Digital Strategy

How to Grow and Scale a Medical Device Company (in a Regulatory Whirlwind)

December 14, 2020

ASP needed a unified platform strategy to make their products faster, improve patient outcomes and increase customer satisfaction — all while remaining compliant with FDA regulations. They came to Propel.

Spinning off a $1B company in a regulated medical device and life sciences industry is not easy — but standing up an entirely new IT stack in less than 12 months is unprecedented. Advanced Sterilization Products (ASP) needed a unified platform strategy to make their products faster, improve patient outcomes and increase customer satisfaction — all while remaining compliant with FDA regulations. 

With Propel, they found that it was not only possible, but achievable in a short timeframe.

In Propulsion 2020’s case study session How to Grow and Scale in a Regulatory Whirlwind: A Lesson in Business Transformation in a Compliant Industry, Chanda Owens, VP of Global Quality and Regulatory Compliance at ASP, and Johnson Lai, Chief Information Officer at ASP, spoke about their experience moving their quality assurance processes to Propel, integrating their ERP, and connecting the quality record to the customer and product records.

Watch the whole session here.

Growth with a deadline

ASP had one year to deploy its own technology stack to run the business after Fortive acquired ASP from Johnson & Johnson. They needed a platform that could help them swiftly intake, investigate, assess, report, and track all aspects of the complaint process, alleviate software overhead costs and gain organizational efficiencies — all while removing themselves from Johnson & Johnson’s legacy systems in the short timeline they were given.

Ultimately, ASP chose these platforms:

  • CRM: Salesforce
  • ERP: SAP
  • QMS and PLM: Propel

In addition to meeting ASP’s targeted timeline, the combination of Salesforce, SAP and Propel provided ASP with an integrated solution for all of their product and quality information, effectively integrating customer, supplier and product data across their entire value chain.

By choosing Propel, ASP was able to consolidate all six of their existing enterprise QMS applications into one fully integrated PLM and QMS solution built on Salesforce within six months.

A “get it done” implementation approach

The number one tip for a successful implementation: Look at it from a process perspective, not just the IT perspective, said Owens.

Get internal buy-in early on short timelines by focusing on the “why” and the benefits of integrating. The requirements and workflows are the same, but the tool doesn’t have to be the same. Once that’s agreed on, it’s easier to discuss “must haves” and “nice to haves” and not get hung up on accidentally replicating the system teammates are accustomed to.

“If you want just what you had, why would we stand up a new system?” asked Lai. “Let’s ask, how can we do it better, faster, more efficiently? How can we solve for tomorrow’s application suites, not today?”

Listen to Owens on evaluating quality systems:

Staying compliant

When it comes to building a compliant and effective QMS system, Owens reminded the panel of the infamous Henry Ford quote: “If I had asked people what they wanted, they would have said faster horses.”

“What are the actual requirements?” she asked. “Then you can play around with the ‘how’ — it’s just the ‘what’ that can’t change.”

ASP is in global markets with several different product categories, which meant that they needed different solutions. Propel gave them the options for modular changes all in one place, instead of doing validations in five different systems.

The benefits of having everything on one system are many, but the main one Owens and Lai mentioned was the seamless traceability of all quality records, such as complaints and CAPAs.

The challenge was moving from several heavily customized systems, to one main system, and losing some customization in the process.

“We had to decide what was unnecessary, and we’d planned for that conversation,” said Owens. “What is the greater good? Overall, the functionality is better for everyone, and change management and buy-in on that level was key.”

Integrating for compliance clarity

ASP’s integration systems are built from the compliance perspective.

“There are so many touchpoints between your quality management system and your order-to-cash ERP system,” Lai said. “We were able to, through a few technical integrations, allow that information to flow between one another. By funneling it all into the ERP, it gave us a lot of cross-functional benefits that we didn't even anticipate, giving teams capabilities we didn't have before.”

Now, when a new change order or BOM is approved, that gets rolled down into production and distribution seamlessly. Prior to this, ASP’s approvals were manual, which meant that a team member would take a drawing and move it manually over into the ERP. This makes compliance much simpler.

For instance, from case to complaint, ASP’s service teams throughout the world are able to resolve issues faster within Salesforce. 

“Many of our complaints happen because our service people are in front of our customers doing preventative maintenance,” said Lai. “We were able to take all those entry points and funnel it through one process, one interface and directly have that passed to our quality team.”

Curious to learn more about ASP’s quality and compliance process made simple (on a tight timeline)? Watch the full session now.

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Joanna Rutter


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