Market Access Medical Devices

The health technology sector cannot succeed in launching medical devices on the market unless each product's approval, reimbursement and medical device pricing strategy is substantively aligned and synchronized with product-specific marketing.

Current constellations for medical devices to gain market access

In today's world, innovative medical devices are launched into a market environment affected by falling prices and narrowing margins. Medical device manufacturers must therefore go straight from being a sole medical device supplier directly to a full-service provider of both outpatient and hospital-based care. The medical device market is undergoing a paradigm shift. That means that small- and medium-sized medical device manufacturers aiming to gain market access are faced with ever-mounting challenges: increasing pressure on prices, more intense focus on benefit and digitization of healthcare and changing EU medical device regulations, while new decision-making pathways establish themselves in procurement processes at hospitals.

Certification of medical devices (also referred to as marketing authorization)

Unlike with pharmaceuticals, there is no marketing approval procedure for medical devices. Instead of a marketing authorization, medical devices legally require CE certification to gain market access within the EU. All medical devices sold within the European Union and governed by EU medical device regulations in their legal venue must be affixed with a CE mark.
The CE marking was introduced in 1995 to promote the free movement of goods within the European Community. By affixing a CE mark and signing a declaration of conformity, the manufacturer indicates to the EU authorities that his medical device is in conformity with the requirements of all relevant directives and is thereby granted market access. Depending on the directive, certain types of medical devices require a notified body in the EU to be involved.
As part of the conformity assessment performed by the notified body, the manufacturer or importer of a medical device must prepare technical documentation or a design dossier. This forms the basis for the authorities to assess whether the EU regulation requirements have been met. These health technology assessments (HTA) are done to ensure that the latest state of the art in science and technology is reflected in the design and manufacture of medical devices accessing the market. The relevant European directives set forth the requirements that safeguard patients, users and third parties and guarantee that health technology products with market access function flawlessly. Manufacturers are moreover obligated to put a quality management system in place that satisfies the EU regulations. Depending on the device class, health technology manufacturers must moreover observe guidelines, ordinances and special regulations falling under the purview of the medical device directives in the EU. Harmonized European standards describe the specific requirements governing the production, performance and safe construction of medical devices.

Certification of medical devices: Classifications

Except for in vitro diagnostic and active implantable medical devices, all types of health technology products are divided into classes. Classification is carried out according to the rules set forth in Annex IX of Council Directive 93/42/EEC.
Therein, four classes are defined (I, IIa, IIb and III). The EU regulations governing the conformity assessment procedure are dictated by the medical device's risk class: Depending on the risk class, this conformity assessment is performed with the involvement of a private, independent inspection and certification body (“notified body”). This notified body is designated under a state procedure and surveilled by the authorities. Only manufacturers of class I medical devices (lowest risk category) are exempted, i.e. can carry out certification without consulting a notified body.

Certification of medical devices: Impact of the CE mark

The CE marking of medical devices and a corresponding declaration of conformity are proof that all applicable EU regulations have been met. In principle, medical devices affixed with the CE marking can move freely within the entire European Economic Area. Post-marketing, medical devices are subject to surveillance by the competent authorities of the EU member states and a medical device surveillance and reporting system for documenting and preventing post-marketing emergent risks (vigilance system).

Pricing innovations on the medical device market

The pricing of innovative medical devices is dictated by the claim the manufacturer makes to market share, the prevailing competitive environment and the manufacturer’s overall portfolio, including the services linked to the product. Modern price models require a logical and straightforward price calculation schema or “price logic” reflecting performance and return performance. Health technology manufacturers have to counterbalance the fact that not every customer needs or can afford the latest and best medical devices available. Most decisive for medical device pricing is that customers are offered multiple levels of service, that truly value-added care benefits can be demonstrated and that an intelligent pricing policy is in place. A sensible business strategy and economically sensible pricing models lay the groundwork for a focus on segments that enable the medical device manufacturer to optimize the strengths of his products accessing the market. Higher prices for innovative medical devices can only be maintained when the added value can be highlighted, and the method or product clearly stands out vis-à-vis comparators and established standards. Usually, this added value extends beyond the mere medical device itself, by including services, solutions and a customer experience.