FAQ

Can you manage QMS?

Yes.  We have a Quality Management System that is ISO 13485 and CFR 820 compliant.  We can implement a QMS, resale a QMS, and host your product in our QMS.

Can you work in my QMS?

Yes.  Our team is well experienced working in many Quality Management Systems, including merging systems and mixed systems.  We've participated in small company systems and large company systems.

Can you prototype?

Yes. For cusomers we develop for, we use our own rapid prototyping equipment for formative, early-iteration designs, and proof of concept.  We use our highly-responsive, highly-capable network of machinists, model-makers, and contract manufacturers to produce high fidelity, substantive prototypes.

Why don't you have a machine shop?

We're located in the world-leading Orthopedic manufacturing community.  Our model works best by leveraging this community.

Do you do regulatory?

Yes.  We are best suited for end-to-end product design and development projects, including regulatory strategy and filing.  

Will you be available after the project is complete?

We can provide ongoing support under several ramp models. 

What do you do?

We have many capabilities ranging from engineering ideation to product sunset.

At our core, we do New Product Development and Introduction (NPD and NPI).

We consult and provide new project discovery or charter, fractionally support in leadership, augment teams by project or by skillset, and perform full program managment.

We design orthopedic stuff, we make stuff, break stuff, and we do it fast.

How do you optimize my project cost and overall satisfaction?

We say 'First Things First' because cost and satisfaction are driven by focus.

Can you handle a large project?

We are suited as a program management firm.  We can run multi year, multi product programs.

How do I minimize the resource impact on my staff, with an outcome that's consistent with my company's goals, brand, and capability?

Consider using our Flex Teams (Tiger Team).

These teams are dead focused on solving your most pressing problem or completing your most urgent project quickly.  They're designed to be flexible to optimize your spend and drive resolution.

Can you manage my project on the outside?

We are ideally suited to run a project for a customer within the confines of Priority Medical and return it to our customer or manage it for them.

I had a bad experience outsourcing my R&D, how are you any different?

We have eliminated hidden pullthrough incentives.
We follow a strict alignment and flexibility code to drive project success.
We've lived through unsatisfying outsourced projects, so we relate and actively focus on the best interest of the customer.  We often say: "put on the customer's jersey"