Case-study-background

Blog

Advice and best practices for writing SOPs, training for product launch, outsourcing technical documentation, and more.

Medical Device Innovators:  Get Used to Being Uncomfortable

The latest MEDTECH 2018 conference, New York's largest gathering of bioscience and medical technology leaders, brought together experts in regulatory and policy, innovation and technology, and startup/business acceleration. This year’s event, “Building Bridges to Better Healthcare,” served to build greater collaboration among the state’s leading innovators, educators, and advisers to strengthen the region’s bio/med industry.

The keynote speaker, Sean Swarner, inspired us all with his message of perseverance in the midst of tremendous adversity.  That theme carried through as our President, Amy Castronova, moderated the Innovation Spotlight panel where cutting-edge bio/med companies and award-winning CEOs shared what it takes to make innovation happen and truly disrupt a market. Here are some highlights from the session:

What it takes to innovate

Being an innovator takes courage and confidence, especially when it comes to embracing change. All companies have organizational inertia and disruption is not often a welcome sight. Change is often viewed as a negative as it challenges existing processes, standard operating procedures, and organizational structure, which can be unsettling to those within an organization. Organizations that succeed at innovating are mission driven, where everyone on the team believes in the mission and has a real thirst for improving the status quo, despite the inherent challenges. 

Understanding the naysayers

If someone in the organization pushes back against an innovative idea, he or she shouldn’t necessarily be viewed as a naysayer. They may simply be trying to gauge the idea's validity or challenge the thinking behind it. If a naysayer hasn't fully embraced an idea or has a different approach, test their hypothesis. If the test works, consider making them a champion.

When it comes to naysaying investors and venture capitalists, innovators may come up against those who seem focused on the negative. While it’s fruitless to argue, take the opportunity to learn from what they have to say and move on to those who are a better fit for your company.

Having the right personality and growth mindset

It takes a certain personality type to lead change. As one panelist suggested, “Be an optimist and twice the pessimist.” Individuals who have a strong support network and a healthy tolerance for risk are well-equipped to succeed.

Failures should be seen as lessons learned, as these experiences only give leaders more information to prepare them for success.

Clearing a path for product launch

Startups and small companies face unique challenges, especially as product launch date draws near. When internal resources are limited, departments are spread thin and people take on multiple roles, which can lead to employee burnout, quality issues, confusing documentation, and poor market adoption. Outsourcing some or all of your technical documentation projects is a decision many medical device companies make in order to stay on budget and on schedule.

Planning to submit your innovative product for FDA clearance? Jump start your product documentation with our easy-to-use IFU template. 

IFU Template

 

Related blogs:

7 Quick Steps for Successful Medical Device Product Launch

Planning a Medical Device Product Launch: 4 Key Steps to a Successful Process

FAQs:  How and Why to Budget for Medical Device Product Documentation

Topics: product launch, regulated industries, medical device launch, documentation, product documentation

 EU MDR