Finding the way out of the licensing labyrinth

Undeniably, FDA licensing and CE certification present the greatest obstacles to putting successful medical products on the market. For young companies in particular, getting a grip on the diverse requirements is a significant risk which not infrequently puts an end to promising, innovative ideas and projects. The example of a start-up in the field of ophthalmology shows how a practically oriented, adaptable sample process can provide a reliable compass by which to keep on track for success.

The development of new, innovative medical products poses a range of challenges to medtech companies. Within the EU, manufacturers have to operate a certified quality management system according to ISO 13485. What is more, for access to the all-important US market the FDA requires a QM system as stipulated by CFR Title 21 Part 820.

In addition to quality management requirements, the manufacturer has to adhere to a range of legislative and normative specifications in order to comply with the basic prerequisites of Appendix I of the European Directive 93/42/EEC relating to all products designed for use on human beings. These range from risk management to chemical, physical and biological properties, from the usability of a product to sterility requirements – to name just a few. There are also certification and documentation requirements, depending on the device classification of the product in question. However, the biggest hurdle in launching a successful medical product is CE certification and FDA licensing: these determine the success of an entire development project and are ultimately the deciding factor as to whether a manufacturer can even put a product on the market.

Many manufacturers have difficulty keeping track of this vast complex of specifications and regulations. And with the fourth amendment of the Medical Product Act (MPG) which came into effect on 21.03.2010, applying the extensions and changes of the European directives to German law, a larger number of companies are currently affected. This is because products now fall under the MPG which were not previously affected by it. For example, software is now classified as a medical product in its own right if it is designed for the detection, monitoring or treatment of disease etc. Any software which derives a recommended diagnosis from figures entered or monitors the interactions between drugs in a patient is now classed as a medical product by law. Some manufacturers of such products have no previous experience whatsoever of the legislative and normative requirements involved

For young companies in particular, the complexity involved in implementing the vast number of regulations and specifications represents significant risks. Difficulties in tackling the wide range of demands and the resulting uncertainties in developing a medical product can considerably delay market maturity and licensing. Forgetting a particular requirement or applying a specification incorrectly can significantly impair the financial success of a product, and it is not rare for promising, innovative ideas and projects to fail for this very reason.

Established manufacturers use internal processes to jump through the hoop of legislative and normative requirements. The risk of delaying market maturity can be reduced by means of established development, business and quality management processes. However, care must be taken to ensure that such processes implement all regulatory obligations correctly and completely: over the years such internal processes have tended to become increasingly detailed and extensive.

Start-ups and companies new to the category of medical product manufacturers do not yet have such a historically developed process landscape in place. In such cases it is a good idea to use a predefined sample processes.

In collaboration with one its partners, Optana Medizintechnik GmbH, the company Method Park Software AG has created just such a sample process. The so-called “unified process” covers all the relevant departments and provides guidance through the entire product lifecycle from the initial idea through to licensing and market monitoring. Instructions are provided which describe all the activities to be carried out, including lists of the documents to be created and the roles and responsibilities linked to each task. The sample process fulfils the relevant requirements of a quality management system according to ISO 13485 and CFR Title 21 Part 820 as well as the relevant specifications for the development of a medical product according to ISO 14971, IEC 62366 and IEC 62304.

This sample process was first put to the test in a start-up which started life as a spin-off from a company established in the market for some time. The spin-off was created with the specific intention of gearing the new company towards the medical technology market in ophthalmology. While there was sufficient technological expertise available since several specialists moved to the new company, there was a complete lack of experience with medical products.The aim of the start-up was to take existing eye-tracking technology, previously used mainly in advertising and to test usability in all kinds of products, and apply this to ophthalmology. An eye-tracking system detects the user’s line of sight and tracks it, thereby enabling analysis. The company wants to apply this eye-tracking information to the precise alignment of a laser when conducting retina surgery. By applying the sample process, the young company was able to start work on the product idea right away. The aim was to swiftly introduce and certify a quality management system according to ISO 13485. Subsequently an initial product was to be swiftly licensed in Europe and the US so as to generate sales and attract investors.

The sample process was installed in single stage without adaptation. This process covered over 40 sets of instructions, classified according to groups. A set of instructions consists of a sequence of activities, each of which is described in detail. Activities are assigned to roles responsible for carrying them out. The main assignments and skills are set out in detail for each role. The process also includes around one hundred forms which are linked to the instructions. This ensures that the right information is documented at the right time; in this way, documents required for licensing purposes cannot be forgotten.

Using the existing documents, the quality management system was approved, staff were provided with the relevant training and the system was installed – all within just a few weeks. Certification was issued 18 months later. Instructions were implemented based on the defined process stages and all activities carried out as described. The documentation of the various activities and outcomes in the linked forms meant that a complete set of documentation was compiled throughout the course of product development – both for CE certification and FDA licensing. The CE label was issued 18 months after certification of the QM system, while approval for the US market followed four months later.

Once licensing had been achieved, changes had to be made to the process. Having grown from a workforce of five to 38, the company was faced with tailoring the sample process to the new situation. This adaptation was very simple due to the fact that activities and roles were described separately and a full set of document templates provided. Once the changes had been made, compliance had to be verified so as to ensure all the relevant requirements were still being met.

Integrated in a process management tool, a sample process such as the one used by the start-up company in this example can be highly effective and efficient. This type of tool, such as “Stages” (Method Park), generally offers a range of functions such as tailoring, integrated document management and a compliance component to ensure specific regulations are met. The option of using such a tool to run an automatic gap analysis against the relevant specifications makes the combination of tool and sample process especially powerful.+

Tobias Bachmann, who is the author of this article, points out: “For young companies in particular, the complexity involved in implementing the vast number of regulations and specifications represents significant risks. Difficulties in tackling the wide range of demands and the resulting uncertainties in developing a medical product can considerably delay market maturity and licensing.