September 13, 2022 | If you’re a small OEM or maybe a start-up, your internal resources can be limited and product development can appear daunting. You want to keep time-to-market to a minimum while also making sure that costs don’t spiral out of control. If you get the process wrong, timelines begin to extend, budgets become stretched and projects can fail.
So, what are the key issues that you’re likely to confront and the pitfalls you should try to avoid?
- Regulatory challenges
Often OEMs may underestimate the bureaucratic challenges of bringing a product to market.
- Misunderstanding manufacturing needs
The complexities of the manufacturing implants and instruments require considerable expertise and planning.
- Inadequate design input
With design, it’s always essential to perform exactly the right steps in the right sequence.
At Lincotek, we design with manufacturing in mind and have more than 200 regulatory filings for clearance globally. Our teams have great experience of planning and a well-defined list of design inputs to streamline your process for maximum efficiency. In fact, we have a group of professionals capable of providing a truly integrated experience across all disciplines when it comes to medical device development. From spine, trauma and sports medicine through to biologics and total joints
We have combined Product Development Engineering with the following services:
- Robust QMS
- Regulatory Services
- Dedicated Prototyping
- Testing with on-site Cadaver Lab
- Design Transfer
- Full-scale manufacturing that includes CNC Machining, casting, additive manufacturing, and surface coatings (thermal spray of Titanium, HA and solution-based enhancers for osteointegration)
We start with the regulatory path in mind and define market needs and opportunities before focusing on design inputs. We are then in a position to move all the way from prototypes to launch. It’s an integrated set of solutions that you won’t find in other businesses.
And as your company benefits from our expertise, ultimately clinicians and patients benefit too.
