Untitled Document

As our offshoring partner, you will benefit in three significant ways:

Increased demand. In the course of educating and advising our clients, we often create significant offshoring demand for services that were perhaps not considered before. The level of FDA scrutiny has substantially increased in the past years, and most medical device / pharma companies are not yet aware of the specifics of the increased focus in key areas of compliance such as 21 CFR Part 11 (ERES), human factors, tools validation, and software inspections & unit testing - just to name a few.
Long term, stable relationships. Product development cycles in the medical devices / pharma space are much longer than in the consumer and IT industries. Even after a successful product launch, follow-up design and V&V work is needed to address component obsolescence, implement PIPs, CAPAs, and feature upgrades. And, of course, derivative product lines. Sustaining engineering is often a prime candidate for offshoring, as it typically requires short-term "bursts" of competent staff. As our partner, you are virtually assured a strong back-end deal flow without a significant marketing effort on your part.
Higher billing rates as you gain relevant expertise in the medical devices / pharma space. Perhaps you have been successful in the recent IT offshoring ramp-up, and you have dabbled into telecom and maybe even aerospace, but so have your competitors and you now compete mostly on price. The medical device / pharma space is different - it's not just about engineering competence; it's a lot about system safety, risk and hazard prevention / containment, and ensuring clinical and procedural effectiveness. If chosen to be our partner, we will help you fill any capability gaps you might have - through advice, guidance, and even on-site training at your offshore facilities. And then we'll market your specialized expertise accordingly.

To qualify, you must first meet a minimum set of requirements. Amongst many others, high on our list is having been independently assessed at a CMMI level 4 or 5 (metrics-driven, or better yet, metrics-optimized), and having enough staff to be able to absorb high volumes of effort for short periods of time ("bursts" of demand). A verifiable track record of having performed more complex product design tasks for a minimum of 2-3 years for clients in this industry is highly helpful.

If you are interested, please start by sending us an email at info@priusmedical.com and we will send you an initial qualification questionnaire. If we feel there is a potential for a partnership, we will approach you to arrange an on-site (offshore) qualification audit. We may initially qualify you only in certain areas of activity (such as tools validation or clinical trials data management) but as you gain experience, your area of qualification will expand. We have a very rigorous qualification process, which we feel is in the best interest of our clients, ourselves, and ultimately you as well.

A symbiotic relationship with us can be very rewarding. We are constantly looking for capable and dependable partners, but since we value and promote strategic relationships, a longer tenure with us will always give you a better preference - so don't delay, contact us right now!

	\| Benefits \| Requirements \|
	As our offshoring partner, you will benefit in three significant ways: Increased demand. In the course of educating and advising our clients, we often create significant offshoring demand for services that were perhaps not considered before. The level of FDA scrutiny has substantially increased in the past years, and most medical device / pharma companies are not yet aware of the specifics of the increased focus in key areas of compliance such as 21 CFR Part 11 (ERES), human factors, tools validation, and software inspections & unit testing - just to name a few. Long term, stable relationships. Product development cycles in the medical devices / pharma space are much longer than in the consumer and IT industries. Even after a successful product launch, follow-up design and V&V work is needed to address component obsolescence, implement PIPs, CAPAs, and feature upgrades. And, of course, derivative product lines. Sustaining engineering is often a prime candidate for offshoring, as it typically requires short-term "bursts" of competent staff. As our partner, you are virtually assured a strong back-end deal flow without a significant marketing effort on your part. Higher billing rates as you gain relevant expertise in the medical devices / pharma space. Perhaps you have been successful in the recent IT offshoring ramp-up, and you have dabbled into telecom and maybe even aerospace, but so have your competitors and you now compete mostly on price. The medical device / pharma space is different - it's not just about engineering competence; it's a lot about system safety, risk and hazard prevention / containment, and ensuring clinical and procedural effectiveness. If chosen to be our partner, we will help you fill any capability gaps you might have - through advice, guidance, and even on-site training at your offshore facilities. And then we'll market your specialized expertise accordingly. To qualify, you must first meet a minimum set of requirements. Amongst many others, high on our list is having been independently assessed at a CMMI level 4 or 5 (metrics-driven, or better yet, metrics-optimized), and having enough staff to be able to absorb high volumes of effort for short periods of time ("bursts" of demand). A verifiable track record of having performed more complex product design tasks for a minimum of 2-3 years for clients in this industry is highly helpful. If you are interested, please start by sending us an email at info@priusmedical.com and we will send you an initial qualification questionnaire. If we feel there is a potential for a partnership, we will approach you to arrange an on-site (offshore) qualification audit. We may initially qualify you only in certain areas of activity (such as tools validation or clinical trials data management) but as you gain experience, your area of qualification will expand. We have a very rigorous qualification process, which we feel is in the best interest of our clients, ourselves, and ultimately you as well. A symbiotic relationship with us can be very rewarding. We are constantly looking for capable and dependable partners, but since we value and promote strategic relationships, a longer tenure with us will always give you a better preference - so don't delay, contact us right now!