New product development processes need to be compliant to regulatory requirements, and this chapter highlights the salient processes and quality systems to put into place to achieve success. Project management is made simple with specific tools provided here. Customer feedback is channeled into specific product characteristics, and the right tools are shown in this chapter. The biopharma industry has statistics showing less than 10% of starting compounds succeed in reaching market approval, and this chapter explains what causes these failures. The key issues that have repeatedly caused failure during device and diagnostic product development are also pointed out. Ethical decisions have to be made during product development as shown in this chapter. Outsourcing is a real option due to the availability of many contract research and manufacturing organizations, and judicious use of this option is discussed in this chapter. Key milestones that reduce risk and show transition from early stage to preclinical prototype stages are reviewed here. Does the popular concept of minimum viable product in software development apply in biomedicine prototyping? Other similar questions that help the reader understand pitfalls and best practices are answered here.

Conducting market research to find solutions, identifying opportunities and defining the value of new inventions are some of the key points covered in this chapter. A carefully defined indication can make the difference between success and failure in medical product development and this chapter explains how to get better at nailing the exact problem to be solved. Market segmentation examples and cases show how to prevent being misled on market size and market projections. A referral chain tool is presented for closely analyzing market positioning and value proposition of the new technology or product. Key market drivers and hurdles used to dynamically determine market size, adoption rates, and strategize on product development cycles are discussed and presented in this chapter.

How do you read a patent and what subject matter is patentable? What is the purpose of a patent? Who is an inventor on the patent if work is done by many people on the project? What is the process of obtaining a patent in my country and globally? Read this chapter to see how you could lose commercialization rights to your own invention. When exactly does an invention or idea become patentable? Once you own a patent, how can you make money from it? What is the process of licensing and the key terms that should be negotiated in such a license agreement? What is the use of a copyright or a trade secret in biotech? What exactly constitutes patent infringement ? These questions and many others are addressed in this chapter on intellectual property.

This chapter simplifies the complex multi-payer healthcare reimbursement market and explains how to position your product for successful reimbursement. The best time to bring reimbursement planning into the product development process is discussed here. The U.S. healthcare system is used as a baseline and the healthcare systems of other countries are reviewed briefly. Reimbursement for devices and administered drugs is based on many factors, and this chapter shows the steps a biomedical product company can take to maximize revenues in the US Healthcare system. The basics of reimbursement – coverage, coding, and payment – are explained in simple terms with diagrams. Case studies help show how individual companies have addressed the reimbursement process for novel breakthrough technologies.

Steps taken to start a new venture can make for rocky road ahead if consideration is not given to the points reviewed in this chapter. How to select and build a team and fairly distribute the founder’s equity, how to select an advisory board or a board of directors, and the importance of establishing a culture within the new company are all points discussed in detail and highlighted through personal stories and case examples. The main components of a business plan are covered in many texts and blogs, so this chapter focuses on the practical issues that few academic texts discuss, such as: how to perform due diligence on your investors and tips on creating slide decks , pitching and presenting business plans, and structuring financials and milestone to meet investors key concerns. The sources of financing and expectations of investors are reviewed with a view to guiding the entrepreneur or executive through the key elements for success, including successful closing on a term sheet or preparing for due diligence so that the process moves smoothly towards closure of the financing. The specific challenges facing an academic technopreneur moving into a decision-making executive (CSO or CEO) role are reviewed and guidance offered on utilizing the strength of the team around them.

The vast world of biotechnology applications to human health is reviewed and the terminology used in the rest of the book is defined here. An overview of the industry, the value chains, the specific types of human health products covered in this text are presented in this chapter. A time-tested way to analyze an industry’s attractiveness for new entrants is presented here using Porter’s five forces model. Technology trends such as mobile health, artificial intelligence, 3D printing, cell and gene therapy, and robotics are presented to the reader in the context of the mission of improving human health. The overall process of development of new products in these various segments of drugs, devices and diagnostics sectors is reviewed here. The reader will leave this chapter with a 30,000-foot view of the industry dynamics and understand the context within which product commercialization is to be done.

Preparing for scale-up in commercial manufacturing is far away from the thoughts of companies involved in product development, but this chapter shows when to start planning and how to plan a practical budget for this activity. For companies with their first product in commercial development, the build vs buy decision is never an easy one and the examples and key points for consideration simplify that process. The biggest challenge in scaling up is the gap in culture between R&D production for experimental testing in preclinical stages and the control and quality oriented culture in the manufacturing location. The case studies and content in the chapter specifically highlight how to achieve a successful technology transfer into commercial GMP manufacturing. The chapter content also gives practical guidelines on what it takes to put GMP and quality systems in place.

From the long path through preclinical development, entering the regulatory field of interactions for human clinical trials can sometimes feel like you are walking into the lion’s den. This chapter guides you through an understanding of how to interact and how to prepare for FDA meetings so that they are on your side rather than fighting you. The common goals of companies and the FDA are highlighted here. Specific issues with identifying the appropriate regulatory approval pathway are discussed here with cautionary case studies. Complex new technologies which combine diagnostics and drugs, or devices and software, or AI-based dynamic software are reviewed here. The best approach to the appropriate regulatory pathway will be clear after reading this chapter. Case studies are used to show successful pathways taken by cutting-edge developments, such as cell-based therapy.