Now, you might be thinking, “My product’s revenue is consistent, my product is compliant, and my market is established. Why would I consider next-generation product development?”

A valid question.

Simply put, in the ever-evolving landscape of medical technology, staying ahead means constantly innovating to meet the changing needs of patients and healthcare providers.

Next-generation product development isn’t a game of staying ahead of the curve but meeting it.

Your revenue is consistent, and your product is compliant today, but it doesn’t guarantee that in a year or two from now, it will be. New technology is being vetted in the MedTech market every day, changing the landscape of what makes a truly usable and compliant medical device.

By not choosing to evolve, your product is at risk of not only being overlooked by a competitor product that does address industry changes, but also nearing the undesirable space of no longer being viable in the marketplace due to regulatory changes.

However, our roadmap to next-generation product development—created based on our over 40 years of experience in the design, development, and manufacturing of medical technology—will help guide you down the path to cost-effective next-generation product development that meets the new market needs and demands.

Let’s dive in!

The industry has changed. Make sure your next gen product addresses the needs of the current market. 

As we all know, value-based healthcare has significantly impacted the performance of medical devices for the last 10+ years.  

Between new pricing expectations, updated performance, and usability assessments, the expectations for medical devices in today’s age have changed.  

A lot.  

Value-based healthcare isn’t the only factor impacting the direction of medical technology. Advancements like AI integration, automation, and data congregation have changed the game for what’s wanted and needed in new medical devices.  

Yes, needed.  

The number of people of working age is expected to contract by 20% over the next 10 years. But operations are seeing the impact of this now. In 10 years, it’s only expected to exacerbate. This realization has left many value analysis committees (VACs) wondering how their operations will function with 20% fewer specialists in rotation to operate technologies.  

This has sparked conversations about how automation and AI technologies have transitioned from wanting to needing. For patient care to be effective, efficient, and operable with fewer resources.  

If your current product isn’t meeting these needs, or where new, automated technologies can be adapted to its current platform (without looking outdated), it’s time to consider next-generation product development.  

Back to the basics: The first steps to next gen product development  

Before diving into the specifics of next-generation product development, we must revisit the basics that we all know—assessing the main areas of regulatory, VAC, and end-user concerns.

It’s crucial that you and your team not only start thinking about what’s next but also assess the current state of your medical device. During this time, you must identify areas for improvement and needs or revisit the lessons learned during its initial development.

Here are some fundamental steps to consider:

Upgrade Evaluation: 

Conduct a comprehensive evaluation of your existing product to determine what upgrades are necessary to stay competitive in the market and to meet regulatory demands. This could include enhancing functionality, improving performance, or addressing safety concerns. 

MAUDE Analysis:  

Reviewing data from the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database can provide valuable insights into potential issues or deficiencies with your current product.  

Identifying and addressing these issues early on can prevent costly recalls or regulatory setbacks down the line—and fix any problems that your market noticed and requested. 

Usability Testing: 

Usability is a critical factor in the success of any medical device. Engage with end-users through focus groups or usability testing to gather feedback on your current product’s usability and identify areas for improvement.

These takeaways can provide key details for your design, development, and manufacturing partners as you progress into next-generation product development.

Competitor Analysis: 

Keep a close eye on your competitors to stay informed about industry trends, emerging technologies, and best practices. Analyzing competitor products can help identify differentiation and innovation opportunities in your product development efforts. 

Cost-effective next generation product development  

So, now that we have covered the ‘why’ and the basics of any product design and development let’s talk about the top ways you can create your next-generation product most cost-effectively.

Adaptable designs for post-prototype production  

When you’re at the beginning of your journey, it’s important to design a product that’s efficient now and when you transition from low-volume to medium-volume production.

In other words, when you’re out of the prototyping stage.

Having a design partner who designs parts of your product that can easily be adapted to different operations without a redesign or reengineering step will not only save you time but also money and resources down the line.

Nearshore or onshore sourcing   

Opting for nearshore or onshore sourcing mitigates logistical complexities and reduces lead times, preparing your device for the market it’s intended for.

Let’s break it down quickly:

By leveraging local suppliers, MedTech companies can streamline supply chain operations and minimize costs associated with international trade.

For example, if you’re in North America and have an established market there, it’s assumed that your next-generation product will be sold in that market.

Evolved best practices for efficient supply chain management have you manufacturing the products where you intend to sell them. So, if you intend to sell your products in North America, you’d solicit a manufacturing partner in North America.

This allows for better quality control, lower production, and shipping costs, and help eliminate the barriers associated with offshore operations. Overall, this will set your next-generation product up for success by improving your product and its time to market.

If you’re not already doing so, nearshoring or onshoring your product development and manufacturing is something to consider.  

Proper component design and manufacturing selection  

Thoughtful component design and manufacturing play a pivotal role in cost optimization. Standardizing components where possible and embracing modular designs facilitates efficient production processes and minimizes expenses. 

This area of focus also includes ensuring that the components you’re choosing to integrate into your devices are modern, sophisticated, and user-friendly. Things like the user interface you choose to optimize play a critical role in the adaptability and usability of your devices today and in the future.


Building serviceability into product design enhances user experience and drives down long-term maintenance costs.

This point relates back to the earlier mention of the smaller workforces that we’re already seeing unfold. With fewer skilled talents in the market now and even fewer in the future, technology is going to be required to do more and to be easier to use and service.

When you consider the design and elements used to create your technology, don’t overlook how easy it will be to conduct regular maintenance. The last thing an end-user will want is to have to send their life-enhancing medical device back to the manufacturer for service when it plays such a vital role in their operations.

Simplified serviceability features empower end-users to perform routine maintenance tasks, reducing reliance on costly professional services. These features might also affect the number of procedures or operations that can be performed at any given time.

A unified partner that supports your next generation product throughout its entire life cycle  

Designing, developing, and manufacturing any medical device—whether first or second generation—takes a lot of time, energy, and resources.

The last thing your team needs is delays caused by gaps and disconnects between supporting organizations.

That’s why choosing a partner offering design, engineering, compliance support, and manufacturing under one roof is ideal. A vertically integrated approach ensures that issues are uncovered and mitigated early—and makes your path to commercialization as quick and cost-effective as possible.

Our unified capital equipment commercialization platform relies on our over 40 years of MedTech experience and redefines the MedTech development and manufacturing industry.  

Working with an organization like MPE Inc. offers you the benefits of working with an onshore, integrated organization that infuses compliance, differentiation, and adoption readiness into every stage of your product life cycle.

In next-generation medical device development, innovation and cost-effectiveness don’t need to be mutually exclusive. By embracing a holistic approach that prioritizes market needs, regulatory compliance, and cost optimization, you can chart a course to sustainable success.

Interested in starting the process of creating your next-generation product? Let’s talk.