Uncertainty and concern best describe the prevailing feelings of many researchers, clinicians, and companies that develop, manufacture, and implement laboratory developed tests (LDTs). The reason for all this uncertainty is the U.S. Food and Drug Administration's (FDA) stated plan to issue a new guidance that would change the paradigm for regulating LDTs.
You are considering an Original Equipment Manufacturing (OEM) partner to support you in bringing your idea to market. The planned IVD device may require components, robotics and modules. You may need integration into an existing platform or the development of a completely new customized system. What else should you take into account when selecting an ideal OEM partner?
You have made the decision to enter into the development of an IVD system solution for your customers. You have learned that inviting an OEM partner into your project could be beneficial to reduce risks and fill expertise or skill gaps, but you are still hesitant. What are the key elements that you should consider to ensure the success of the collaboration?
How to overcome challenges like inefficient workflow and a lack of suitably trained staff is the question increasingly facing laboratories in markets ranging from diagnostics to food and beverages. Could sample-to-answer systems be the answer?
Human genetics and drug discovery are now inextricably linked. Large pharmaceutical companies, small biotech and even academic laboratories are sequencing data to identify potential targets for new therapies. But is this information being used to the best effect?