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Medical Device and Diagnostic Industry

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Medical Product Outsourcing

Making the Transition from Healthcare Products to Healthcare Solutions


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More Bang, Less Buck

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Medical Product Outsourcing

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

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Software: Head in the Cloud

Medical and Life Sciences

Welcome to the paper archives. To download papers, click on the title from the list below. We encourage sharing so be sure to tell a friend or colleague.


Guidelines for Effective Medical Software Test Automation | 2008
Amit Shah, Tim Bosch

In highly competitive markets, under tight schedule and budget constraints, medical device and medical information system companies must maintain a high level of quality and meet performance, reliability, and safety demands. Automated software testing can optimize the overall testing process, reduce time to market and improve quality. Unfortunately, most organizations that do attempt automated software testing fail due to inadequate planning and lack of a systematic and structured approach uniquely designed for their products. This white paper discusses the key steps for implementing an effective automated software testing program for medical software that will minimize risk, significantly increase the likelihood of success, and demonstrate a return on investment.


Keys to Product Strategy | 2007
Making it Easier to Build the Right Product the Right Way
Charlie Alfred, Tim Bowe

The keys to successful product development rely on the ability to build the right product, at the right time, for the right cost, using the right resources. This paper is about identifying the keys to defining a product strategy destined to succeed. It outlines some tough questions that your organization must grapple with prior to establishing an effective product strategy. It also proposes actions that you must take if your organization is unable to answer any of these questions.


Increase the Efficiency and Pace of Medical Device Software Development by Going Agile | 2007
Tim Bosch

Many medical device companies develop software using a traditional, waterfall methodology where each step is taken in sequence – requirements, design, implementation, verification, validation. Although this has been a widely accepted approach for years, many organizations are now seeking approaches that yield demonstrable value faster and are better able to adapt to changing business needs. This paper describes how medical device manufacturers can increase the efficiency and pace of software development by adopting or adapting agile development methods while preserving quality and meeting design control demands.


An Agile Development Approach for Healthcare Information Systems Software | 2007
Tim Bosch

Many companies developing today's healthcare information systems develop software using a traditional, waterfall methodology where each step is taken in sequence – requirements, design, implementation, verification, validation. Often, this style of software development is tied to the organization's phased, gated product life cycle approach driven by management approval and budget allocation decision points. Although this has been a widely accepted approach for years, many organizations are now seeking approaches that yield demonstrable value faster and are better able to adapt to changing business needs. This paper describes how healthcare information system providers can increase the efficiency and pace of software development by adopting or adapting agile development methods while preserving quality and meeting design control demands.


Real-time Software Development Principles for Embedded Devices | 2006
Karl Aeder

Many of today's embedded device control systems require some amount of deterministic software device control. By employing proven software architectural approaches organizations can realize significant reductions in time to market and engineering costs across the initial development, enhancement, and maintenance of the software over its lifetime. This paper discusses the challenges associated with developing real-time control software, and makes both architecture and development process recommendations that can limit the risks associated with these challenges. A short case study is also included to show how these approaches were applied to a real world situation that resulted in commercial success.


Rapidly Leveraging Product Acquisitions in the Medical Marketplace | 2006
Tim Bowe, Norm Delisle, Hoyt Lougee

Leading companies in the medical industry have a long history of using mergers and acquisitions as an alternative method of advancing their product offerings. Technology acquisitions, however, can be notoriously difficult to effectively leverage. Even when the product technology is a winner, developing an effective product integration strategy requires a strong understanding of product technology evolution, or migration. This paper examines critical factors in aligning business and technology strategies to extract the most market leverage and top-line growth from combined or restructured product lines. The paper draws from approaches achieving success in other heavily consolidating industries and applies them to the unique challenges facing medical device and systems manufacturers.


Navigating the Integration and Interoperability Rapids | 2006
Tim Bosch

Integrated and interoperable medical devices and medical systems, both within an enterprise and across healthcare delivery organizations, are essential to support patient safety, patient confidentiality, and for the delivery of quality healthcare. While the benefits of sharing healthcare information are well understood and accepted by patients, care givers, and the healthcare industry at large, current systems and devices often fall short of expectations, and the rate of adoption by care delivery organizations remains low. This white paper defines "integration" and "interoperability" and presents best-practice approaches to each based on real world experience.


The RIGHT Next Step in Your Product Development | 2005
Tim Bowe, Tim Bosch

You're responsible for developing your company's next product. Whether you're developing it from the ground up, migrating an existing product to a new platform, or you just acquired a product critical to your business needs, the issues involved are enough to keep even the best manager up at night. The options may be obvious - enhance the current product, build a new product, or buy an existing product – but the differences in cost, time, and ROI are enormous. This white paper discusses how to quickly and efficiently evaluate your product assets directly against documented business drivers and assess the viability of various options. Using this knowledge, you can then drive the development process guided by well-understood goals that enable organizational control over ill-informed trade-offs that can cripple a product strategy. Productivity increases, surprises decrease.


Migrating Medical Software Systems – An Alternative to Developing 'From Scratch' | 2005
John Cadigan, Jim Everett-Wilson, Norm Delisle

Medical systems developers face a difficult decision when they decide to develop a new product: should they enhance existing software or should they create a brand new software platform? It is not always easy to determine the lowest risk, lowest cost path. This paper describes an approach for incrementally migrating existing legacy software systems to a new software architecture. This approach reduces overall risk, reduces initial investment, and provides an extremely attractive return on investment.


Accelerate Market Penetration by Ensuring Your Medical Product's 'Sellability' | 2005
George Iglesias, Tim Bowe, Tim Bosch

The critical importance of a product's "sellability" - the set of properties that enables a clinician or a physician to quickly recognize the product's value - is often overlooked. Just as reliability, performance, safety, and functionality are highly valued attributes of successful new products, sellability is equally important and must always remain a core element of the product. This paper explores the importance of designing sellability into a product and verifying that it remains intact throughout the product's development. It also presents real product examples that highlight the fundamental concepts of sellability and its impact on market acceptance.


Four Winning Strategies for Achieving Quality Software in Medical Products | 2004
Tim Bowe, Tim Bosch, George Plourde

Medical device, imaging, and information management system companies are faced with ever-increasing pressure to get new products to market faster while continuing to comply with the Quality System Regulation and Design Control requirements. In addition to these pressures, financial realities force companies like yours to demand a high value return and guaranteed delivery when investing finite resources (time, money, and people) in complex, software-intensive system development. The competitive landscape is fierce, and making the best possible business decisions regarding product development has never been more important. By embracing four critical strategies discussed in this paper, you can gain control of your software budget, schedule, and quality in a way that will help ensure customer acceptance and a prosperous product life.


Whatever Happened to 2-Year Medical Product Development? | 2004
Reducing Time-to-Market for Software-Based Medical Products
Tim Bowe, Hoyt Lougee, Jim Everett-Wilson, John Cadigan

Competitive advantage in the medical industry depends upon time-to-market.

Short-term profit and long-term business viability both hinge on the manufacturers' ability to quickly transition from product concept, through product development to market introduction. This paper discusses the increased importance of time-to-market for medical products, and shows that successful product development requires additional focus in four areas. Tying it all together will streamline the process of product development chartering the program with clear, focused and understood goals. Gaining control over the requirements process is the best start on the road to the return of the two-year development cycle.


Increasing Medical Product Value with Early Evaluation of System Architecture | 2004
Tim Bosch, John Cadigan

A product's business requirements and technology decisions come together for the first time in the system architecture. It is at this early juncture that companies can realize great value in evaluating the architecture from both technical and business perspectives, so that appropriate and early "course corrections" can be made. This paper discusses the importance of evaluating system architectures at the earliest stage of system definition, using quantifiable assessments of system suitability and value to guide and inform business decisions. A case study to highlight and explore how these assessment techniques are applied to a real world medical product is included.


New Strategies for Managing Medical Software Development | 2003
Hoyt Lougee, John Cadigan

The ability to produce the right product at the right time can often be the difference between success and failure for companies. The need to get products to market quickly is driving improved development strategies. When time-to-market goals are not realized, financial opportunity immediately becomes opportunity cost. High-performance teams are the core element of successful product development efforts. Yet, building high-performance teams is time consuming, costly and risky; and, in virtually all product development companies, high-performance teams are unsustainable. This paper discusses the importance of time to market, key attributes of high-performance teams, and an improved strategy to engage such teams without incurring the risk, cost, and delay required to build one.


A Management Approach to Medical Product Line Architecture Strategy | 2003
Tim Bowe, Charlie Alfred, John Cadigan

Whether your product is an imaging system with different capabilities intended for large hospitals, small hospitals and physician's offices, or a medical device targeted at office and in-home markets, the pressure to more effectively develop product lines is increasing. Coupled with these market pressures are the financial realities associated with the process of developing complex products. This paper discusses the development of product line architectures from the perspective of executives and managers. We show how ineffectively executing a product line architecture strategy can have serious and long-term ramifications for the organization. We also explore new techniques developed to permit a more rigorous approach to the creation of product line architectures, resulting in significant improvements in efficiencies and a commensurate drop in development risk.


Assessing .NET from Organizational, Marketing, and Technical Perspectives | 2003
Tim Bowe, Mark Hersey, John Cadigan

With the software systems of many medical devices and information systems entering their end-of-life period, product and technical managers are faced with the task of deciding the technical direction of the next-generation products. .NET is a natural choice for many of these software development projects, but not all. In this paper, we guide managers in evaluating whether .NET is indeed the right choice for their organization, to ensure .NET is not adopted simply because it is the latest thing from Microsoft or the next resume enhancing opportunity for their software development engineers. In this evaluation, we consider key .NET adoption criteria from three points of view: Business, Marketing and Engineering.


Securing e-Medical: A Primer on Protecting Health Information | 2002
Brian D. Handspicker

Are you ready? With the HIPAA mandate for protecting health information nearly upon us, do the medical information systems you develop support HIPAA? Is your own environment secure enough to protect your customers? This paper provides a primer on security issues associated with developing, deploying, and supporting secure e-medical systems. This is the first in a series of papers from Foliage discussing secure e-medical.


Securing e-Medical: Architecting Protected Health Information Systems | 2002
Brian D. Handspicker

How do you get ready for HIPAA? How do you know which security scenarios you must support? What security technology issues do you need to be sensitive about? How do you make tradeoffs between potential security solutions? This paper discusses the architectural issues associated with developing, deploying, and supporting secure e-medical systems. This is the second in a series of papers from Foliage discussing secure e-medical. Be sure to read the first installment, "Securing e-Medical: A Primer on Protecting Health Information."


Next Generation Point of Care Information Systems | 2001

Electronic integration of point-of-care (POC) test information has been hampered by multiple, incompatible, proprietary approaches to connecting POC devices to networks and information systems. This paper unveils a vision for delivering healthcare departmental information systems, using the latest POC integration standards, clinical information standards and web services technologies.


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