Medtech Startups Have Unique NPD Needs. Here are 6 Criteria for Ensuring Your Partner is Up to the Challenge

The healthcare innovations space is continuing to expand at an accelerating pace. With medtech representing the largest market segment with a projected volume of US $378,055 in 2021 alone, companies are mounting a full-frontal attack to successfully deliver new products. For medtech startups, the new product development (NPD) process and product launch can be especially precarious.

In this piece, we’ll identify six criteria for helping medtech startups vet potential NPD partners, exploring how each criterion plays a part in meeting their unique needs.

1. Multiple Medical Device Merit Badges

The medtech industry is subject to incredibly rigorous quality control and safety standards, but the task of auditing partners to ensure compliance can ding startups on already tight budgets. Startups can save themselves the time and expense of an audit by identifying a partner with all the necessary medtech “merit badges.” Specifically, look for a partner with FDA-registered facilities and ISE and ISO certifications (ISO 9001:2015, ISO 13485:2016, ISO 80079-34, and IEC 60601-1). At Pivot International, we are a leading global one-source partner with these certifications and many more.

2. A Portfolio of Award-Winning Medtech Products

Quality control and compliance are one thing; the ability to develop innovative products that achieve market success is another. Look for a partner with an extensive portfolio of award-winning products created for a variety of partners. At Pivot, our extensive medtech portfolio includes:

• A digital otoscope designed for infants and toddlers that industry thought leaders have described as “changing the face of pediatric core.”
• A smartphone-compatible ophthalmoscope. (Winner of a coveted European Product Design Award for Best Design for Humanity)
• A groundbreaking respiratory device used in the treatment of COVID-19 and other respiratory conditions. (Recipient of a prestigious German Design Award)

3. In-House Design for Manufacturing (DFM)

At Pivot, we like to think of DFM as a secret superpower that few partners can offer. Design for Manufacture (DFM) is a criterion that all companies should look for, regardless of size. But because startups typically have slender margins that can make it difficult for them to remain afloat should anything go awry in the NPD process, DFM can be particularly critical for three reasons:

It ensures from the get-go that a product can be cost-effectively manufactured at scale, guarding against back-to-the-drawing-board hazards that come with anything less than an integrative approach.
It supercharges innovation since engineers must find creative workarounds to accommodate the limitations of manufacturing methods and equipment.
It optimizes supply chain costs and security by providing the best possible chance of strategic substitutions of materials, parts, and components — all without cutting corners or compromising product functionality, safety, performance, or UX.

For these reasons, Pivot’s in-house DFM talent and advanced supply chain management make us one of the best and safest choices that your startup can bet on.

4. Flexible Manufacturing Options

Startups are particularly vulnerable to the twin threats of excess inventory and product shortages. This makes it essential to select a partner with flexible manufacturing options to enable rapid scaling of production to market demand. With 320,000 square feet of flexible manufacturing across three continents, we give you the ability to quickly ramp up production or dial it back as needed. Our investment in mirror-mounted twinned SMT lines also allows you to “toggle” production between two different continents to help drive down the costs of distribution.

5. Team-Oriented and Highly Collaborative

For startups, achieving market success demands an all-hands-on-deck approach to NPD. At Pivot, we pride ourselves on our reputation for being team-oriented and creating highly collaborative relationships with our partners. Achieving high levels of cooperation and coordination between all stakeholders is simply the best way to ensure a winning outcome. Not only does this promote greater synergy and alignment between stakeholders, but it also helps to keep the process running smoothly and makes for a more personal experience.

6. Global Reach, Local Roots

Although Pivot boasts nine subsidiaries with multiple offices and facilities worldwide, we are American-born, made, and based. With headquarters in the American heartland, our medtech startup partners can easily be on site from nearly anywhere in the US in a matter of hours. If this is your first time undertaking NPD, working with a US-based partner who speaks your language can make communication easier and help you feel more confident about moving forward. What’s more, working with a US-based partner ensures you avoid scheduling challenges that often occur when stakeholders are located in different time zones.

There are currently massive opportunities for capitalizing on the booming medtech market. If you’re a medtech startup preparing to undertake NPD, we are the partner you’ve been looking for! With product solutions that span six markets and fourteen industries, broad technical know-how, world-class talent, and nearly a half-century of experience, we’ll work with you every step of the way to achieve a successful launch! Contact us today to learn more about how we can help you grow your business!