Balancing agility and discipline in a medical device software organisation

Agile development techniques are becoming increasingly popular in the generic software development industry as they appear to offer solutions to the problems associated with following a plan-driven Software Development Life Cycle (SDLC). However, agile methods may not be suited to all industries or organisations. For agile methods to succeed, an organisation must be structured in a way to accommodate agile methods. Medical device software development organisations are bound by regulatory constraints and as a result face challenges when they try to completely follow an agile methodology, but can reap significant benefits by combining both agile and plan-driven SDLC such as the Waterfall or V-Model. This paper presents an analysis of a medical device software development organisation based in Ireland, which is considering moving to agile software development techniques. This includes the performing of a Home-Ground Analysis to determine how agile or disciplined1 the organisation currently is. Upon completion of the Home-Ground Analysis recommendations were made to the organisation as to how they could tailor their existing structure to better accommodate agile development techniques. These recommendations include adopting agile practices such as self-organising teams to promote a culture of “chaos” within the organisation

Association of Urinary Biomarkers With Disease Severity in Patients With Autosomal Dominant Polycystic Kidney Disease: A Cross-sectional Analysis

Background: Disease monitoring of autosomal dominant polycystic kidney disease (ADPKD) will become more important with potential upcoming therapeutic interventions. Because serum creatinine level is considered of limited use and measurement of effective renal blood flow (ERBF) and total renal volume are time consuming and expensive, there is a need for other biomarkers. We aimed to investigate which urinary markers have increased levels in patients with ADPKD; whether these urinary markers are associated with measured glomerular filtration rate (mGFR), ERBF, and total renal volume; and whether these associations are independent of albuminuria (urine albumin excretion [UAE]). Study Design: Diagnostic test study. Setting & Participants: 102 patients with ADPKD (Ravine criteria) and 102 age-and sex-matched healthy controls. Index Test: 24-hour urinary excretion of glomerular (immunoglobulin G), proximal tubular (kidney injury molecule 1 [KIM-1], N-acetyl-beta-D-glucosaminidase, neutrophil gelatinase-associated lipocalin [NGAL], and beta(2)-microglobulin), and distal tubular (heart-type fatty acid binding protein [H-FABP]) damage markers and inflammatory markers (monocyte chemotactic protein 1 [MCP-1] and macrophage migration inhibitory factor). Reference Test: Disease severity assessed using measures of kidney function (mGFR and ERBF, measured using clearance of iothalamate labeled with iodine 125 and hippuran labeled with iodine 131 during continuous infusion, respectively) and structure (total renal volume, measured using magnetic resonance imaging). Other Measurements: 24-hour UAE. Results: In 102 patients with ADPKD (aged 40 +/- 11 years; 58% men), levels of all measured urinary biomarkers were increased compared with healthy controls. Excretion of immunoglobulin G and albumin relatively were most increased. ERBF and mGFR values were associated with urinary excretion of beta(2)-microglobulin, NGAL, and H-FABP independent of UAE, whereas total renal volume was associated with KIM-1, NGAL, and MCP-1 independent of UAE. Limitations: Cross-sectional, single center. Conclusions: Levels of markers for multiple parts of the nephron are increased in patients with ADPKD. In addition to measurement of UAE, measurement of urinary beta(2)-microglobulin, KIM-1, H-FABP, MCP-1, and especially NGAL could be of value for determination of disease severity in patients with ADPKD. Am J Kidney Dis 56: 883-895. (C) 2010 by the National Kidney Foundation, Inc.Mechanisms of disease, diagnostics and therap

Dishonourable Discharge Pending

We report on the actual industrial use of formal methods during the development of a software bus. At Neopost Inc., we developed the server component of a software bus, called the XBus, using formal methods during the design, validation and testing phase: We modeled our design of the XBus in the process algebra mCRL2, validated the design using the mCRL2-simulator, and fully automatically tested our implementation with the model-based test tool JTorX. This resulted in a well-tested software bus with a maintainable architecture. Writing the model, simulating it, and testing the implementation with JTorX only took 17% of the total development time. Moreover, the errors found with model-based testing would have been hard to find with conventional test methods. Thus, we show that formal engineering can be feasible, beneficial and cost-effective