In our last edition of the Protocol Link Newsletter for 2016, we share some noteworthy industry links, discuss the transition from MDD to MDR, examine the FDA's priority review voucher, and close with a dialogue by the President of Protocol Link about the fundamentals of leadership.

The Transition from MDD to MDR:
Are You Ready?
 
If you are an In Vitro Diagnostic (IVD) or medical device manufacturer that distributes products in the European Union or other countries that rely on the CE Mark or Declaration of Conformity, you should be preparing to meet the challenges on your business due to the upcoming changes to the EU Medical Device Directive and In Vitro Diagnostic Directive, to the Medical Device Regulation (MDR) and IVD MDR.

FDA's Priority Review Voucher Delivers First-Ever Approval for a Drug for Duchenne Muscular Dystrophy
 
For slightly over a decade, the US FDA has issued a handful of special priority review vouchers to expedite the review process of new drug products.  These drugs usually fall into two categories which are intended to treat so-called "orphan" diseases and "neglected" tropical diseases. However, the drug market for treating them is so small, that under the standard drug development process, the prospect of a company recuperating its drug development cost and making a return on investment can be difficult.

A Word From Our Staff...
2017 Leadership Expectations-- Through the Organization
This is the time of year most Leaders are busy identifying the key goals to achieve next year.  At Protocol Link, our consulting work frequently involves being asked to provide fresh, effective approaches for how to achieve these goals, both business and GMP-compliance-related.  To do this, we bring our experiences, then collaborate with operating heads, managers and SMEs to create and implement "do-able" strategies that deliver maximum value.

We have found that a clear understanding and role acceptance of Leadership through the ranks at our Client sites is critical to accomplishing these goals.  Most projects/goals have many cross-functional sub-parts that have to be orchestrated and accomplished to achieve the bigger mission.  Look critically at your organization and avoid the pitfalls we see too often:
  • The mandate and objective is not communicated clearly from the top
  • The designated Leader has not been truly trained to lead, especially cross-functionally
  • Contributors are not accountable for the outcome - just "contributing"
  • Accountability for goal achievement is not enforced across departments - silos are allowed to exist
  • Lower level SMEs are not allowed to participate fully
What you can do:
  • Plan, then act - think through the obstacles you must overcome and address each one tactically
  • Get the most out of your entire organization - knowledge and skills are everywhere, if you look
  • Define what you need from each player - make sure they know their role
  • Delegate responsibilities where feasible - team members should be accountable to each other
  • Supplement with outside expertise to ensure you incorporate ideas from "outside the box"
  • Communicate constantly - progress, needs, successes, recognition; no stagnation allowed
Effective leaders are built via engaging experiences and having excellent role models  from whom to learn.  Use 2017 to grow your company by leveraging and building leadership skills up and down the organization.  You will be amazed by what you will accomplish.


Steve Weltler
President--Protocol Link, Inc.

Protocol Link, Inc.
175 E. Hawthorn Parkway, Suite 210
Vernon Hills, IL 60061

Like us on Facebook    Follow us on Twitter    View our profile on LinkedIn