Time to market is a major challenge for the orthopedic OEMs

Gianfranco Viola, Director of Global Sales and Marketing, Lincotek Medical (former Eurocoating SpA), discusses how we can help you get your product to market efficiently.

11 February 2019

Heightened regulatory requirements are placing an increasing amount of strain on organizational and financial resources. In our experience, launching a new implantable device would take approximately 6 to 8 months in the first decade of the millennium. The average project timespan, from product development to registration, is three to four times longer today, essentially due to increased regulatory complexity.

This means that launching a new product today basically takes much longer and costs considerably more than it used to while selling prices are steadily shrinking. There are two levers OEM’s are using to address this situation: increase regulatory strength and streamline their supply chain in order to minimize production costs.

  • Focussing resources towards regulatory risks limiting other key competences; more quality and regulatory resources might mean that less energy is made available, for instance, to R&D.
  • Larger investments and longer time to market also means that the inherent cost of launching a new product is increasing. In a shrinking selling price scenario, the only way out is reducing production costs once the product is on the market.

Our role, as contract manufacturers, is to help OEM’s along those efforts.

With these goals in mind, we developed our one-stop shop approach; we brought together the core competencies of R&D, manufacturing and regulatory affairs, in order to offer the opportunity to our clients to tap from a portfolio of solutions. We can drive a new development through all the milestones, complementing the client’s organization.

That basically means that we can either help you developing a new product or have a product developed for you, registered for you, manufactured for you, whether it is the incremental evolution of your existing portfolio, or an innovative 3D-printed application. Importantly, we can cut the time to market with you or for you.

Find out more about our one-stop shop solutions.