What are the challenges for start-ups gaining medical device approval?

Maik Endler, Knoell Germany, examines the challenges for start-ups gaining medical device approval.

Putting medical devices onto the market is complex and expensive. This is a particular challenge for small companies and start-ups, whether as a result of global and national regulatory demands, the associated requirements for staff qualification, or the provision of sufficient capital.

How can you satisfy these demands without losing sight of the goal of bringing your product idea to the market as quickly as possible? As a consulting business, the Knoell Group has been dealing with these questions for a number of years and has developed methods for addressing them in an efficient and customer-oriented manner.

Smaller businesses are usually focused on their core competence – generally the development of new and innovative medical device technology. Owing to their lack of experience with regulatory demands, certain points are not taken into consideration sufficiently during development.

Normally, prototypes or products almost ready for series production are manufactured without taking medical device approval into account. It is at this juncture that most companies begin to tackle approval issues, and then realise the range of demands is broader than originally assumed. This can lead to delays or the cancellation of the project for lack of profitability. Often a decision is made at the beginning of the project to forgo the assistance of consulting services providers.

Few consulting companies can provide comprehensive product-oriented advice going beyond the regulatory demands. There is a practical disconnect between regulatory demands and concrete implementation in an actual product. The essential phases of product development together with their core aspects need to be worked out, and insufficient attention is usually paid to them.

There is a lack of the overall view of the procedures that need to be followed to develop a compliant medical device. The main phases are the conceptual planning phase, the specification phase, and the verification and validation phase including clinical assessment, and possibly conducting clinical studies.

Conceptual planning

During this phase, customer requirements are determined, the regulatory strategy is defined, and these form the basis for identifying development requirements. Little effort is applied during this phase. Sometimes it is often skipped, although it is in this phase that the scope of all subsequent activities is defined and development strategies may be prepared thanks to the choice of requirements that allow an efficient path through to approval to be taken.

Possible variables include the choice of markets for initial approval as well as the product’s specific purpose. Both factors influence the requirements, the scope of verification and validation, and the product's time to market. Available capital, which needs to be used efficiently by start-ups, also plays a major role.

Specification phase

If sufficient care has been taken with the conceptual planning phase, the specification phase should provide no major challenge. However, inadequate specifications will be defined without the corresponding preparatory work. This includes, for example, the choice of materials. These are usually selected to satisfy technical requirements. However, insufficient consideration may have been given to the biocompatibility of the materials, which may result in the specifications being revised at a later date, in repeat verifications, and in delays and additional costs.

Verification and validation phase

The verification and validation phase provides supporting evidence. The specifications first need to be verified against regulatory demands (eg performing biological, mechanical and electrical tests), and second, validated against customer requirements. This evidence is generally provided by performing standard tests. However, it is important to ensure that verification activities match the specifications and regulatory requirements.

This coherence is generally lacking, resulting in queries and possibly in deviations following assessment by the approval authorities. Validation of customer requirements is usually neglected, which is normally covered by usability validation. Besides development requirements, this is the area that is most often neglected in product development. Companies are insufficiently aware of the significance of fitness for purpose. However, it constitutes the connection between the developed product and the designated application, the intended purpose.

Inexperienced companies should look for partners who cover the spectrum of consulting services across all phases of product development. Additional support from a consulting company in coordinating tests and the scientific exchange of information between service providers (testing laboratories, clinical research organization) can create freedom for companies to concentrate on their core competence. All this results in highly efficient, cost-optimised approval concepts and significant competitive advantage.