Medical devices

Peira sits in Flanders at the heart of medical breakthroughs. Through its partnerships with several research groups at university hospitals and its close collaboration with the biopharmaceutical sector, the company is well placed to transform your innovative ideas into sellable products.

Peira will design, develop and manufacture your products conform its rigourous quality management system and product realisation process that allows you to obtain the required certifications for a timely market introduction of your innovative idea.

The company will act as your CDO (contract design organisation) and CMO (contract manufacturing organisation) in order to help you bringing products to market faster at a lower cost, compared to an in-house operation. Outsourcing those activities to Peira will help new start ups to avoid the valley of death as well as established companies to speed up new market introductions.

Business development process

Business development proces

Product realisation process

Product realisation proces

Idea generation phase

New businesses and product development starts with a good idea. In this early stage of the product realization process the customer and Peira evaluate together the common interest and the strategic fit for both companies to team up for a partnership. Available resources, intellectual property, confidentiality issues, partnership boundaries and business plans are discussed in this early stage.

After evaluation by both parties and a positive outcome a quotation is made or an agreement is signed between both parties and concept creation can start.

Concept creation

After order confirmation or signing of the cooperation agreement the concept creation phase is started based on more detailed input from the customer, regulatory and internal requirements.

A feasibility study based on internal (own portfolio, competences …) and external factors (cost estimates, general principle …) is made.

The concept will describe the general working principle and a basic risk analysis with regard to customer, statutory, regulatory and internal requirements will be performed.

Firewall 1

Go/no go decision based on fulfillment of customer, regulatory and internal requirements. A project plan to proceed is agreed upon.

Proof of Principle

The customer provides more input on the specifications and the critical parameters. A full risk analysis with regard to customer, regulatory and internal requirements is done.

Product requirements (function, performance, safety …), identification and traceability requirements, bill of materials, components, subassemblies are defined.

Prototyping

A working prototype with full specifications including bill of materials is built and the design is frozen.

Firewall 2

Go/no go decision based on the verification results of the prototyping phase is made. The project plan is updated or next steps are defined.

Pre-series

A series of engineering samples, typically 5 – 20 pieces is produced. All parameters and customer requirements are checked and tested in real-life conditions. Samples are validated and pass product acceptance test.

Firewall 3

Go/no go decision based on evaluation of validation test results and on fulfillment of customer, regulatory and internal requirements.

An updated project plan with allocated resources is made or next steps are defined.

Design for manufacturing

Determination and investigation of parameters critical to production/assembly and quality control (e.g. quality, logistics, cost …).

Manufacturing scale up

During this phase all necessary steps to scale up manufacturing with regard to forecast/planning, including inspection and quality control, are determined. Product starts to sell in the marketplace and sales forecasting process has been initiated.

Routine manufacturing

The product is now well accepted by the users of the product and has become a standard selling product for Peira’s customer. All products which are released by Peira fully comply with customer, regulatory and internal requirements. All risks are at acceptable levels.

Service provision

Peira concludes customized service level agreements and makes practical arrangements with its customer/the marketeer in order to timely repair and maintain products that have been released by Peira.