5 Strategies for Streamlining Medical Product Development and Approval


Manufacturers struggle with many logistical issues, but product development and approval are challenges that can single handedly make-or-break a company. This is especially true for medical device, equipment and supplies manufacturers who face additional pressure and regulatory standards for their products. Fortunately, the process doesn’t need to be as hard as most organizations make it. Based on 25 years working with manufacturers, these are our five strategies for streamlining medical product development and approval.

1) Get on the Same Page

It sounds simple, but getting your product team, stakeholders, leadership, and other departments on board about what to make next can be a real challenge. To avoid getting stuck in the concept phase, your organization needs to come together about the business outcomes your products need to achieve. This will give everyone involved a “why” to ground their decision making and point you towards the products that most align with your vision. In addition, defining your desired business outcomes allows your priorities to fall into place during the development phase. After all, if a feature doesn’t align with the business outcomes you agree upon, then it can either be eliminated or minimized.

2) Move Forward Through Smart Decision Making

Another obstacle that drags out development time is decision making. Committing to choices that will cement the nature of your products is intimidating, and many teams drag their feet or hand off these decisions to others. These unnecessary handoffs waste time and can result in the wrong person deciding how a project moves forward. This can not only decrease the value of your product, it also sets you behind your competitors, as rapid delivery is an increasingly important differentiator in the marketplace. Once your team is on the same page, assign the right person to each of your decision-making duties. Once an important choice is made, your team can come together to go over any questions that arise before moving forward.

3) Crystalize Traceability

Traceability is one of the most important factors for medical manufacturers who want to stay on top of demonstrating compliance with governmental, environmental, security, or privacy rules. With traceability, you can prove that your system has been tested thoroughly to meet contractual terms. It can also be used internally to link your development and test activities back to the business rationale. When engineering and business are connected, it is easy to assess if a product is on the right track for meeting business outcomes.

A few of the traceability facets your system should include are:

  • Engineering activities such as change impact analysis (examining dependencies to resolve issues arising from changes)
  • Change and risk analysis (supporting general engineering and management reporting procedures)
  • Verification (requirements have test cases, epics have stories, systems have components, components have sub-components)

When organizing your system, it is also necessary to think about Corrective Action/Preventive Action (CAPA). CAPA must be part of your overall product development strategy. With an ERP, you can identify, analyze, and resolve quality issues with closed-loop CAPA processes during the development stage and beyond. Learn how a one-stop shop like Datix can ensure that your ERP system is set up to unlock the traceability and the CAPA features you need.

4) Collaborate

Collaboration is a powerful tool to developing the best products possible, but it must be channeled correctly so that you don’t dilute your vision with too many perspectives. Group meetings should focus on resolving a specific requirement, specification, or use case. In addition, collaboration works best when everyone sticks to your business processes for decision making and does their assigned work instead of being distracted by tangents. By staying focused, your team can meet its deadlines and go through the approval process with ease.

5) Work Smarter, Not Harder

Your teams are creative, but they don’t need to reinvent the wheel every time. When making a new product, think about if there are any well developed, already-made features or resources that your team can reuse. For instance, you can reuse code or entire IP blocks during product software development. When you start with a strong template, it is far easier for your team to build a strong product and track their improvements to the design. If you want to have your reusable resources systematically verified and readily accessible by your team, consider working with a software consultant like Datix. Our team will analyze every aspect of your business so that your team can have the resources they need right at their fingertips.

Wrap Up

Both product development and the approval process are stressful for manufacturers, but they don’t have to be. Working with a trusted partner like Datix allows you to receive nonbiased guidance about how to get high-quality products approved faster by implementing your business processes with your software. When you work with Datix, we take care your systems so you can do what you do best: provide exceptional products and customer service to you clients. Our team will partner with you every step of the way to bring your organization to the next level.

Read our Ultimate ERP for Ophthalmic Goods Manufacturing or our Ultimate ERP for Dental Manufacturing

About Datix

When medical manufacturers are implementing a new ERP or software solution, Datix is the partner of choice. Datix has 25 years of ERP consultation experience and has worked with all the major software applications. At Datix, we will work with you every step of the way so that you see an increase in productivity, customer satisfaction, and profits.

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