Meridian Bioscience

Dan Dror Siman-Tov

Diagnostic Leadership Authority

NPD – new product development, is the framework that engulfs all the functions involved in the development of new products. Marketing will initiate the process while driving to approve the project that will be chosen to be developed based on many factors such as market research, platform menu, business strategy, and competition. Next, a project manager will be assigned to drive the core team, consisting of leaders from all departments. The next steps within the life cycle of the NPD will be – design inputs, research, design and development, design freeze, transfer to production, clinical trial, and regulatory submission. To accomplish the design, development, and clearance of a new IVD product, strong R&D leadership is invaluable.

Now, the question is, what is R&D’s role within this long process that typically takes three years? The way I see this, the pathway to success must rely on strong R&D leadership. The R&D leader's role covers all aspects of the NPD life cycle and must be a strong communicator that can establish productive work relationships within the company. The obvious goal is to develop a high-quality diagnostic device that can successfully pass a clinical trial and regulatory scrutiny and is reproducible and easy to manufacture. In those three years, R&D needs to drive most of the processes. Communication is key for healthy processes and open, collaborative discussions. For example, identify gaps in the clinical plan and collaborate with the clinical team to improve the plan. Work with the regulatory team and challenge their approach so that both teams will agree on the best regulatory pathway, which will assist with determining the target endpoint value for sensitivity and specificity andidentifyingthe reference testing or the predicate device.

" To summarize, R&D's strong leadership includes working well with others and having a strong voice when other functions need to be challenged or recognized."

Collaboration with operations is one of the most challenging areas that requires strong R&D leadership. It is very easy to get into conflicts with ops since there is always this thin line between ‘The design is not manufacturable’ to ‘Your process needs to be improved to manufacture this product.’ The right thing to do is to work with ops from the start and ensure they are engaged early in the process. Invite the ops to lead the R&D meetings once you complete research and enter development. This will ensure that relationships and trust will be built, and the ops team will be engaged and exposed toall the challenges we have as R&D in developing the product. Also, R&D will be guided by ops on what is the best pathway to continue development from a manufacturing point of view.

Another key component of solid R&D leadership is team empowerment, specifically at the core team level. The core team usually meets once per week. In these meetings, the R&D leader, usually at a director level, drives and challenges all departments. This cannot be a meeting in which R&D presents data, and we move forward to the next meeting. We need all the functions to have ownership and provide updates about progress, gaps, and action items. The PM's role is to ensure that the project moves forward and that all departments are delivering, but strong R&D leadership will allow us to deliver a high-quality product on time.

A strong R&D leader recognizes the importance of design controls and good documentation – it is said that the only thing which is as important as your product performance is the strength of the documentation. I can’t stress enough how important it is to lock in an RA and QA person early in development and assign them to review all the protocols, especially during verification and validation, as this data is submitted as part of the regulatory submission. This strategy will ensure that the studies are high quality and meet regulatory requirements.

From a personal perspective, the first diagnostic kit I developed was in 2001- Dengue IgM/IgG. Since then, I had the opportunity to lead numerous R&D groups, restructure R&D organizations and impact the NPD process workflow in several companies.I’ve adapted my leadership style to fit my current role, which resulted in four successful FDA 510(k) product clearances and one new FDA-cleared platform in four years. But it’s not about me, it’s all about the team. We can’t deliver or bring value to the business without a strong team. On the other hand, the team will not deliver or even stay in business if they do not have strong leaders who have EQ and understand their need to grow, develop and be recognized, appreciated, and have a voice. And above all, respect for their hard work.

So, to summarize, R&D’s strong leadership includes working well with others and having a strong voice when other functions need to be challenged or recognized. Drive for a positive work environment for employees to not only deliver but make sure they enjoy and value what we do to assist physicians with high-quality diagnostic tools to give the right treatment to their patients.