Top Three Best Practices for Biotech Product Development and Commercialization

With so many rapid breakthroughs and disruptive innovations, biotech is constantly evolving.  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 with 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 giant corporations. Our integrated teams have over two decades of experience helping clients overcome challenges.

To help you avoid these common challenges as you approach the development of your first or next product, we are sharing three 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 ensure it will be a viable and thriving product.  You can refine the product concept by performing market research and analysis to understand the need for this product in the market. From there, you can define who your user will be, how they intend to use your product, and their expected result. This exercise will determine the high-level product framework.  Under this framework, you can come up with clear product definitions that can be translated into product requirements and priorities. A successful customer-centric product will be prioritized based on customer needs and the performance needed for the system.

Defining your biotech or medical device product happens through brainstorming, clear market research and analysis, and the inclusion of consultants or subject matter experts (SMEs). Ensure that your SMEs have experience in designing, developing, and producing 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 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 expected during the 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 applying engineering knowledge at concept to get to a design that minimizes the risk of loss and improves reliability.  Some examples may include pre-validation of your novel chemistry or assay works, risk assessment (in compliance with ISO 14971:2007), and failure mode and effects analysis (FMEA). This strategy will ensure the product will remain reliable for its intended use throughout its lifetime.  We recommend you allow plenty of time for these exercises before starting the design work.

Another important aspect of reliability engineering is to take design shortcuts, such as utilizing OEM or pre-assembled parts only after considering the impact of how well these sub-assemblies can integrate.  Identifying a partner who can provide component integration and fabrication expertise can save you time and money and de-risk downstream failures.

Principle #3: Engage in Regular Reviews with the Full Design Team

Meeting regularly with your functional teams to review progress allows you to infuse new design ideas, bring up design problems, or identify lower-cost solutions. It will ensure product requirements are met and identify any issues that could come up during the 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 focus on delivering your product with your best interests in mind.  We meet regularly with you at every decision point and 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 scale up quickly.

Moving from Development to Manufacturing

At Gener8, we aim to help you create the best possible product. We have the expertise and capability to design, prototyping, and manufacture your final products.  This in-depth knowledge can help you take the best approach to commercialize your product and avoid pitfalls that can hamper your progress.

Please look at what our industry-leading expertise can do for your product development.