Mark Dohnalek, President & CEO of Pivot International07.13.23
Medical device innovation is moving rapidly. As technology advances and data becomes more precise, an abundance of opportunities for manufacturers, engineers, and product development designers to create, build and deploy continues to grow. But no company can do it alone because no one workforce has a monopoly on creativity and resources. To be truly successful, it is critical that medical device manufacturers seek and find the right technology and supply chain partners to support what is needed to outsource across technology, compliance, production, service, and distribution needs.
Here are four important areas for consideration when your team meets with and reviews potential partners' traits, skills, capabilities, and attitudes.
Mark Dohnalek is President & CEO of Pivot International, an award-winning US-based global manufacturing, engineering, medtech and product development firm with 17 offices across three continents. He can be reached at mdohnalek@pivotint.com and on LinkedIn.
Here are four important areas for consideration when your team meets with and reviews potential partners' traits, skills, capabilities, and attitudes.
1. How strong are their current resources & backup plans?
You already know your team doesn’t have the skill sets, machinery, workforce, technology, or other capabilities in these areas, which is why you are outsourcing to a partner. So, it is essential they will be able to fulfill the required deliverables and meet timelines by having a primary and seamless backup plan if unexpected challenges arise. Ask all questions that would apply to likely and unlikely “what if” scenarios to learn details on their process when there is an internal or external disruption.2. How do they stay up-to-date on compliance regulations?
Medical device development must undergo scrutiny in many areas to meet ongoing compliance regulations. This requires constant monitoring of updates and changes both domestically and globally. Whether your innovation is patient, provider, or research focused, the entire project can become vulnerable if a new standard is missed. That is why having a team that understands this and is prepared to follow and act on all current guidelines with the ability to adapt to future changes. Ask questions about their company’s organizational structure to manage legal logistics and regulatory shifts to ensure they have transparent processes for tracking, measuring, and reporting on this part of your product development as it happens.3. What is their customer support responsiveness?
If they are being retained at your fulfillment center, you must know the specifics on how they will handle returns, exchanges, refunds, maintenance, and other customer support services in all of the countries you serve. What process exists to receive and fix materials damaged in shipping or sent to the wrong address? Find out if they are prepared to handle your operating time zone and language needs whether you require a multilingual staff to 24/7 on-call agents. Does their training include empowering the workforce with immediate decision-making? What they do matters because it will directly impact your company's reputation, customer confidence, and brand trust. Prioritize supply chain partners that have a history of positive customer support experiences and a plan for facing unexpected challenges.4. How well are they equipped with advanced technology?
Being trained to develop the MedTech you need, whether for a wireless app or other vital features, is only the first step in knowing if they are the right technology partner for you. It is important to know how advanced their organization systems are in terms of having a robust order management system, cybersecurity protections and threat alerts, workforce training on new equipment, and overall scalability on existing machinery and adaptability on new platforms. They must be able to continue seamlessly on your supply chain services while weathering the storm of various disruptions.Final Thoughts
Working with a reputable supply chain partner is essential for success in your medical device manufacturing and business success. Not only must they have the operations and skills to support you, but they should also possess shared sensibilities, so your teams are aligned on the same seriousness of purpose. Whether you’re at the beginning of building your business or switching from your existing 3PL providers, knowing their current capabilities and approach to future scenarios is essential.Mark Dohnalek is President & CEO of Pivot International, an award-winning US-based global manufacturing, engineering, medtech and product development firm with 17 offices across three continents. He can be reached at mdohnalek@pivotint.com and on LinkedIn.