Solutions Services Markets About Connect 3 Best Practices for Biotech Product Development and Commercialization Gener8 | April 30, 2021 With so many rapid breakthroughs and disruptive innovations, biotech is in constant state of evolution. The big question is, how do innovators like you take your concept to market, while avoiding pitfalls that can slow down the process and risk your early-to-market advantage? Designing and developing a product presents many challenges involving technical feasibility, build process, budget, regulatory compliance, and manufacturability. Getting assistance from a trusted partner that has experience in biotechnology and medical device product development will save you time, money, and stress. Gener8 has served that role for biotech and medical device companies, from small startups to huge corporations. Our integrated teams have more than two decades of experience helping clients overcome any challenges. To help you avoid these common challenges as you approach the development of your first or next product, we are sharing 3 guiding principles that our design leads live by. Principle #1: Define the Product Early On Analyze and reflect on your idea from every angle to make sure it will be a viable and thriving product. You can refine the product concept by performing market research and analysis to understand the need of this product in the market. From there, you can define who your user will be, how they intend to use your product, and what their expected result is. This exercise will define the high-level product framework. Under this framework, you will be able to come up with clear product definitions that can be translated into product requirements and with priorities. A successful customer-centric product will be prioritized based around customer need and performance needed for the system. Defining your biotech or medical device product happens through a combination of brainstorming, clear market research and analysis, and the inclusion of consultants or subject matter experts (SMEs). Make certain that your SMEs have experience in the design, development, and production of biotech and medical devices for your target market so they can properly guide and advise you throughout this process. While defining the product takes the work of many different stakeholders, clearly written and prioritized requirements will enable rapid development. It helps keep your multifaceted team on the same page, clearly communicates the goal that you are working towards, and helps engineering teams match a design solution with each product requirement needed to get to market. Principle #2: Designing for Reliability Early On to Avoid Costly Redesigns Downstream Reliability questions and unexpected failures are common during product development phase. However, you can avoid these issues that can lead to costly redesign and product recalls by implementing a Design for Reliability conceptual framework. This includes identifying potential causes for failure early on and apply engineering knowledge at concept to get to a design that minimizes risk of failure and improves reliability. Some of the examples may include pre-validation of your novel chemistry or assay works, risk assessment (in compliance with ISO 149711:2007), and failure mode and effects analysis (FMEA). This strategy will ensure the product will remain reliable for its intended use throughout its intended lifetime. We recommend you allot plenty of time for these exercises before starting the design work. Another important aspect of reliability engineering is to avoid taking design shortcuts such as utilizing OEM or pre-assembled parts without considering the impact of how well these sub-assemblies can integrate with each other. Identifying a partner who can provide expertise in component integration and fabrication can save you time, money and de-risk against downstream failures. Principle #3: Engage in Regular Reviews with Full Design Team Meeting regularly with your functional teams to review progress together gives you the opportunity to infuse new design ideas, bring up design problems, or identify lower-cost solutions together. It will ensure product requirements are met and identify any issues that could come up during transfer to production. However, too often different functional product development teams can get siloed and lose sight of the goal because they are overwhelmed with other company goals and projects. Working with Gener8 will help you break down the walls between the functional teams such as engineering, software development, and prototyping. Our experts are focused on delivering your product with your best interests in mind. Not only do we meet regularly with you at every decision point, we also rapidly create an alpha prototype early on so you can immediately test the product concept and refine the product design to avoid expensive re-design. Once we move forward with beta production, we will have de-risked any manufacturing variability for you to quickly scale up. Moving from Development to Manufacturing At Gener8, our goal is to help you create the best possible product. We have the expertise and capability in design, prototyping, manufacturing of your final products. This in-depth knowledge can help you take the best approach to commercializing your product and avoid pitfalls that can hamper your progress. Come see what our industry-leading expertise can do for your product development. Posted in Articles Gener8 Success with Us Click below for more information on how we can help. Contact Gener8 Copyright © 2021. Gener8, LLC. All rights reserved.