Our aspiration is to promote awareness of health tech patient safety and operational principles for the benefit of various actors. Thus, we offer our expertise for developing successful business in the field of health tech.
Our service offering consists for example of organizational development, market research, product management and strategies, and professional resources. We also help in finding suitable partners and subcontractors!
Business health check
Recognize critical development areas and strengths in terms of your business and product
Health check is a great starting point for development of your business and product to health tech field. We review operational models and guidelines, compile a report of strengths and areas to develop and present suggestions for development in priority order.
Health check is designed for organizations involved in the life cycle of medical devices or software, industry newcomers, investors requiring more information about a company’s status, and research institutes and universities wishing to commercialize research results.
The following topics can be reviewed:
- Development of critical regulatory areas, e.g. Medical Device Regulation (MDR, EU 2017/745) In Vitro Diagnostic Regulation (IVDR, EU 2017/746) and General Data Protection Regulation (GDPR, EU 2016/679)
- Local regulations in a single European country or other main market area (e. g. USA, FDA)
- Risk management with patient safety focus
- Market specifics in a single country
- Critical business areas with competitiveness focus
- Obstacles for business and sales
- User experience and risk regarding a product or a service
Business development, markets, and sales support
Get even more power to your business
Successful business is a combination of planning and actions. We offer our extensive health tech expertise to support with both: we help with planning a functional business model, commercialization of a new innovative product, and initiating sales.
When you aim for new markets, Clinipower can conduct market research for you to map out business potential. Our specialty area is German speaking Europe, that is, DACH area. We also investigate reimbursement solutions and make applications and market research related to it.
Management support
Support for health tech organization development
In the health tech field, operational practices that are in accordance with regulative requirements are an inseparable part of organizations. When a new organization is founded, the requirements can be taken into account from the very beginning. Transition to the health tech field usually requires changes in operations of an organization and individuals.
Clinipower offers support in organization development and change management when entering the health tech field. We consult management about field specific management principles.
Product management and strategy
Systematicality to products in a health tech field specific way
A product strategy points the direction for decision making to achieve the defined objectives. Product management and portfolio management aims to ensure success of products and competitiveness of an organization.
In the health tech field, one must understand clinical environment and consider the regulatory life cycle and certification when planning product strategy and management. We offer field specific support in designing product strategy, product management and portfolio management.
People and expertise
We offer our experience and know-how for your benefit
You can make big things even with small resources with the help of our expert advisors. Clinipower provides competent professional resources for a specific project and specialized areas of expertise, and for example for short term needs in case of personnel changes. As an example, our quality manager -service is a cost-effective way to take care of regulatory requirements and communication with authorities.
We also help in finding suitable partners and subcontractors.
Clinipower arranges extensive training programs or targeted courses on specific topics to support expertise in your organization. See up-to-date details on our Koulutukset-page (in Finnish) or contact us.
Read more
How often should audits be conducted in a health technology company?
The frequency of audits in a health technology company is primarily determined by the requirements of the ISO 13485 standard and the MDR/IVDR regulations. Internal audits must be conducted in accordance with the audit plan defined in the quality management system. External audits performed by a notified body are carried out annually. The regularity of audits ensures the functionality and compliance of the quality management system.
EU4MEDTECH – Transforming Medical Technology Evaluation
European health technology development is undergoing a transition, and new regulatory requirements are challenging companies to find effective solutions. Clinipower…
CE marking for medical device
CE marking is a critical prerequisite for the successful marketing of medical devices in Europe. This mandatory marking indicates that the product meets all applicable EU regulations and is safe for its intended use. Health technology product development nowadays requires a deep understanding of the CE marking process from the early stages of development work, as considering regulatory requirements later can cause significant delays and costs. The new Medical Device Regulation (MDR) has significantly tightened requirements, and companies need even deeper expertise to navigate successfully in the complex regulatory environment. CE marking (Conformité Européenne) is a statutory compliance marking that indicates a medical device meets all applicable EU directives and regulations. Without CE marking, a medical device may not be placed on the market in the European Economic Area. The marking is the manufacturer’s declaration that the product has been designed and manufactured in accordance with applicable […]
Our experts
Maija Laukkanen
CEO, Sales
Christian Wagner
Senior Advisor, Product Portfolio Management
