黑料社

Providing product solutions for today's market requires OEMs to be deftly pitched between healthcare's reactive past and its more proactive and innovative future. It requires a necessary evolution of the medical device development process and timeline.

Healthcare worldwide is at an exciting inflection point. On the one hand is reactive medicine, which to a large extent describes the profile of the existing system: You get sick, visit your healthcare provider, get treated and go home.

Where we're going, however, is to a more proactive vision of healthcare. In other words, patient engagement should not start after the onset of illness; it needs to begin earlier, with focus on wellness and prevention.

The Evolution of the Medical Device Product Development Lifecycle

Historically, the medical device development process for a conservatively managed healthcare company ranged between three to eight years, or even longer for a Class II or Class III device. Innovative new technologies, patient engagement platforms and other macro trends are shaking up the status quo.

Macro trends are creating a myriad of opportunities in the healthcare industry; opportunities applicable from the already-popular wearable devices to the more complex patient monitoring products. Progress has been impressive, but healthcare's medical device product development lifecycle timelines must synch up closely with the pace of key macro trends like innovation and rapid technology evolution.

In addition, traditional medical device companies have been conservative, and known to do as little as possible with their commercial devices. Combining long medical device development cycles with long product lifecycles creates numerous problems from a supply chain perspective. These issues are typically addressed through minor incremental fixes or "band-aids" without design input from key stakeholders.

You can imagine the thought process: Quickly react by applying a band-aid to address the problem and minimize manufacturing process disruptions. Unfortunately, this reactive approach has been shown to create complacent environments with significant impact to their medical product quality, their reputations, and in many cases, costly regulatory challenges. This is yesterday's approach. Modular architectures to bridge the gaps in performance and value within the products is the only way to future-proof and ensure quality management today.

Put another way, the impact of fast-evolving technology isn't limited to just current and new medical device products, but also extends to ones that hit the market many years ago. If a healthcare product hasn't been redesigned or updated in a decade, keeping it in production can be more complicated than building something brand new due to end-of-life or other supply chain challenges.

The slow-moving, risk-averse and heavily regulated nature of the healthcare industry makes it challenging to progress through the production cycle. Unfortunately, the band-aid approach only increases risk for the company and the patient. Unlike smart home solutions, which can be experimented with and adjusted to some degree, digital health devices are much more precise and calculated. Solutions cannot be glitchy or ineffective; they must be decidedly functional, safe and effective. After all, an inaccurate diagnosis or poor treatment method could be the difference between life and death.

There is always a risk that a product will not reach the market. In my experience, companies abandon healthcare projects more frequently because of the intense focus on technology, feasibility studies and issues with human factors. However, if product development is front-loaded and the right modular strategy is utilized, a much greater number of products would reach the market.

More and more, the push for the latest and greatest is being driven by user needs and wants. In addition, emerging technologies have created an urgency to speed up the healthcare product development cycle.

The point is that a great infusion pump that is more than 10 years old may still function well and serve its designed purpose, but it's less effective and accepted if the product is not aligned with the most current technology and customer expectations. Therefore, medical device developers must take steps to better align their product development lifecycles with buyer expectations. The truth is in the data.

In 2020, 41% of digital health solution providers had medical device product development and launch cycles that were less than 18 months. In 2021, 50% said the same thing, according to 黑料社's Digital Health Technology Trends Report based on a survey of over 200 healthcare decision-makers. More impressively, 19% said their product cycles were less than 12 months, up from 7% in 2018.

Download 黑料社’s 2021 Digital Health Technology Trends report.

While a Class III or Class II device is likely to go through a longer development and product launch cycle, the experience and expectation with digital solutions are still much shorter than the traditional average. The majority of companies surveyed in 2021 said their products were in the testing or validation stage, with some consumers having the opportunity to try the devices for themselves. Most products, from in-body devices to pharmaceutical equipment, are in the hands of consumers for either testing or full use.

Regardless of the product type, today's market indicates that medical device manufacturers need to iterate every two to three years, not once a decade. This is a true crossroads for many long-standing, stable healthcare franchises: Adapt to the accelerating pace of change or become a footnote. What's the best way to navigate the exciting but challenging road ahead?

Here are three considerations for medical device manufacturers looking to accelerate their development lifecycles:

1. Take a Modular Approach to Medical Device Design & Development

Companies from many industries, like automotive, are leveraging modular design as the best adaptive strategy for managing accelerating innovation in their markets. Going modular has allowed them to keep pace at the speed of innovation, which in turn helps mitigate the risk of supply chain disruption.

But modularity has a different definition depending on who you ask, so let's first clarify what we mean by "modular design." Think about a smartphone. Yes, the charger, case and a screen protector are all separate elements. But dissect it down further — there's the power system, the user interface, operating software, camera, various sensors and more. The overall architecture of the phone is comprised of each of these separate pieces or modules. Its modularity enables a product management strategy built upon distinct technology roadmaps that differ or may align depending on their componentry.

Some healthcare companies choose to work with a design and manufacturing solutions provider (like 黑料社) — a partner with different core capabilities and talents to help them accelerate the time-to-market of their product. Furthermore, these partners also bring deep experience and exposure across many product and therapy domains.

Medical device manufacturing partners can help with all the "dissecting" required by comprehensive product architecture — in effect providing eyes and ears to help ensure you don't run into component obsolescence issues or other sourcing complications that drive excessive or unplanned development costs. They help you maintain a technology edge and provide support across every part of the process: from prototyping and clinical trial to premarket approval and regulatory requirement compliance.

If you choose not to have external partners, you will need an internal team. The responsibilities of this team should include analyzing market insights, macroeconomic developments and current trends to determine the right technology mix for your product — now and into the future. That way, if today's Bluetooth® wireless module evolves to 5G or Wi-Fi 6 in the next few years, your cross-functional teams can use the intelligence on hand to predict and proactively implement the necessary changes to the design process seamlessly.

A modular approach to your medical device design allows you to be proactive and better prepared for the technological changes that are sure to present in the next decade. At its essence, modular product design creates a virtuous circle of feedback and revision, enabling the most traction and acceptance for your product in the market. Modularity also decreases the possibility of costly production disruptions due to potential sourcing complications encountered in your supply chain.

2. Focus on Supplier Relationships

"We can't find this part" is an unfortunately common headache in healthcare. In some cases, a single part (which may cost as little as a few pennies apiece) can slow or even shut down production lines in healthcare due to its availability.

Some medical device manufacturers try to overcome this by doing last-time or "end of life" (EOL) buys, paying exorbitant amounts to brokers in hopes of securing inventory for an uncertain future. But what happens when a component is no longer manufactured or available on the market?

Imagine running out of a 10-cent legacy part in your inventory, potentially shutting down your multimillion-dollar production lines for 20 weeks (time to find, redesign and requalify a new part). If these manufacturing lines generate $10 million a week, it means that the need of a 10-cent part costs your company $200 million in revenue. Simply redesigning the product from scratch to future-proof it would be much cheaper!

These scenarios create an urgency to make product changes or patches — now. But these patches are typically made hastily and only focus on specific parts in isolation, resulting in a lot of challenges with the product's configuration management.

If you're proactive and adopt a modular design approach to your medical devices, you could eliminate costly decisions in the future by selecting the correct strategy today. None of this is possible without strong supplier relationships, however, and it goes beyond just working with recommended suppliers.

While some of your recommended suppliers might understand the technology roadmap of the medical device industry a little better or be able to supply at the volumes your company is projecting, these inputs alone don't necessarily define a collaborative, win-win relationship. What you need in today's unpredictable and even volatile market are the predictive analytics and insights of deeply experienced sourcing and supply chain professionals along with design-focused teams who can help you conduct a risk analysis of your product's roadmap. Just the design verification process alone can be a game-changer.

Armed with these inputs from trusted partners, you will be able to better forecast where your product needs to be in the coming years. It also allows you to upgrade your product in a predictable number of cycles to help your company protect and increase market share.

Managing these key supplier relationships can be time-consuming and complex. Therefore, working with an external partner can help you simplify the process and show tangible benefits.

3. Expand Your Product Development Ecosystem

In speeding up the medical product development process, modular design, reference designs and strong supplier relationships can go a long way. But it's important to keep in mind that healthcare is not the only industry that has experienced, is experiencing or will experience this transition. In fact, many others have gone through very similar transitions just in the last decade. One element that makes the transition easier? Ecosystem partnerships.

Ever since the U.S. Food & Drug Administration (FDA) started allowing deeper collaborations between companies to work together delivering complete solutions, new entrants have been able to make their way into the healthcare industry. Your company doesn't have to be the domain expert on every part or module of a product. As long as you're the domain expert in areas that are most critical to your product, there are always external partners you can rely on for other aspects including software, communication, display, user interface, power and data management.

In addition, there are several advantages to working with the FDA or other regulatory bodies native to each government. Engaging with these regulatory bodies early can help shorten the healthcare product lifecycle. Rewinding 30 or 40 years, it's hard to imagine — almost amusing to recall — the initial resistance to the personal computer. There's uncertainty in "newness," and it's always played a big part in slowing adoptions of revolutionary new innovations.

My guess is that connected devices and other digital health elements like cloud-based platforms and remote patient monitoring devices will become integrated in the same way. Working with government agencies to pinpoint concerns and risks and address them earlier is a distinct advantage for companies looking to accelerate the FDA approval process for regulatory requirements.

At this unique inflection point for healthcare businesses and their management, the challenges are daunting, but certainly not insurmountable with the right partner. In fact, the opportunity presented by today's market is exceptional. And success will be recognized by improvements in customer satisfaction and acceptance, as well as market share growth and revenue.

For healthcare companies to be successful and create the greatest rewards in the future, their products must be designed in a way for a simple adaption to the transforming macro trends. Trends are driving fast changes in innovation, technology adaptation, connected care, value-based care, personalized medicine and the overall increasing consumerization of healthcare. But as much of the landscape is new, even futuristic, the techniques of navigation are proven and well-practiced, particularly for those who have experience working across market segments with rapidly evolving technologies.

As stated, the rewards will be significant for those who respond with a culture change to align with the agility of this market. And the best time to start making the necessary changes, and selecting the right strategy, is today.