A German SME is offering its business development services in the European and US healthcare market on the basis of an outsourcing agreement

Germany is a market that has great opportunities for healthcare companies. There are 82 million inhabitants living in a wealthy and aging society. The market in the hospital sector is comparably open and public health funds and private insurance companies have the ability to finance innovative projects and procedures. On the other hand, the German health system has complex decision-making structures and challenges such as benefit assessment for certain new methods or changes by the EU medical device regulation. A Berlin-based SME active in the field of consulting for the healthcare industry is offering strategic and operational support in the fields of market access, health economics, reimbursement and business development. Their market access services include regulatory and compliance advice, market potential analysis and pricing strategy as well as advice on operational structure and fiscal representation. As experts on the topic of reimbursement they prepare reimbursement applications for submission to healthcare authorities and dialogues with stakeholders. They are also able to provide health economic simulations focusing on cost utility, cost benefit and cost effectiveness which can be an essential part of a public affairs strategy regarding reimbursement or a public relations strategy. As they have many years of experience in the healthcare business of the United States, they are also able to offer their services to clients interested in entering the US market. Their offices in San Francisco and Minneapolis and partners in Boston, Denver, St. Louis and Florida enable them to provide market access services all over the United States. The United States remains the largest medical device market in the world at $156 billion (about 40 percent of worldwide in 2017), and it is expected to grow to $208 billion by 2023.The regulatory requirements for medical devices and pharma are predictable and manageable. Personal liability for company owners and officers can be provided by various easily-formed US corporate structures. North American physicians are very innovation-oriented and open to considering new med devices and treatments. Next to providing market analyses and market access support, the company is partnering with experienced law firms that support their clients with profound legal advice – also regarding Food and Drug Administration (FDA) approval - if needed. All those services are part of a strategy development process which is tailored to the client's needs. The client is looking for companies that want to introduce their products to the German, European or US market and need support with their market access strategy, questions of reimbursement and the regulatory framework. They are offering their services in the framework of an outsourcing agreement.