After years of research, development, trials, and testing, the final step for most life sciences companies is commercialization. By commercializing your discovery, your business can distribute your life-saving product to the masses and begin to profit from your hard work.
However, moving from the clinical trial phase to commercialization takes time, and the process requires more than just FDA approval. For instance, if you develop and distribute your product in-house, you must have a plan for handling manufacturing, sales, inventory and order management. Likewise, if you plan to eventually sell your business, you must carefully prepare your company’s finances and documentation to meet government regulations and entice investors.
Whether you plan to manufacture and sell your product in-house, outsource production to a third party or sell your business entirely, a robust enterprise resource planning (ERP) technology like NetSuite can help your life sciences organization streamline processes, improve reporting, and navigate the complexities of commercialization.
Preparing for Commercialization
As you prepare for the final phase of your journey, several factors may affect what software and level of integration are needed for a successful launch. Some of the considerations organizations face at this point include:
- Regulatory Requirements: What are your legal, regulatory, and internal reporting requirements? Can you manage these requirements with your current software?
- Compliance: Most life sciences products introduce FDA regulation and compliance factors. How will you manage this aspect of your business?
- Development: If you intend to manufacture and distribute your product yourself, how will you manage these processes? Will you manufacture in-house? Or outsource to a third party? Similarly, who will be selling your product? Where will you store inventory, and how will you manage it?
- Visibility: What level of visibility do you need into your products’ development and supply chain movements?
- Outsourcing: Will you be outsourcing work to contract manufacturing or sales organizations? If so, how will you monitor their progress? Are your systems powerful enough to manage recurring invoices and approval requests?
Arguably the most crucial aspect to consider is what your organizational roadmap looks like. For example, will you stay in research and development? Or move into a product manufacturing environment? Your answers to these questions will shape how you proceed in all other areas.
If you plan to move forward with manufacturing and selling your product, you must ensure your organization has the technological infrastructure to handle all aspects of the undertaking, including manufacturing, sales, inventory management, and order management. NetSuite offers various functions and capabilities to support in-house operations and third-party management so that you can go to market successfully.
How Technology Enhances Life Sciences Commercialization
With the complexities of reporting, FDA approval, manufacturing and distribution, it is impossible to go to market without the right technology. NetSuite offers advanced reporting, automation, auditing and supply chain management solutions to simplify these processes and reinforce your commercialization strategy.
Consider implementing an ERP like NetSuite in the following areas of your operation to help you prepare for commercialization:
First, determine whether you will manufacture your product in-house or outsource production to a third party.
If you outsource, an ERP system like NetSuite will provide greater visibility into your partner’s operation and help you manage production from afar. In addition, NetSuite will provide real-time tracking and updates, so you can see where your product is at every step of the manufacturing process. Because NetSuite can automate CRO billing and invoicing, the software is also a fantastic resource for your financial department.
If you decide to manufacture your product in-house, it is vital to consider various manufacturing processes before moving forward with a new software solution, such as:
- How will you make your product?
- How much labor is required?
- What is the time scale of your manufacturing process?
- How many locations are manufacturing your product?
- Does your product contain a bill of materials? If so, does it consist of quantities or recipes?
Your answer to these questions will determine what level of implementation is best for your company.
Inventory management introduces a significant strategy shift for most life sciences organizations – especially those that previously focused solely on research and development. Companies preparing for commercialization must shift gears and determine how they will track and manage their final product.
How will you account for inventory quantities on your balance sheet? What will procurement look like? Do you have the infrastructure to house your product pre-distribution?
Your procurement system will require a tighter integration into your ERP environment to manage these changes effectively. For example, your accounts payable may have been the only system integrated with your ERP in previous phases. Now, as you prepare to launch your product, you must ensure purchasing, receiving, supply planning and product catalogs are interconnected and reporting to a central system.
In addition to procurement, your systems should be able to manage physical inventory and provide real-time tracking and traceability. For instance, your ERP should send real-time updates when stock is moved from one location to another. It should also alert you when a product is lost, damaged, or no longer usable.
Does your new product require lot numbers or serialization? Do you need visibility into an item’s movement through the supply chain? How will you account for inventory ownership? A robust ERP solution will have the ability to support and streamline these factors so you can successfully manage inventory and meet reporting requirements.
Sales and Order Management
Once you have a plan for manufacturing and inventory management, how will you manage sales and order management? Will you hire a sales team in-house? Or will you outsource this aspect of your organization as well?
If you decide to sell your product in-house, you will need a quality customer relationship management (CRM) solution to help your teams track orders, keep up with buyer information, and manage the customer experience. Once a customer or sales rep places an order into your system, you will need a capable ERP to handle shipping, invoicing, revenue recognition, sales tax, commissions, reorder requests, and return processes.
NetSuite has built-in ERP and CRM capabilities designed to handle complex workflows and processes. With the right software in place, you can improve your team’s efficiency and productivity while providing an unforgettable shopping experience for your customers.
When Should You Implement NetSuite?
As you prepare to go to market with your product, you will need systems in place to ensure this phase in your journey goes smoothly. Because it can take a few months to integrate NetSuite into your existing systems (or fully migrate your data), it is vital to begin this process early.
If you don’t know where to start or need help getting your current ERP solution up-to-speed, consider contacting a certified NetSuite partner for assistance. A trusted partner like Sikich will work alongside you to identify gaps in your existing tech stack and prepare your systems for commercialization. Contact us to learn more or schedule a consultation.