Ilsa, I'm glad we finally met in person at 10x. We had a similar conversation about "full service" here: https://www.linkedin.com/groups/78665/78665-6126378231051407362

Ilsa Webeck Thanks Joe, Great to meet you too!

Frances Cohen I tend to disagree that the design and development service should include market research and planning. If you want strong core competencies in Medical Device Engineering, you will probably dilute your engineering expertise if they also "know" also know your market and help you plan it. Product Marketing and Device Engineering are very different disciplines. From what I have seen, the less specialized your service provider is, the less true expertise they can provide for your targeted needs.

Ed D. Quite so Frances C, core competencies must be retained internally.

We consider ourselves a full service medical device testing and regulatory company, but it only applies to Engineering, Regulatory, and some clinical services. We are not a research or marketing organization and don't have the people available with those skills. Sales and Marketing are very specialized skills, especially in the digital age, so you need to get specialists who are experts in those fields (as in Joe Hage) as they are not typically in the genetic makeup of engineers or regulatory scientists.

Bill Watson I'm generally wary of giving third-party consulting firms an unlimited engagement. My experience has been that's usually an excuse to not have firm plans within your own company. I have seen things like one-time engagements to translate an in-house electrical engineer's circuit schematic into an IPC 610 Class III printed circuit board layout or paying a certified auditor to audit the quality system work well. The key is that you're engaging talent to support in-house expertise vs. papering over the fact that you have a hole in required in-house capability.

Edward Dolan To Frances' comment, I agree that you always need to looking for specific expertise. But it becomes a matter of balancing values (all goods; few bads). Does the intelligent, smooth integration of disciplines in this firm give it an edge? Would I be getting more by coordinating myself 2 or 3 different firms, each with greater depth in their own areas of expertise?

Thanks for the shout out, Richard.

Our consulting practice is focused on biomarker application to IVD and LDT development and bringing those tests to market. Obviously, we think we add value, but it is a fairly narrow space. Our clients are usually beginning to market tests that are new to them. Maybe it's a new disease area or a very innovative tests. Often they are scrambling to understand the nuances of an area not familiar to them after signing a distribution deal with the developer of the test. We find success in these types of projects.

We provide 'assistance' in design and can provide turnkey services like machining, forming, assembly and test (where applicable) of many different materials.