Time to Market
Technology, regulatory, healthcare policies have a strong influence in development and commercialization of medical devices. Time to market is a challenging issue which require perfect planning and implementation to soar in the existing medical devices market.

• Disruptive technologies may necessitate new selling channels.

• Time consuming regulatory approval may be required for new technologies.

• Exploding healthcare costs may constraint new innovative medical devices to administrative and insurance hurdles to obtain reimbursment approval.

Technology
The future orientation of technology has to be examined cautiously and regularly. Watch for discontinuities resp. disruptive technologies to take the right turn at the right moment.
Knowledge and innovation management as well as market intelligence play a key role in being flexible to changes.
For example progress in molecular biology/genetics delivered non biological solutions to clinical problems as ultrasound appliances for tissue repair.

Regulatory
Global regulations from the FDA/CDRH or the EEC are balanced by local regulations as for example the MPG in Germany or the regulatory in Japan. Inconsistent requirements between markets can contribute to slow down the approval process. The innovation process should reflect the requirements of the regulatory to guarantee success of approval.
Moreover, biological (cell) based solutions can be seen as medicinal products (i.e. pharmaceutical products or drugs) submitted to other regulatory. New biological products are often on the edge between medical devices and drugs, necessitating profound knowledge of both regulatory contents to get approval.

Healthcare
Acceptancy of new devices is often linked to reimbursment issues. Evidence based medicine plays a major role in getting approval of insurances or national healthcare system for reimbursment. The costly and time consuming challenge consists in generating the cost-effectiveness evidence and establish the reimbursment process.
New innovative devices may necessitate re-education in clinical practice.

Expectations vs. Reality
The often observed discrepancy between expectations and reality extend over the whole medical devices market.
Innovation can be defined as a successeful product fulfilling most of the requirements defined by users, i.e. when reality meets expectations from the perspective of the user.
A particular care has to be taken in establishing an attractive concept for a new product. Success is only guaranteed when the balance between marketing pull and technology push is reached, offering useful information about markets, competitors, and available and coming technologies. Thus the product will satisfy the demand.

Innovation is fed by success fed by innovation !