concept-development

The new rules of medtech engineering, design & manufacturing

Jon Smith, Vice President of Business Development, HiArc

article-listen-medtech

As a part of my role, I get to speak with a wide range of people across the MedTech and biopharma industry, CEOs, start-up founders, program managers, R&D leaders, clinical experts, procurement heads. And what I have heard so many times in the last year is this:

 

The rules are changing. The industry is in a state of shift. Healthcare is undergoing a much needed transformation: powered by data, AI and a new generation of entrepreneurs and visionary leaders.

 

The timelines are shorter. Budgets are smaller. The stakes are higher. And the challenges, whether in microfluidics, robotics, or diagnostics are more complex than ever before. The days of rigid, one-size-fits-all design and manufacturing are behind us.

 

I’ve heard people say that “If you want to make better products for healthcare, you need to think like a designer, act like an engineer, and feel like a patient.”

 

That’s never been more true, or more urgent. Today, innovation doesn’t follow a straight line. It loops, pivots, evolves. Complexity is the new normal, and agility is a must.

 

 

Rule 1: Listen harder

Over the last year we dug deep. We listened. We spoke with clients and dozens of partners and experts across the medical technology ecosystem. We asked where the pressure points were, what kept them up at night, and what an ideal partnership really looked like.

That contributed to us changing the name of KMC Systems to HiArc.

 

And, we are leaning into the things that we do best and clients want more than ever: personalization, honesty, tenacity. In a market with too many companies that are too big, too rigid, too remote, HiArc is a strategic partner who really thinks like a true extension of the client's team. One that prioritizes collaboration over contracts, thinking over templating, and early-stage innovation over late-stage fixes.

 

 

Rule 2: Be flexible

Legacy approaches to product development are collapsing under their own weight. Under developed or non-specific contracts. Siloed functions. Delayed decisions. It's all too slow and too risky for today’s MedTech pioneers.

 

“Speed, flexibility, and integrity are the new pillars of health innovation. Everything else is table stakes.”
Dr. Jeroen Tas, former Chief Innovation & Strategy Officer, Philips Healthcare

 

We’ve designed HiArc to move differently. We fuse design, engineering, and manufacturing into a seamless, collaborative process, crafted entirely around you. No hand-offs. No silos. Just velocity and precision from day one.

 

 

Rule 3: Be an expert before you need to be one

To stay truly adaptive, we’ve gone further. We’re not just updating how we build—we’re rewiring how we think. We need to be ahead of the market and confident with all the major technologies and developments in our industry.

That’s why we are launching “HiArc Labs”, our new hub of intellectual depth and technical mastery, designed to help our teams and clients stay at the leading edge fast-moving areas of medical technology, such as: Microfluidics, Optics & Imaging, Thermodynamics, Robotics.

“Invention without deep domain insight is just guessing. The future belongs to those who combine expertise with adaptability.”

John Halamka, MD, President, Mayo Clinic Platform

 

Rule 4: Look at partnership differently

We’re not just a contract manufacturer. And we don’t want to be.

 

We’re bespoke, high-end solution architects—ready to adapt and become exactly what our clients need and the future of healthcare demands. Hence the name change.

 

But this is more than just a name change. It’s an organizational commitment, to being engineered around our clients.

 

We believe this helps us to solve the problems others can’t—or won’t.

 

Engage early to shape the technical and strategic foundation.

 

Scale intelligently once the path is proven.

 

Respect your IP, your process, and your product vision.

 

We operate like an extension of your team—de-risking your process and accelerating your path to market. Because your challenge becomes ours. And the result is a solution you won’t find anywhere else.

 

 

Rule 5: Engineer for a future of change

2026 will be a defining year for MedTech.

 

As technology continues to improve, we predict the implementation of AI, virtual and augmented reality and cloud computing will continue to influence the industry. Digital health will also continue to expand and focus on the personalization of healthcare and how it relates to patient engagement.

 

What clients want are partners agile enough to pivot and adapt to changing needs.

“You can’t outsource innovation. You can only partner with people who understand the problem as deeply as you do.”
Dr. Atul Butte, UCSF Institute for Computational Health Sciences*

 

In 2026 and beyond, the leaders won’t be the largest players. They’ll be the ones who move fastest and think deepest. And HiArc is perfectly poised.

 

We’re not just builders. We’re thinkers.

 

We’re HiArc.

 

Engineered around you.

Related Services

Concept

Expert grounding for big ideas - collaborative and mission-driven.

Engineering design

From initial concept to precision design - seamless, integrated, yours.

Manufacturing

Where prototype meets production - compliant, stable, and real-world ready.

Support

Performance that lasts. Sustaining your solutions in the real world.

Ready to Transform Your Business?

Get Started Today