34-35 PRODUCT READINESS - Is your healthcare product market-ready?

New healthcare products often face challenges in gaining market acceptance, especially if they combine multiple types, like drugs, devices, diagnostics or digital tools. The most innovative products may face the biggest hurdles because there are no existing examples to guide their market entry. The readiness of a healthcare product for adoption can be evaluated using four key categories.

Value for customers – the greater the value for customers, the stronger the basis for all other adoption factors; major risks are hard to overcome
Pathway to market – strict healthcare laws mean regulatory approval and funding or reimbursement often create major obstacles
Healthcare system fit – unfortunately, even the best healthcare products may need major policy changes or new infrastructure
Stakeholder support – healthcare professionals (HCPs)/providers focus on direct benefits, while patients can become strong supporters or critics.

Because the healthcare market is complex, new products often face multiple obstacles to market readiness. Everyone who has launched one knows the challenges.

The illustrative assessment examples below come from past projects, expert discussions and public research:

Before launching a new healthcare product, cross-functional teams – including regulatory, market access, medical affairs, marketing and other relevant functions – should evaluate the product’s market readiness. Ideally, this assessment takes place before entering late-stage development to allow time for generating any additional evidence if needed.

Some healthcare product companies use a structured market readiness assessment to guide their product launch teams through a comprehensive qualitative evaluation across categories. A simplified example is shown in Table 1. In practice, market readiness assessments may include a dozen or more criteria for each category.

We recommend keeping the framework simple enough for individuals or teams to complete within an hour. Ideally, cross-functional team members assess the market individually and consolidate the results to identify both shared views and differences. The main value of the qualitative assessment lies not in the score, but in the dialogue, alignment on major risks and drivers, and the development of effective launch initiatives and mitigation plans for major risks.

At times, cross-functional product teams recognise they’ve hit a barrier and must revisit the product’s core value or supporting evidence before moving forward. Refocusing on a more specific target use or patient subgroup can lead to stronger benefits and better outcomes.

We applied the qualitative assessment framework to three illustrative case studies to demonstrate its ability to guide discussions effectively. The first case focuses on peritoneal dialysis (PD), a treatment for end-stage renal disease. Unlike the more commonly used haemodialysis, which is typically performed in dialysis centers, PD can be done at home, including overnight.

The key value of the product was significantly greater patient independence, though limited by the risk of peritonitis, an infection of the peritoneum. Over time, gentler dialysis regimens helped preserve residual kidney function (RKF), which was associated with an early survival advantage for PD patients. However, declining efficiency of the peritoneal membrane could result in ‘technique failure’, necessitating a switch to haemodialysis.

The major risks associated with peritoneal dialysis limited its global adoption to about 10% of patients, compared to 73% in Hong Kong in 2022:

Providers/HCPs: peritoneal dialysis shifts costs away from dialysis centres
Infrastructure: haemodialysis tariffs led to investments into dialysis centres capacity
Policy: only a few countries adopted a PD-first policy, like Hong Kong in 1985.

The second example is integrated diabetes management, which encompasses a wide range of technologies and services, including blood glucose monitoring, insulin pens, advanced insulin delivery systems such as pumps, other diabetes medications like GLP-1s, digital health tools and multidisciplinary care involving general practitioners, endocrinologists, diabetologists and dietitians. This extensive array of products and healthcare services highlights the inherent complexity of integrated diabetes management.

A few healthcare companies, particularly those specialising in blood glucose monitoring and emerging digital health solutions, have sought to position their products as foundations for integrated diabetes management – for example, Omada Health, which focuses on type 2 diabetes. In the Netherlands, Diabeter has pursued excellence in diabetes care by concentrating on type 1 diabetes. Since 2015, Diabeter has been part of the US-based healthcare company Medtronic.

The main risks of integrated diabetes management are outlined below and were addressed through an innovative ten-year value-based contract between Diabeter and Zilveren Kruis in the Netherlands, launched in January 2019 to enhance type 1 diabetes care:

Evidence: major challenge to show superior outcomes to highly diverse standard-of-care
Financing: traditional fee-for-service model rather than holistic multi-year contract
Providers/HCPs: no incentives for improving long-term outcomes and reducing total costs of diabetes-related care.

The third example focuses on weight management drugs. After the GLP-1 drug semaglutide demonstrated over 15% weight loss following successful titration in the first year of treatment, many patients began using it even when paying out-of-pocket. The early popularity of already available Ozempic, a diabetes medication that also contains semaglutide, has worsened supply shortages that started in 2022 and that the FDA declared as being resolved on 21 February 2025.

The second-to-market drug, tirzepatide (Zepbound), demonstrated even greater weight loss of about 18%. In the US, it was launched at price parity with the first-generation GLP-1 obesity drug liraglutide (Saxenda), despite its superior efficacy – highlighting the aim to offer strong value, even for self-paying patients. Supporting evidence included the SURMOUNT-5 study, a 72-week, multicentre, randomised, open-label phase 3b trial comparing Zepbound with Wegovy in adults with obesity or overweight and at least one comorbidity, published in the New England Journal of Medicine on 11 May 2025.

The major risks associated with weight loss drugs are outlined below and were addressed by the two leading treatments, Wegovy (semaglutide) and Zepbound (tirzepatide):

Evidence: questions vs established standard-of-care (risky head-to-head clinical trials!)
Financing: limited uptake with fully self-paying patients given reimbursement preference
Policy: weight management not considered part of publicly-paid-for healthcare systems (the SELECT trial showed about a 20% relative risk reduction for major cardiovascular events for semaglutide patients over approximately 40 months, helping the reimbursement case).

So, how can healthcare companies determine whether their product is market-ready? We recommend a multi-step approach, outlined below:

Step 1: Maximise value for the customer (the foundation)
Step 2: Assess the remaining categories
Step 3: Align on key initiatives

Ongoing: Monitor market readiness disruptions. In the first step, we recommend focusing on how to maximise value for customers. Pharmaceutical companies often use target product or value profiles and focus on specific patient sub-populations, while medical device companies emphasise intended use and benefits. For most conditions, patients already receive treatment before a new healthcare product reaches the market. The greater the unmet need, the more varied and experimental the standard of care becomes – making it harder to generate comparative evidence.

In steps 2 and 3, the cross-functional team evaluates the remaining categories, prioritises key focus areas and develops tailored initiatives related to necessary adjustments in financing, reimbursement, policy or infrastructure. Ongoing stakeholder engagement helps secure the support of HCPs, providers and patients.

Finally, healthcare product teams continuously monitor market dynamics and potential disruptions to readiness. They often identify early signals, such as new evidence on their product, competitor launches or changes in the healthcare system. When necessary, these developments may prompt a reassessment of steps 1 to 3 to ensure their healthcare product is market-ready.