Health technology product development projects are known for major budget overruns and unexpected costs. Million-class savings are possible when understanding which factors truly cause the highest costs and how they can be avoided. Successful health technology product development requires a systematic approach where risks are identified early and regulatory requirements are considered from the beginning.
Which factors cause the highest costs in health technology product development?
The highest costs typically arise from late-stage changes that force a return to the drawing board. When a product is already in the development phase and it is discovered that regulatory requirements are not met or usability testing reveals serious deficiencies, correction costs can rise exponentially. Particularly expensive is the situation where the product’s risk classification has been defined incorrectly in the early stages of the project.
Correcting usability problems at a late stage is another significant cost factor. Medical device usability design requires deep understanding of the clinical environment and user groups. When usability testing is conducted only at the end, changes may require significant redesigns to both technical implementation and user interface.
Strategic approach to ensuring cost-effective product development
Cost-effective product development begins with thorough concept design and testing. The size of the problem and demand must be understood and validated before developing the solution. Success metrics are defined in advance and solution models are systematically iterated. This approach shortens product development time and enables product success in the market.
Considering regulatory requirements during the design phase is critical. MDR and IVDR regulations, FDA requirements, and international standards such as ISO 13485 and IEC 62304 must be integrated as part of the product development process from the beginning. Building a quality management system as part of product development ensures that all requirements are met without expensive post-hoc corrections.
Added value of Clinipower’s expert services to product development projects
Clinipower’s deep industry expertise and international network support cost-effective product development on multiple levels. Practical experience with both startup companies and international health technology giants enables the creation of realistic schedules and budgets. This experience helps avoid the most common pitfalls that cause additional costs in projects.
Regulatory expertise and risk management specialization are particularly valuable services that can save millions of euros during the project lifecycle. When regulatory requirements are identified and considered in the early stages of the project, expensive redesigns and delays are avoided. Clinipower’s team can assess the product’s potential path to market and identify critical risks that may affect project success.
The innovation process, which models a new health technology innovation MVP version’s journey from idea to market launch, includes phase-specific checklists for progress monitoring. This systematic approach ensures that the project stays within budget and schedule while meeting all critical requirements.
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