Combination Products – A Strategic Inflection

Key Highlights and Takeaways by Bob M. Weber, Managing Director of MedTech at Next Stage Solutions, Inc. | weber@nextstagesolutions.com

Addressing the complexities of clinical challenges in the future, an increasing number of newly developed medical devices will be used in conjunction with pharmaceutical and biologic products to create “combination products”.  These combination products are designated as a special class of products within the FDA. The current and future regulatory and market challenges of introducing combination products were discussed by a group of distinguished speakers including former FDA commissioner Dr. Andrew Von Eschenbach.

Below are some key highlights and takeaways from the various presentations from the recent MDG Seminar “Addressing the Challenges of Combination Products, Moving to Interoperable Solutions” at the Lahey Clinic in Burlington, MA.

· A strategic inflection in the Life Sciences area is happening NOW! Such a change that you will not recognize it.  We have moved from observing manifestations to understanding mechanisms.  This is the Strategic Inflection.

· The Process – Discovery, Development, Delivery |  The Product – Integrated Interoperable Solutions

· Discovery, Development, Delivery is no longer linear but circular.  Need to integrate them more seamlessly.

· Speed = Success |  Coordinate Financial Resources, Intellectual Capital, and Infrastructure

· Need collaborative efforts between Financial Investors, Academia, Industry, and Government

· MDG can play a leadership role in driving change. They can be the Int
egrator.

· Changes in Discovery – team approach, emphasis on milestones and outcomes, new fields

· Changes in Development – shift from “components” to “solutions”; collaboration and share of IP (Intellectual Property) at the outset; new business model for ROI (Return on Investment)

· Changes in Delivery – New Systems ; Advanced Technologies; New Regulatory Policies & Practices

· Important: Product has “value” to the patient/customer if it is a solution to their problem.

· For an Integrated Interoperable Solution, there will be a need for: sharing of cost, profit, and recognition; new valuation models for component pricing; market based vs. government imposed regulations.

· The game has changed from “Golf” to “Basketball” (not track & field). Performance of the team will determines success.

· The path for combination products has many challenges: technical (collaborators don’t speak the same language); Regulatory; Reimbursement Issues; Health Economic Outcomes; Marketing Regulations for promoting products.

· Pricing could be key: Cost of Alternative +  Your Unique Value Proposition – Cost of New Product = Difference in price premium of New Products.

· Healthcare Economics will look at the relationship of cost (lower to higher) and effect (better to worst).

· There will be a need to realign the benefits to all stakeholders in order to get a benefit for all – Physicians, Facilities, and payers.

· Value will be defined in terms of time:    Shorter timeframes – lower admissions, lower re = admissions (30 – 90 days).  Medium timeframes – fewer revisions, removals, reductions.  Long-term timeframes –  disease redemption, resource reduction

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