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Featured Article:

Medical Device and Diagnostic Industry

Innovation in Today's Transforming Healthcare Environment


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Featured Article:

Medical Device and Diagnostic Industry

Securing Today's Healthcare Enterprise Systems


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Featured Article:

Medical Product Outsourcing

Making the Transition from Healthcare Products to Healthcare Solutions


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Featured Article:

Medical Product Outsourcing

More Bang, Less Buck

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Featured Article:

Medical Product Outsourcing

Interview: Under Review - Today's OEM/CMO Relationship

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Featured Article Series:
Medical Product Outsourcing

Rediscovering Systems Engineering in the Medical Device Industry

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Featured Article:

Medical Product Outsourcing

Software: Head in the Cloud

Medical and Life Sciences

We continually add to this library so check back frequently. Additional papers on technologies, methodologies, business and market trends affecting the Medical and Life Sciences industry can be found in the papers archive section. Be sure to check it out and share your findings with colleagues.

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Thriving in Today's Value-Based Healthcare Landscape | 2016
Tim Bosch

The American healthcare system continues to evolve at a blinding pace as new care delivery and payment models change the landscape. The uncertainty of this disruptive shift is reverberating across the healthcare value chain. For healthcare IT companies, the challenge is clear: adopt new business models or risk being left behind in a marketplace driving rapidly toward an evolving future.


Innovation in Today's Transforming Healthcare Environment | 2015
Tim Bosch

Everyone knows the healthcare industry is changing in dramatic ways. The movement toward an outcomes-based, patient-centric, cost-conscious environment is well underway. The question for manufacturers of diagnostic devices and other clinical laboratory systems is how will this shift impact them—and what do they need to do to compete effectively, maintain or grow market share, and stay profitable?


The Future of Diabetes Care Demands Advanced Connectivity | 2014
Adam Hesse

The future landscape of diabetes disease management is being driven by the demand for data, placing pressure on device manufacturers to develop solutions that can easily communicate data and share intelligence where and when needed. Advanced connectivity is a basic requirement to meet these market demands. While enabling advanced connectivity is challenging, it is also the gateway to new opportunities in diabetes disease management. This article discusses the factors to consider when developing an advanced connectivity strategy and how to get started.


Controlling Cost in Complex Systems Development | 2013
Tim Bowe, Amit Shah, Chris Miles

A key goal of an effective product development process is to reduce and manage risk. Understanding the source of these risks is fundamental to developing strategies to mitigate them. A comprehensive mitigation strategy for complex systems must include the use of sophisticated simulation tools to provide an effective testing base throughout the development process and beyond. Use of simulators has shown to not only improve the overall quality of the delivered product, but also reduce both the development time and associated product lifecycle costs. This paper focuses on the benefits to be gained by using simulators in the development and testing of complex systems, along with an ROI model.


The Changing Healthcare Ecosystem - Are You Ready? | 2013
Consider a "Systems Thinking" Approach
Tim Bosch

The shift to an outcomes based, cost-conscious healthcare ecosystem poses radical implications for medical device manufacturers. Innovating in this climate is further complicated by the demand to develop value-based products that leverage technology in a way that transforms healthcare. Adopting a systems thinking approach to product development allows you to achieve value-driven solutions by taking a holistic view of your product and the environment in which it operates. This paper explains the basic principles of systems thinking, and discusses when and why medical device manufacturers should consider a systems thinking approach.


Improving Business Results through Value Engineering (PoV) | 2012
Sree Iyer, Myron Pugh

Medical device manufacturers are faced with the constant challenge to drive down product costs for a variety of reasons – lower cost targets aligned with emerging markets, competitive need to improve product margins, or a desire to extend the life of legacy products that are experiencing parts obsolescence. These goals can be addressed by well-run Value Engineering (VE) projects with a proper focus on upfront assessment and Return on Investment (ROI) analysis aligned with business goals. This Point-of-View paper will examine three key aspects for a successful VE project and explain why, in combination, they are likely to yield success.


Lab-on-a-Chip and Point-of-Care Testing: The Technology Works, But How Do You Make a Successful Product? (PoV) | 2012
Tim Bowe

The rapid introduction of Lab-on-a-Chip (LOC) technology is accelerating the move to Point-of-Care Testing (POCT). However, many companies are finding that perfecting the LOC technology is only part of building a viable business model. The need for a complete system approach for POCT is a pre-requisite to broad and rapid market adoption. Due to the remote and disconnected nature of POCT – whether at the bedside or in the field – a complete system solution must allow for mobile and cloud technologies that connect the point of care to the continuum of care. This paper reviews some of the challenges inherent in the successful launch of these products into the POCT market - looking at the products from a systems perspective.


How the Earliest Development Phases Make or Break a Product | 2012
Purging Risk in Product Development
Christopher Miles, Charlie Alfred

Too many product development efforts carry unnecessary risks of failure or serious delay that could be mitigated early in the planning and development cycles. Typically 80% of the critical product decisions are made in the first 20% of the project. This paper explores an approach for preventing errors, omissions and risks from wreaking havoc during your product development initiatives. The proposed approach encompasses the use of a "scenario-based" verification process to test design decisions as soon as possible, and at each phase or level of product development.


What Product Software Costs to Build and Own | 2011
Software Development and Maintenance Effort/Cost Models
Wayne Lobb, David Warburton, Tim Bosch

In Foliage's extensive experience developing products, we have found that, on average over time, professional software R&D staffs create or modify about 700 lines of software logic per person per month, and own about 50,000 lines of software source code per person. The cost to build and own one line of product-software source for its whole lifetime ranges between $10-$50 or more. These numbers depend on numerous factors and this paper describes how Foliage measures software size, categorizes staff for comparison purposes and concludes with recommended actions if your numbers appear to be out of line with the rest of your industry.


Automated Testing Strategies for Real-Time Embedded Medical Systems | 2011
Amit Shah, Tim Bosch

Medical device companies, especially those with real-time embedded system products, are often burdened with lengthy verification cycles. Even small development efforts of just a few weeks can result in months of verification. Manual testing is time-consuming and error prone, with functional and system testing that starts late in the software development lifecycle. While there are proven automated test tools and techniques for unit and integration testing, most medical device companies have yet to embrace an overall automated testing strategy that fully develops automation capabilities for the full range of testing required for embedded real-time medical devices. This paper examines the challenges associated with testing embedded real-time medical systems and presents strategies that address these challenges through automation that will improve quality and reduce verification cycle time and costs.


Architecture in an Agile World | 2011
Dan O'Connor

Efficient agile development teams can improve an organization's responsiveness and help control engineering costs. Misaligned software architectures, however, can detract from these benefits, and agile refactoring does not scale to achieve a major architectural reset. In this paper, Foliage promotes "architecture strategy" as a lightweight approach that is complimentary to agile development and offers six key success factors to keep your agile projects cycling in the right direction.


Technical Debt in Medical Software | 2010
Early Intervention Leads to Longer Product Life
Dan O'Connor

Debilitating "technical debt" can derail product development programs, resulting in costly missed market opportunities. This paper provides a quick introduction to the technical debt metaphor as it pertains to best practices in software development, and is then applied to the particular complexities in the development of medical software. We describe where short-term technical debt can be a useful tool and how excessive, unattended debt can hinder quality in the field and cripple development velocity. Specific guidelines are provided on how to assess your current applications for technical debt as you begin planning a technical approach to support your product roadmap.


Tapping the Power of Systems Engineering | 2010
Charlie Alfred, Jesse Ambrosina, Tom Mariano

Featuring systems engineering as a central discipline is a major step in improving effectiveness in product development. The successful application of a systems-view to business and technology challenges enables the development of medical devices that effectively meet clinical and market demands. A thorough systems view also allows for adaptability to changing market conditions and enhances the integration of seamless integration paths- which lead to product development efforts that are on schedule, within budget, and without latent defects. This paper explores how an absent or undisciplined systems engineering role can contribute to a series of development problems that manifest as poor product performance, late products, or products incapable of scaling – especially when product complexity and specialization increase.


Your Health Information System is Now a Medical Device | 2010 
Are you Ready?
Tim Bosch

The Food and Drug Administration (FDA) has already begun to inform health information technology (HIT) companies that based on the reliance by care givers on the electronic information managed and presented by HIT systems, the HIT systems themselves (or key aspects of them) fall within the definition of a medical device. Have you thought about how to align your organization and development processes with those required for a medical device? This paper offers HIT companies insight into a few key features providers will look for when considering software vendors for their EHR options, especially now that health information systems are being treated with the same rigor and scrutiny as "traditional" medical devices.


Medical Product Development Strategies in Tough Economic Times | 2009
Tim Bosch

Today's economic outlook presents both interesting problems and opportunities for the companies with which we work. The practice of belt tightening has forced burgeoning trends to the forefront of product development, while other trends have been in the making for a while. As product development teams have been forced to streamline their processes and do more with less, a diverse set of trends are proving to be efficient, cost effective means of doing more with less. This paper identifies and reviews these trends including remote access for diagnostics, monitoring, and support; product line re-engineering; geographically distributed, but integrated, design and development teams; and, more sophisticated test strategies.


Interoperability – Are We There Yet? | 2009
Tim Bosch

The harmonization of standards and the establishment of certification criteria represent significant advances toward the hoped-for seamless sharing of information and common understanding of that information. Yet the landscape is still heavily populated with systems and products operating under the "old rules." Your ability to support your customers in that effort starts with your ability to provide a certified solution in a timely fashion. And that requires an appropriate assessment of your current capabilities, and the proper planning and alignment of your business goals with your product planning and execution.


Avoiding Pitfalls in Incremental Product Line Adoption | 2009
Mark Hersey, Dan O'Connor

Although the concept of forming a product line may be new to you, many before have faced the dual challenges of making strategic progress towards a more efficient software development model while still meeting the urgent needs of existing development plans. This paper offers industry experience that Foliage has gained in helping clients make a successful transition from a "product-centric" approach to a "product-line based" approach to software development; and, focuses specifically on the most important issues that inevitably arise when beginning to form a product line by adopting an incremental migration approach.


The Medical Device Development Edge: Software Design-For-Test | 2009
Wayne Lobb, Karl Aeder, Tim Bosch

Designing and implementing software from the start for simulation and automated testing can save months of development calendar time. Software design-for-test consistently enables the rapid recognition and resolution of issues for both software and hardware before formal integration activities commence. Several cost-effective software design-for-test techniques have proven to be practical, pragmatic, and efficient such as methodical use of programming interfaces for simulation; strict isolation of test code from production code; deterministic functional testing of event-driven control; and structured logging that supports efficient event reconstruction for diagnostics.


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