Medica/CompaMed
Overcoming Device Development, Compliance Challenges—From the Booth 2025
John Zawacki provides advice for companies striving to shorten product development cycles without compromising on global regulatory and sustainability mandates.
By: Michael Barbella
Managing Editor
Photo: TekniPlex Healthcare.
As one of the world’s largest medical trade shows, Medica and CompaMed offers attendees a hands-on peek at the latest medtech, digital health, and wellness innovations. Among the exhibitors at the four-day show are finished device OEMs and their supply chain support network; between both the sourcing and distribution side of the value chain are countless product innovations, from items as simple as surgical gloves and hypodermic needles to microfluidics, smart sensor solutions, and advancements like a robot-assisted orthosis and customized 3D neurostimulation helmet.
More than 5,300 exhibitors from 70 nations are showcasing their products and capabilities at Medica and CompaMed. The sheer number of participating companies makes it nearly impossible to meet with every organization that could provide value. Consequently, MPO has spoken with exhibitors capable of serving medical device manufacturers that are seeking new or specialized partners to address current or future project challenges. The following “From the Booth” feature with John Zawacki, senior director of Strategic Marketing at TekniPlex Healthcare, will provide insights on choosing the right manufacturing partner and overcoming common medical device development challenges.
Michael Barbella: What technology or service are you emphasizing at Medica/CompaMed this year?
John Zawacki: At Compamed 2025, TekniPlex Healthcare is emphasizing Interventional Design-to-Commercialization Services and our Sustainability-Focused Materials Science innovations. This means offering manufacturers a true partnership, from collaborative device concepting, prototyping, and design, through advanced manufacturing, and final packaging. We specialize in complex class II/III interventional devices and medical packaging systems, and our display features component samples, specialty tubing, and sustainable packaging solutions. Attendees can learn about our advances in bio-based PVC resins and lower-carbon footprint materials that meet stringent EU and US ESG standards, without compromising performance.
Barbella: What’s the most common challenge customers inquire about and how do you address it?
Zawacki: The most frequent challenge we hear: “How do I accelerate device development and ensure global compliance with tough regulatory and sustainability mandates?” Our answer is two-fold:
For speed: We integrate design, engineering, and manufacturing expertise in-house, compressing timelines from concept to launch. Our process covers component qualification, V&V, supply chain, and packaging, and this vertical integration reduces the risk of projects getting stuck between disconnected partners or third-party resources.
For compliance and ESG: We bring regulatory knowledge, validation methodologies, and robust materials science knowledge. Whether the concern is EU MDR changes, ISO 11607 packaging, or documentation for FDA PMA/510(k), our experts support the process, provide sustainable and innovative material options, and execute collaboratively with your team.
Barbella: If you could give one piece of advice to companies seeking a manufacturing partner before they make a decision, what would it be?
Zawacki: Prioritize a global partner whose capabilities span the full value chain—from early design through market launch and lifecycle sustainability. Why? Products, markets, and supply chains are changing faster than ever. Only a global partner offering end-to-end support, including component design, process validation, packaging, and sustainable materials, can deliver resilience, compliance, and speed in today’s environment. TekniPlex Healthcare minimizes risk, saves time, and makes you agile when the market or regulatory requirements shift.
Barbella: What are the forces driving medical device manufacturers to seek your technology/services over doing it in-house?
Zawacki: Manufacturers face twin pressures: speed-to-market and expanding regulatory/sustainability requirements. Our customers are responding to:
- The need for faster launch cycles: Outsourcing with TekniPlex Healthcare lets them tap proven processes and experienced teams.
- Internal gaps: Many OEMs lack one or more of specialty materials science, global supply chain, and/or packaging expertise, and struggle to keep up with regulatory changes and ESG goals globally.
- Risk management: Outsourcing critical steps and/or dual-sourcing within TekniPlex Healthcare means fewer delays handling manufacturing, documentation, testing, or global shipping logistics.
- Innovation: They want access to the latest advancements in functional surfaces, barrier films, and miniaturized components, without burdening in-house R&D teams.
Barbella: In what ways is your company able to aid in getting a product (project) to market faster?
Zawacki: TekniPlex Healthcare accelerates project timelines by:
- Offering design-for-manufacture feedback from the start, avoiding costly redesigns.
- Bundling regulatory, quality, and packaging expertise in project teams that work together from the start, eliminating hand-offs and gaps.
- Leveraging a global footprint (facilities across EU, Americas, and Asia-Pacific) for parallel development and rapid scale-up.
- Utilizing sustainability-driven materials proven to pass compliance swiftly, ensuring products qualify for global launches quickly.
TekniPlex Healthcare is located at Medica/CompaMed in Hall 8B, Stand N02.


