Velentium Blog

Dan Purvis

Dan Purvis

Dan is the founder of MedDeviceTrack and the CEO of Velentium, a Medical Device consulting firm.

Recent Posts by Dan Purvis:

Transformational Leadership: Boost Speed Through Being Teachable

At Velentium, we place a high value on quick learners who are resourcefully able to teach themselves and learn quickly from others how to rapidly work through problems until a solution is found. But when we say we value “quick learners,” what is it we're really valuing? Is it reading speed? Raw intelligence? The ability to synthesize ideas?

Topics: Transformational Leadership

Transformational Leadership: Maintain Access Corridors for the Unfamiliar

Deep immersion in a technical field is good and necessary in today’s world of hyper-specialization. How else would we develop expertise, hone skills, and discover the limits and possibilities of a given specialty?

Topics: Transformational Leadership

Transformational Leadership: Navigating Miracles

Sometimes, your boss or client will ask for a miracle, such as a deliverable before you're ready. Like many of us, you'll probably feel tempted to avoid conflict and nod agreement. Under pressure, this often feels like the easiest way through. But it's fraught with risk: you're risking your reputation, your relationship with your boss, client, and team, and maybe even your job.

Topics: Transformational Leadership

Transformational Leadership: Challenge Skeptics to Invest

Whether your team is floating new ideas during a brainstorming session or seeking approval on a controversial proposal, skepticism is inevitable. But is skepticism an obstacle... or an opportunity?

Topics: Transformational Leadership

Transformational Leadership: Acknowledge Who You're Not

It may feel counter-intuitive, but referring potential clients to companies that operate just outside your specialty or overlap with you can actually be a great way to build your network, develop your brand, and double-down on your strengths.

Topics: Transformational Leadership

Transformational Leadership: Thought of the Day - Expect to Go Unrecognized

Whenever you launch something truly new, you should expect to cause some confusion and misunderstanding - maybe even to encounter resistance. Even your target market might be unenthused at first. And you may chart multiple routes before finding your way.

When resistance happens, your response is critical to the success of the launch. If you respond in frustration or discouragement, you risk scuttling the launch just offshore. But if you remind yourself that the people you're trying to help haven't spent the same amount of time thinking about the problem the same way you have, and that everyone needs time to get used to new ideas, new processes, and new solutions, you'll be in a much better position to set sail. Optimism must originate with the founder!

Part of your job, post-launch, is to persevere in the same hope that caused you to start the project in the first place. Almost always, that will mean helping others recognize its value.  Often, it will mean re-clarifying your own vision. And once you are afloat, don't be surprised if you end up cruising along the shoreline right where the breakers break. It is hard. It is worth it! Stick to your vision and persevere!
Topics: Transformational Leadership

Leadership Forum: What is Leadership?

  A recent article in a business journal asked “how can you be a good leader if you don’t know what leadership really is?” In an effort to answer this question, the article offered no less than thirty definitions, obtained from “30 business owners and experts”.  While this list of answers points out the difficulty of arriving at a conclusive definition of leadership, I submit that it can be boiled down to one word: responsibility.

The Mobile Medical Trend

The trend towards increasing numbers of mobile medical apps is clear.  A recent article in the Wall Street Journal unequivocally declared that “the medicalized smartphone is going to upend every aspect of health care.” Until recently, this trend also resulted in confusion: what regulatory requirements would these software-based medical apps be held to?

Don't Let Software Delay Your Device

No one wants delays in medical device approval by the FDA.  Yet, in 2013, nearly 60% of 510k submissions were given a designation of Refuse-to-Accept (RTA), indicating that the FDA would not even consider the submission in its current form.  An RTA designation significantly delays the approval process.  How does medical device software affect the chances of a 510(k) or PMA submission not being reviewable?

Who's in Charge Here, Anyway?: The World of Medical Standards

When it comes to standards governing the design and manufacture of medical devices, the sheer number of applicable standards can be dizzying to the software developer. Numbers and letters seem to hover over everything: ISO 13485, ISO 14971, 21 CFR Part 820, 93/42/EED, etc. While it might be understandable that a software development company would want to ignore all of the standards as inapplicable to their work of designing software, a working knowledge of these standards is important for the successful integration of software into a medical device.