Life Sciences & Healthcare

Each medical product and its use in the clinical routine, in fact even daily procedures in hospitals, harbour substantial potentials for innovation and process improvements. An example of our software partner Induct demonstrates that the idea of an individual employee likewise has the potential of a major achievement. During her daily routine, a nurse anaesthesiologist in Denmark had the idea of supplying neonates with oxygen delivered through a pacifier rather than attaching the oxygen tubes separately. With the help of the innovation platform Induct, this simple idea turned into a pioneering innovation, which both medical institutions as well as the young patients are benefitting from.

In other words, it is not about collecting and evaluating ideas from as many prospective parties as possible. What is important is the continuous support of knowledge and innovation processes, from the idea to the marketable product. Quality and risk management elements need to be included as well. Our health care experts help you boost your innovative capacity and improve your processes.

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Many medical devices manufacturers regularly invest in innovations. The merits of this endeavour are uncontested. Based on information provided by industry associations, the medical technology sector in Germany achieves nearly one third of its own sales with products that are newer than three years old. This high innovative share was the only reason why the medical technology sector has survived the latest global economic crisis relatively unscathed. Furthermore, the USA as well as Asia and the Middle East have recently evolved with lightning speed to become the main foreign markets.

Yet, investments in medical technology innovations are not always successful. Not enough ideas and patent applications submitted by companies can successfully be transformed into innovations and make it to the market. The stringent national and international formalities such as the MPG (Medical Devices Act) and the amendment of the corresponding EU directive as well as the rules issued by the FDA (U.S. Food and Drug Administration) are one of the main reasons for this. They define in minute detail the framework within which innovations are permissible.

For medical devices manufacturers, it is vital that they master the balancing act between innovations and formalities to achieve lasting success. This is where modern PLM solutions come in. PLM stands for Product Life cycle Management and describes the strategic approach used for the joint (collaborative) generation, administration, distribution and utilisation of product-defining information. Involved employees have access to all current relevant information. At the same time, development processes are clearly defined in accordance with the formalities and the documentation of the results is supported. This refers to all phases of the product life, ranging from requirement management to system draft, compilation of the specifications, construction, testing and conformity assessment to serial production. In the subsequent phases, PLM can likewise be used for tasks such as product observation, service support and issue management. PLM achieves its full potential when cross-sectional tasks such as project management, quality management, risk management and document management are equally supported.

PLM also supports the development of new products in the sense that the potential end users, starting from the physician or nurse to the patient, can be integrated along the entire product life cycle. The integration of the various users or specialists can be a decisive factor. Based on the practice, they know best what kind of changes can further increase the practicality or safety for instance of a medical device. In so doing, realistic 3D illustrations are helpful. They

• substantially enhance the understanding,
• improve the information exchange,
• prevent future operating errors,thus
• contributing to better usability and risk reduction.

Medical technology is a highly complex field, posing many challenges to employees in this field. More than ever it is vital that employees receive the best possible support to help them focus on their core responsibilities and develop innovative products. Our medical devices experts will help you promote the innovative capacity of your employees and improve your processes.

Standard Operating Procedures (SOPs) describe the procedure within a process, contain a text-based description and are given to the persons in charge of executing them as an explanation. The use of SOPs is especially common for pharmaceutical and biotechnology processes. In so doing, all process development steps must be ensured and documented within the meaning of GxP and FDA, in order to meet the required quality.
Smaller laboratories or chemistry and biotechnology firms must permanently attempt to simplify the effort of compiling and maintaining standard operating procedures (SOPs), including the appropriate forms as well as the organisation of training. Suitable software can perform some of these routine tasks and help with the compliance of the stipulated formalities.

Information is considered the raw material of the 21st century. An information base that is as broad as possible, combined with a goal-oriented aggregation and processing is essential to make decisions quickly and safely. In the process, it is important to provide the decision maker with the appropriate information in the appropriate format and optionally to document it to secure and track decisions.
The use of tools capable of handling heterogeneous and in part extensive sources of information is required because structured and unstructured information must often be included for the evaluation of complex situations, such as it is found for example in in-house data bases and in specialist forums and user evaluations. In addition, increased safety requirements need to be considered, because personal data is often involved particularly in the health care sector. Our goal is to support you with modern solutions and technologies.