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Development of orthopaedic devices & instruments. 2017-05-19T11:11:43+00:00

Development of orthopaedic devices & instruments

Starting from the initial user needs, we develop orthopaedic devices and instruments. Our process contains 5 stages and for each stage we have defined the most important objectives to meet. We have organized our process in such a way that activities of each phase contribute to reach that objective. This approach makes our organisation very efficient to develop orthopaedic products.

Bird’s-eye view

Time-to-market

In today’s product development environment, products and the technologies are changing rapidly. This means that time to market and finding ways of optimizing it are critical components that directly affect revenue. For example, if your product launch is delayed by 6 months, that’s 6 months for your competitor to grab market share, and less overall revenue for you to pursue when you finally do go to market.
Baat Medical has developed a controlled development process. This enables our customers to control and predict time-to-market.

Risk management

Risk management planning needs to be an on-going effort that cannot stop after a qualitative risk assessment. Risk management includes front-end planning of how major risks will be mitigated and managed once identified. Baat Medical takes risk management seriously, therefore we incorporate risk mitigation strategies and specific action plans in the project plan.

Example, sales volume is reduced from plan due to delayed product launch. Getting back on plan is unlikely as a result of increased competition.

Project costs & control

We have a defined development process in place. In general, the process starts with the basic user requirements as input. During the execution of the project, points in the project timeline are defined where the management team and the project team will assess risks and make a decision to

  1. proceed,
  2. cancel the project,
  3. place the project on hold, or
  4. request additional work in the current phase.

Explore & Design

The explore and design phases are based on a creative basis, guided by experience. This phase costs around 400 man-hours and a realistic time frame amounts to four months. We have pointed out deliverables for each phase.

1. Explore

Choose concept and define verification & validation strategy

  • Translate the user needs into specifications;
  • Create various concepts to verify user needs and specifications;
  • Carry out risk analysis in order to indicate critical aspects that need attention;
  • Point out the strategy to validate the final product and determine the CE path way.

2. Design

Create functional model(s) and find out if the indicated key issues can be solved.

All activities within this phase are focussed on answering whether the final product would meet all user needs and technical specifications. Beside the development of the devices itself, the production process, packaging and labelling will be developed. Typical activities within this phase are:

  • Strength calculations and initial mechanical testing;
  • Developing the surgical technique using artificial bone or cadaver trial;
  • Clinical literature research and Risk analysis;
  • Investigation of the IP landscape;
  • Obtain a reliable estimation of the cost of goods.

Engineer, Validate & Transfer

The engineering and validation phases are focussing on detailing, testing and documentation. In these phases the risks are reduced. In fact these phases consist of hard working, following operating procedures and drafting documentation. A rough estimate for these phases amounts to 1.200 man-hours and a realistic time frame of 8-12 months.

3. Engineer

To completely define the design, production process and packaging.

  • Generation of production drawings and implementation of the production routing;
  • Production of tooling and first products needed for validation testing;
  • Risk analysis for production, inspection plans.

4. Validate

Prove safety and performance for all users and prescribers of the products

  • Carry out mechanical validation testing;
  • Sterilization and cleaning validation;
  • Packaging and transport testing;
  • Producing rationales in case a test is not conducted.

5. Transfer

Make products and documentation available for serial production and market release.

  • Transfer the design history file and technical file to the customer;
  • Release production process, products and documentation;
  • CE registration;
  • Implement files in the documentation system of the customer.