Back to Entries blog

Compliance Meet Platform: Why are we dedicated to making life easier for medical device startups

Compliance Meet Platform: Why are we dedicated to making life easier for medical device startups

Dear Reader,

Years ago I worked for a medical device startup whose ambitions were bold and respectable. Their aim was to bring back at least some muscle movement for those who have been paralyzed. But it was a tough nut to crack. Even if we could've developed the technology, the regulations and standards didn't bend for us, or we didn't have the resources to bend them. And we knew it. Yet, the company persisted. Two million euros of subsidy from Finnish taxpayers were consumed and only lessons learned. Think of the high hopes that were dashed.

Through years of working in the medical device industry, most recently in certification, I've seen many ambitious cases have a hard time coping with regulations and standards. Despite their bleak appearance, these texts are crucially important. They have evolved over the decades in the hands of highly professional people around the world, and are essential for the safety of our species and the environment in which we live. These regulatory texts summarize a great deal of wisdom that only collective experience can capture, making them invaluable for sharing this critical knowledge.

On the downside, regulations and standards may be difficult to read and interpret, despite any guidelines with which they may be provided. Brilliant innovations do not reach the ill, because startups lack the resources to comply. If startups focus more on compliance, they will not have time to establish effective marketing or distributor networks. They are restricted by scarce resources, limited know-how on compliance, and many times they are simply too risky for proper funding. If only they had a better chance to prove their case!

There are numerous requirements to which every organization must adapt in connection with their own value proposal. However, too many organizations repeat the same basic steps as the organization next door: setting up procedures, technical documentation, and other building blocks of quality management systems. What if startups, or any enterprise, established the basics in a matter of hours or days instead of pondering such issues for weeks, months, or even years?

The heart of our value proposal is to call into action the massive knowledge base of regulations, standards, and the various guidelines related to them. We are designing a platform where the highly knowledgeable have the tools to bend the basic requirements to which all of us must comply. Organizations around the world can then focus on tasks that add value within their specialty. We believe this will cause resources to be unleashed, lead to healthier startups, and cause less frustration for the entire ecosystem, as well as foment more interaction between industry stakeholders.

To underline our proposal, we consider ourselves an Earthporation, as opposed to a corporation. Not an object loosely connected to our environment or humanity, but most responsibly a part of them. We will do our utmost to let your innovations strive, so you can provide safer and more effective healthcare where the need is most urgent.

Share this Post:

Posted by Heikki Pitkänen

Heikki Pitkänen
Heikki is backed up with 17 years of experience from the Medical Device industry, most recently from certification bodies, and is active in international standardization. He is passionate with the modern startup, business model and service design concepts and believes in co-operation between knowledgeable parties for reaching great achievements.

LinkedIn