Accelerating Time to Market by Streamlining Medical Device Testing


Accelerating Time to Market by Streamlining Medical Device Testing

One of the biggest challenges in medical device manufacturing is simply getting the product to market quickly.

Speed to launch isn’t just about competitive advantage; it’s also about making a difference in patients’ lives. The sooner you can bring your device or product to market, the sooner it can help the people who truly need it.

Accelerating time to market, though, can’t come at the cost of safety or quality. Product launches involve so much inherent complexity, with so many possibilities for costly delays and emergent problems, that it’s absolutely essential to seek out opportunities to sync up processes—and engage the right expertise.

Sometimes, OEMs overlook the role of efficient, streamlined testing processes in speeding time to market. This article will look at the role that outsourced medical device testing plays in hitting launch timelines and provide guidance in finding an expert partner.

Why outsource medical device testing?

To bring products to market, OEMs must navigate the challenges and risks of regulatory compliance, limited resources, tight launch timelines, and access to critical expertise.

The path to bringing products to market safely, quickly, and profitably runs right through product testing. Required product, packaging, and environmental testing and validation all take time, though. And delays in the testing phase have significant implications and risks, from missed launch timelines and lost market opportunities to compromised patient safety and reputational damage.

In today’s ultracompetitive market, too, manufacturers face a great deal of pressure to get everything right, from timeline to safety. An expert outsourcing partner can provide cost-competitive access to key technical and regulatory expertise along with the resources and integration to hit aggressive product launch timelines. What’s more, an outsourcing partner with medical device testing capabilities helps OEMs optimize testing processes and timelines with a single, expert point of contact.

How to streamline medical device testing

There are five key aspects to streamlining medical device testing to speed time to market. They include:

#1. Align with robust upfront discovery.

A thorough upfront discovery process can make all the difference in meeting your product launch timeline. An expert partner learns everything necessary about your product and brings in deep expertise in current and evolving regulatory compliance. This informs what tests your product will actually need, including product, packaging, and environmental monitoring—and how and to which sensitivities to actually perform them.

Evaluate potential partners on their process, including when they conduct product research and how they determine required tests, approach, timelines, and other considerations to support your success.

#2. Collaboratively develop a clear test plan.

After discovery, comprehensive testing planning and documentation is the next key step. A clear plan defines what’s needed to meet industry and regulatory requirements and maintain consistent quality. A clear test plan also incorporates realistic lead times to minimize the risk of delays or emergent problems. If integration with other adjacent services is desired or required, the test plan incorporates it.

#3. Ensure regulatory compliance.

In an industry like medtech, with ever-evolving regulations, there is no “one and done.” Success depends on having a deep understanding of relevant regulations and involving regulatory experts throughout the testing phase, to avoid delays and reduce the risk of non-compliance.

An expert testing services partner will understand exactly what is required to ensure and remain in compliance, including the specific type(s) of test needed and the relevant standard. In addition, the partner will be able to provide a birds-eye view of the evolving industry regulatory environment to also provide guidance on what may be coming down the road, and what could affect your product. This proactive management helps to reduce the risk of unforeseen delays.

#4. Lean on tight process management.

Many moving parts mean there is no time to waste. Tightly coordinated process management cuts down on back and forth and cost. It also reduces risk and helps to proactively navigate the emergent challenges inherent in product launches.

#5. Communicate, communicate, communicate.

Finally, informed decisions and fast response can sometimes mean all the difference in an aggressive product launch timeline. When something does happen, an expert partner’s ability to “scramble the jets” and respond quickly and effectively to get a timeline back on track can mean the difference between hitting or missing an important milestone. This can come down to very specific needs like exactly which test is required, or how it should be conducted, or how to manage lead times for in-process testing to make up for ground lost elsewhere.

Streamlining medical device testing with an expert partner can help medical device manufacturers bring safe, life-changing products to market faster, ultimately benefitting patients as well as fostering business success. Optimizing testing processes can also decrease development cycle time and help firms gain competitive edge.

Millstone services give medical device manufacturers access to the comprehensive product, packaging, and laboratory testing service expertise they need with a single expert point of contact. In addition, Millstone’s end-to-end Tier 1 service, available with adjacent testing, provides a streamlined approach to expert sourcing, with contract manufacturing, quality critical inspection, in-process testing, cleaning, packaging, and sterilization handled under a single PO. Millstone’s testing services are also available as standalone contract services.

Today Millstone offers post-manufacturing and aftermarket services to more than 50 customers, including some of the top 10 orthopedic companies in the world. We are constantly evolving our processes and services to help OEMs achieve sustainable success. We offer packaging, logistics, and testing services—all with an unparalleled focus on quality.

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