For health-care startups, navigating the rapidly changing landscape of clinical trials, regulatory requirements and reimbursement rules has become increasingly difficult in recent years.
“It’s easier to invent a product than to put all the pieces together to take it to market,” observed Mona Patel, vice president of clinical training and fellowship education for Boston Scientific’s Neuromodulation Division.
A MGCS panel of health-care industry veterans drilled down on some of the changes buffeting startups in the pharmaceutical, medical-device and related life-sciences sectors and offered prescriptions for success. They agreed that clinical, regulatory and reimbursement strategies need to be considered altogether and integrated early in the product-development process to avoid trip points and shortfalls later on.
“We’ve gone through a decade of generic penetration, so a lot of great drugs have gotten very cheap,” observed Seth Reno, chief commercial officer at Gemphire Therapeutics. “Your commercial team has to jump in earlier to help the clinical team understand the market changes and craft a strategy in which both teams align.”
Among his recommendations to pharma startups:
- Reassess the viability of your strategy when new scientific evidence impacts the standard of care and raises the bar.
- Understand the changes in established regulatory pathways and views around value for patients, payers and physicians.
- Look at where your company can make its value case.
- Gain a deep understanding of the patient and condition you want to treat.
- Talk to other clinical researchers who have attempted drug development in the past.
“There has been a strong trend to get clinical-studies data that demonstrate the safety and effectiveness of a device,” said Jennifer Mischke, global vice president of consulting services at NAMSA. “However, a number of key stakeholders (regulatory, reimbursement, etc.) also have a vested interest in that data. So it’s important to bring these multi-faceted needs for data to the forefront of clinical-studies planning.”
Other advice for medical-device developers included:
- Put together a team focused on moving products through the pipeline.
- Deliver an effective and differentiated launch plan with aligned strategies for regulatory, marketing, clinical and scientific communication.
- Understand your unique business situation and align stakeholders.
- Take a cross-functional approach to planning.
- Identify the critical path to commercial success.
Europe is shifting from directives to regulations and laws that will bring it more into equilibrium with U.S. regulations, but also impact companies trying to launch products overseas, according to Fuller. “What’s happening in Europe is unprecedented,” she added. “In the regulatory space, changes are occurring rapidly in the U.S. and Europe,” reported Kay Fuller, president of Medical Device Regulatory Solutions.
“Many startups have thought it was easier to get products into Europe. Now, it will be easier to get products through the FDA in the U.S.”
To deal with fluctuations in the regulatory space, Fuller advised:
- Adopt an early regulatory strategy that will help speed products to market.
- Create a roadmap for preclinical and human testing.
- Be aware of the impact of Brexit and the 21st Century Cures Act (2016) on medical product development.
“Strategies to curb spending have intensified,” she explained. “[Secretary of Health and Human Services] Alex Azar and [FDA Commissioner] Scott Gottlieb are focused on prevention and wellness, avoidance of unnecessary and harmful care, and lower costs. The reality is that the FDA will look at where a product works; and the payer or CMS will look at what its value [for the patient] is.”
“This is an incredibly interesting time for reimbursement,” stated Randel Richner, founder and president of Richner Consultants.
Richner recommended several strategies:
- Combine technologies, drugs and services for a total patient solution to address provider needs under new payment models.
- Integrate your regulatory and commercial strategy.
- Call out the value of drugs and technologies in contracting arrangements.
- Use population data analytics to identify opportunities within alterative payment models (APMs).
- Engage in key policy initiatives.
Panel presented by BioArbor with support from MichBio