bad debts. Furthermore, your fulfillment partner should be able to answer all your questions regarding bookkeeping and tax declarations and provide these services if necessary.
With Kalms Operations as your Third Party Logistics provider, not only will our services be flexible and tailor-made to you, but we will be actively involved in creating your success. Our services can be added or canceled and are personalized to the needs and size of your business in Europe. We constantly monitor our services and procedures to improve communication and efficiency.
Step 4: Establish a multilingual, locally based customer service team
European clients prefer local customer service in their time zone and who speak their language. However, employing a customer service team in Europe is costly and time-consuming to find skilled staff for your company.
Customer Service is not only responsible for taking orders but must deliver effective complaint management and handle your client’s needs. A locally based, multilingual team must handle all problems, provide the delivery status and manage payment methods. They should also issue monthly reports on the number of shipments, customers shipped to with shipping data, issued invoices, warehouse stock and the shelf lives of stored goods.
Kalms Operations customer service’s goal is to provide these services in a way that creates a positive customer service experience. Our team will answer the phone in your name using dedicated phone numbers and fax lines. We will provide service at the agreed upon times, per when and where your product is used. Furthermore, they will take orders and provide services, answer requests, use a customer-branded email address and keep all customer-related documents and files as well as provide monthly statistics.
To further your presence in Germany, your company can establish a virtual office with your locally based customer service team. This can be highly beneficial, as it cultivates a presence in Germany without having to establish a formal entity; which would include renting an office and hiring staff. With a virtual office with Kalms Operations in Berlin, you can take the first steps to establish yourself in Germany.
From our effective complaint management to our handling of your products, our multilingual customer service team will always go above and beyond for your company and your clients. Plus, establishing a virtual office can increase your presence and the effectiveness of your company in Germany.
Step 5: Marketing material Logistics
When you begin selling your medical device in Europe, your top priority will be identifying a warehouse for your device. However, another priority should be finding a provider for marketing material warehousing and logistics. This may even be applicable before commercial roll-out, e.g. when promoting the new product at a conference. Without a marketing material warehouse located in Europe, your company must ship material, and possibly heavy equipment internationally to clients or venues as needed, which is costly and time inefficient.
By utilizing a warehouse for your marketing material, you can save time and money by sending your material in bulk and allowing a warehouse to handle the logistics of shipments to clients. Likewise, if your company exhibits at an international trade fair or congress, the logistics of delivering and taking down your booth are time-consuming and costly. Instead, you can employ the marketing material logistic services of a warehouse to coordinate the delivery and safe return of your booth supplies.
Kalms Operations is here to solve all your marketing material logistical needs. With our fast-reach marketing warehouse in Central-Europe, your customers and your team are promptly provided with product information, conventional marketing material and product samples/equipment, with reasonable costs and significantly reduced risk of damage. Kalms Operations’ support considerably reduces the need for extensive shipments to Europe. We monitor the stock of your marketing materials as well as shipments to events or clients, as well as managing the delivery and safe return of all marketing material and other booth materials from congresses or trade fairs.
Step 6: Increase sales and improve Business Development plan
Does your product reach its goals? In the complex structure of the European Healthcare systems, it’s easy to lose overview of your product’s success. Sometimes small improvements can make a big difference, especially by utilizing professional contacts in the health care sector. Business development may not be top of mind as you expand your company in Europe, however, it is an essential component as it helps create long-lasting value for your company.
Kalms Operations develops your business's overall plan for reaching prospective customers to turn them into clients of your product/service. We support you in communicating your products' attributes to the target customers based on their needs, competitive pressures and communication channels.
When building your pricing strategy, we consider segments, ability to pay, market conditions, competitive moves, margins and cost. The strategy will be targeted at the defined customers and against competitors. We evaluate the impact of approaching your customers directly, online, by phone or by using a combination of these channels; contracting a distributor or sales agent may also be part of this consideration. We propose a sales and distribution structure enabling your business to execute on this strategy successfully.
Kalms Group offers tailor-made solutions for your needs. In addition to the services of Kalms Operations, Kalms Consulting helps create market success by determining the best way to reimburse your product.
Step 7: Find a local logistical partner (Kalms Operations)
The road to operational success in Germany and Europe is not an easy one. That is why you need an experienced logistical partner whom you can trust to help guide you through the process.
Kalms Operations supports your company from the first stages. We are there to support you when you begin reaching out to start clinical trials and may only have a few shipments and only need support with a few other activities. We will be there to answer all your questions regarding topics like how a hospital can purchase your device, rules surrounding giving away free samples of your product, what needs to be invoiced, VAT and customs. Kalms Operations excels at clarifying the process of initiating operations in Germany.
Kalms Operations is, therefore, your ideal choice; we offer practical logistical solutions to help ensure your operational success in Germany and Europe. As a Third Party Logistics provider, we provide central logistical and administrative services worldwide for companies who require a distribution center abroad.
Our mission is to be your smart one-stop solution for all your logistical and warehousing needs; we will be actively involved in creating your success. This mission is supported by offering personal and multilingual customer service, flexible and scalable service modules and same-day response to your customers and your inquiries, while complying with all regulations.
Whether your European business is about to start or already in place, a reliable partner is essential for your success. We are your best option to grow your business in Europe and build a successful distribution operation.