(Research Triangle Park, N.C.) As part of an ongoing effort to build a stronger technology community in North Carolina, NCTechNews will be publishing Q&A profile sessions with select businesses and organizations throughout our state. In today’s installment, NCTechNews talks with Samir Dandekar, one of the co-founders of Apex-based Code Refinery, a software development firm specializing in the medical devices and diagnostics market sectors.

Q: When did Code Refinery launch and why?
A: Our company launched in 1997 to fill unmet needs in turnkey software development services specifically for lab automation and integration.

Q: What type of funding or startup assistance did Code Refinery seek and receive?
A: Code Refinery was bootstrapped with an initial investment of $1000.00 by Mike Brown and Samir Dandekar.

Q: Where is your HQ and how many employees do you have?
A: Our headquarters are in Apex, NC and our company is made up of 7 employees and 3 partners.

Q: Who are Code Refinery’s competitors, and what are your company’s differentiators?
A: Our competition consists of a variety of small to mid-size software development companies who also service the IVD market.  Our differentiators are as follows:

· We have an established quality system and engineering infrastructure that meets FDA CFR 820 regulations.  Our internal systems allow clients to leverage our infrastructure if they don’t have one internally. In addition, our clients are reassured knowing that their products will be developed under a disciplined and well-organized process.

· We leverage design tools that are validated which help us automate many tasks during the software design, development and validation phases. Our clients have the ability to access their project information 24/7 through a secure web portal so they can always stay in the loop regarding their product development.

· Our track record over 15 years with a variety of clients means that there is high probability that we have encountered a similar situation for our prospective clients and can quickly propose a solution for their problem.

· Our engagement process not only deals with the immediate problems but also emphasizes the discovery of our client’s ambitions. This way we can give our customer a tailored solution which can grow and adapt to their future needs.

Q: Does Code Refinery develop new technologies or re-apply existing technologies to solve a problem?
A: We leverage existing technologies to create custom solutions.

Q: What are Code Refinery’s core products or services?
A: Our core offering is providing software development services in two areas:

· In-vitro diagnostic devices and computer controlled surgical instruments which require FDA clearance in order to be marketed.

· Systems that automate a lab process and are subject to potential FDA inspections because they must comply with the FDA Quality System Regulation for Good Manufacturing Practices.

Q: Who are Code Refinery’s customers?
A: Below are some of our customers:

· Baxter BioLife Plasma (www.biolifeplasma.com)

· BD Diagnostics

· Emergent BioSolutions (www.ebsi.com)

· Amgen (www.amgen.com)

· Gen-Probe (www.Gen-Probe.com)

· National Human Genome Research Institute (www.nhgri.gov)

· Tecan (www.tecan.com)

· bioMerieux (www.biomerieux.com)

· LipoScience (www.liposcience.com)

· Mead Johnson (www.mjn.com)

Q: What problems does Code Refinery solve?
A: We solve the problem of producing high quality, FDA compliant software used by in-vitro diagnostic devices, laboratory automation and computer controlled surgical instruments.

Q: Please share any examples of situations where Code Refinery products or services achieved a positive result for clients.

· National Human Genome Institute: Delivered a system to automate labor intensive research protocols for the Human Genome Mapping project.  This system was an key step which significantly increased the sample processing throughput and provided innovative methods to greatly improve the efficiency of their research. (http://www.code-refinery.com/case%5Fstudies/genome/) (http://www.code-refinery.com/case%5Fstudies/genome/)

· Mead Johnson Nutritionals – Delivered a fully integrated and FDA compliant QC system which allowed MJN to test their finished nutritional products and guarantee label claims from release to the shelf life of their vitamins and other nutritional products.  This system has been operational since 2005 and continues to be a vital part of their production process. (http://www.code-refinery.com/case%5Fstudies/MeadJohnson/)

· Tecan:  Delivered full documentation, testing and verification for the Novartis CPT pooling software used in the automated screening of HIV, HCV, HBV and West Nile Virus.  Novartis received FDA 510 (k) approval (BK040058) for their software.  (http://www.code-refinery.com/case_studies/Tecan/)

Q: What new products or services will Code Refinery be rolling-out in 2012?
A: In 2012 we will:

· Achieve ISO 13485 & 9001 registration by end of Q1 2012.  This will increase our medical device software development capabilities by becoming certified with the ISO 13485 and ISO 9001 standards.  We were fortunate to be selected to receive the North Carolina Incumbent Workforce training grant in 2011, which provided the funding for this training effort.

· Launch Readiness Review, a packaged service to quickly assess if a client’s software is “FDA binder” ready for approval.  This assessment will uncover any gaps, if they exist, and address those gaps before your device submission is sent to the FDA.  The FDA has 90 days to respond after they have received your submission and addressing issues early helps clients avoid costly delays later.

Q: What makes Code Refinery relevant to the future of your industry?
A: The medical device market continues to grow at a rapid pace.  Software is becoming more complex and devices built on a mobile platform are becoming common place in healthcare.  It is and will be imperative that software is produced with patient safety as the number one requirement. An article written by the LA Times pointed out that between 1983 and 1997, 1 in 4 medical devices used software and today, about one-half of medical devices contain software as a key component.  Software problems are now the third leading cause for recalls of medical devices. There is increased scrutiny being placed on medical devices and this will only continue.  The economic climate and increased competition means that manufacturers will continue to rely on partners to help them develop software for their device, all the more reason to partner with experts, such as Code Refinery, where patient safety and product quality is a deep-rooted part of the company fabric and culture.