Outsourcing seems to be a popular topic these days for medical device companies. There are publications devoted to the topic. Outsourcing certainly has its place.

A recent post at MD&DI reminds readers that FDA regulations apply to outsourcing relationships. This should come as no surprise. Companies need to properly evaluate, qualify, and monitor suppliers. Typically these activities should coincide with the risk the supplier represents. The concept of outsourcing certainly isn’t new. However, many companies are outsourcing more and more. And the types of activities and services being outsourced today are activities and services that a company would have held tightly just a few years ago.

An established medical device company likely is aware of supplier and purchasing controls and associated regulations. Chances are these companies have quality procedures in place too. Just realize that the more third parties are utilized, the more robust these systems need to be.

I have a few quality resource needs where I need your help:

1. A component manufacturer in central Indiana is in search of a quality manager with product development and business development experience. This is a full-time position.
2. A start-up is in search of someone with medical device documentation and quality system experience. Ideally, the person will have medical device and regulatory experience as well. This is likely a limited scope and duration (~20 hours per week for <6 months).
3. A start-up is in search of someone with medical device experience–specifically regarding supplier selection and inspection of human biologics. This is likely limited to establishing biologic-related systems.
4. A service provider is looking to place a quality / regulatory resource with a medical device company with FDA warning letter issues.

Send resumes to me. Call for further explanation. Share this request with others too.
Cheers,
j
jspeer@creoquality.com
765 346 3987

I’ve been catching up on some reading (can you tell from recent posts?). Here are some links to recent articles from Medical Device Network.

“When the Auditor Comes Knocking” reviews some of the finer points to consider in regards to audits.

“Regulations Rewritten” discusses impact that medical device regulations have on companies, especially start-ups.

“Collaboration is the Key” shares some points to consider when outsourcing.

The role of quality in a medical device company is absolutely essential. However, many companies seem to struggle with the concepts of quality. In some companies, the quality role is power heavy and dictates initiatives to the rest of the organization. In others, the quality role is put on the back burner.

The article “The Century of Quality” from Medical Product Outsourcing discusses issues that medical device companies need to consider in respect to the quality role.

While outsourcing is not a new concept, it is just now gaining in popularity in the medical device industry. Creo Quality, LLC is a result of the willingness of companies to outsource services.

Here is a link to “Taking the Pulse of Full-Service Outsourcing” from Medical Product Outsourcing. The article goes into some detail about medical device outsourcing trends and benefits.

Enjoy!

I have quite a bit of experience with medical device product development. Most of my experience, though, came from a large, private, well-funded, well-established medical device company with a plethora of resources to support every aspect of product development.

My current data point is in process and with a start-up medical device company. Every decision made and dollar spent needs to support absolute needs. Too bad medical device product development has lots of gray and is not as simple as black and white.

One sometimes gray topic is biocompatibility. The start-up device intended use is fuzzy and does not fit with ISO 10993 biocompatibility test matrix. We have speculated about possible fits. The trouble is the potential testing is quite lengthy and very, very expensive. And some of the test descriptions just don’t make sense.

We have received some great advice from a biocompatibility expert. He suggested risk assessment would be ideal for our device application. I think this seems very practical.

Biocompatibility practicality is also the subject of this article from MD&DI. Chemical characterization is another possible approach to address biocompatibility. Bottom line: make sure testing is value added and necessary.