Matt Perry
VP of program management at Veranex
Recently we sat down with Matt Perry, VP of program management at Veranex, to talk about common project management issues within medtech, and his recommendations for overcoming them based on more than two decades of experience working on a wide variety of products and projects.
What is your career experience?
I have more than 25 years of product development and program management experience all in medical device development, from early concept development through verification and validation and transfer to manufacturing. I have extensive experience leading cross-functional teams, working with small start-up companies and larger strategics. I’ve worked on a range of products from electromechanical capital systems to handheld surgical instruments and high-volume disposables.
What are common challenges you see in project management within the medtech industry?
One of the main challenges within the industry is a fragmented workforce. Early-stage startups need teams to support research, design & engineering, regulatory affairs, commercial strategy, and both pre-clinical and clinical work. Larger, more established organizations often need to outsource work across a number of these areas in order to address gaps in internal capabilities or simply augment their teams due to bandwidth constraints. In either case, this often results in companies/OEMs working with a number of different partner organizations on a single program, resulting in handoffs, inefficiencies, and major communication and coordination challenges…and ultimately higher development costs and longer time to market.
Are there different challenges for different sized companies?
Strategics are generally very siloed. In the ideation stages of programs, teams won’t always have enough access to all key resources until certain milestones are hit and the program is officially chartered. This can leave programs in limbo, or at times moving at glacial speed. Conversely, Veranex has access to a whole team, and can align on strategy/risks early. If they’re outsourcing in any way, going to companies that only have one piece of puzzle — to stitch those together is challenging. To project manage all of that is difficult and cumbersome. Our program managers are trained to facilitate and coordinate efforts across our teams and service offerings, and our business is structured for coordination, leadership, and oversight all under one roof.
Start-ups and early-stage companies do not generally have the luxury of staffing programs internally. When faced with the realities of outsourcing, the challenges are very much the same — if not greater, as they often lack the processes, quality management system, and resources needed to own critical workstreams or lead programs internally.
How can project management affect outcomes?
Program management can affect outcomes in a number of ways, including:
- Highlighting and documenting risks and mitigations
- Managing definition of done, fidelity, prioritization of team members, and navigating unexpected challenges that will inevitably arise during development
- Facilitating critical coordination and communication across teams to eliminate misalignment and wasted time and money
What’s a common issue you see when it comes to project management?
We’ve seen a number of projects where a client initially hired a design firm that did not have integrated development capabilities, let alone full end-to-end services. The design was completed, at which time it was “thrown over the wall” to an engineering firm for detailed design and/or a contract manufacturer (CM) to complete Design for Manufacturing and DHF development (formal design inputs/outputs, risk assessment, and V&V). Upon reviewing the design, the engineering firm or CM then assesses that the design is not manufacturable and/or did not consider all the product and/or user risks associated with the design.
These situations create unnecessary design loops, additional spend, and ultimately increase time to market, which can drastically impact successful commercialization. Too often, Veranex is given the opportunity to provide integrated development services after the above situation has occurred. While we relish these opportunities and are fully capable of ‘design rescue’, this is not the ideal project scenario for our clients as valuable time and capital has been lost.
In revisiting that kind of scenario, what would you recommend doing differently?
It’s easy to play Monday morning quarterback, and each program has unique challenges and constraints. However, there is ample evidence that products have a higher chance of commercial success when there is a solid foundation to build on. While not necessarily applicable to all programs, efforts including creation of commercial and regulatory strategies, conducting formal design research, creating a human factors plan, mapping the user journey, creating a risk management plan and mapping out use related risks are all ways to de-risk development and inform the design and development process. Constructing a design and development plan that leverages the right mix of these activities, while limiting handoffs between development partners will ultimately minimize design loops and maximize the odds of commercial success.
What sets Veranex apart?
At Veranex, we recognize that not all programs require the same approach and strategy. Our clients vary from start-ups with limited funding to multi-national OEMs with stringent stage gates and vast in-house expertise. Veranex has the resources, capabilities and flexibility to structure a program that best balances our clients’ priorities in terms of budget, appetite for risk and need for speed — and our teams and procedures have been intentionally designed to do just that. Furthermore, given our broad range of capabilities and subject matter expertise, we are able to adjust our strategies and scale based on the evolving needs of our clients, bringing the right resources into projects at the right time.